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clopidogrel

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Description

Clopidogrel: A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

clopidogrel : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group, the methylene hydrogen of which is replaced by a methoxycarbonyl group (the S enantiomer). A P2Y12 receptor antagonist, it is used to inhibit blood clots and prevent heart attacks. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID60606
CHEMBL ID1771
CHEBI ID37941
SCHEMBL ID4769
MeSH IDM0155432

Synonyms (127)

Synonym
AC-19024
BIDD:GT0284
HY-15283
AB00053786-07
BRD-K27721098-065-02-9
KBIO1_000787
DIVK1C_000787
sr-25990
methyl (2s)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)ethanoate
113665-84-2
SPECTRUM_000105
clopidogrel
methyl (2s)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate
CHEBI:37941 ,
D07729
clopidogrel (usp/inn)
clopidogrel (tn)
MLS001304711
(+)-clopidogrel
DB00758
BSPBIO_003211
methyl 2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothieno(3,2-c)pyridin-5-yl)acetate
methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate
clopidogrel [inn:ban]
hsdb 7430
thieno(3,2-c)pyridine-5(4h)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (s)-
KBIOGR_000689
KBIO2_005681
KBIO3_002431
KBIO2_000545
KBIOSS_000545
KBIO2_003113
NINDS_000787
SPECTRUM4_000175
SPBIO_000463
SPECTRUM2_000512
SPECTRUM3_001606
IDI1_000787
NCGC00163329-02
MLS001165708
smr000550475
MLS001195633
HMS2090O21
(s)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate
methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate
cge ,
HMS502H09
r-130964
zyllt
sr 25990
r 130964
clopidogrel acino
nsc-758613
CHEMBL1771
clopidogrel hexal
bdbm50318910
cpd000550475
nsc748298
nsc-748298
HMS3259B08
STK580572
BBL010770
methyl (2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate
HMS2234N16
AKOS005504280
a74586sno7 ,
clopidogrel winthrop
thrombo
(+)-(s)-clopidogrel
clopidogrel 1a pharma
(s)-clopidogrel
unii-a74586sno7
clopidogrel teva (hydrogen sulphate)
nsc 758613
bdbm50397662
NCGC00163329-04
clopidogrel [inn]
clopidogrel [mi]
(s)-methyl .alpha.-(4,5,6,7-tetrahydrothieno(3,2-c)pyridin-5-yl)-.alpha.-(o-chlorophenyl)acetate
clopidogrel [hsdb]
clopidogrel [vandf]
clopidogrel [ema epar]
clopidogrel [who-dd]
CS-0656
plavix®
gtpl7150
methyl (2s)-2-(2-chlorophenyl)-2-{4h,5h,6h,7h-thieno[3,2-c]pyridin-5-yl}acetate
CCG-221243
NC00703
SCHEMBL4769
AB00053786-08
(+)-(s)-(2-chlorophenyl) (6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetic acid methyl ester
methyl(+)-(s)-alpha-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4h) acetate
(s)-(+)-methyl (2-chlorophenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyrid-5-yl)acetate
(+)-(s)-2-(2-chlorophenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyrid-5-yl)acetic acid methyl ester
methyl (+)-(s)-alpha-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4h)-acetate
methyl-(s)-(+)-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridine-5-yl)-acetate
(s)-(+)-methyl (2-chlorophenyl)(6,7-dihydro-4h-thieno[3,2-c]pyrid-5-yl)acetate
methyl (s)-(+)-alpha-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridin-5(4h)-acetate
(+) clopidogrel
MLS006011891
thieno[3,2-c]pyridine-5(4h)-acetic acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (.alpha.s)-
AB00053786_10
AB00053786_09
DTXSID6022848 ,
methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7-dihydrothieno-[3,2-c]pyridine-5(4h)-acetate
N11780
SBI-0052755.P002
HMS3715J08
'methyl (2s)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)ethanoate'
Q410237
DS-13362
mfcd05662337
thiaminelaurylsulphate
BRD-K27721098-065-05-2
AMY8913
thieno[3,2-c]pyridine-5(4h)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (alphas)-
methyl (2s)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate sulfate
EN300-7388859
(s)-methyl2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate
(s)-methyl alpha-(4,5,6,7-tetrahydrothieno(3,2-c)pyridin-5-yl)-alpha-(o-chlorophenyl)acetate
dtxcid202848
(+)-methyl-alpha-5-
b01ac04
methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7dihydrothieno
methyl (2s)-(2-chlorophenyl)(6,7-dihydrothieno(3,2-c)pyridin-5(4h)-yl)acetate
(alphas)-alpha-(2-chlorophenyl)-6,7-dihydrothieno

Research Excerpts

Toxicity

We identified 2,252, 2,450, and 549 adverse event reports attributed to clopidogrel, ticagrelor, and prasugrel use, respectively. Our meta-analysis aimed to demonstrate whether intensified antithrombotic regimens with ticgrelor plus aspirin have more beneficial effects.

ExcerptReferenceRelevance
" These results indicate that clopidogrel is more effective and safer than aspirin in reducing adverse cardiovascular events in patients with atherosclerosis."( Results of the CAPRIE trial: efficacy and safety of clopidogrel. Clopidogrel versus aspirin in patients at risk of ischaemic events.
Creager, MA, 1998
)
0.3
" The incidence of early permanent discontinuations of the study drug due to adverse events was almost identical in both treatment groups (11."( Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events.
Boissel, JP; Gent, M; Harker, LA; Pilgrim, AJ, 1999
)
0.3
" The primary end point consisted of major peripheral or bleeding complications, neutropenia, thrombocytopenia, or early discontinuation of study drug as the result of a noncardiac adverse event during the study-drug treatment period."( Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLAS
Bertrand, ME; Gershlick, AH; Rupprecht, HJ; Urban, P, 2000
)
0.31
" Closure of the femoral access site after carotid stenting using a Perclose closure device is safe and effective even in patients receiving an aggressive anticoagulation and antiplatelet therapy."( Safety and efficacy of the Perclose suture-mediated closure device following carotid artery stenting under clopidogrel platelet blockade.
Borisch, I; Feuerbach, S; Finkenzeller, T; Hamer, O; Lenhart, M; Link, J; Paetzel, C; Toepel, I; Zorger, N, 2004
)
0.32
" Primary endpoints were a composite of death and non-fatal myocardial infarction (MI) (efficacy endpoint) as well as a composite of major adverse side effects (safety endpoint) as considered in every single study."( Safety and efficacy evaluation of clopidogrel compared to ticlopidine after stent implantation: an updated meta-analysis.
Bracchetti, D; Casella, G; Fontanelli, A; Galvani, M; Ottani, F; Pavesi, PC; Rubboli, A; Sangiorgio, P, 2003
)
0.32
"Early administration of a combined regimen of clopidogrel and aspirin following off-pump CABG is safe and is associated with a relatively low incidence of major adverse cardiac events, bleeding, PE, and DVT."( A feasibility study of the safety and efficacy of a combined clopidogrel and aspirin regimen following off-pump coronary artery bypass grafting.
Benhameid, O; Endo, M; Shennib, H, 2003
)
0.32
"Low-dose aspirin (acetylsalicylic acid) has been shown to be as effective as high-dose aspirin in the prevention of stroke, with fewer adverse bleeding events."( Adverse effects and drug interactions of antithrombotic agents used in prevention of ischaemic stroke.
Weinberger, J, 2005
)
0.33
"To report procedure-related complications and neurological adverse events of unprotected over-the-wire (OTW) and protected rapid exchange (RX) carotid artery stenting (CAS) in a single-center patient series during an 8-year period."( Procedure-related complications and early neurological adverse events of unprotected and protected carotid stenting: temporal trends in a consecutive patient series.
Ahmadi, A; Amighi, J; Boltuch, J; Dick, P; Minar, E; Mlekusch, W; Sabeti, S; Schillinger, M; Schlager, O, 2005
)
0.33
" No group differences in mortality or adverse cardiac events were observed at 6 months."( Early administration of clopidogrel is safe after off-pump coronary artery bypass surgery.
Cooper, WA; Craver, JM; Guyton, RA; Halkos, ME; Lattouf, OM; Petersen, R; Puskas, JD, 2006
)
0.33
" An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations."( Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry.
Berge, C; Deme, M; Gershlick, AH; Guagliumi, G; Guyon, P; Lotan, C; Schofer, J; Seth, A; Sousa, JE; Stoll, HP; Urban, P; Wijns, W, 2006
)
0.33
"The use of clopidogrel in addition to standard therapy for AMI is safe and effective."( [Effectiveness and safety of clopidogrel bisulfate in complex therapy of patients with acute coronary syndrome with ST segment elevation].
Giliarov, MIu; Malova, EV; Novikova, NA; Sulimov, VA; Syrkin, AL, 2006
)
0.33
"We performed a systematic review to define the relative and absolute risk of clinically relevant adverse events with the antiplatelet agents, aspirin and clopidogrel."( Systematic review and meta-analysis of adverse events of low-dose aspirin and clopidogrel in randomized controlled trials.
Laine, L; McQuaid, KR, 2006
)
0.33
" However, clopidogrel therapy may be accompanied by rare life-threatening adverse events."( Non-bleeding side effects of clopidogrel: have large multi-center clinical trials underestimated their incidence?
Almsherqi, ZA; McLachlan, CS; Sharef, SM, 2007
)
0.34
" GP IIb/IIIa inhibitors and clopidogrel, separately, have been shown to decrease adverse outcomes in patients with non-ST-elevation acute coronary syndromes, but the need for combination therapy is uncertain."( Effectiveness and safety of glycoprotein IIb/IIIa inhibitors and clopidogrel alone and in combination in non-ST-segment elevation myocardial infarction (from the National Registry of Myocardial Infarction-4).
Bromberg-Marin, G; Canto, JG; Marin-Neto, JA; Parsons, LS; Rogers, WJ, 2006
)
0.33
" Among the thienopyridines, clopidogrel is considered to be a safer alternative to ticlopidine due to its decreased incidence of hematologic adverse effects."( Hematologic adverse effects of clopidogrel.
Arora, R; Balamuthusamy, S,
)
0.13
"0001), and major adverse cardiac events (8."( Safety of sirolimus-eluting stenting and its effect on restenosis in patients with unstable angina pectoris (a SIRIUS substudy).
Holmes, DR; Kuntz, RE; Leon, MB; Mishkel, G; Moses, JW; Popma, JJ; Raizner, AE; Satler, LF; Teirstein, PS; Wang, P; Weisz, G; Wilensky, RL, 2007
)
0.34
"Clopidogrel has a favourable side effect profile, in which the most serious complications are related to bleeding diathesis."( Noncardiogenic pulmonary edema associated with clopidogrel: a serious but unexpected side effect of clopidogrel.
Akyol, A; Eksik, A; Erdinler, IC; Ucer, E; Yazici, S, 2007
)
0.34
"We compared the rates of major adverse cardiovascular events (MACE) as well as the rates of bleeding in medically managed patients randomized to ENOX versus UFH in the ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) trial, stratified by concomitant clopidogrel use."( Efficacy and safety of enoxaparin versus unfractionated heparin in patients with ST-segment elevation myocardial infarction also treated with clopidogrel.
Antman, EM; Braunwald, E; Dalby, A; Duris, T; Gao, R; Lopez-Sendon, J; Morrow, DA; Murphy, SA; Pfisterer, M; Sabatine, MS, 2007
)
0.34
" We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up."( Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry.
Aurier, E; Benassi, A; Cremonesi, A; Grilli, R; Guastaroba, P; Magnavacchi, P; Manari, A; Maresta, A; Marzocchi, A; Percoco, G; Piovaccari, G; Saia, F; Varani, E, 2007
)
0.34
"The CCT appears to be relatively safe compared with other regimens."( Safety of the cardiac triple therapy: the experience of the Quebec Heart Institute.
Bergeron, S; Brulotte, S; Lemieux, A; Magne, J; Nguyen, CM; Poirier, P; Sénéchal, M, 2007
)
0.34
" One major adverse clinical event (0."( Effectiveness and safety of reduced-dose enoxaparin in non-ST-segment elevation acute coronary syndrome followed by antiplatelet therapy alone for percutaneous coronary intervention.
Davis, KE; Denardo, SJ; Tcheng, JE, 2007
)
0.34
" No mortality or extrathoracic bleeding occurred in either group, and there were no differences in the incidence of adverse myocardial events or hospital length of stay."( Clopidogrel is safe early after on- and off-pump coronary artery bypass surgery.
Bourke, ME; Chan, V; Kulik, A; Mesana, TG; Ressler, L; Ruel, M,
)
0.13
"Loading with 375 mg of clopidogrel and 325 mg of aspirin appears to be safe when administered up to 36 hours after stroke and transient ischemic attack onset in this pilot study."( LOAD: a pilot study of the safety of loading of aspirin and clopidogrel in acute ischemic stroke and transient ischemic attack.
Albright, KC; Allison, TA; Grotta, JC; Meyer, DM,
)
0.13
" In conclusion, clopidogrel resinate was proved to be an efficient and safe polymeric salt as a candidate for a new clopidogrel salt."( The efficacy and safety of clopidogrel resinate as a novel polymeric salt form of clopidogrel.
Ahn, KB; Ahn, SK; Choi, MH; Im, DS; Ki, MH; Kim, BS; Shin, HJ, 2008
)
0.35
"Mild and moderate chronic kidney disease (CKD) is associated with decreased survival and increased adverse events after a percutaneous coronary intervention (PCI)."( The efficacy and safety of short- and long-term dual antiplatelet therapy in patients with mild or moderate chronic kidney disease: results from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.
Berger, PB; Best, PJ; Brennan, DM; Califf, RM; Dasgupta, A; Steinhubl, SR; Szczech, LA; Topol, EJ, 2008
)
0.35
"Clopidogrel pretreatment before PCI is beneficial and safe regardless of whether a GPI is used at the time of PCI."( Efficacy and safety of clopidogrel pretreatment before percutaneous coronary intervention with and without glycoprotein IIb/IIIa inhibitor use.
Cannon, CP; Fox, KA; Hamdalla, HN; Mehta, SR; Sabatine, MS; Steinhubl, SR; Topol, EJ, 2008
)
0.35
" The indication, dosage, duration of therapy, and adverse events were examined."( Safety and efficacy of clopidogrel in children with heart disease.
Boshoff, D; Eyskens, B; Gewillig, M; Mertens, L, 2008
)
0.35
"Clopidogrel therapy in a pediatric population appears to be relatively safe and effective; however, randomized, controlled prospective studies are needed to determine the true efficacy and safety of clopidogrel in children."( Safety and efficacy of clopidogrel in children with heart disease.
Boshoff, D; Eyskens, B; Gewillig, M; Mertens, L, 2008
)
0.35
" The number of patients with adverse events and bleeding complications, and their severity, were significantly greater in the triple therapy group (p<0."( A randomised controlled trial of triple antiplatelet therapy (aspirin, clopidogrel and dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility.
Bath, PM; England, T; Gray, LJ; Sare, GM; Sprigg, N; Willmot, MR; Zhao, L, 2008
)
0.35
"Long term triple antiplatelet therapy was asociated with a significant increase in adverse events and bleeding rates, and their severity, and a trend to increased discontinuations."( A randomised controlled trial of triple antiplatelet therapy (aspirin, clopidogrel and dipyridamole) in the secondary prevention of stroke: safety, tolerability and feasibility.
Bath, PM; England, T; Gray, LJ; Sare, GM; Sprigg, N; Willmot, MR; Zhao, L, 2008
)
0.35
" CONCLUSION , This data shows that tenecteplase is safe and effective in Indian patients with STEMI and conforms to the international ASSENT-2 trial data."( Efficacy and safety of tenecteplase in Indian patients with st-segment elevation myocardial infarction.
Jayanthi, K; Prabhakar, D; Ramachandran, P; Sathyamurthy, I; Srinivasan, KN; Vaidiyanathan, D,
)
0.13
"It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events."( Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes.
Chen, X; Gao, R; Han, Y; Jiang, T; Jing, Q; Li, H; Li, Y; Li, Z; Liu, H; Liu, Y; Qiu, J; Shang, X; Xu, B; Yang, L; Zhang, H, 2009
)
0.35
"This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting."( Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes.
Chen, X; Gao, R; Han, Y; Jiang, T; Jing, Q; Li, H; Li, Y; Li, Z; Liu, H; Liu, Y; Qiu, J; Shang, X; Xu, B; Yang, L; Zhang, H, 2009
)
0.35
" For antiplatelet agents, the most important risk is excess bleeding, especially as emerging evidence suggests that excess bleeding is associated with adverse long-term outcomes; thus prevention and management of excess bleeding is critically important."( Safety and tolerability of antiplatelet therapies for the secondary prevention of atherothrombotic disease.
Spinler, SA, 2009
)
0.35
" In view of recent data demonstrating adverse outcomes in patients discontinuing clopidogrel, this study is useful in optimally managing this group of patients."( Safety of carotid endarterectomy in patients concurrently on clopidogrel.
Chapital, AB; Fleming, MD; Fowl, RJ; Money, SR; Scott, P; Stone, WM,
)
0.13
" The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months."( Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction.
Cheong, SS; Cho, YH; Hong, MK; Hong, TJ; Jeong, MH; Kim, JJ; Kim, KS; Kim, YH; Lee, CW; Lee, JH; Lee, NH; Lee, SG; Lee, SH; Lim, DS; Park, DW; Park, SJ; Park, SW; Seong, IW; Seung, KB; Yang, JY; Yoon, J; Yun, SC, 2009
)
0.35
"We assessed the safety of thrombolysis under APs in 11,865 patients compliant with the European license criteria and recorded between 2002 and 2007 in the Safe Implementation of Treatments in Stroke (SITS) International Stroke Thrombolysis Register (SITS-ISTR)."( Safety of intravenous thrombolysis for acute ischemic stroke in patients receiving antiplatelet therapy at stroke onset.
Ahmed, N; Diedler, J; Ford, GA; Lees, KR; Luijckx, GJ; Overgaard, K; Ringleb, P; Soinne, L; Sykora, M; Uyttenboogaart, M; Wahlgren, N, 2010
)
0.36
" A low postoperative dose of aprotinin in patients receiving clopidogrel is safe and has comparable effects regarding postoperative bleeding complications as a high dose."( Low postoperative dose of aprotinin reduces bleeding and is safe in patients receiving clopidogrel before coronary artery bypass surgery. A prospective randomized study.
Istad, R; Ringdal, MA; Tangen, G; Tølløfsrud, S; Øvrum, E; Øystese, R, 2010
)
0.36
" In the Japanese population, however, the impact of clopidogrel on the occurrence of early adverse events is unknown."( Safety and efficacy of clopidogrel treatment in Japanese patients undergoing drug-eluting stent implantation.
Hayashi, F; Iijima, R; Nakamura, M; Sugi, K, 2010
)
0.36
" Primary end point was the combined incidence of major adverse coronary events and major bleedings."( Safety of drug eluting stents in patients on chronic anticoagulation using long-term single antiplatelet treatment with clopidogrel.
Di Sciascio, G; Irini, D; Pasceri, V; Patti, G; Pelliccia, F; Pristipino, C; Roncella, A; Speciale, G; Varveri, A, 2010
)
0.36
"Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation."( Safety of drug eluting stents in patients on chronic anticoagulation using long-term single antiplatelet treatment with clopidogrel.
Di Sciascio, G; Irini, D; Pasceri, V; Patti, G; Pelliccia, F; Pristipino, C; Roncella, A; Speciale, G; Varveri, A, 2010
)
0.36
" Logistic regression showed that only the incomplete revascularization was the independent risk factor of adverse events (odds ratio (OR)=2."( Safety and effectiveness of percutaneous coronary intervention (PCI) in elderly patients. a 5-year consecutive study of 201 cases with PCI.
Chen, Q; Ke, D; Li, G; Liu, Y; Wu, Q; Yang, Y,
)
0.13
"The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis <1%) at 9 months."( Long-term effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis results of the TRUE (Tuscany Registry of sirolimus for unselected in-stent restenosis) registry at 4 years.
Angioli, P; Bolognese, L; Carrera, A; Ducci, K; Falsini, G; Fineschi, M; Gori, T; Grotti, S; Liistro, F; Pierli, C, 2010
)
0.36
" The incidence of major adverse cardiac events was collected at 4 years."( Long-term effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis results of the TRUE (Tuscany Registry of sirolimus for unselected in-stent restenosis) registry at 4 years.
Angioli, P; Bolognese, L; Carrera, A; Ducci, K; Falsini, G; Fineschi, M; Gori, T; Grotti, S; Liistro, F; Pierli, C, 2010
)
0.36
" Secondly, the efficacy and safety disparity of clopidogrel, statins and irinotecan each among races and genetic variants are discussed to illustrate that pharmacogenetic knowledge is important for the interpretation and prediction of drug interaction-induced adverse events, whereas drug interaction -induced adverse events are equally informative for identifying genes-based mechanisms involved."( Ongoing challenges in drug interaction safety: from exposure to pharmacogenomics.
Bai, JP, 2010
)
0.36
"We observed a clustering of adverse events in the 0 to 90 days after stopping clopidogrel."( Adverse events after stopping clopidogrel in post-acute coronary syndrome patients: Insights from a large integrated healthcare delivery system.
Clarke, CL; Go, AS; Ho, PM; Magid, DJ; Peterson, ED; Rumsfeld, JS; Sedrakyan, A; Shetterly, SM; Tsai, TT; Wang, TY, 2010
)
0.36
" Despite the widespread usage and favorable safety profile, much attention has focused recently on potential adverse events associated with use."( Safety of proton pump inhibitors: current evidence for osteoporosis and interaction with antiplatelet agents.
Johnson, DA, 2010
)
0.36
"Tirofiban is safe and effective in patients with ACS."( Safety evaluation of tirofiban.
Tebaldi, M; Valgimigli, M, 2010
)
0.36
"Proton pump (H(+)/K(+)-adenosine triphosphatase) inhibitors (PPIs) are widely used to treat patients with acid-related disorders because they are generally perceived to be safe and effective."( Safety of proton pump inhibitor exposure.
Metz, DC; Yang, YX, 2010
)
0.36
" However, the incidence of adverse ischemic events post-PCI appeared to be higher in patients receiving bivalirudin without adequate pretreatment with clopidogrel."( Efficacy and safety of bivalirudin in patients receiving clopidogrel therapy after diagnostic angiography for percutaneous coronary intervention in acute coronary syndromes.
Bergman, G; Feldman, DN; Minutello, RM; Moussa, I; Wong, SC, 2010
)
0.36
"In patients presenting with ACS and receiving clopidogrel treatment after angiography (before or within 30 min of PCI), peri-procedural bivalirudin monotherapy suppresses acute and long-term adverse events to a similar extent as does UFH plus GP IIb/IIIa inhibitors, while significantly lowering the risk of bleeding complications."( Efficacy and safety of bivalirudin in patients receiving clopidogrel therapy after diagnostic angiography for percutaneous coronary intervention in acute coronary syndromes.
Bergman, G; Feldman, DN; Minutello, RM; Moussa, I; Wong, SC, 2010
)
0.36
" Acute or chronic use can cause bleeding, a major adverse effect, which can lead to drug discontinuation or noncompliance with therapy."( The safety of clopidogrel.
Kleiman, NS; Mangalpally, KK, 2011
)
0.37
" Thrombotic thrombocytopenic purpura, a rare but important adverse event, has also been reviewed."( The safety of clopidogrel.
Kleiman, NS; Mangalpally, KK, 2011
)
0.37
"Dual antiplatelet therapy (DAT) with clopidogrel plus aspirin is a well-established antithrombotic strategy, with hemorrhage being the chief adverse event (AE) of concern."( National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin.
Budnitz, DS; Kegler, SR; Shehab, N; Sperling, LS, 2010
)
0.36
"To estimate the numbers and rates of emergency department (ED) visits for hemorrhage-related AEs (hemorrhage or evaluation for potential hemorrhage) from DAT in the United States and put them in the context of those from warfarin, we analyzed AEs from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, 2006-2008, and outpatient prescribing from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, 2006-2007."( National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin.
Budnitz, DS; Kegler, SR; Shehab, N; Sperling, LS, 2010
)
0.36
" It is concluded that MEGX test widens opportunities for personalization and safe pharmacotherapy."( [Individual pharmacotherapy safety in the assessment of cytochrome P-450 3A4 (CYP3A4) isoenzyme activity].
Kukes, IV; Paukov, SV; Ruvinov, IuV; Sivkov, AS, 2010
)
0.36
" In 199 patients treated with DAT alone (control group) and 103 patients treated with rabeprazole plus DAT (rabeprazole group), we examined the incidences of GI bleeding and major adverse cardiac events (MACE) including stent thrombosis."( [Efficacy and safety of concomitant use of rabeprazole during dual-antiplatelet therapy with clopidogrel and aspirin after drug-eluting stent implantation: a retrospective cohort study].
Chubachi, H; Ikee, R; Miyasaka, Y; Saito, S; Yasu, T, 2010
)
0.36
" The secondary end point assessed by three of these studies was major adverse cardiac events (MACEs: cardiovascular death, myocardial infarction and thromboembolic complications)."( Safety and efficacy of triple antithrombotic therapy after percutaneous coronary intervention in patients needing long-term anticoagulation.
Arora, R; Bedi, U; Khosla, S; Molnar, J; Singh, M; Singh, PP, 2011
)
0.37
"To evaluate the safety (primary outcome, defined as any bleeding complication or thrombocytopenia) and adverse outcomes (secondary outcomes, defined as death from cardiovascular causes, myocardial infarction or stroke) of clopidogrel therapy in patients aged ≥75 years with stable or unstable coronary artery disease undergoing PCI, and to compare these outcomes with those in younger controls."( Safety of clopidogrel in older patients: a nonrandomized, parallel-group, controlled, two-centre study.
Aydogdu, S; Balbay, Y; Cagirci, G; Cay, S; Demir, AD; Erbay, AR; Maden, O; Sen, N, 2011
)
0.37
" The rate of the first adverse (secondary) outcome of the composite of death from cardiovascular causes, myocardial infarction or stroke was higher in older patients (12."( Safety of clopidogrel in older patients: a nonrandomized, parallel-group, controlled, two-centre study.
Aydogdu, S; Balbay, Y; Cagirci, G; Cay, S; Demir, AD; Erbay, AR; Maden, O; Sen, N, 2011
)
0.37
"034), and major adverse cardiac events (2."( Antiplatelet therapy after placement of a drug-eluting stent: a review of efficacy and safety studies.
Cheng, JW; Dorsch, MP; Goldberg, T; Mohammad, RA, 2010
)
0.36
" At 1-year follow-up, major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), acute coronary syndrome leading to hospitalization and nonfatal stroke, were recorded."( Safety of clopidogrel and proton pump inhibitors in patients undergoing drug-eluting stent implantation.
Capodanno, D; Cicorella, N; Gavazzi, A; Guagliumi, G; Lettieri, C; Lortkipanidze, N; Musumeci, G; Nijaradze, T; Romano, M; Rosiello, R; Rossini, R; Sirbu, V; Tarantini, G; Valsecchi, O, 2011
)
0.37
"0), and major adverse cardiac events (2."( Safety and efficacy of clopidogrel reloading in patients on chronic clopidogrel therapy who present with an acute coronary syndrome and undergo percutaneous coronary intervention.
Ben-Dor, I; Gaglia, MA; Gonzalez, M; Mahmoudi, M; Maluenda, G; Pichard, AD; Sardi, G; Satler, LF; Suddath, WO; Syed, AI; Torguson, R; Wakabayashi, K; Waksman, R; Xue, Z, 2011
)
0.37
"Within a regional STEMI system of care, half-dose fibrinolysis combined with immediate transfer for PCI may be a safe and effective option for STEMI patients with expected delays due to long-distance transfer."( Safety and efficacy of a pharmaco-invasive reperfusion strategy in rural ST-elevation myocardial infarction patients with expected delays due to long-distance transfers.
Dirks, TG; Duval, S; Garberich, RF; Harris, JL; Henry, TD; Larson, DM; Madison, JD; Sharkey, SW; Stokman, PJ; Westin, RK, 2012
)
0.38
"Even very short-term dual antiplatelet therapy seems safe after coronary stenting with Genous in de novo coronary artery lesions located in secondary branch vessels."( Evaluating the safety of very short-term (10 days) dual antiplatelet therapy after Genous™ bio-engineered R stent™ implantation: the multicentre pilot Genous trial.
Biondi-Zoccai, G; Bramucci, E; Colombo, A; Ferlini, M; Grinfeld, L; Iadanza, A; Morice, MC; Petronio, AS; Pierli, C; Sangiorgi, GM, 2011
)
0.37
" However, a randomized controlled trial that compared clopidogrel alone with the combination of clopidogrel and omeprazole found no increase in adverse cardiovascular outcomes and a reduction in the rate of adverse gastrointestinal outcomes attributable to omeprazole."( Recent safety concerns with proton pump inhibitors.
Chen, J; Howden, CW; Leontiadis, GI; Yuan, YC, 2012
)
0.38
"High platelet reactivity (HPR) under treatment with clopidogrel or aspirin is associated with adverse outcome."( Dual non-responsiveness to antiplatelet treatment is a stronger predictor of cardiac adverse events than isolated non-responsiveness to clopidogrel or aspirin.
Christ, G; Delle-Karth, G; Drucker, C; Huber, K; Jilma, B; Maurer, G; Neunteufl, T; Siller-Matula, JM; Tolios, A, 2013
)
0.39
" The rates of the composite of cardiac adverse events (acute coronary syndrome, stent thrombosis, stroke, death and revascularization) were recorded during 12-month follow-up."( Dual non-responsiveness to antiplatelet treatment is a stronger predictor of cardiac adverse events than isolated non-responsiveness to clopidogrel or aspirin.
Christ, G; Delle-Karth, G; Drucker, C; Huber, K; Jilma, B; Maurer, G; Neunteufl, T; Siller-Matula, JM; Tolios, A, 2013
)
0.39
"The composite endpoint of cardiovascular adverse events occurred more often in patients with high platelet reactivity (HPR) to both agonists ADP and AA (37."( Dual non-responsiveness to antiplatelet treatment is a stronger predictor of cardiac adverse events than isolated non-responsiveness to clopidogrel or aspirin.
Christ, G; Delle-Karth, G; Drucker, C; Huber, K; Jilma, B; Maurer, G; Neunteufl, T; Siller-Matula, JM; Tolios, A, 2013
)
0.39
"Dual low responsiveness to clopidogrel and aspirin is a strong predictor of cardiac adverse events, especially in patients with diabetes mellitus, which underlines the need for personalized antiplatelet treatment."( Dual non-responsiveness to antiplatelet treatment is a stronger predictor of cardiac adverse events than isolated non-responsiveness to clopidogrel or aspirin.
Christ, G; Delle-Karth, G; Drucker, C; Huber, K; Jilma, B; Maurer, G; Neunteufl, T; Siller-Matula, JM; Tolios, A, 2013
)
0.39
" The drug is associated with rare adverse effects such as thrombotic thrombocytopenia purpura, acute hepatotoxicity, and neutropenia."( Prasugrel as a safe alternative for clopidogrel-induced polyarthralgias.
Coulter, CJ; Montandon, SV, 2012
)
0.38
" Therefore, it remains unclear how to best manipulate PARs for safe antithrombotic activity."( Safety and efficacy of targeting platelet proteinase-activated receptors in combination with existing anti-platelet drugs as antithrombotics in mice.
Hamilton, JR; Jackson, SP; Lee, H; Mountford, JK; Sturgeon, SA, 2012
)
0.38
"Our results indicate that PAR antagonists used in combination with aspirin provide a potent yet safe antithrombotic strategy in mice and provide insights into the safety and efficacy of using PAR antagonists for the prevention of acute coronary syndromes in humans."( Safety and efficacy of targeting platelet proteinase-activated receptors in combination with existing anti-platelet drugs as antithrombotics in mice.
Hamilton, JR; Jackson, SP; Lee, H; Mountford, JK; Sturgeon, SA, 2012
)
0.38
"We analyzed data from 31 627 patients treated with intravenous alteplase enrolled in the Safe Implementation of Treatments in Stroke (SITS) International Stroke Thrombolysis Register."( Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe Implementation of Treatments in Stroke (SITS) symptomatic intracerebral hemorrhage risk score.
Ahmed, N; Egido, JA; Ford, GA; Lees, KR; Mazya, M; Mikulik, R; Toni, D; Wahlgren, N, 2012
)
0.38
"To clarify the frequency of Japanese patients who are resistant to antiplatelet agents, and then clarify correlations between resistance and thromboembolic adverse events in neurointervention."( [Resistance to antiplatelet agents assessed by a point-of-care platelet function test and thromboembolic adverse events in neurointervention].
Asai, T; Haraguchi, K; Izumi, T; Matsubara, N; Miyachi, S; Naito, T; Wakabayashi, T; Yamanouchi, T, 2012
)
0.38
" Thromboembolic adverse events occurred in 7 patients."( [Resistance to antiplatelet agents assessed by a point-of-care platelet function test and thromboembolic adverse events in neurointervention].
Asai, T; Haraguchi, K; Izumi, T; Matsubara, N; Miyachi, S; Naito, T; Wakabayashi, T; Yamanouchi, T, 2012
)
0.38
" In conclusion, both non-metabolized clopidogrel and ticlopidine as well as metabolites of these compounds are toxic towards myeloid progenitor cells."( Toxicity of clopidogrel and ticlopidine on human myeloid progenitor cells: importance of metabolites.
Brecht, K; Donzelli, M; Krähenbühl, S; Maseneni, S; Taegtmeyer, AB, 2012
)
0.38
"In this meta-analysis, TAT was associated with significantly effective outcomes for TLR and TVR without any increase in major adverse events but was associated with tolerance issues compared with DAT after DES implantation."( Cilostazol added to aspirin and clopidogrel reduces revascularization without increases in major adverse events in patients with drug-eluting stents: a meta-analysis of randomized controlled trials.
Bonneau, HN; Kaneda, H; Koo, BK; Nagai, R; Sakurai, R, 2013
)
0.39
", drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean."( Aspirin- and clopidogrel-associated bleeding complications: data mining of the public version of the FDA adverse event reporting system, AERS.
Kadoyama, K; Okuno, Y; Sakaeda, T; Tamura, T, 2012
)
0.38
", drug-adverse event pairs, found in 1,644,220 AERs from 2004 to 2009, 736 adverse events were listed as warfarin-associated adverse events, and 147 of the 736 were bleeding complications, including haemorrhage and haematoma."( Aspirin- and clopidogrel-associated bleeding complications: data mining of the public version of the FDA adverse event reporting system, AERS.
Kadoyama, K; Okuno, Y; Sakaeda, T; Tamura, T, 2012
)
0.38
"Diabetes mellitus is an independent predictor of adverse clinical events after drug-eluting stent implantation."( Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study.
Chen, X; Han, Y; Jiang, T; Jing, Q; Li, Y; Liu, H; Ma, Y; Wang, G; Wang, S; Wang, X; Yan, G; Yang, L; Zhang, L; Zhu, G, 2013
)
0.39
" The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR)."( Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study.
Chen, X; Han, Y; Jiang, T; Jing, Q; Li, Y; Liu, H; Ma, Y; Wang, G; Wang, S; Wang, X; Yan, G; Yang, L; Zhang, L; Zhu, G, 2013
)
0.39
" Other common adverse effects of ticagrelor such as dyspnea and ventricular pauses appear to be mild and self-limited."( Safety profile and bleeding risk of ticagrelor compared with clopidogrel.
Lincoff, AM; May, CH, 2012
)
0.38
" Proton pump inhibitors cause few adverse effects with short-term use; however, long-term use has been scrutinized for appropriateness, drug-drug interactions, and the potential for adverse effects (e."( Reducing adverse effects of proton pump inhibitors.
Ament, PW; Dicola, DB; James, ME, 2012
)
0.38
" The primary endpoint was the incidence of bleeding adverse events."( Clopidogrel two doses comparative 1-year assessment of safety and efficacy (COMPASS) study in Japanese patients with ischemic stroke.
Minematsu, K; Tanahashi, N; Uchiyama, S, 2012
)
0.38
" No significant difference between the groups was detected in the incidence of bleeding adverse events, which was 14."( Clopidogrel two doses comparative 1-year assessment of safety and efficacy (COMPASS) study in Japanese patients with ischemic stroke.
Minematsu, K; Tanahashi, N; Uchiyama, S, 2012
)
0.38
" The CP-load group experienced more in-hospital major adverse cardiac events (5."( Safety of reloading prasugrel in addition to clopidogrel loading in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Chen, F; Kent, KM; Kitabata, H; Loh, JP; Pendyala, LK; Pichard, AD; Satler, LF; Suddath, WO; Torguson, R; Waksman, R, 2013
)
0.39
"OH 44195: The insertion of small-bore chest tube in patients receiving clopidogrel can be safe if performed by experienced operators and by using US guidance along with lateral insertion site, which has the lowest risk of lacerating the intercostal arteries."( Safety of ultrasound-guided small-bore chest tube insertion in patients on clopidogrel.
Boujaoude, Z; Dammert, P; Pratter, M, 2013
)
0.39
" Major adverse cardiovascular events, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization, and bleeding events were analyzed after 1-year follow-up."( Efficacy and safety of triple antiplatelet therapy in obese patients undergoing stent implantation.
Gao, W; Ge, H; Guo, Y; Zhang, Q; Zhou, Z, 2013
)
0.39
" We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions."( Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial.
Carrie, D; Cattan, S; Cayla, G; Eltchaninoff, H; Furber, A; Georges, JL; Helft, G; Le Feuvre, C; Leclercq, F; Metzger, JP; Prunier, F; Sebagh, L; Vicaut, E, 2013
)
0.39
" In conclusion, compared with immediate PCI, d-PCI after ATT in selected, stabilized patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization is probably safe and associated with a reduction in thrombotic burden, angiographic complications, and the need of revascularization."( Safety and efficacy of intense antithrombotic treatment and percutaneous coronary intervention deferral in patients with large intracoronary thrombus.
Alfonso, F; Bañuelos, C; Echavarría-Pinto, M; Escaned, J; Fernández, C; Fernandez-Ortiz, A; García, E; Gonzalo, N; Gorgadze, T; Hernández, R; Ibañez, B; Jiménez-Quevedo, P; Lopes, R; Macaya, C; Nuñez-Gil, IJ, 2013
)
0.39
"TAT could significantly reduce the rates of MACEs and cardiac death in comparison to DAT, but more attention should be paid to adverse side effects of the drugs."( Efficacy and safety of triple-antiplatelet therapy after percutaneous coronary intervention: a meta-analysis.
Fu, ZX; Li, J; Tang, HQ; Zhang, Y, 2013
)
0.39
"Thulium VapoEnucleation of the prostate seems to be a safe and efficacious procedure for the treatment of symptomatic BPO in patients at high cardiopulmonary risk on OA."( Safety and effectiveness of Thulium VapoEnucleation of the prostate (ThuVEP) in patients on anticoagulant therapy.
Bach, T; Brüning, M; Gabuev, A; Gross, AJ; Herrmann, TR; Netsch, C; Stoehrer, M, 2014
)
0.4
" Hepatotoxicity is a rare but potentially serious adverse reaction associated with clopidogrel."( Hepatocellular toxicity of clopidogrel: mechanisms and risk factors.
Bouitbir, J; Brecht, K; Krähenbühl, S; Lindinger, PW; Maseneni, S; Zahno, A, 2013
)
0.39
" No patient experienced any adverse effects in the postoperative period related to the use of ticagrelor."( Safety and efficacy of ticagrelor for neuroendovascular procedures. A single center initial experience.
Dixon, T; Freeman, WD; Hanel, RA; Johns, G; Miller, DA; Navarro, R; Nordeen, JD; Sapin, M; Taussky, P; Tawk, RG, 2014
)
0.4
" All of our patients showed immediate platelet inhibition after a loading dose of 180 mg of ticagrelor, with no adverse effects."( Safety and efficacy of ticagrelor for neuroendovascular procedures. A single center initial experience.
Dixon, T; Freeman, WD; Hanel, RA; Johns, G; Miller, DA; Navarro, R; Nordeen, JD; Sapin, M; Taussky, P; Tawk, RG, 2014
)
0.4
"The data generated from this large single-center experience in AF patients treated with DES revealed that dual therapy with OAC plus clopidogrel for 6-12 months followed by monotherapy with OAC appears both safe and effective at long-term follow-up."( Long-term safety and efficacy of dual therapy with oral anticoagulation and clopidogrel in patients with atrial fibrillation treated with drug-eluting stents.
Abdel-Wahab, M; Akin, I; El-Mawardy, M; Geist, V; Richardt, G; Seivani, Y; Sulimov, DS; Toelg, R, 2013
)
0.39
" However, no data are available regarding its impact on adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI)."( Comparison of clinical efficacy and safety of clopidogrel resinate with clopidogrel bisulfate in patients undergoing percutaneous coronary intervention.
Chang, K; Cho, JS; Chung, WS; Her, SH; Jeong, SH; Kim, CJ; Kim, PJ; Park, MW; Seung, KB; Yim, HW, 2013
)
0.39
" We compared cumulative adverse outcomes during a 1-year follow-up after PCI in the overall population and in the PS-matched cohort."( Comparison of clinical efficacy and safety of clopidogrel resinate with clopidogrel bisulfate in patients undergoing percutaneous coronary intervention.
Chang, K; Cho, JS; Chung, WS; Her, SH; Jeong, SH; Kim, CJ; Kim, PJ; Park, MW; Seung, KB; Yim, HW, 2013
)
0.39
"In this large real-world PCI population, CR was as effective and as safe as CB in preventing adverse clinical outcomes."( Comparison of clinical efficacy and safety of clopidogrel resinate with clopidogrel bisulfate in patients undergoing percutaneous coronary intervention.
Chang, K; Cho, JS; Chung, WS; Her, SH; Jeong, SH; Kim, CJ; Kim, PJ; Park, MW; Seung, KB; Yim, HW, 2013
)
0.39
" The present study was aimed to assess the safety aspect of DLBS1033 in a preclinical setting, which included observation on toxic signs after acute and repeated administrations, and the drug's effect on prenatal development and drug interaction."( Toxicity studies of a bioactive protein with antithrombotic-thrombolytic activity, DLBS1033.
Adnyana, IK; Anggadireja, K; Sigit, JI; Sukandar, EY; Tjandrawinata, RR, 2014
)
0.4
" However, the comparative risks of gastrointestinal (GI) adverse events during DAPT are not clear."( Gastrointestinal adverse events after dual antiplatelet therapy: clopidogrel is safer than ticagrelor, but prasugrel data are lacking or inconclusive.
Can, MM; Dinicolantonio, JJ; Kuliczkowski, W; Pershukov, IV; Serebruany, VL, 2013
)
0.39
" The safety profile was evaluated by using adverse events (AEs), which were assessed by physical examination, vital signs, ECGs, clinical laboratory tests, and interviews."( The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, si
Huh, W; Jung, JA; Kim, JR; Kim, MJ; Kim, TE; Ko, JW; Lee, SY; Park, KM, 2013
)
0.39
" The prevalence of adverse events was assessed at each visit through a direct interview."( Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients: multi-center, randomized, double-blind, phase IV, non-inferiority clinical trial.
Choi, DJ; Kang, HJ; Kim, HS; Kim, MA; Koo, BK; Lee, HY; Lee, S; Oh, BH; Park, KW, 2013
)
0.39
" There was no significant difference in the drug-related adverse events between the two groups (12."( Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients: multi-center, randomized, double-blind, phase IV, non-inferiority clinical trial.
Choi, DJ; Kang, HJ; Kim, HS; Kim, MA; Koo, BK; Lee, HY; Lee, S; Oh, BH; Park, KW, 2013
)
0.39
" The included end-points were major adverse cardiovascular event (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), death, myocardial infarction (MI), stent thrombosis, bleeding and other drug adverse events."( Long-term clinical efficacy and safety of adding cilostazol to dual antiplatelet therapy for patients undergoing PCI: a meta-analysis of randomized trials with adjusted indirect comparisons.
Chen, Y; Huang, X; Tang, Y; Xie, Y; Zhang, Y, 2014
)
0.4
" Perioperative mortality, morbidity and the incidence of adverse events were balanced between the groups without statistical significance."( [Effectiveness and safety of tranexamic acid in patients receiving on-pump coronary artery bypass grafting without clopidogrel and aspirin cessation].
Li, LH; Shi, J; Wang, GY; Wang, YF; Xue, QH; Yuan, S, 2013
)
0.39
" We analysed adverse events (AEs) consistent with either pulmonary infection or sepsis, and subsequent mortality, in 18,421 PLATO patients treated with ticagrelor or clopidogrel."( Lower mortality following pulmonary adverse events and sepsis with ticagrelor compared to clopidogrel in the PLATO study.
Åsenblad, N; Becker, RC; Cannon, CP; Held, C; Husted, SE; James, SK; Siegbahn, A; Steg, PG; Storey, RF; Varenhorst, C; Wallentin, L; Ycas, J, 2014
)
0.4
" However, the adverse event rate after the substitution to clopidogrel remains undetermined."( Safety evaluation of substituting clopidogrel for ticlopidine in Japanese patients with ischemic stroke--Hiroshima ticlopidine, clopidogrel safe exchange trial.
Aoki, S; Hosomi, N; Ito, H; Kataoka, S; Kohriyama, T; Matsumoto, M; Mihara, C; Mukai, T; Nezu, T; Noda, K; Nomura, E; Ohtsuki, T; Ota, T; Takamatsu, K; Takeda, I; Torii, T; Yamada, A; Yokoyama, T, 2014
)
0.4
" The primary end point of this study was adverse events of interest, including clinically significant reduced blood cell counts, hepatic dysfunction, bleeding, and other serious side effects."( Safety evaluation of substituting clopidogrel for ticlopidine in Japanese patients with ischemic stroke--Hiroshima ticlopidine, clopidogrel safe exchange trial.
Aoki, S; Hosomi, N; Ito, H; Kataoka, S; Kohriyama, T; Matsumoto, M; Mihara, C; Mukai, T; Nezu, T; Noda, K; Nomura, E; Ohtsuki, T; Ota, T; Takamatsu, K; Takeda, I; Torii, T; Yamada, A; Yokoyama, T, 2014
)
0.4
"The adverse event rates after the substitution of ticlopidine for clopidogrel is similar to the adverse event rates of patients who were initially treated with clopidogrel."( Safety evaluation of substituting clopidogrel for ticlopidine in Japanese patients with ischemic stroke--Hiroshima ticlopidine, clopidogrel safe exchange trial.
Aoki, S; Hosomi, N; Ito, H; Kataoka, S; Kohriyama, T; Matsumoto, M; Mihara, C; Mukai, T; Nezu, T; Noda, K; Nomura, E; Ohtsuki, T; Ota, T; Takamatsu, K; Takeda, I; Torii, T; Yamada, A; Yokoyama, T, 2014
)
0.4
" Major adverse cardiovascular events, comprising all-cause death, nonfatal infarction, nonfatal stroke, and ischaemia-driven target vessel revascularization, was the primary efficacy end point."( Efficacy and safety of tirofiban-supported primary percutaneous coronary intervention in patients pretreated with 600 mg clopidogrel: results of propensity analysis using the Clinical Center of Serbia STEMI Register.
Asanin, M; Brdar, N; Djuricic, N; Krljanac, G; Lasica, R; Marinkovic, J; Mrdovic, I; Perunicic, J; Savic, L, 2014
)
0.4
"Antiplatelet therapy, especially aspirin, still offers safe and effective treatment for ischemic stroke prevention in patients with end-stage renal disease undergoing dialysis."( Effectiveness and safety of antiplatelet in stroke patients with end-stage renal disease undergoing dialysis.
Chen, CY; Huang, YB; Lai, WT; Lee, CT; Lee, KT, 2014
)
0.4
" Five adverse events (3."( Efficacy and safety of antiplatelet-combination therapy after drug-eluting stent implantation.
Cho, YK; Hur, SH; Jung, BC; Kim, H; Kim, KB; Kim, KS; Kim, W; Kim, YN; Lee, BR; Lee, JB; Lee, JH; Nam, CW; Park, HS; Park, JS; Yang, DH; Yoon, HJ, 2014
)
0.4
" Other adverse events observed in patients treated with this platelet inhibitor are discussed, including hematological complications, and cutaneous and hepatic idiosyncratic reactions."( Efficacy and safety of prasugrel in acute coronary syndrome patients.
Delzor, F; Nanau, RM; Neuman, MG, 2014
)
0.4
" The primary efficacy endpoint was the incidence of major adverse cardiovascular events (MACE) at 24 weeks, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke."( Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study.
Isshiki, T; Kimura, T; Kitagawa, K; Miyazaki, S; Nakamura, M; Nanto, S; Nishikawa, M; Ogawa, H; Saito, S; Takayama, M; Yokoi, H, 2014
)
0.4
" Cilostazol-based TAPT compared with DAPT is associated with improved angiographic outcomes and decreased risk of TLR and TVR but does not reduce major cardiovascular events and is associated with an increase in minor adverse events."( Efficacy and safety of cilostazol based triple antiplatelet treatment versus dual antiplatelet treatment in patients undergoing coronary stent implantation: an updated meta-analysis of the randomized controlled trials.
Bai, J; Chen, J; Chen, P; Eikelboom, JW; Gong, X; Kong, D; Li, C; Liu, J; Meng, H; Xu, L; Yang, Z; Zou, F, 2015
)
0.42
" Prasugrel is at least as effective and safe as clopidogrel in patients with ACS undergoing early invasive management."( Efficacy and Safety of Prasugrel Compared With Clopidogrel for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.
Brener, SJ; Lella, LK; Wang, A,
)
0.13
"This meta-analysis demonstrates that short-term combination of clopidogrel and aspirin is effective and safe for stroke prevention in high vascular risk patients."( Efficacy and safety of adding clopidogrel to aspirin on stroke prevention among high vascular risk patients: a meta-analysis of randomized controlled trials.
Chen, S; He, L; Li, H; Li, M; Li, Y; Peng, Y; Shen, Q; Tang, Y, 2014
)
0.4
"7, p NS], and in adverse cardiac or cerebrovascular events (MACCE) (5 vs."( Safety and efficacy of in-hospital clopidogrel-to-prasugrel switching in patients with acute coronary syndrome. An analysis from the 'real world'.
Almendro-Delia, M; Blanco Ponce, E; Caballero-Garcia, A; Cruz-Fernandez, MJ; Garcia-Rubira, JC; Gomez-Domínguez, R; Gonzalez-Matos, C; Hidalgo-Urbano, R; Lobo-Gonzalez, M, 2015
)
0.42
"Early surgery appears safe for patients with hip fracture though there may be a small increase in the rate of blood transfusion."( Is early hip fracture surgery safe for patients on clopidogrel? Systematic review, meta-analysis and meta-regression.
Doleman, B; Moppett, IK, 2015
)
0.42
" Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database."( Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.
Abe, J; Hara, H; Kinosada, Y; Miyamura, N; Nakamura, M; Nishibata, Y; Sekiya, Y; Suzuki, H; Suzuki, Y; Tsuchiya, T; Umetsu, R; Uranishi, H, 2015
)
0.42
"No treatment emergent adverse events in the 300/75 mg and 600/150 mg regimen were observed in EMs, IMs, and PMs."( A Randomized Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Clopidogrel in Three Different CYP2C19 Genotype Groups of Healthy Japanese Subjects.
Hasegawa, S; Kajiwara, M; Kobayashi, M, 2015
)
0.42
"Despite recent advances in stent design and constantly improving protective pharmacological strategies, complications and adverse events following percutaneous coronary interventions (PCI) are still major factors influencing morbidity and mortality."( Independent Predictors of Major Adverse Events following Coronary Stenting over 28 Months of Follow-Up.
Bulaeva, NI; Fortmann, S; Golukhova, EZ; Grigorian, MV; Ryabinina, MN; Serebruany, VL, 2015
)
0.42
"The aim of our study was to triage clinical and laboratory predictors of major adverse clinical events (MACE) following coronary stenting."( Independent Predictors of Major Adverse Events following Coronary Stenting over 28 Months of Follow-Up.
Bulaeva, NI; Fortmann, S; Golukhova, EZ; Grigorian, MV; Ryabinina, MN; Serebruany, VL, 2015
)
0.42
"The primary efficacy endpoints were all-cause death and major adverse cardiovascular events (MACEs)."( Efficacy and safety analysis of new P2Y12 inhibitors versus clopidogrel in patients with percutaneous coronary intervention: a meta-analysis.
Ding, SL; Fang, D; Fang, Q; Gan, XD; Li, KY; Peng, S; Wan, J; Wei, BZ, 2015
)
0.42
" Rates of adverse events were similar between the two groups."( Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.
Kang, K; Kim, BK; Kim, HJ; Koh, SH; Lee, SJ, 2016
)
0.43
" Endpoints included major adverse cardiac effects (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), death, stent thrombosis, bleeding and adverse drug reactions during a 9-12 months period, as well as platelet activities."( Comparing the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in type 2 diabetes mellitus patients after coronary stents implantation: a systematic review and meta-analysis of randomized controlled trials.
Bundhun, PK; Chen, MH; Qin, T, 2015
)
0.42
"Four studies including 1005 patients reporting the adverse clinical outcomes and six studies including 519 patients reporting the platelet activities, with a total of 1524 patients have been analyzed in this meta-analysis."( Comparing the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in type 2 diabetes mellitus patients after coronary stents implantation: a systematic review and meta-analysis of randomized controlled trials.
Bundhun, PK; Chen, MH; Qin, T, 2015
)
0.42
" No significant difference in stent thrombosis and bleeding risks between these 2 groups shows TAPT to be almost as safe as DAPT in these diabetic patients."( Comparing the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in type 2 diabetes mellitus patients after coronary stents implantation: a systematic review and meta-analysis of randomized controlled trials.
Bundhun, PK; Chen, MH; Qin, T, 2015
)
0.42
" Outcome measures were overall bleeding, major bleeding, and major adverse cardiac events (MACE)."( Safety and Efficacy of Switching From Clopidogrel to Prasugrel in Patients Undergoing Percutaneous Coronary Intervention: A Study-level Meta-analysis From 15 Studies.
Cavallari, I; De Luca, L; Patti, G; Ricottini, E, 2016
)
0.43
"To present the systematic assessment on the efficacy and bleeding adverse events of dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin-mono-antiplatelet therapy in patients with ischemic stroke or transient ischemic attack."( [Meta-analysis on the efficacy and adverse events of aspirin plus clopidogrel versus aspirin-monotherapy in patients with ischemic stroke or transient ischemic attack].
Gao, P; Hu, Y; Qian, J; Tang, X; Yang, C, 2015
)
0.42
" Operating early on patients on clopidogrel is safe and does not appear to confer any clinically significant bleeding risk."( Clopidogrel and hip fractures, is it safe? A systematic review and meta-analysis.
Della Torre, PK; Shatwell, MA; Soo, CG; Yolland, TJ, 2016
)
0.43
"There was no major adverse cardiac event (MACE) and pouch infection were observed among 3 groups in perioperation."( [Safety of implantation permanent pacemaker at different times in patients with dual antiplatelet therapy].
Cong, H; Li, X; Li, Z; Wang, Z; Zhang, F; Zhang, L, 2016
)
0.43
"We consecutively enrolled 375 patients with IS after they received clopidogrel therapy, and venous blood samples were subjected to genotyping allelic variants of genes modulating clopidogrel absorption (ATP binding cassette subfamily B1, ABCB1), metabolic activation (cytochrome P450[CYP] 3A and CYP2C19), and biologic activity (platelet membrane receptor [ P2Y12, P2Y1)], and glycoprotein IIIa [ GPIIIa]) and statistically analyzing their interactions with clopidogrel sensitivity (CS) and adverse events, risk of IS recurrence, myocardial infarction, and death during 6 months of follow-up."( Interaction of CYP2C19, P2Y12, and GPIIIa Variants Associates With Efficacy of Clopidogrel and Adverse Events on Patients With Ischemic Stroke.
Cheng, W; Lin, J; Wang, C; Wang, Y; Yi, X; Zhou, Q, 2017
)
0.46
" Single locus analysis showed that only the CYP2C19*2(rs4244285) variant was independently associated with CS and risk of adverse events after adjusting covariates."( Interaction of CYP2C19, P2Y12, and GPIIIa Variants Associates With Efficacy of Clopidogrel and Adverse Events on Patients With Ischemic Stroke.
Cheng, W; Lin, J; Wang, C; Wang, Y; Yi, X; Zhou, Q, 2017
)
0.46
"Sensitivity of patients with IS to clopidogrel and clopidogrel-induced adverse clinical events may be multifactorial but is not determined by single gene polymorphisms."( Interaction of CYP2C19, P2Y12, and GPIIIa Variants Associates With Efficacy of Clopidogrel and Adverse Events on Patients With Ischemic Stroke.
Cheng, W; Lin, J; Wang, C; Wang, Y; Yi, X; Zhou, Q, 2017
)
0.46
" Adverse events (AEs) and abnormalities in blood, urine, liver, and kidney function were monitored."( Efficacy and Safety of Vinpocetine as Part of Treatment for Acute Cerebral Infarction: A Randomized, Open-Label, Controlled, Multicenter CAVIN (Chinese Assessment for Vinpocetine in Neurology) Trial.
Hu, H; Huang, Y; Kong, Y; Li, C; Li, Y; Nao, J; Song, Y; Tan, L; Zhang, J; Zhang, W, 2016
)
0.43
" Vinpocetine could be an effective and safe component of treatment regimen for acute cerebral infarction."( Efficacy and Safety of Vinpocetine as Part of Treatment for Acute Cerebral Infarction: A Randomized, Open-Label, Controlled, Multicenter CAVIN (Chinese Assessment for Vinpocetine in Neurology) Trial.
Hu, H; Huang, Y; Kong, Y; Li, C; Li, Y; Nao, J; Song, Y; Tan, L; Zhang, J; Zhang, W, 2016
)
0.43
" The secondary endpoints were 6-month major adverse cardiac events (MACE), which included cardiac death, nonfatal myocardial infarction, or ischemic symptoms driven target vessel revascularization."( Safety and efficacy of policosanol in patients with high on-treatment platelet reactivity after drug-eluting stent implantation: two-year follow-up results.
Guo, L; Han, Y; Li, Y; Liu, X; Wang, X; Wang, Y; Xu, K; Zang, H; Zhao, W, 2016
)
0.43
" Major adverse cardiac events occurred in 4 (8."( Safety and efficacy of policosanol in patients with high on-treatment platelet reactivity after drug-eluting stent implantation: two-year follow-up results.
Guo, L; Han, Y; Li, Y; Liu, X; Wang, X; Wang, Y; Xu, K; Zang, H; Zhao, W, 2016
)
0.43
" The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis."( Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI.
Abizaid, A; Bhatt, DL; Chieffo, A; Colombo, A; Costa, RA; Feres, F; Genereux, P; Gilard, M; Giustino, G; Hong, MK; Jang, Y; Kim, BK; Kim, HS; Leon, MB; Morice, MC; Palmerini, T; Park, KW; Redfors, B; Sardella, G; Sawaya, F; Stone, GW; Valgimigli, M, 2016
)
0.43
"We wished to explore the relationship between CYP3A5 polymorphisms and adverse events in patients undergoing clopidogrel therapy."( Association between CYP3A5 polymorphisms and the risk of adverse events in patients undergoing clopidogrel therapy: Meta-analysis.
Wang, CH; Wang, YQ; Zhang, JH, 2016
)
0.43
" The primary outcome was major adverse cardiovascular events (MACE)."( Association between CYP3A5 polymorphisms and the risk of adverse events in patients undergoing clopidogrel therapy: Meta-analysis.
Wang, CH; Wang, YQ; Zhang, JH, 2016
)
0.43
"No significant correlation was found between CYP3A5 polymorphisms and adverse events due to clopidogrel therapy."( Association between CYP3A5 polymorphisms and the risk of adverse events in patients undergoing clopidogrel therapy: Meta-analysis.
Wang, CH; Wang, YQ; Zhang, JH, 2016
)
0.43
"Using data on 11 955 acute myocardial infarction (MI) patients treated with percutaneous coronary intervention at 233 hospitals and enrolled in the TRANSLATE-ACS study, we compared whether discharge PPI use altered the association of 1-year adjusted risks of major adverse cardiovascular events (MACE; death, MI, stroke, or unplanned revascularization) and Global Use of Strategies To Open Occluded Arteries (GUSTO) moderate/severe bleeding between prasugrel- and clopidogrel-treated patients."( Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acu
Baker, BA; Cohen, DJ; Effron, MB; Faries, DE; Jackson, LR; Ju, C; McCoy, LA; Messenger, JC; Peterson, ED; Wang, TY; Zettler, M, 2016
)
0.43
"Exploratory analyses of adverse event reports (AERs) from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database (2004-2012 periods) were conducted."( Dipeptidyl Peptidase-4 Inhibitor-Associated Risk of Bleeding: An Evaluation of Reported Adverse Events.
Hansen, RA; Rahman, MM; Scalese, MJ, 2017
)
0.46
" We took into consideration adverse events including death from any cause, major stroke within 30 days, and death between 30 days and 1 year later from any stroke."( The Feasibility and Safety of Separate Carotid Artery Stenting Using the Restrict Protective Method for Bilateral Carotid Stenosis.
Bishnori, I; Goto, S; Ishikawa, K; Kato, Y; Ohshima, T; Yamamoto, T, 2017
)
0.46
" We observed no adverse events, restenosis, or recurrent symptoms during follow-up."( The Feasibility and Safety of Separate Carotid Artery Stenting Using the Restrict Protective Method for Bilateral Carotid Stenosis.
Bishnori, I; Goto, S; Ishikawa, K; Kato, Y; Ohshima, T; Yamamoto, T, 2017
)
0.46
" Outcomes were evaluated for major adverse cardiovascular events (MACE) and bleeding at 1 year."( Comparative Effectiveness and Safety Analysis of Dual Antiplatelet Therapies Within an Integrated Delivery System.
Boyd, A; Chambers, A; Chanas, T; Coons, JC; Eckardt, J; Ensor, CR; Iasella, CJ; Lemon, LS; Lyons, J; Merkel, A; Rihtarchik, L; Smith, R; Wang, N; Williams, K, 2017
)
0.46
"Thromboembolic and hemorrhagic complications are among the most feared adverse events in the endovascular treatment of aneurysms, and this is particularly the case for flow diverter devices."( A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures.
Adeeb, N; Griessenauer, CJ; Gupta, R; Moore, JM; Ogilvy, CS; Patel, AS; Shallwani, H; Siddiqui, A; Thomas, AJ; Youn, R, 2017
)
0.46
"Ticagrelor is a safe and effective agent for prevention of thromboembolic complications following flow diverter deployment when compared to clopidogrel."( A Multicenter Cohort Comparison Study of the Safety, Efficacy, and Cost of Ticagrelor Compared to Clopidogrel in Aneurysm Flow Diverter Procedures.
Adeeb, N; Griessenauer, CJ; Gupta, R; Moore, JM; Ogilvy, CS; Patel, AS; Shallwani, H; Siddiqui, A; Thomas, AJ; Youn, R, 2017
)
0.46
"In a cohort receiving PED, a 600-mg loading dose of clopidogrel should be safe and efficacious in those off the standard protocol or showing <30% platelet inhibition before treatment."( Safety and Efficacy of a 600-mg Loading Dose of Clopidogrel 24 Hours Before Pipeline Embolization Device Treatment.
Atallah, E; Bekelis, K; Chalouhi, N; Hasan, D; Jabbour, P; Rosenwasser, RH; Saad, H; Smith, M; Tjoumakaris, S; Zarzour, H, 2017
)
0.46
"The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers."( Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS).
Cabrera-Fuentes, HA; Cherepanov, V; Kim, MH; Litvinov, O; Marciniak, TA; Serebruany, VL,
)
0.13
"From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors."( Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS).
Cabrera-Fuentes, HA; Cherepanov, V; Kim, MH; Litvinov, O; Marciniak, TA; Serebruany, VL,
)
0.13
"Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96."( Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS).
Cabrera-Fuentes, HA; Cherepanov, V; Kim, MH; Litvinov, O; Marciniak, TA; Serebruany, VL,
)
0.13
" Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints."( Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS).
Cabrera-Fuentes, HA; Cherepanov, V; Kim, MH; Litvinov, O; Marciniak, TA; Serebruany, VL,
)
0.13
" The main outcomes of the study included major adverse cardiac events (MACEs) and bleeding events during 12 months of follow-up."( The efficacy and safety of cilostazol as an alternative to aspirin in Chinese patients with aspirin intolerance after coronary stent implantation: a combined clinical study and computational system pharmacology analysis.
Cheng, JH; Feng, ZW; Hu, ZH; Li, XY; Lv, QZ; Shi, HT; Wang, QB; Wang, Z; Wu, HY; Xie, XQ; Xu, Q; Xue, Y, 2018
)
0.48
"The present study indicated that long-term oral low-dose aspirin was safe for patients with both TBAD and coronary heart disease who underwent EVAR."( Safety and Necessity of Antiplatelet Therapy on Patients Underwent Endovascular Aortic Repair with Both Stanford Type B Aortic Dissection and Coronary Heart Disease.
Fu, WX; He, RX; Jing, QM; Liu, HW; Liu, YJ; Wang, XZ; Yuan, WJ; Zhang, L; Zhou, TN, 2017
)
0.46
" Secondary outcomes include target lesion revascularization, major bleeding, ipsilateral major amputation, all-cause mortality, and all adverse events that take place in those six months."( SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial.
Ahn, S; Cho, MJ; Cho, S; Ha, J; Kim, SY; Lee, J; Min, SI; Min, SK, 2017
)
0.46
" The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up."( Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy.
Cho, DK; Choi, S; Hong, BK; Hong, MK; Jang, Y; Jeon, DW; Kang, TS; Kang, WC; Kim, BK; Kim, BO; Kim, JS; Kim, S; Kim, YH; Kwon, HM; Lee, BK; Lee, OH; Min, PK; Shin, DH; Woo, SI; Yoon, YW, 2018
)
0.48
"We sought to investigate whether double antiplatelet therapy (DAPT) is safe in patients after LAAC."( Dual antiplatelet therapy is safe and efficient after left atrial appendage closure.
Czub, P; Fojt, A; Grygier, M; Hendzel, P; Kapłon-Cieślicka, A; Karolczak, N; Kochman, J; Lodziński, P; Maksym, J; Marchel, M; Mazurek, T; Opolski, G; Piątkowski, R; Wilimski, R, 2018
)
0.48
"LAAC followed by DAPT seems to be a safe and efficient alternative for stroke prevention in patients with NVAF who have contraindications to anticoagulation therapy."( Dual antiplatelet therapy is safe and efficient after left atrial appendage closure.
Czub, P; Fojt, A; Grygier, M; Hendzel, P; Kapłon-Cieślicka, A; Karolczak, N; Kochman, J; Lodziński, P; Maksym, J; Marchel, M; Mazurek, T; Opolski, G; Piątkowski, R; Wilimski, R, 2018
)
0.48
"This study was aimed to investigate the correlation between CYP2C19 and ABCB1 polymorphisms and the recurrence of ischemic cardiovascular adverse events in patients with coronary artery disease treated with clopidogrel."( CYP2C19 and ABCB1 genetic polymorphisms correlate with the recurrence of ischemic cardiovascular adverse events after clopidogrel treatment.
Fang, W; Gan, Q; Han, W; Hou, X; Liu, Y, 2018
)
0.48
" One-year follow-up visit was carried out to record the incidence of cardiovascular adverse events after drug-eluting stent implantation was inset."( CYP2C19 and ABCB1 genetic polymorphisms correlate with the recurrence of ischemic cardiovascular adverse events after clopidogrel treatment.
Fang, W; Gan, Q; Han, W; Hou, X; Liu, Y, 2018
)
0.48
"Follow-up visit results suggested that the patients with high on-treatment platelet reactivity (HPR) had a higher recurrence rate of cardiovascular adverse events after PCI operation and clopidogrel treatment."( CYP2C19 and ABCB1 genetic polymorphisms correlate with the recurrence of ischemic cardiovascular adverse events after clopidogrel treatment.
Fang, W; Gan, Q; Han, W; Hou, X; Liu, Y, 2018
)
0.48
"CYP2C19*3 polymorphism could be an important predictive factor of HPR and ischemic cardiovascular adverse events after clopidogrel treatment."( CYP2C19 and ABCB1 genetic polymorphisms correlate with the recurrence of ischemic cardiovascular adverse events after clopidogrel treatment.
Fang, W; Gan, Q; Han, W; Hou, X; Liu, Y, 2018
)
0.48
" As for intracranial hemorrhage (ICH), stroke recurrence, and adverse event (AE) rate, there were no significant differences of efficacy among 7 drug therapies."( Aspirin plus dipyridamole has the highest surface under the cumulative ranking curves (SUCRA) values in terms of mortality, intracranial hemorrhage, and adverse event rate among 7 drug therapies in the treatment of cerebral infarction.
Liu, X; Zhang, JJ, 2018
)
0.48
" Efficacy outcomes included ischemic stroke, stent thrombosis, major adverse cardiovascular event (MACE), all-cause mortality and myocardial infarction (MI); safety outcome was major bleeding."( Efficacy and safety of triple therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing coronary stenting: A meta-analysis.
Huang, J; Liu, L; Tang, X; Zhang, X, 2018
)
0.48
" The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischaemic and haemorrhagic adverse events at follow up in PAD patients undergoing percutaneous transluminal angioplasty (PTA)."( On-Treatment Platelet Reactivity is a Predictor of Adverse Events in Peripheral Artery Disease Patients Undergoing Percutaneous Angioplasty.
Antoniucci, D; Basili, S; Elmahdy, MF; Giusti, B; Gori, AM; Grifoni, E; Marcucci, R; Migliorini, A; Paniccia, R; Pratesi, C; Pulli, R; Valenti, R; Violi, F, 2018
)
0.48
"TAT under TEG guidance appears to be a safe antiplatelet strategy in patients undergoing stenting for extracranial and/or intracranial artery stenosis."( The safety of triple antiplatelet therapy under thromboelastography guidance in patients undergoing stenting for ischemic cerebrovascular disease.
Jiang, WJ; Li, C; Liu, AF; Qiu, H; Wang, K; Wu, Z; Zhang, Y; Zhou, J, 2019
)
0.51
"We assessed primary causative adverse events (PCAE) after BC and GC in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)."( Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System.
Agewall, S; Atar, D; Geudelin, B; Hall, TS; Hyun Kim, M; Lomakin, N; Marciniak, TA; Serebruany, VL, 2019
)
0.51
" However, the overall adverse event profile suggests potentially better safety of BC over GC formulations."( Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System.
Agewall, S; Atar, D; Geudelin, B; Hall, TS; Hyun Kim, M; Lomakin, N; Marciniak, TA; Serebruany, VL, 2019
)
0.51
" We analyzed the occurrence of major adverse cardiovascular events and periprocedural myocardial infarction."( Efficacy and Safety of Loading Doses With P2Y12-Receptor Antagonists in Patients Without Dual Antiplatelet Therapy Undergoing Elective Coronary Intervention.
Abellán-Huerta, J; Jurado-Román, A; López-Lluva, MT; Lozano-Ruiz Poveda, F; Piqueras-Flores, J; Sánchez-Pérez, I, 2019
)
0.51
" At the end of follow-up, major adverse cardiovascular event rate was not different between groups."( Efficacy and Safety of Loading Doses With P2Y12-Receptor Antagonists in Patients Without Dual Antiplatelet Therapy Undergoing Elective Coronary Intervention.
Abellán-Huerta, J; Jurado-Román, A; López-Lluva, MT; Lozano-Ruiz Poveda, F; Piqueras-Flores, J; Sánchez-Pérez, I, 2019
)
0.51
"To describe and evaluate the bleeding-related adverse events associated with use of P2Y12 inhibitors utilizing data from the FDA Adverse Event Reporting System (FAERS) database."( Evaluation of adverse events involving bleeding associated with oral P2Y12 inhibitors use in the Food and Drug Administration adverse event reporting system.
Abou-Ali, A; Fahmy, AI; Mekkawy, MA, 2019
)
0.51
"We identified 2,252, 2,450, and 549 adverse event reports attributed to clopidogrel, ticagrelor, and prasugrel use, respectively."( Evaluation of adverse events involving bleeding associated with oral P2Y12 inhibitors use in the Food and Drug Administration adverse event reporting system.
Abou-Ali, A; Fahmy, AI; Mekkawy, MA, 2019
)
0.51
" Secondary outcomes were adverse bleeding events (safety outcome)."( Efficacy and safety of alternative oral administrations of P2Y12-receptor inhibitors: Systematic review and meta-analysis.
Bilotta, F; Campo, G; Parodi, G; Pavasini, R; Serenelli, M; Tonet, E; Vitali, F, 2019
)
0.51
" Compared with nonsmokers within the first year of follow-up, the reductions of stroke and major adverse cardiovascular event rate were 18% ( P=0."( Effectiveness and Safety of Platelet ADP -P2Y12 Receptor Inhibitors Influenced by Smoking Status: A Systematic Review and Meta-Analysis.
Chen, S; Cui, Y; Gong, Y; Hu, K; Jiang, J; Liu, Z; Mu, G; Wang, Z; Xiang, Q; Xie, Q; Zhou, S, 2019
)
0.51
"Clopidogrel combined with low-dose aspirin is safe and effective in antithrombotic therapy for children with KD complicated by CAA."( [Clinical effect and safety of clopidogrel combined with aspirin in antithrombotic therapy for children with Kawasaki disease complicated by small/medium-sized coronary artery aneurysms].
Chen, TT; Guo, YH; Li, Y; Liu, YL; Lu, YH; Shi, K; Wang, XM, 2019
)
0.51
" This practice, especially in complex PCI, could be affected by a higher rate of peri-procedural adverse events."( Safe and Effective Management of Antiplatelet Therapy in a Clopidogrel-Naive Patient Undergoing "Ad Hoc" Complex Coronary Intervention: A Case Report.
Colombo, A; Marchese, A; Resta, F; Tito, A, 2020
)
0.56
"Patients who are at increased risk for MI can be maintained on DAPT up to the time of CABG because surgery is safe when patients are offered PPT."( Dual antiplatelet therapy up to the time of non-elective coronary artery bypass grafting with prophylactic platelet transfusion: is it safe?
Charif, F; El Zein, A; Hamdan, R; Issa, M; Jassar, Y; Saab, M; Younes, M; Youness, G, 2019
)
0.51
" Aspirin alone appears to be safe for use in those patients."( Clopidogrel plus Aspirin Use is Associated with Worse Long-Term Outcomes, but Aspirin Use Alone is Safe in Patients with Vasospastic Angina: Results from the VA-Korea Registry, A Prospective Multi-Center Cohort.
Baek, SH; Cho, SS; Gwon, HC; Han, SH; Her, SH; Jo, SH; Kim, SE; Lee, BK; Lee, KY; Lee, MH; Park, KH; Rha, SW; Seo, WW; Suh, JW; Yang, TH, 2019
)
0.51
" In conclusion, treatment with low-dose IC TNK appears safe and well tolerated during PPCI."( Feasibility and Safety of Low-Dose Intra-Coronary Tenecteplase During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (ICE T-TIMI 49).
Bainey, KR; Devireddy, C; Gibson, CM; Gopalakrishnan, L; Grip, L; Guo, J; Kazziha, S; Kumar, V; Marshall, JJ; Mavromatis, K; Pinto, D; Singh, P; Stouffer, GA, 2020
)
0.56
"Although the number of adverse events (AEs) increased with vicagrel dose, none were considered serious, suggesting that vicagrel is safe and well-tolerated."( Platelet inhibitory activity, tolerability, and safety of vicagrel, a novel thienopyridine P2Y12 inhibitor.
Chen, H; Chen, W; Gong, Y; Lai, X; Li, H; Li, X; Li, Y; Liu, C; Liu, X; Liu, Y; Sheng, L; Sun, H; Xu, H; Yang, J; Yang, M; Yuan, F, 2020
)
0.56
" The primary efficacy endpoint was major adverse cardiovascular events (MACE) defined by each study, and the safety endpoint was TIMI non-CABG major bleeding."( Efficacy and Safety of Potent Oral P2Y
Han, Y; Jiang, Z; Li, Y; Li, Z; Ma, S; Song, H; Yu, P, 2020
)
0.56
" However, an increased risk of ticagrelor-related adverse events prompted the evaluation of low-dose regimens."( Efficacy and safety of different ticagrelor regimens versus clopidogrel in patients with coronary artery disease: a retrospective multicenter study (SUPERIOR).
Cang, H; He, M; Li, J; Li, Y; Liu, G; Mu, H; Shi, J; Sun, D; Wang, J; Wang, W; Xu, M; Zhang, C; Zhang, H; Zhang, Z; Zhao, C; Zhao, S, 2021
)
0.62
" Concomitant administration of single-dose DS-1040 with multiple-dose aspirin, multiple-dose clopidogrel, or single-dose enoxaparin, consistent with clinically relevant dose regimens, was safe and well tolerated with no serious treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, bleeding-related TEAEs, and no significant changes in coagulation parameters."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
" The primary endpoint was major adverse cardiovascular events (MACE), including cardiovascular (CV) death, all-cause death, myocardial infarction (MI), stent thrombosis and stroke."( Efficacy and safety of clopidogrel versus prasugrel and ticagrelor for coronary artery disease treatment in patients with CYP2C19 LoF alleles: a systemic review and meta-analysis.
Gwak, HS; Lee, N; Seong, JM; Yoon, HY, 2020
)
0.56
"Compared with ASA, DAPT showed a non-significant impact on long-term survival and demonstrated to be a safe option."( Early dual antiplatelet therapy versus aspirin monotherapy after coronary artery bypass surgery: survival and safety outcomes.
Amorim, MJ; Barros, AS; Cerqueira, RJ; Ferreira, AF; Leite-Moreira, AF; Lourenço, AP; Moreira, R; Pinho, P; Rocha-Gomes, JN; Saraiva, FA, 2020
)
0.56
" The endpoints were major adverse cardiac events (MACEs), death, stroke, myocardial infarction (MI), stent thrombosis, and bleeding events."( Efficacy and Safety of Ticagrelor Compared to Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis.
Li, D; Li, X; Shen, S; Wu, H; Xiang, X, 2020
)
0.56
" The primary endpoint for efficacy was the rate of major adverse cardiac events (MACEs)."( Efficacy and safety of low dose ticagrelor in patients with acute coronary syndrome: a systematic review and meta-analysis.
Chen, Q; Li, D; Lu, C; Wang, C; Wang, S; Wang, Y; Wang, Z; Xu, T; Xuan, H; Zhang, H; Zhang, Y, 2020
)
0.56
" The aim of this study is to investigate the efficacy and safety of switching from ticagrelor to clopidogrel in AMI patients with no adverse event during the first month after the index PCI with newer-generation DES."( A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALO
Ahn, Y; Chang, K; Choo, EH; Hwang, BH; Jeon, DS; Jeong, MH; Kim, CJ; Kim, HY; Kim, MC; Park, CS; Park, MW; Seung, KB; Yoo, KD, 2021
)
0.62
"TALOS-AMI is a multicentre, randomised, open-label study enrolling 2,590 AMI patients with no adverse events during the first month after the index PCI."( A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALO
Ahn, Y; Chang, K; Choo, EH; Hwang, BH; Jeon, DS; Jeong, MH; Kim, CJ; Kim, HY; Kim, MC; Park, CS; Park, MW; Seung, KB; Yoo, KD, 2021
)
0.62
" Efficacy (major adverse cardiovascular events, acute or chronic limb ischaemia, vascular amputation, peripheral revascularisation) and safety (all-cause mortality and overall bleeding) outcomes were evaluated via Bayesian network meta-analyses."( Efficacy and Safety of Antiplatelet Therapies in Symptomatic Peripheral Artery Disease: A Systematic Review and Network Meta-Analysis.
Cimminiello, C; De Carlo, M; Di Minno, G; Fazeli, MS; Sayre, T; Siliman, G, 2021
)
0.62
"98) significantly reduced major adverse cardiovascular events risk compared with aspirin."( Efficacy and Safety of Antiplatelet Therapies in Symptomatic Peripheral Artery Disease: A Systematic Review and Network Meta-Analysis.
Cimminiello, C; De Carlo, M; Di Minno, G; Fazeli, MS; Sayre, T; Siliman, G, 2021
)
0.62
"This updated network meta-analysis confirms that clopidogrel significantly decreases the risk of major adverse cardiovascular events compared with aspirin, without increasing bleeding risk."( Efficacy and Safety of Antiplatelet Therapies in Symptomatic Peripheral Artery Disease: A Systematic Review and Network Meta-Analysis.
Cimminiello, C; De Carlo, M; Di Minno, G; Fazeli, MS; Sayre, T; Siliman, G, 2021
)
0.62
" Major adverse cardiovascular and cerebrovascular events (MACCEs) and bleeding events according to ticagrelor or clopidogrel use were compared."( Efficacy and Safety of Ticagrelor and Clopidogrel in Patients with Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.
Gao, R; Guo, T; Li, J; Li, Y; Qiao, S; Qiu, H; Tang, Y; Wang, Y; Xu, B; Yan, L; Yang, Y; Zheng, J, 2021
)
0.62
" On the other hand, the difference between ticagrelor and clopidogrel for net adverse clinical events was significant (4."( Efficacy and Safety of Ticagrelor and Clopidogrel in Patients with Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.
Gao, R; Guo, T; Li, J; Li, Y; Qiao, S; Qiu, H; Tang, Y; Wang, Y; Xu, B; Yan, L; Yang, Y; Zheng, J, 2021
)
0.62
"In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use."( Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.
Anand, SS; Bauersachs, R; Berkowitz, SD; Bonaca, MP; Brackin, T; Brasil, D; Capell, WH; Debus, ES; Haskell, L; Hess, CN; Hiatt, WR; Jaeger, N; Madaric, J; Muehlhofer, E; Nehler, MR; Pap, AF; Patel, MR; Sillesen, H; Szalay, D, 2020
)
0.56
" However, there were no significant differences in the adverse drug reactions between the two groups."( Tirofiban combined with heparin's effect and safety in the treatment of mild to moderate acute ischemic stroke.
Chen, M; Dai, X; Deng, X; Fu, S; Gong, Q; He, W; Huang, L; Li, C; Luo, Q; Qiu, T; Wang, J; Wang, M; Xiao, H, 2021
)
0.62
"Genetic variations of enzymes that affect the pharmacokinetics and hence effects of medications differ between ethnicities, resulting in variation in the risk of adverse drug reactions (ADR) between different populations."( The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.
Aoki, Y; Chandler, RE; Lönnstedt, IM; Wakao, R, 2021
)
0.62
"Prasugrel/ticagrelor, compared to clopidogrel, reduces risk of major adverse cardiovascular event (MACE) in Hong Kong ACS population."( Efficacy and safety comparing prasugrel/ticagrelor and clopidogrel in Hong Kong post-acute coronary syndrome patients-A 10-year cohort study.
Lam, ASM; Lee, VWY; Yan, BPY, 2021
)
0.62
" The primary effectiveness endpoint was a major adverse cardiovascular event (MACE), and the primary safety endpoint was a major bleeding event."( Comparison of effectiveness and safety between ticagrelor and clopidogrel in patients with acute coronary syndrome and on dialysis in Taiwan.
Hsieh, KP; Hwang, SJ; Li, YS; Wang, SH; Yang, YH, 2022
)
0.72
" Intravenous (IV) tirofiban alone or combined with DAPT was shown to be safe and effectively improved clinical outcome in progressive ischemic stroke patients."( Assessing the Efficacy and Safety of Tirofiban in Combination With Dual-antiplatelet Therapy in Progressive Ischemic Stroke Patients.
Chang, W; Li, L; Lin, F; Liu, H; Yin, J; Zhang, H; Zhao, Y, 2021
)
0.62
"Our study suggested that tirofiban use appears to be safe as monotherapy in AIS treatment compared with common dual antiplatelet therapy, however, no improvement in functional outcomes was found."( Association between tirofiban monotherapy and efficacy and safety in acute ischemic stroke.
Chen, C; Hu, W; Liu, D; Liu, J; Liu, T; Luo, W; Song, J; Tao, C; Yuan, X; Zhang, C; Zhu, Y, 2021
)
0.62
"To assess the efficacy and safety of low-dose prasugrel compared to clopidogrel based on the occurrence of major adverse cardiac events (MACEs) and major bleeding in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI)."( Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis.
Kengkla, K; Kumtep, W; Saokaew, S; Senthong, V; Ungsriwong, S; Wongsalap, Y, 2022
)
0.72
" The primary endpoint was net adverse clinical event, defined as the primary efficacy endpoint of death, myocardial infarction, or cerebrovascular accident and the primary safety endpoint of any bleeding event."( Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.
Flahive, J; Fraielli, K; Gill, K; Servati, N, 2021
)
0.62
"This small cohort study suggests, in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention, the net adverse clinical event rate does not differ between clopidogrel and potent P2Y12 inhibitors in the setting of triple antithrombotic therapy."( Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.
Flahive, J; Fraielli, K; Gill, K; Servati, N, 2021
)
0.62
"Early hip fracture surgery is safe for elderly patients within 5 days of clopidogrel withdrawal, without increased perioperative blood loss, transfusion requirement, complications, and mortality compared with patients not taking antiplatelet drugs."( Safety of early surgery for geriatric hip fracture patients taking clopidogrel: a retrospective case-control study of 120 patients in China.
Li, B; Wang, G; Wu, XB; Yang, MH; Yao, DC; Zhang, P; Zhang, WC; Zhou, Y; Zhu, SW, 2021
)
0.62
" CONCLUSIONS Continuing anticoagulation or antiplatelet was safe in not increasing bleeding complications or perioperative transfusion requirements."( Is Continuing Anticoagulation or Antiplatelet Therapy Safe Prior to Kidney Transplantation?
Alonso-Escalante, JC; Machado, L; Tabar, KR; Thai, N; Tindall, R; Uemura, T, 2021
)
0.62
"This study indicated that compared with patients without clopidogrel administration, elderly patients with hip fractures who receive clopidogrel as long-term anti-platelet therapy are relatively safe for surgery in less than 5-7 days after discontinuation of clopidogrel."( Evaluation of Clopidogrel Safety in Geriatric Patients with Hip Fracture: A Retrospective Study.
Chong, H; Wang, G; Wu, X; Yang, M; Zhang, W; Zheng, S; Zheng, Y; Zhou, Y, 2021
)
0.62
"To establish the safety and efficacy of different dual antiplatelet therapy (DAPT) combinations in patients with acute coronary syndrome (ACS) according to their baseline ischaemic and bleeding risk estimated with a machine learning derived model [machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE) score]."( Safety and efficacy of different P2Y12 inhibitors in patients with acute coronary syndromes stratified by the PRAISE risk score: a multicentre study.
Abu-Assi, E; Bruno, F; Cerrato, E; Chieffo, A; Conrotto, F; D'Ascenzo, F; De Ferrari, GM; De Filippo, O; Dominguez-Rodriguez, A; Elia, E; Gallone, G; Henriques, JPS; Iannaccone, M; Kinnaird, T; Leonardi, S; Liebetrau, C; Manzano-Fernández, S; Omedè, P; Patti, G; Piroli, F; Raposeiras-Roubin, S; Wańha, W, 2022
)
0.72
" Thus, if those patients needed operative treatment for BPH, they may be at high risk of hemorrhage or its related adverse effects with the usage of anti-thrombotic drugs during the peri-operative time."( Safety of not withholding clopidogrel therapy during the immediate several days pre- and post-trans-urethral resection of prostate (TURP): a retrospective cohort study.
Abdulhamid, AK; Khalaf, RJ, 2022
)
0.72
"The continuation of usage of anti-thrombotic therapy (clopidogrel) during peri-operative period in patients with TURP for BPH is a safe practice."( Safety of not withholding clopidogrel therapy during the immediate several days pre- and post-trans-urethral resection of prostate (TURP): a retrospective cohort study.
Abdulhamid, AK; Khalaf, RJ, 2022
)
0.72
" The primary outcome endpoint was evaluated based on the adverse cardiac and cerebrovascular events within 12 months."( Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.
Bai, L; Cui, XR; Fu, LZ; Yang, XH; Zhang, JD; Zhou, YQ,
)
0.13
"00%) main adverse cardiac and cerebrovascular events occurred during the 12 months of follow-up, including 5 (9."( Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.
Bai, L; Cui, XR; Fu, LZ; Yang, XH; Zhang, JD; Zhou, YQ,
)
0.13
" Cilostazol therapy significantly increased the risk of adverse events of headache (odds ratio, 12."( Efficacy and Safety of Cilostazol for Atherosclerosis: A Meta-analysis of Randomized Controlled Trials.
Huang, T; Wan, H; Wu, Q; Wu, T; Yang, P; Zhang, H, 2022
)
0.72
" Net adverse clinical events were identified as the composite end point, which was defined as a composite of cardiovascular death, myocardial infarction, revascularization, stroke, and bleeding at 12 months after acute coronary syndromes."( Efficacy and Safety of De-escalation of Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: A Meta-Analysis of Randomized Clinical Trials.
Bai, N; Ma, Y; Niu, Y; Shang, YS; Wang, ZL; Zhong, PY, 2022
)
0.72
" Safety endpoints included adverse events (AEs) and Bleeding Academic Research Consortium-defined any bleeding."( Antiplatelet effect, safety, and pharmacokinetics of vicagrel in patients with coronary artery disease undergoing percutaneous coronary intervention.
Gong, Y; Han, Y; Jiang, H; Kang, Y; Lai, X; Li, J; Li, Y; Liu, B; Liu, Y; Ma, S; Qi, Z; Ren, L; Sun, H; Tang, C; Tang, Y; Zhao, X; Zheng, M, 2022
)
0.72
" Safety endpoints included bleeding events and adverse events (AEs)."( Efficacy and Safety of Prasugrel vs Clopidogrel in Thrombotic Stroke Patients With Risk Factors for Ischemic Stroke Recurrence: A Double-blind, Phase III Study (PRASTRO-III).
Kamouchi, M; Kimura, K; Kitazono, T; Koyama, N; Matsumaru, Y; Matsuo, H; Nakamura, M; Tsutsumi, J; Umemura, K, 2023
)
0.91
"OACs plus single antiplatelet therapy and dual antiplatelet therapy alone are both safe and efficacious management strategies after CVSS stent placement."( Safety and efficacy comparison between OACs plus single antiplatelet and dual antiplatelet therapy in patients with cerebral venous sinus stenosis poststenting.
Bai, C; Chen, Z; Ding, Y; Ilagan, R; Ji, X; Meng, R; Wu, X, 2022
)
0.72
" Major adverse cardiovascular events and bleeding events were assessed by using Mantel-Haenszel-pooled risk ratio and 95% con- fidence interval."( Efficacy and Safety of Ticagrelor in East Asian Patients with Acute Coronary Syndrome: A Meta-Analysis of Randomized Controlled Trials.
Lin, J; Qin, Q; Xie, C; Zhu, J, 2022
)
0.72
" The effectiveness outcome was major adverse cardiovascular events (MACE) defined as a composite of recurrent myocardial infarction, repeat revascularization, stroke, or cardiovascular death at 12 months."( Effectiveness and safety of P2Y12 inhibitors in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a nationwide registry-based study.
Bhatt, DL; Butt, JH; Christensen, MK; Fosbøl, EL; Gislason, G; Godtfredsen, SJ; Jørgensen, SH; Kragholm, KH; Køber, L; Leutscher, P; Pareek, M; Sessa, M; Torp-Pedersen, C, 2022
)
0.72
" Many randomized, double-blind, placebo-controlled, multicenter clinical trials suggest that NBP is a safe and effective treatment for ischemic stroke."( Efficacy and safety of butylphthalide in secondary prevention of stroke: study protocol for a multicenter, real world trial based on Internet.
Lv, J; Xie, Z; Zhao, D; Zhao, G, 2022
)
0.72
"), and adverse events of patients in groups."( Efficacy and safety of butylphthalide in secondary prevention of stroke: study protocol for a multicenter, real world trial based on Internet.
Lv, J; Xie, Z; Zhao, D; Zhao, G, 2022
)
0.72
" Effectiveness endpoints were evaluated by the major adverse cardiovascular events, encompassing all-cause death, non-fatal myocardial infarction, and clinically driven revascularization."( Comparative Effectiveness and Safety of Ticagrelor Versus Clopidogrel for Elderly Chinese Patients Undergoing Percutaneous Coronary Intervention: A Single-Center Retrospective Cohort Study.
Chen, Y; Gao, H; Han, P; Li, C; Lian, K; Liang, Y; Liu, Y; Tan, Z; Tao, F; Wang, Q; Wang, Z; Xu, S; Yang, L; Zhang, A; Zhang, Y; Zhao, S; Zhu, B, 2022
)
0.72
"Ticagrelor was associated with a lower incidence of major adverse cardiovascular events than clopidogrel at 12 months in elderly Chinese patients with coronary artery disease, without a significant increase of Bleeding Academic Research Consortium bleeding events."( Comparative Effectiveness and Safety of Ticagrelor Versus Clopidogrel for Elderly Chinese Patients Undergoing Percutaneous Coronary Intervention: A Single-Center Retrospective Cohort Study.
Chen, Y; Gao, H; Han, P; Li, C; Lian, K; Liang, Y; Liu, Y; Tan, Z; Tao, F; Wang, Q; Wang, Z; Xu, S; Yang, L; Zhang, A; Zhang, Y; Zhao, S; Zhu, B, 2022
)
0.72
"The first 3 months after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) is a high-risk period for adverse events, including ischemic and bleeding events, which decrease greatly with time."( Efficacy and Safety of Clopidogrel Versus Ticagrelor for Stabilized Patients With Acute Coronary Syndromes After Percutaneous Coronary Intervention: Results From a Real-World Registry in China.
Li, X; Lin, Y; Peng, W; Zhang, Y, 2023
)
0.91
" Major adverse cardiovascular and cerebrovascular events (MACCE) were considered the primary end point, and major bleeding was considered the secondary end point."( Efficacy and Safety of Clopidogrel Versus Ticagrelor for Stabilized Patients With Acute Coronary Syndromes After Percutaneous Coronary Intervention: Results From a Real-World Registry in China.
Li, X; Lin, Y; Peng, W; Zhang, Y, 2023
)
0.91
" The primary comprehensive endpoint was a major adverse cardiovascular event (MACE) composite of cardiovascular death, stroke, or myocardial infarction, while the secondary endpoints were cardiovascular death, all-cause stroke, ischemic stroke, myocardial infarction, and all-cause death."( Prophylactic Efficacy and Safety of Antithrombotic Regimens in Patients with Stable Atherosclerotic Cardiovascular Disease (S-ASCVD): A Bayesian Network Meta-Regression Analysis.
Chen, X; Jiang, L; Liu, C; Su, J; Zheng, N; Zhong, J, 2023
)
0.91
" The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke."( Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority ra
Gong, Y; Li, J; Wang, X; Wang, Y; Zhou, T, 2023
)
0.91
" Our meta-analysis aimed to demonstrate whether intensified antithrombotic regimens with ticagrelor plus aspirin have more beneficial effects and fewer adverse events compared to those of clopidogrel plus aspirin in East Asian patients with ACS undergoing PCI."( Safety and Efficacy of Ticagrelor versus Clopidogrel in East Asian Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Treated with Dual Antiplatelet Therapy: A Meta-Analysis of Randomized Controlled Trials.
He, X; Li, J; Ma, S; Qiu, M; Qu, X; Wang, Q; Wang, X; Wu, C; Zhang, L, 2023
)
0.91
" The primary endpoint was bleeding events, and the secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs, including cardiovascular death, nonfatal myocardial infarction [MI], and stroke), all-cause death, and definite/probable/possible stent thrombosis."( Safety and Efficacy of Ticagrelor versus Clopidogrel in East Asian Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Treated with Dual Antiplatelet Therapy: A Meta-Analysis of Randomized Controlled Trials.
He, X; Li, J; Ma, S; Qiu, M; Qu, X; Wang, Q; Wang, X; Wu, C; Zhang, L, 2023
)
0.91
"This real-world study suggests that cilostazol is effective and safe for noncardioembolic ischemic stroke and may be associated with better effectiveness in hypertensive patients compared to clopidogrel."( Long-term effectiveness and safety of cilostazol versus clopidogrel in secondary prevention of noncardioembolic ischemic stroke.
Je, NK; Lee, YJ, 2023
)
0.91
" Outcomes included major adverse cardiovascular events, all cause death, major bleeding and myocardial infarction."( Comparison efficacy and safety of different antiplatelet or anticoagulation drugs in chronic coronary syndromes patients: A Bayesian network meta-analysis.
Liu, C; Ma, L, 2023
)
0.91
" In head-to-head comparison, no significant difference was observed between all antithrombotic treatment strategies with respect to primary endpoint of major adverse cardiovascular events."( Comparison efficacy and safety of different antiplatelet or anticoagulation drugs in chronic coronary syndromes patients: A Bayesian network meta-analysis.
Liu, C; Ma, L, 2023
)
0.91

Pharmacokinetics

Clopidogrel and dabigatran etexilate did not appear to have significant effects on the pharmacokinetic and pharmacodynamic profiles of either agent.

ExcerptReferenceRelevance
" These data and those of previous studies indicate that a dose of 300 to 400 mg produces a rapid onset of the pharmacodynamic action of clopidogrel, with levels of inhibition close to steady-state reached within 2 hours."( Clopidogrel loading dose regimens: kinetic profile of pharmacodynamic response in healthy subjects.
Bachmann, F; Cariou, R; Geudelin, B; Hauert, J; Savcic, M; Wyld, PJ, 1999
)
0.3
"In order to obtain a global assessment of circulating clopidogrel-related products and of the excretion of the drug, the pharmacokinetic behavior and the excretion balance of 14C radioactivity following the administration of a single dose of 75 mg of 14C-labeled clopidogrel were compared in 6 clopidogrel-free healthy male subjects (Period I) and after 7 days of once daily therapy with the unlabeled drug in these subjects (at steady state) (Period II)."( Pharmacokinetic profile of 14C-labeled clopidogrel.
Broekhuysen, J; Deroubaix, X; Lins, R; Necciari, J, 1999
)
0.3
"The potential influence of clopidogrel on the pharmacokinetics of theophylline was evaluated in 15 healthy male subjects during the pharmacokinetic steady state of theophylline, after single and multiple doses."( Clopidogrel does not affect the pharmacokinetics of theophylline.
Caplain, H; Necciari, J; Thebault, JJ, 1999
)
0.3
" Pharmacokinetic analysis of clopidogrel was limited due to low plasma concentrations arising from rapid hydrolysis to SR 26334."( Cirrhosis does not affect the pharmacokinetics and pharmacodynamics of clopidogrel.
Much, DR; Necciari, J; Nichola, P; Slugg, PH; Smith, WB; Vargas, R, 2000
)
0.31
" In preparation for such a study, we have performed a pharmacodynamic study of the platelet inhibitory effects of clopidogrel in patients on maintenance hemodialysis."( A pharmacodynamic study of clopidogrel in chronic hemodialysis patients.
Fiore, L; Hasbargen, JA; Kaufman, JS; O'Connor, TZ; Perdriset, G, 2000
)
0.31
" Pharmacokinetic analysis of this new product showed it to have a more consistent and reproducible absorption compared with immediate-release dipyridamole."( Clinical pharmacokinetics of antiplatelet agents used in the secondary prevention of stroke.
Lenz, T; Wilson, A, 2003
)
0.32
" The lesser long-term pharmacodynamic potency of aspirin relative to clopidogrel raises the prospect of the need for more effective antiplatelet agents or a synergistic combination therapy for stroke prevention in the future."( Serial changes in platelet activation in patients after ischemic stroke: role of pharmacodynamic modulation.
Chang, HW; Chang, YY; Chen, MC; Chen, SS; Chen, WH; Kao, YF; Lai, SL; Lan, MY; Liu, JS; Yip, HK, 2004
)
0.32
" To evaluate possible pharmacokinetic determinants of this response variability, we developed a sensitive and specific liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for quantification of unmodified inactive clopidogrel, its inactive carboxyl metabolite, and its active thiol metabolite in plasma."( Pharmacokinetics of clopidogrel after administration of a high loading dose.
Gorchakova, O; Harlfinger, S; Kastrati, A; Lazar, A; Schömig, A; Schömig, E; Taubert, D; von Beckerath, N, 2004
)
0.32
" The method was successfully applied to the pharmacokinetic study of the two different polymorphs of clopidogrel bisulfate in Wistar rat."( Estimation of carboxylic acid metabolite of clopidogrel in Wistar rat plasma by HPLC and its application to a pharmacokinetic study.
Barot, D; Lohray, VB; Mohan, PR; Sharma, K; Singh, SS, 2005
)
0.33
" Pharmacokinetic parameters for these groups were calculated and compared with one another."( Interaction study of aspirin or clopidogrel on pharmacokinetics of donepezil hydrochloride in rats by HPLC-fluorescence detection.
Aboul-Enein, HY; Nakashima, K; Nishiwaki, J; Ohwaki, Y; Wada, M; Yamane, T, 2007
)
0.34
" Ketoconazole decreased R-138727 and clopidogrel active metabolite Cmax (maximum plasma concentration) 34-61% after prasugrel and clopidogrel dosing."( Cytochrome P450 3A inhibition by ketoconazole affects prasugrel and clopidogrel pharmacokinetics and pharmacodynamics differently.
Brandt, JT; Darstein, C; Ernest, CS; Farid, NA; Jakubowski, JA; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2007
)
0.34
" The developed assay method was applied to a pharmacokinetic study in human volunteers after oral administration of clopidogrel at a dose of 150 mg."( Determination of clopidogrel in human plasma by liquid chromatography/tandem mass spectrometry: application to a clinical pharmacokinetic study.
Shin, BS; Yoo, SD, 2007
)
0.34
" The pharmacodynamic response to clopidogrel is more variable than the response to prasugrel, but the reasons for variation in response to clopidogrel are not well characterized."( Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel.
Brandt, JT; Close, SL; Ernest, CS; Farid, NA; Iturria, SJ; Lachno, DR; Payne, CD; Salazar, D; Winters, KJ, 2007
)
0.34
"Genotyping was performed for CYP1A2, CYP2B6, CYP2C19, CYP2C9, CYP3A4 and CYP3A5 on samples from healthy subjects participating in studies evaluating pharmacokinetic and pharmacodynamic responses to prasugrel (60 mg, n = 71) or clopidogrel (300 mg, n = 74)."( Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel.
Brandt, JT; Close, SL; Ernest, CS; Farid, NA; Iturria, SJ; Lachno, DR; Payne, CD; Salazar, D; Winters, KJ, 2007
)
0.34
" Decreased exposure to its active metabolite is associated with a diminished pharmacodynamic response to clopidogrel."( Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel.
Brandt, JT; Close, SL; Ernest, CS; Farid, NA; Iturria, SJ; Lachno, DR; Payne, CD; Salazar, D; Winters, KJ, 2007
)
0.34
" The therapeutic usefulness of clopidogrel has been limited by documented inter-individual heterogeneity in platelet inhibition, which may be attributable to known clopidogrel pharmacokinetic variability."( Smoking behaviour modulates pharmacokinetics of orally administered clopidogrel.
Al-Zumyli, R; Arafat, T; Bulatova, NR; Yousef, AM, 2008
)
0.35
" Clopidogrel carboxylate plasma levels were measured and non-compartmental analysis was used to determine peak plasma concentration (C(max)), time to peak plasma concentration (T(max)), elimination half-life (t(1/2e)), and area under the curve (AUC(0-->infinity))."( Smoking behaviour modulates pharmacokinetics of orally administered clopidogrel.
Al-Zumyli, R; Arafat, T; Bulatova, NR; Yousef, AM, 2008
)
0.35
" Pharmacokinetic parameter estimates (AUC(0-t last), C(max), and t(max)) and inhibition of platelet aggregation (IPA) by light transmission aggregometry were assessed at multiple time points after the LD and final MD."( Effect of ranitidine on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel.
Ernest, CS; Farid, NA; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
" The lack of a clinically meaningful effect of high-dose atorvastatin on the pharmacodynamic response to prasugrel after the loading or maintenance dose indicates that no dosage adjustment should be necessary in patients receiving these drugs concomitantly."( Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects.
Brandt, JT; Ernest, CS; Farid, NA; Jakubowski, JA; Konkoy, CS; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
" The involvement of the phenomenon with CYP2C19 led some to believe that it was a pharmacokinetic issue."( Clopidogrel resistance: pharmacokinetic or pharmacogenetic?
Ford, NF, 2009
)
0.35
" We hypothesized that decreased CYP2C19 activity affects the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel."( Genetic variation of CYP2C19 affects both pharmacokinetic and pharmacodynamic responses to clopidogrel but not prasugrel in aspirin-treated patients with coronary artery disease.
Brandt, JT; Braun, OO; Close, SL; Erlinge, D; James, S; Man, M; Siegbahn, A; Varenhorst, C; Walker, J; Wallentin, L; Winters, KJ, 2009
)
0.35
" For prasugrel, there was no statistically significant difference in active metabolite exposure or pharmacodynamic response between CYP2C19 EM and RM."( Genetic variation of CYP2C19 affects both pharmacokinetic and pharmacodynamic responses to clopidogrel but not prasugrel in aspirin-treated patients with coronary artery disease.
Brandt, JT; Braun, OO; Close, SL; Erlinge, D; James, S; Man, M; Siegbahn, A; Varenhorst, C; Walker, J; Wallentin, L; Winters, KJ, 2009
)
0.35
" For pharmacokinetic analysis, blood was drawn at 0, 20, 40, 60, 90, 120, 180, 240 and 360 min after clopidogrel loading and peak plasma concentrations (C(max)) of the AMC were quantified with liquid chromatography-tandem mass spectrometry (LC-MS/MS)."( Which platelet function test is suitable to monitor clopidogrel responsiveness? A pharmacokinetic analysis on the active metabolite of clopidogrel.
Bouman, HJ; Breet, NJ; Hackeng, CM; Parlak, E; Taubert, D; ten Berg, JM; ten Cate, H; van Werkum, JW, 2010
)
0.36
" Although the approved loading dose is 60 mg, earlier studies of prasugrel suggested that active-metabolite exposure and pharmacodynamic response may be higher in Asian subjects than in white subjects."( Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy Chinese and white volunteers: an open-label trial.
Farid, NA; Jakubowski, JA; Kelly, R; Kothare, P; Li, YG; Natanegara, F; Ni, L; Payne, CD; Richard Lachno, D; Salazar, DE; Small, DS; Teng Loh, M; Tomlin, M; Winters, KJ; Yuen, E, 2010
)
0.36
"This study compared the pharmacodynamic response to a single 30-mg dose of prasugrel in healthy Chinese and white subjects and the response to a single 30-mg dose of prasugrel and a single 300-mg dose of clopidogrel in healthy Chinese subjects."( Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy Chinese and white volunteers: an open-label trial.
Farid, NA; Jakubowski, JA; Kelly, R; Kothare, P; Li, YG; Natanegara, F; Ni, L; Payne, CD; Richard Lachno, D; Salazar, DE; Small, DS; Teng Loh, M; Tomlin, M; Winters, KJ; Yuen, E, 2010
)
0.36
" The 90% confidence intervals (CIs) for the log-transformed ratios for pharmacokinetic parameters (Cmax and AUC) of SR26334 fell within the predefined pharmacokinetic equivalence range of 80 - 125%."( Pharmacokinetics and the antiplatelet effect of a new clopidogrel formulation, clopidogrel besylate, in healthy subjects.
Jeon, SH; Kim, JS; Kim, KA; Lee, GH; Park, JY; Ryu, JH, 2010
)
0.36
"To determine pharmacodynamic and pharmacokinetic properties of clopidogrel and the metabolite SR 26334 in dogs."( Pharmacodynamic and pharmacokinetic evaluation of clopidogrel and the carboxylic acid metabolite SR 26334 in healthy dogs.
Brainard, BM; Budsberg, SC; Kleine, SA; Papich, MG, 2010
)
0.36
"This study is a phase 3, multi-dose, pharmacodynamic comparison of prasugrel versus clopidogrel in Asian patients with ACS undergoing PCI."( Prasugrel versus clopidogrel in Asian patients with acute coronary syndromes: design and rationale of a multi-dose, pharmacodynamic, phase 3 clinical trial.
Boonbaichaiyapruck, S; Ge, J; Goh, YS; Hong, BK; Hou, CJ; Pinton, P; Zhu, J, 2010
)
0.36
"Pharmacogenomic and pharmacokinetic aspects of clopidogrel nonresponsiveness were considered in detail."( Nonresponders to clopidogrel: pharmacokinetics and interactions involved.
Di Girolamo, G; Giorgi, MA; González, CD, 2010
)
0.36
" It has been suggested that staggering administration of clopidogrel and omeprazole may overcome this pharmacodynamic (PD) interaction."( Pharmacodynamic effects of concomitant versus staggered clopidogrel and omeprazole intake: results of a prospective randomized crossover study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Charlton, RK; Darlington, A; Desai, B; Dharmashankar, K; Ferreiro, JL; Ueno, M, 2010
)
0.36
" John's wort (SJW), a CYP2C19 and CYP3A4 inducer, enhances the pharmacodynamic response of clopidogrel."( The effect of St John's Wort on the pharmacodynamic response of clopidogrel in hyporesponsive volunteers and patients: increased platelet inhibition by enhancement of CYP3A4 metabolic activity.
Gurbel, PA; Lau, WC; Rubenfire, M; Shields, T; Tantry, US; Welch, TD, 2011
)
0.37
"This report is the first to demonstrate the superior pharmacodynamic effect of ticagrelor compared with clopidogrel irrespective of CYP2C19 genotype."( First analysis of the relation between CYP2C19 genotype and pharmacodynamics in patients treated with ticagrelor versus clopidogrel: the ONSET/OFFSET and RESPOND genotype studies.
Armstrong, M; Bliden, KP; Butler, K; Gurbel, PA; Storey, RF; Tantry, US; Wei, C, 2010
)
0.36
" Clopidogrel significantly increased the half-life (242% of control phase) and area under the plasma concentration-time curve from 0 to infinity (AUC(inf)) (227% of control phase) of sibutramine and decreased the apparent oral clearance (31% of control phase) of sibutramine."( Effects of clopidogrel on the pharmacokinetics of sibutramine and its active metabolites.
Bae, JW; Jang, CG; Lee, SY, 2011
)
0.37
" The aim of this study was to perform serial pharmacodynamic assessments of prasugrel with high-dose clopidogrel in patients with DM."( A pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 Trial.
Angiolillo, DJ; Badimon, JJ; Baker, BA; Effron, MB; Frelinger, AL; Jakubowski, JA; Michelson, AD; Ojeh, CK; Saucedo, JF; Zhu, B, 2011
)
0.37
" This has led to the development of other P2Y12 receptor inhibitors, such as prasugrel and ticagrelor, with different pharmacokinetic characteristics that influence their pharmacodynamics."( Beyond efficacy: pharmacokinetic differences between clopidogrel, prasugrel and ticagrelor.
Cohen Arazi, H; Di Girolamo, G; Giorgi, MA; Gonzalez, CD, 2011
)
0.37
" However, the pharmacokinetic advantages of both prasugrel and ticagrelor allow clinicians to center patient management by selecting the best drug for the appropriate subject."( Beyond efficacy: pharmacokinetic differences between clopidogrel, prasugrel and ticagrelor.
Cohen Arazi, H; Di Girolamo, G; Giorgi, MA; Gonzalez, CD, 2011
)
0.37
" The pharmacokinetic profile of the thienopyridine clopidogrel has resulted in highly variable pharmacokinetics and efficacy responses."( Pharmacokinetics, drug metabolism, and safety of prasugrel and clopidogrel.
Achar, S, 2011
)
0.37
" The aim of this study was to assess the impact of CCB therapy on the pharmacodynamic effect and the clinical efficacy of clopidogrel after drug-eluting stent placement."( Lack of impact of calcium-channel blockers on the pharmacodynamic effect and the clinical efficacy of clopidogrel after drug-eluting stenting.
Bernlochner, I; Kastrati, A; Mehilli, J; Morath, T; Neumann, L; Sarafoff, N; Schömig, A; Sibbing, D, 2011
)
0.37
" The primary pharmacodynamic end point was adenosine diphosphate-induced platelet aggregation (in AU · min) with multiple electrode platelet aggregometry after loading with 600 mg clopidogrel."( Lack of impact of calcium-channel blockers on the pharmacodynamic effect and the clinical efficacy of clopidogrel after drug-eluting stenting.
Bernlochner, I; Kastrati, A; Mehilli, J; Morath, T; Neumann, L; Sarafoff, N; Schömig, A; Sibbing, D, 2011
)
0.37
" In the present study, we evaluated the possible pharmacokinetic interactions of Danshen extract with docetaxel and clopidogrel in rats."( Danshen extract does not alter pharmacokinetics of docetaxel and clopidogrel, reflecting its negligible potential in P-glycoprotein- and cytochrome P4503A-mediated herb-drug interactions.
Jang, YP; Kim, HJ; Lee, JH; Lee, YJ; Oh, JH; Shin, YJ, 2011
)
0.37
"Safety concerns have recently emerged based on a drug interaction between clopidogrel and proton pump inhibitors leading to reduced pharmacodynamic effects."( Pharmacodynamic evaluation of pantoprazole therapy on clopidogrel effects: results of a prospective, randomized, crossover study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Charlton, RK; Darlington, A; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, MK; Pham, JP; Seecheran, N; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2011
)
0.37
"Pantoprazole therapy used at high doses is not associated with modulation of the pharmacodynamic effects of clopidogrel, irrespective of timing of drug administration."( Pharmacodynamic evaluation of pantoprazole therapy on clopidogrel effects: results of a prospective, randomized, crossover study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Charlton, RK; Darlington, A; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, MK; Pham, JP; Seecheran, N; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2011
)
0.37
"Population pharmacokinetic (PK) and pharmacodynamic (PD) modeling of clopidogrel was developed from pooled data from healthy volunteers (n = 44) and stroke patients (n = 35)."( Population pharmacokinetic/pharmacodynamic modeling of clopidogrel in Korean healthy volunteers and stroke patients.
Han, S; Hwang, Y; Kang, W; Lee, HW; Lee, J; Lim, MS; Seong, SJ; Sohn, DR; Yim, DS; Yoon, YR, 2012
)
0.38
" This article provides an overview on antiplatelet drug response variability, an update on definitions, including the role of pharmacodynamic testing, underlying mechanisms - with emphasis on recent understandings on pharmacogenetics and drug-drug interactions - and current and future perspectives on individualized antiplatelet therapy."( Antiplatelet drug therapy: role of pharmacodynamic and genetic testing.
Angiolillo, DJ; Tello-Montoliu, A; Ueno, M, 2011
)
0.37
"Prasugrel demonstrated higher active metabolite exposure and more consistent pharmacodynamic response across all three predicted phenotype groups compared with clopidogrel, confirming observations from previous research that CYP2C19 phenotype plays an important role in variability of response to clopidogrel, but has no impact on response to prasugrel."( Pharmacokinetics and pharmacodynamics following maintenance doses of prasugrel and clopidogrel in Chinese carriers of CYP2C19 variants.
Close, SL; Farid, NA; Ho, M; Jakubowski, JA; Kelly, RP; Natanegara, F; Shen, L; Small, DS; Walker, JR; Winters, KJ, 2012
)
0.38
" Other pharmacokinetic parameters estimated for FA were also altered by the coadministrations, but no statistically significant differences were observed."( Pharmacokinetics of ferulic acid and potential interactions with Honghua and clopidogrel in rats.
Li, Y; Liu, C; Mi, S; Wang, N; Zhang, Y, 2011
)
0.37
" The present first-in-human study assessed the pharmacokinetic and pharmacodynamic effects of PM103 and its safety in 144 healthy human subjects."( Pharmacokinetics and platelet aggregation inhibitory effects of a novel intravenous formulation of clopidogrel in humans.
Adams, MP; Cooper, WD; Cushing, DJ; Kowey, PR; Machatha, S; Mosher, GL; Souney, PF; Zhang, B, 2012
)
0.38
" The pharmacokinetic and pharmacodynamic effects of clopidogrel have been significantly influenced by the enzyme activity of the ABCB1 C3435T and the CYP2C19 system."( Interaction analysis between genetic polymorphisms and pharmacodynamic effect in patients treated with adjunctive cilostazol to dual antiplatelet therapy: results of the ACCEL-TRIPLE (Accelerated Platelet Inhibition by Triple Antiplatelet Therapy Accordin
Hwang, JY; Hwang, SJ; Jeong, YH; Kim, IS; Kim, S; Koh, EH; Kwak, CH; Kwon, TJ; Park, JR; Park, Y; Yoon, SE, 2012
)
0.38
" This study aimed to define pharmacodynamic (PD) profiles, including high platelet reactivity (HPR) rates, among elderly patients on maintenance clopidogrel therapy and to assess the PD effects of prasugrel 5 mg/day in elderly with HPR."( Platelet function profiles in the elderly: results of a pharmacodynamic study in patients on clopidogrel therapy and effects of switching to prasugrel 5 mg in patients with high platelet reactivity.
Angiolillo, DJ; Calvi, V; Capodanno, D; Capranzano, P; D'Urso, L; Miccichè, E; Tamburino, C, 2011
)
0.37
" However, if cilostazol exerts different pharmacodynamic (PD) effects according to levels of on-treatment platelet reactivity remains unknown."( Pharmacodynamic effects of adjunctive cilostazol therapy in patients with coronary artery disease on dual antiplatelet therapy: impact of high on-treatment platelet reactivity and diabetes mellitus status.
Angiolillo, DJ; Capodanno, D; Capranzano, P; Darlington, A; Desai, B; Dharmashankar, K; Ferreiro, JL; Rollini, F; Tello-Montoliu, A; Ueno, M, 2013
)
0.39
" If cigarette smoking is associated with a dose-response effect on pharmacodynamic measures in clopidogrel-treated patients is unknown."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
"A dose-response effect was observed for all pharmacodynamic parameters tested."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
" Pharmacodynamic end-points were vasodilator-stimulated phosphoprotein P2Y(12) platelet reactivity index, maximal platelet aggregation to 5 and 20 μmol/l adenosine diphosphate, and VerifyNow P2Y12 platelet response units."( A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Bhatt, DL; Brooks, JK; Frelinger, AL; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2012
)
0.38
"Pharmacokinetic and pharmacodynamic responses with omeprazole demonstrated assay sensitivity."( A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Bhatt, DL; Brooks, JK; Frelinger, AL; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2012
)
0.38
" In the ONSET-OFFSET study (parallel group trial) and the RESPOND study (crossover trial), the pharmacodynamic effects of ticagrelor were compared with clopidogrel in patients with coronary artery disease (CAD)."( Pharmacokinetics and pharmacodynamics of ticagrelor in patients with stable coronary artery disease: results from the ONSET-OFFSET and RESPOND studies.
Bliden, K; Butler, K; Gurbel, PA; Husted, SE; Høimark, L; Storey, RF; Tantry, US; Teng, R; Wei, C, 2012
)
0.38
" Expression of the 3435T/T genetic variant encoding the MDR1 gene for the P-glycoprotein efflux transporter results in a significantly reduced maximum drug concentration and area under the plasma concentration-time curve as intestinal absorption of clopidogrel is reduced; and the expression of the mutant *2 allele of CYP2C19 results in similar pharmacokinetic effects as the two cytochrome P450 (CYP)-mediated steps required for the production of the active metabolite of clopidogrel are impaired."( Comparative pharmacokinetics and pharmacodynamics of platelet adenosine diphosphate receptor antagonists and their clinical implications.
Ferro, A; Floyd, CN; Passacquale, G, 2012
)
0.38
" A prospectively designed platelet function substudy was performed in a selected cohort of patients to provide insight into the pharmacodynamic effects of cangrelor, particularly in regard to whether cangrelor therapy may interfere with the inhibitory effects of clopidogrel."( Pharmacodynamic effects of cangrelor and clopidogrel: the platelet function substudy from the cangrelor versus standard therapy to achieve optimal management of platelet inhibition (CHAMPION) trials.
Angiolillo, DJ; Becker, RC; Bhatt, DL; French, WJ; Harrington, RA; Huber, K; Liu, T; Prats, J; Price, MJ; Saucedo, JF; Schneider, DJ; Shaburishvili, T, 2012
)
0.38
"This substudy of the Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability and Efficacy in Nonurgent Percutaneous Coronary Intervention patients (INNOVATE-PCI) trial evaluated the pharmacokinetic and pharmacodynamic effects of two dosing regimens of IV followed by oral elinogrel (120 mg IV plus 100 mg oral twice daily; 120 mg IV plus 150 mg oral twice daily) versus standard clopidogrel therapy (300-600 mg oral loading dose plus 75 mg oral maintenance dose) in 56 patients undergoing nonurgent PCI."( Pharmacokinetic and pharmacodynamic effects of elinogrel: results of the platelet function substudy from the intravenous and oral administration of elinogrel to evaluate tolerability and efficacy in nonurgent percutaneous coronary intervention patients (I
Angiolillo, DJ; Broderick, S; Buerke, M; Conley, PB; Dabrowski, M; Gurbel, PA; Harrington, RA; Jennings, LK; Kochman, J; McClure, MW; Neumann, FJ; Rao, SV; Saucedo, JF; Stephens, G; Stumpf, J; Trenk, D; Welsh, RC; Wójcik, J, 2012
)
0.38
"To evaluate the pharmacokinetic and pharmacodynamic effects of concomitant administration of single loading doses of clopidogrel or multiple doses of clopidogrel with multiple doses of dabigatran etexilate."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013
)
0.39
"3-131%), as did its pharmacodynamic effects on the inhibition of platelet aggregation."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013
)
0.39
"When given concomitantly, dabigatran etexilate and clopidogrel at clinically relevant doses did not appear to have significant effects on the pharmacokinetic and pharmacodynamic profiles of either agent."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013
)
0.39
"As ticagrelor, clopidogrel and cangrelor therapies may be used in the same clinical setting, their potential pharmacodynamic interactions are of interest."( Evaluation of ticagrelor pharmacodynamic interactions with reversibly binding or non-reversibly binding P2Y(12) antagonists in an ex-vivo canine model.
Emanuelsson, BM; Ravnefjord, A; van Giezen, JJ; Weilitz, J, 2012
)
0.38
" No pharmacodynamic interaction occurred between ticagrelor and cangrelor."( Evaluation of ticagrelor pharmacodynamic interactions with reversibly binding or non-reversibly binding P2Y(12) antagonists in an ex-vivo canine model.
Emanuelsson, BM; Ravnefjord, A; van Giezen, JJ; Weilitz, J, 2012
)
0.38
"The extent of the pharmacodynamic drug-drug interactions observed between clopidogrel and cangrelor or ticagrelor apparently depends on the level of receptor occupancy when clopidogrel is administered."( Evaluation of ticagrelor pharmacodynamic interactions with reversibly binding or non-reversibly binding P2Y(12) antagonists in an ex-vivo canine model.
Emanuelsson, BM; Ravnefjord, A; van Giezen, JJ; Weilitz, J, 2012
)
0.38
" The pharmacokinetic (PK) characteristics of clopidogrel have been studied previously in whites or Korean volunteers, but these PK characteristics may not be fully extrapolated to the Chinese people."( Pharmacokinetics of clopidogrel in healthy Chinese volunteers.
Chen, SL; Ding, L; Fan, HW; Tan, J; Wang, GJ; Zou, JJ, 2012
)
0.38
" The measured pharmacokinetic parameters did not differ significantly between the clopidogrel besylate and clopidogrel bisulfate groups."( Comparative pharmacokinetics/pharmacodynamics of clopidogrel besylate and clopidogrel bisulfate in healthy Korean subjects.
Cho, JY; Jang, IJ; Kim, BH; Kim, JR; Lim, KS; Shin, HS; Shin, SG; Yoon, SH; Yu, KS, 2012
)
0.38
"In this study, we investigated pharmacokinetic drug interactions of clopidogrel with P-gp inhibitors in rats and dogs."( Pharmacokinetic interactions of clopidogrel with quercetin, telmisartan, and cyclosporine A in rats and dogs.
Lee, JH; Lee, YJ; Oh, JH; Shin, YJ, 2012
)
0.38
" At steady-state ticagrelor (50 mg bid, or 200 mg bid), concomitant aspirin (300 mg qd) had no effect on mean maximum plasma concentration (Cmax), median time to Cmax (tmax), or mean area under the plasma concentration-time curve for the dosing interval (AUC0-τ) for ticagrelor and its primary metabolite, AR-C124910XX."( Evaluation of the pharmacokinetics and pharmacodynamics of ticagrelor co-administered with aspirin in healthy volunteers.
Butler, K; Maya, J; Teng, R, 2013
)
0.39
"Healthy subjects (n = 160; ages 20 to 53 years; homozygous CYP2C19 extensive metabolizer genotype; no nicotine for 6 weeks, prescription drugs for 4 weeks, over-the-counter drugs for 2 weeks, and no caffeine or alcohol for 72 h; confined; restricted diet) received clopidogrel 75 mg/day for 9 days, at which time clopidogrel pharmacokinetic and pharmacodynamic endpoints were measured."( Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet f
Barnard, MR; Bhatt, DL; Brooks, JK; Frelinger, AL; Lampa, M; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2013
)
0.39
" All identified factors together accounted for only 18% of intersubject variation in pharmacokinetic parameters and 32% to 64% of intersubject variation in PRI, MPA, and PRU."( Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet f
Barnard, MR; Bhatt, DL; Brooks, JK; Frelinger, AL; Lampa, M; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2013
)
0.39
"Previous studies involving a loading dose (LD) of 60 mg prasugrel have suggested that active metabolite exposure and pharmacodynamic responses may be higher in persons of Asian ethnicity than in Caucasian subjects."( Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers.
Jung, DK; Kim, MH; Zhang, HZ, 2013
)
0.39
"The goal of this study was to investigate the impact of high-dose atorvastatin on the pharmacodynamic (PD) effects of double-dose clopidogrel in statin-naive patients with stable coronary artery disease (CAD) and high-on-treatment platelet reactivity (HTPR) while on standard-dose clopidogrel before percutaneous coronary intervention (PCI)."( High-dose atorvastatin on the pharmacodynamic effects of double-dose clopidogrel in patients undergoing percutaneous coronary interventions: The ACHIDO (Atorvastatin and Clopidogrel HIgh DOse in stable patients with residual high platelet activity) study.
Abbate, R; Angiolillo, DJ; Bellandi, F; Giusti, B; Leoncini, M; Maioli, M; Marcucci, R; Toso, A, 2013
)
0.39
" Most pharmacokinetic and pharmacodynamic studies in vivo were conducted using small sample sizes and were single centered, resulting in conflicting data."( Pharmacodynamic impacts of proton pump inhibitors on the efficacy of clopidogrel in vivo--a systematic review.
Chen, J; Chen, SY; Lian, JJ; Luo, TC; Zeng, XQ, 2013
)
0.39
" Randomized controlled trials that compared pharmacodynamic impacts of a PPI on the efficacy of clopidogrel in vivo were included."( Pharmacodynamic impacts of proton pump inhibitors on the efficacy of clopidogrel in vivo--a systematic review.
Chen, J; Chen, SY; Lian, JJ; Luo, TC; Zeng, XQ, 2013
)
0.39
" A population pharmacokinetic (PK) model was developed using NONMEM(®) to describe the time course of clopidogrel-IM in plasma and to design a sparse-sampling strategy to predict clopidogrel-IM exposures for use in characterizing anti-platelet activity."( Population pharmacokinetic analysis of clopidogrel in healthy Jordanian subjects with emphasis optimal sampling strategy.
Arafat, T; Melhem, M; Reynolds, DK; Van Wart, SA; Xue, B; Yousef, AM, 2013
)
0.39
" The validated assay was successfully applied to the quantification of all four thiol metabolites in human plasma in support of a human pharmacokinetic study."( A validated HPLC-MS/MS assay for quantifying unstable pharmacologically active metabolites of clopidogrel in human plasma: application to a clinical pharmacokinetic study.
Arnold, ME; Furlong, MT; Kadiyala, P; Mariannino, T; Mylott, W; Roongta, V; Savant, I; Scott, L; Yuan, M, 2013
)
0.39
"This study assessed pharmacodynamic (PD) response to the reduced prasugrel maintenance dose of 5 mg in very elderly (VE) patients (≥75 years of age)."( Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients.
Angiolillo, DJ; Brown, PB; Erlinge, D; Foley, DP; Gurbel, PA; Jakubowski, JA; James, S; Lindahl, TL; Luo, J; Moser, BA; Small, DS; Svensson, P; Ten Berg, JM; Wagner, H; Winters, KJ; Zhou, C, 2013
)
0.39
"To assess the impact of smoking on clinical and pharmacodynamic response to clopidogrel."( The impact of smoking on clinical efficacy and pharmacodynamic effects of clopidogrel: a systematic review and meta-analysis.
Chai, H; Chen, M; Huang, DJ; Li, Q; Liu, W; Luo, XL; Peng, Y; Ren, X; Wang, XQ; Zhang, C; Zhao, ZG, 2014
)
0.4
"Smoking appears to positively modify the relative clinical efficacy and pharmacodynamic effects of clopidogrel."( The impact of smoking on clinical efficacy and pharmacodynamic effects of clopidogrel: a systematic review and meta-analysis.
Chai, H; Chen, M; Huang, DJ; Li, Q; Liu, W; Luo, XL; Peng, Y; Ren, X; Wang, XQ; Zhang, C; Zhao, ZG, 2014
)
0.4
"This article is an overview of currently used antithrombotic therapies in the management of ischaemic stroke with special focus on their pharmacokinetic properties and how these properties may influence their clinical utility."( Pharmacokinetic considerations for antithrombotic therapies in stroke.
Apostolakis, S; Lip, GY; Shantsila, E, 2013
)
0.39
"This study examined the effects of curcumin on the pharmacokinetic and pharmacodynamic properties of warfarin and clopidogrel in Wistar rats."( Curcumin alters the pharmacokinetics of warfarin and clopidogrel in Wistar rats but has no effect on anticoagulation or antiplatelet aggregation.
Liu, AC; Lou, HX; Zhao, LX, 2013
)
0.39
" In patients with high on-treatment platelet reactivity (HTPR) while on standard-dose clopidogrel, high-dose atorvastatin enhances the pharmacodynamic (PD) effects of double-dose clopidogrel."( Pharmacodynamic effects of adjunctive high dose atorvastatin on double dose clopidogrel in patients with high on-treatment platelet reactivity depending on diabetes mellitus status.
Abbate, R; Angiolillo, DJ; Bellandi, F; Giusti, B; Leoncini, M; Maioli, M; Marcucci, R; Toso, A, 2014
)
0.4
"This study was designed to compare the pharmacokinetic properties and safety profile of a fixed-dose combination formulation of ASA and clopidogrel with concurrent administration of each agent in healthy male Korean volunteers."( The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, si
Huh, W; Jung, JA; Kim, JR; Kim, MJ; Kim, TE; Ko, JW; Lee, SY; Park, KM, 2013
)
0.39
" However, the effects of EV-077 on pharmacodynamic (PD) profiles in patients with DM and coronary artery disease (CAD) while on antiplatelet therapy is poorly explored and represented the aim of this in vitro pilot investigation."( Pharmacodynamic effects of EV-077 in patients with diabetes mellitus and coronary artery disease on aspirin or clopidogrel monotherapy: results of an in vitro pilot investigation.
Angiolillo, DJ; Bender, N; Darlington, A; Desai, B; Franchi, F; Muñiz-Lozano, A; Patel, R; Rollini, F; Sakariassen, KS; Tello-Montoliu, A; Wilson, RE, 2014
)
0.4
" There was no significant difference in the pharmacodynamic effects of clopidogrel on platelet reactivity from baseline to 6-months follow-up (297 ± 57 vs."( Pharmacodynamic effect of clopidogrel in patients undergoing transcatheter aortic valve implantation.
Bednar, F; Kocka, V; Linkova, H; Sulzenko, J; Tousek, P; Widimsky, P, 2013
)
0.39
" The calculated concentrations were used to determine the pharmacokinetic parameters of the analytes."( Clinical pharmacokinetics of clopidogrel and its metabolites in patients with cardiovascular diseases.
Burchardt, P; Danielak, D; Główka, F; Karaźniewicz-Łada, M; Komosa, A; Kruszyna, L; Lesiak, M, 2014
)
0.4
" To observe whether antithrombin agents affect the pharmacokinetic and pharmacodynamic properties of batifiban in combination therapy and optimize clinical administration dosage of batifiban, an open-label and parallel study was conducted."( Pharmacokinetic and pharmacodynamic properties of batifiban coadministered with antithrombin agents in Chinese healthy volunteers.
Chen, H; Chen, K; He, XM; Jia, MM; Li, J; Li, SF; Li, WY; Liu, MZ; Wang, YH; Wu, SL; Zhou, Y, 2013
)
0.39
" A population pharmacokinetic (PK) model was developed from a randomized, cross-over, drug-interaction study in healthy male Korean subjects (n = 17)."( Population pharmacogenetic-based pharmacokinetic modeling of efavirenz, 7-hydroxy- and 8-hydroxyefavirenz.
Abdelhady, AM; Desta, Z; Jiang, F; Overholser, BR; Shin, JG; Yeo, CW, 2014
)
0.4
"Increased body weight is independently associated with impaired clopidogrel pharmacodynamic (PD) response."( Pharmacodynamic effects of standard dose prasugrel versus high dose clopidogrel in non-diabetic obese patients with coronary artery disease.
Angiolillo, DJ; Bass, TA; Darlington, A; Desai, B; Ferreiro, JL; Guzman, LA; Patel, R; Rollini, F; Tello-Montoliu, A; Ueno, M, 2014
)
0.4
" The AUC0-24 and Cmax of active clopidogrel metabolite decreased with both omeprazole and rabeprazole, and conditions of bioequivalence were not met, except for AUC0-24 with rabeprazole."( Effects of rabeprazole on the antiplatelet effects and pharmacokinetics of clopidogrel in healthy volunteers.
Azizi, M; Ducint, D; Funck-Brentano, C; Gaussem, P; Molimard, M; Remones, V; Steichen, O; Szymezak, J, 2013
)
0.39
" However, under our experimental conditions and proton-pump inhibitor doses, there was no significant pharmacodynamic interaction between rabeprazole or omeprazole and clopidogrel, despite a significant decrease in the formation of clopidogrel active metabolite."( Effects of rabeprazole on the antiplatelet effects and pharmacokinetics of clopidogrel in healthy volunteers.
Azizi, M; Ducint, D; Funck-Brentano, C; Gaussem, P; Molimard, M; Remones, V; Steichen, O; Szymezak, J, 2013
)
0.39
" This investigation aimed to evaluate the effect of hypothermia on the pharmacodynamic response of aspirin and clopidogrel in patients (n = 20) with ST elevation myocardial infarction undergoing primary PCI."( Impact of mild hypothermia on platelet responsiveness to aspirin and clopidogrel: an in vitro pharmacodynamic investigation.
Angiolillo, DJ; Ariza, A; Cequier, A; Ferreiro, JL; Gómez-Hospital, JA; Gómez-Lara, J; Gracida, M; Homs, S; Lorente, V; Marcano, AL; Rivera, K; Romaguera, R; Roura, G; Sánchez-Elvira, G; Sánchez-Salado, JC; Sosa, SG; Teruel, L, 2014
)
0.4
" We verified if the pharmacodynamic effects of CYP3A4-metabolized statins (atorvastatin) and non-CYP3A4-metabolized statins (pitavastatin) differ in patients with coronary artery disease (CAD) treated with DAPT."( Pharmacodynamic comparison of pitavastatin versus atorvastatin on platelet reactivity in patients with coronary artery disease treated with dual antiplatelet therapy.
Franzoni, F; Gaudio, C; Greco, C; Marazzi, G; Pelliccia, F; Polacco, M; Rosano, G; Speziale, G; Spoletini, I; Vitale, C, 2014
)
0.4
"Smokers have a greater relative benefit of clopidogrel therapy compared with nonsmokers, likely attributed to its enhanced pharmacodynamic (PD) effects."( Cigarette smoking and antiplatelet effects of aspirin monotherapy versus clopidogrel monotherapy in patients with atherosclerotic disease: results of a prospective pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Bhatti, M; Cho, JR; Darlington, A; Degroat, C; Desai, B; Ferrante, E; Ferreiro, J; Franchi, F; Guzman, LA; Muniz-Lozano, A; Patel, R; Rollini, F; Tello-Montoliu, A; Zenni, MM, 2014
)
0.4
"This article focuses on the pharmacokinetics of prasugrel and recently published pharmacodynamic and clinical studies."( Pharmacokinetic evaluation of prasugrel for the treatment of myocardial infarction.
Coons, JC; Harris, J; Schwier, N; Seybert, AL, 2014
)
0.4
"Prasugrel exhibits favorable pharmacokinetic and pharmacodynamic properties compared to clopidogrel."( Pharmacokinetic evaluation of prasugrel for the treatment of myocardial infarction.
Coons, JC; Harris, J; Schwier, N; Seybert, AL, 2014
)
0.4
"In patients referred for PPCI, ticagrelor bolus following clopidogrel resulted in more rapid and profound platelet inhibition, demonstrating a positive pharmacodynamic interaction."( A comparative pharmacodynamic study of ticagrelor versus clopidogrel and ticagrelor in patients undergoing primary percutaneous coronary intervention: the CAPITAL RELOAD study.
Blondeau, M; Dick, A; Froeschl, M; Glover, C; Hibbert, B; Labinaz, M; Le May, MR; Marquis, JF; Maze, R; Moudgil, R; Pourdjabbar, A; Ramirez, FD; Simard, T; So, DY, 2014
)
0.4
" Pharmacokinetic effects were estimated by measuring active metabolite of clopidogrel, and pharmacodynamic effects by inhibition of adenosine diphosphate (ADP)-induced platelet aggregation."( Effect of esomeprazole with/without acetylsalicylic acid, omeprazole and lansoprazole on pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Andersson, T; Galbraith, H; Nagy, P; Niazi, M; Nylander, S; Ranjan, S; Wallentin, L, 2014
)
0.4
" Here, we assessed effects of CYP2C19 metaboliser status on pharmacokinetics (PK) and pharmacodynamic (PD) responses to prasugrel 5-mg and 10-mg and clopidogrel 75-mg using data from two PK/PD studies in stable coronary artery disease (CAD) patients (GENERATIONS and FEATHER)."( The effect of CYP2C19 gene polymorphisms on the pharmacokinetics and pharmacodynamics of prasugrel 5-mg, prasugrel 10-mg and clopidogrel 75-mg in patients with coronary artery disease.
Angiolillo, DJ; Bergmeijer, TO; Brown, PB; Duvvuru, S; Erlinge, D; Gurbel, PA; Jakubowski, JA; James, S; Lindahl, TL; Moser, BA; Small, D; Sundseth, S; Svensson, P; Tantry, US; ten Berg, JM; Walker, JR; Winters, KJ, 2014
)
0.4
" Neither the absolute ADP-induced P2Y12 receptor-activated platelet aggregation, exposure to CAMD nor the pharmacokinetic parameters of proguanil, cycloguanil and 4-CPB exhibited any significant differences among the genotype groups."( CYP2C19*17 increases clopidogrel-mediated platelet inhibition but does not alter the pharmacokinetics of the active metabolite of clopidogrel.
Brosen, K; Damkier, P; el Achwah, AB; Nielsen, F; Pedersen, RS; Stage, TB; Vinholt, PJ, 2014
)
0.4
" The serum concentrations of IVA and N-demethyl ivabradine were determined by ultra-performance liquid chromatography-mass spectrometry and pharmacokinetic parameters were calculated using DASver3."( The effect of clopidogrel on pharmacokinetics of ivabradine and its metabolite in rats.
Chen, H; Hu, GX; Huang, CK; Lian, QQ; Shang-Guan, WN; Sun, W; Wang, Z; Wang, ZS; Zhang, XD; Zhu, GH, 2015
)
0.42
"The objective was to compare the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ticagrelor with clopidogrel among subjects of Hispanic ethnicity, as the PD and PK effects of antiplatelet agents among Hispanics are not specifically known."( A randomised trial of the pharmacodynamic and pharmacokinetic effects of ticagrelor compared with clopidogrel in Hispanic patients with stable coronary artery disease.
Angiolillo, DJ; Caplan, R; Carlson, G; Clavijo, L; Maya, J; Price, MJ; Teng, R, 2015
)
0.42
" This review considers pharmacodynamic and clinical data to guide clinicians when switching between antiplatelet drugs is considered."( Pharmacodynamic and clinical implications of switching between P2Y12 receptor antagonists: considerations for practice.
Bagai, A; Chua, D; Cohen, EA; Fitchett, D; Saw, J; Verma, S; Vijayaraghavan, R; Welsh, R, 2014
)
0.4
" The aim of this study was to evaluate the pharmacodynamic profile of 5 different anti-platelet treatments in the acute phase of STEMI in patients undergoing primary PCI."( A pharmacodynamic comparison of 5 anti-platelet protocols in patients with ST-elevation myocardial infarction undergoing primary PCI.
Andell, P; Björnsson, S; Erlinge, D; Götberg, M; Harnek, J; Koul, S; Martinsson, A; Norström, E; Scherstén, F; Smith, JG, 2014
)
0.4
" The covariates including demographic characteristics, laboratory indexes, combined medication, complications and genetic polymorphisms of related enzymes were screened for their influence on the pharmacokinetic and pharmacodynamics parameters."( [Population pharmacokinetics and pharmacodynamics of clopidogrel in patients with acute coronary syndrome].
Ding, XL; Gao, J; Hang, YF; Jiang, B; Miao, LY; Xie, C; Xue, L, 2014
)
0.4
" In the present study, a dynamic physiologically based pharmacokinetic (PBPK) model was developed in Simcyp for clopidogrel and clopi-H4 using a specific sequential metabolite module in four populations with phenotypically different CYP2C19 activity (poor, intermediate, extensive, and ultrarapid metabolizers) receiving a loading dose of 300 mg followed by a maintenance dose of 75 mg."( Physiologically based pharmacokinetic modeling for sequential metabolism: effect of CYP2C19 genetic polymorphism on clopidogrel and clopidogrel active metabolite pharmacokinetics.
Boulenc, X; Djebli, N; Fabre, D; Fabre, G; Hurbin, F; Sultan, E, 2015
)
0.42
" The method was applicable for the quality control of the mentioned drugs in raw material, bulk drug and pharmaceutical formulations as well as in pharmacokinetic studies."( Liquid Chromatographic Method for Simultaneous Quantitation of Clopidogrel, Aspirin and Atorvastatin in Rat Plasma and Its Application to the Pharmacokinetic Study.
Akhalaque Ahmad, RA; Chatpalliwar, VA; Chhajed, SS; Porwal, PK, 2015
)
0.42
" Clopidogrel carboxylic acid was used for the pharmacokinetic study of clopidogrel."( Effect of fluvoxamine on the pharmacokinetics and pharmacodynamics of clopidogrel in rats.
Bai, X; Chen, F; Fang, C; Han, M; Liu, M; Yang, G; Yang, Y; Zhao, J; Zhu, Q, 2015
)
0.42
" The ginsenoside Rg, from FDDP was determined by HPLC and its pharmacokinetic parameter were finally compared."( [Effect of Clopidogrel on Pharmacokinetic of Fufang Danshen Dripping Pill (FDDP)].
Dai, GL; Ju, WZ; Ma, ST; Sun, BT; Tan, HS; Zhao, WZ, 2014
)
0.4
"Long term with clopidogrel has effect on the pharmacokinetic character of Rg, from FDDP, this research may provides theoretical support for the FDDP-clopidogrel combination treatment in clinical."( [Effect of Clopidogrel on Pharmacokinetic of Fufang Danshen Dripping Pill (FDDP)].
Dai, GL; Ju, WZ; Ma, ST; Sun, BT; Tan, HS; Zhao, WZ, 2014
)
0.4
" Among the heterozygous CYP2C19*2 subjects, all pharmacodynamic parameters measured by whole blood impedance aggregometry were significantly different between subjects with different CYP3A5*3 genotypes."( The impact of genetic polymorphisms of drug metabolizing enzymes on the pharmacodynamics of clopidogrel under steady state conditions.
Kanjanawart, S; Nakkam, N; Tassaneeyakul, W; Tiamkao, S; Vannaprasaht, S, 2015
)
0.42
" Clopidogrel 75 mg (day 3) had no significant effect on the pharmacokinetic variables of simvastatin or simvastatin acid compared with placebo."( Clopidogrel Has No Clinically Meaningful Effect on the Pharmacokinetics of the Organic Anion Transporting Polypeptide 1B1 and Cytochrome P450 3A4 Substrate Simvastatin.
Backman, JT; Itkonen, MK; Neuvonen, M; Neuvonen, PJ; Niemi, M; Tornio, A, 2015
)
0.42
" Pharmacodynamic studies have shown that this interaction is avoided when clopidogrel is given at the end of the cangrelor infusion."( Pharmacodynamic Effects When Clopidogrel is Given Before Cangrelor Discontinuation.
Agarwal, Z; Gogo, P; Schneider, DJ; Seecheran, N, 2015
)
0.42
"The primary objective of the present study was to evaluate the pharmacokinetic and pharmacodynamic interactions between clopidogrel and cilostazol in relation to the CYP2C19 and CYP3A5 genotypes."( The pharmacokinetic and pharmacodynamic interaction of clopidogrel and cilostazol in relation to CYP2C19 and CYP3A5 genotypes.
Ghim, JL; Kim, DH; Kim, EY; Kim, HS; Lim, Y; Oh, M; Shin, JG, 2016
)
0.43
" Plasma concentrations of clopidogrel, cilostazol and their active metabolites (clopidogrel thiol metabolite, 3,4-dehydrocilostazol and 4″-trans-hydroxycilostazol), and adenosine diphosphate-induced platelet aggregation were measured for pharmacokinetic and pharmacodynamic assessment."( The pharmacokinetic and pharmacodynamic interaction of clopidogrel and cilostazol in relation to CYP2C19 and CYP3A5 genotypes.
Ghim, JL; Kim, DH; Kim, EY; Kim, HS; Lim, Y; Oh, M; Shin, JG, 2016
)
0.43
"The aim of the present case report was to describe a novel pharmacokinetic drug–drug interaction between the antiplatelet agent clopidogrel and the antineoplastic agent paclitaxel."( Neurotoxicity and low paclitaxel clearance associated with concomitant clopidogrel therapy in a 60-year-old Caucasian woman with ovarian carcinoma.
Backman, J; Bergmann, TK; Brosen, K; Filppula, AM; Launiainen, T; Nielsen, F, 2016
)
0.43
" Pharmacodynamic assessments were conducted using three assays (vasodilator-stimulated phosphoprotein, VerifyNow P2Y12, and light transmittance aggregometry, LTA) at baseline, 30 min, 2, 24 h, and 1 week."( A head-to-head pharmacodynamic comparison of prasugrel vs. ticagrelor after switching from clopidogrel in patients with coronary artery disease: results of a prospective randomized study.
Angiolillo, DJ; Bass, TA; Bhatti, M; Cho, JR; DeGroat, C; Dunn, EC; Ferrante, E; Franchi, F; Guzman, LA; Muniz-Lozano, A; Rollini, F; Singh, K; Wilson, RE; Zenni, MM, 2016
)
0.43
" Pharmacodynamic effect was measured by an impedance method with a Multiplate analyzer."( Impact of CYP3A4*1G Allele on Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel.
Bergus, P; Burchardt, P; Danielak, D; Główka, F; Karaźniewicz-Łada, M; Komosa, A; Wiśniewska, K, 2017
)
0.46
" Pharmacokinetic parameters of clopidogrel and its metabolites were not significantly different in carriers of *1G allele, comparing to wt/wt homozygotes."( Impact of CYP3A4*1G Allele on Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel.
Bergus, P; Burchardt, P; Danielak, D; Główka, F; Karaźniewicz-Łada, M; Komosa, A; Wiśniewska, K, 2017
)
0.46
"CYP3A4*1G might not be a significant contributor to the variability in pharmacokinetic and pharmacodynamic response to clopidogrel therapy."( Impact of CYP3A4*1G Allele on Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel.
Bergus, P; Burchardt, P; Danielak, D; Główka, F; Karaźniewicz-Łada, M; Komosa, A; Wiśniewska, K, 2017
)
0.46
"In this review, we discuss the unique pharmacodynamic properties of several antiplatelet drugs with their possible potential molecular of mechanisms on inhibiting platelet aggregation."( The pharmacodynamics of antiplatelet compounds in thrombosis treatment.
Geraldine, P; Jayakumar, T; Sheu, JR; Yang, CH; Yen, TL, 2016
)
0.43
"To complete a systematic review evaluating the currently available evidence regarding the pharmacokinetic and pharmacodynamic activity of orally administered clopidogrel, prasugrel and ticagrelor during the acute phase of a myocardial infarction in relation to mechanical reperfusion with primary percutaneous coronary angioplasty."( Pharmacokinetics and pharmacodynamics of oral P2Y12 inhibitors during the acute phase of a myocardial infarction: A systematic review.
Cotton, JM; Cox, AR; Khan, N, 2016
)
0.43
"Twelve papers were included in our final analysis; seven relating to pharmacodynamic studies, one to a pharmacokinetic study and four to pharmacokinetic/pharmacodynamic studies."( Pharmacokinetics and pharmacodynamics of oral P2Y12 inhibitors during the acute phase of a myocardial infarction: A systematic review.
Cotton, JM; Cox, AR; Khan, N, 2016
)
0.43
" Plasma miR-142 was negatively associated with H4 Cmax (r = -0."( Plasma miR-142 accounting for the missing heritability of CYP3A4/5 functionality is associated with pharmacokinetics of clopidogrel.
Chen, JY; He, GD; Li, HP; Li, XX; Lin, HM; Liu, JE; Meng, JX; Tang, L; Tang, QJ; Wang, LY; Wu, H; Zhang, MZ; Zhong, SL; Zhong, WP, 2016
)
0.43
"Genetic variants in the pharmacokinetic (PK) mechanism are the main underlying factors affecting the antiplatelet response to clopidogrel."( Genomewide Association Study Identifies Novel Genetic Loci That Modify Antiplatelet Effects and Pharmacokinetics of Clopidogrel.
Chen, JY; He, GD; Lei, HP; Li, HP; Li, XX; Lin, HM; Liu, SW; Ma, DL; Mai, LP; Sun, S; Tang, L; Wang, XP; Wu, H; Zhang, B; Zhang, ZW; Zhong, SL; Zhong, WP; Zhou, HK, 2017
)
0.46
"Clopidogrel is a key antiplatelet drug that has substantial interpatient variability in pharmacodynamic response."( Obesity and Inflammation and Altered Clopidogrel Pharmacokinetics and Pharmacodynamics.
Monte, SV; Norgard, NB, 2017
)
0.46
"A number of reports have demonstrated that obesity is a risk factor for a reduced clopidogrel pharmacodynamic response."( Obesity and Inflammation and Altered Clopidogrel Pharmacokinetics and Pharmacodynamics.
Monte, SV; Norgard, NB, 2017
)
0.46
" This review encompasses the most recent updates on factors influencing pharmacokinetic and pharmacodynamic responses to clopidogrel."( Pharmacokinetic and Pharmacodynamic Responses to Clopidogrel: Evidences and Perspectives.
Chen, XP; Li, MP; Tang, J; Zhang, YJ, 2017
)
0.46
"In this single-center, prospective, randomized pharmacodynamic study, 52 ESRD patients on HD were prescribed clopidogrel (300mg loading dose [LD], then 75mg daily), standard-dose ticagrelor (180mg LD, then 90mg twice daily), or low-dose ticagrelor (90mg LD, then 90mg daily) for 14days."( The pharmacodynamics of low and standard doses of ticagrelor in patients with end stage renal disease on hemodialysis.
Ihm, CG; Jeong, KH; Kim, JB; Kim, JS; Kim, KS; Kim, W; Kim, WS; Lee, TW; Woo, JS, 2017
)
0.46
" This post hoc analysis investigated the pharmacodynamic effects of ticagrelor versus clopidogrel loading dose (LD) in troponin-negative acute coronary syndrome patients with or without DM undergoing percutaneous coronary intervention in the Ad Hoc PCI study."( Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention.
Angiolillo, DJ; Carlson, GF; Dangas, G; Franchi, F; Khan, ND; Mehran, R; Raveendran, G; Rollini, F; Sweeny, JM; Teng, R; Waksman, R; Zhao, Y, 2017
)
0.46
" A physiologically based pharmacokinetic (PBPK) model was developed for dasabuvir to evaluate the DDI potential with clopidogrel, the acyl-β-D glucuronide metabolite of which has been reported as a strong mechanism-based inhibitor of CYP2C8 based on an interaction with repaglinide."( Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction Between Clopidogrel and Dasabuvir.
Badri, P; Bow, D; Fischer, V; Fu, W; Shebley, M, 2017
)
0.46
" In the present study, a joint parent-metabolite population pharmacokinetic model was developed to adequately describe observed concentrations of clopidogrel and its active thiol metabolite (H4)."( Influence of genetic co-factors on the population pharmacokinetic model for clopidogrel and its active thiol metabolite.
Burchardt, P; Danielak, D; Graczyk-Szuster, A; Główka, F; Karaźniewicz-Łada, M; Komosa, A; Kruszyna, Ł; Lesiak, M, 2017
)
0.46
"Searching for pharmacokinetic interaction studies between clopidogrel and omeprazole in humans was performed in PubMed."( A pharmacokinetic model of drug-drug interaction between clopidogrel and omeprazole at CYP2C19 in humans.
Lohitnavy, M; Lohitnavy, O; Morasuk, T; Tangamornsuksan, W; Thiansupornpong, P, 2017
)
0.46
"Our clopidogrel-omeprazole pharmacokinetic interaction model with a description of competitive inhibition at CYP2C19 could successfully describe concentration-time courses from the selected datasets."( A pharmacokinetic model of drug-drug interaction between clopidogrel and omeprazole at CYP2C19 in humans.
Lohitnavy, M; Lohitnavy, O; Morasuk, T; Tangamornsuksan, W; Thiansupornpong, P, 2017
)
0.46
"The long-term pharmacodynamic effects of Ticagrelor versus Clopidogrel in patients undergoing early percutaneous coronary intervention (PCI) after fibrinolytic therapy is unknown."( Long-term pharmacodynamic effects of Ticagrelor versus Clopidogrel in fibrinolytic-treated STEMI patients undergoing early PCI.
Bagai, A; Booker, J; Cantor, WJ; Cheema, AN; Crawford, JJ; Dehghani, P; Goodman, SG; Harenberg, S; Kelly, S; Lavi, S; Lavoie, A; Mehta, SR; Pon, Q; Yang, A; Zimmermann, RH, 2018
)
0.48
" A sequential, open-label, and two-period pharmacokinetic drug interaction study was designed to compare clopidogrel pharmacokinetic parameters before and after 7 days of administration of Danshen capsules in twenty healthy male volunteers."( Effects of Danshen capsules on the pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Xu, M; Yu, HB; Zhang, LT; Zheng, XT; Zhong, ZF; Zhou, CH, 2018
)
0.48
" Thus, this prospective study sought to evaluate the pharmacodynamic effect of clopidogrel monotherapy in patients on phenprocoumon undergoing PCI and assessed clinical outcomes."( Pharmacodynamic safety of clopidogrel monotherapy in patients under oral anticoagulation with a vitamin K antagonist undergoing coronary stent implantation.
Abdelrazek, S; Bömicke, T; Chafai, A; Eltaweel, S; Ferenc, M; Hochholzer, W; Neumann, FJ; Stratz, C; Trenk, D; Valina, C, 2019
)
0.51
" Concentrations of clopidogrel and the clopidogrel active metabolite derivative (CAMD) were measured in each blood sample by use of liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were determined with a noncompartmental model."( Pharmacokinetics and competitive pharmacodynamics of ADP-induced platelet activation after oral administration of clopidogrel to horses.
Knych, HK; Kozikowski, TA; Norris, JW; Tablin, F; Watson, JL, 2019
)
0.51
"Although acid suppressants are needed to attenuate gastrointestinal bleeding (GIB) after percutaneous coronary intervention (PCI), pharmacodynamic interaction between clopidogrel and proton pump inhibitor (PPI) can increase the risk of high platelet reactivity (HPR)."( Influence of rabeprazole and famotidine on pharmacodynamic profile of dual antiplatelet therapy in clopidogrel-sensitive patients: The randomized, prospective, PROTECT trial.
Ahn, JH; Bae, JS; Hwang, JY; Hwang, SJ; Jang, JY; Jeong, YH; Kang, MG; Kim, KH; Koh, JS; Kwak, CH; Park, JR; Park, Y, 2020
)
0.56
"Possible interaction between clopidogrel and CYP3A4-metabolised atorvastatin or non-CYP3A4-metabolised rosuvastatin was investigated based on pharmacokinetic parameters of clopidogrel and its metabolites as well as the platelet reactivity test in patients undergoing coronary angiography/angioplasty."( Influence of statin treatment on pharmacokinetics and pharmacodynamics of clopidogrel and its metabolites in patients after coronary angiography/angioplasty.
Burchardt, P; Dolatowski, F; Gumienna, A; Główka, F; Karaźniewicz-Łada, M; Rzeźniczak, J; Słomczyński, M, 2019
)
0.51
" To investigate the pharmacokinetic interaction between FDDP and CBT after oral administration of FDDP, CBT and their combination in rats, a novel LC-MS method with segmented scan modes (multiple reaction monitoring and selected ion monitoring) and polarity (positive and negative ionization) was developed."( Segmented scan modes and polarity-based LC-MS for pharmacokinetic interaction study between Fufang Danshen Dripping Pill and Clopidogrel Bisulfate Tablet.
Du, Y; Guo, MZ; Ji, L; Ji, S; Ma, YS; Shao, X; Su, ZY; Tang, DQ; Wang, YJ; Zhao, L, 2019
)
0.51
" In this study, we established an UPLC-MS/MS spectrometry method for the determination of XQ-1H and investigated the pharmacokinetic effect of clopidogrel on XQ-1H in rats subjected to middle cerebral artery occlusion (MCAO)."( Pharmacokinetics and pharmacodynamics analysis of XQ-1H and its combination therapy with clopidogrel on cerebral ischemic reperfusion injury in rats.
Chen, X; Fang, W; Fei, Y; Hou, K; Khadankhuu, B; Li, F; Li, Y; Xu, D, 2020
)
0.56
"There were significant differences in the pharmacokinetic parameters of the H4 active metabolite of CLP in the atorvastatin and rosuvastatin group divided according to their CYP2C19 genotype."( Impact of genetic variants of selected cytochrome P450 isoenzymes on pharmacokinetics and pharmacodynamics of clopidogrel in patients co-treated with atorvastatin or rosuvastatin.
Burchardt, P; Danielak, D; Główka, F; Karaźniewicz-Łada, M; Krzyżańska, D; Rzeźniczak, J; Słomczyński, M, 2020
)
0.56
" The impact of LOF alleles on the pharmacodynamic response to half-dose prasugrel in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) is unknown."( Pharmacodynamic study of prasugrel or clopidogrel in non-ST-elevation acute coronary syndrome with CYP2C19 genetic variants undergoing percutaneous coronary intervention (PRAISE-GENE trial).
Ann, SH; Cho, YR; Guo, LZ; Jin, C; Jin, E; Kim, MH; Kim, SJ; Lee, MS; Park, JS; Shin, ES, 2020
)
0.56
" Clopidogrel has long been the gold standard but has major pharmacological limitations such as a slow onset and long duration of effect, as well as weak platelet inhibition with high inter-individual pharmacokinetic and pharmacodynamic variability."( Pharmacokinetics and Pharmacodynamics of Approved and Investigational P2Y12 Receptor Antagonists.
Dingemanse, J; Schilling, U; Ufer, M, 2020
)
0.56
" Here we describe the results of 3 studies that evaluated the safety and tolerability of DS-1040 along with the effect on DS-1040 pharmacokinetic (PK) parameters, when dosed alone or when coadministered with aspirin (NCT02071004), clopidogrel (NCT02560688), or enoxaparin in healthy subjects."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
" The pharmacokinetic parameters were derived by a noncompartmental model."( Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.
Chen, X; Gong, S; Hu, C; Hu, X; Li, L; Pei, T; Yang, J; Zhang, L, 2020
)
0.56
" The pharmacokinetic profiles of pemafibrate with virtual administrations of P450 inhibitors and/or disease interactions were generated using a physiologically based pharmacokinetic (PBPK) model previously established for co-administration of pemafibrate with OATP1B1 inhibitors."( Modelled plasma concentrations of pemafibrate with co-administered typical cytochrome P450 inhibitors clopidogrel, fluconazole or clarithromycin predicted by physiologically based pharmacokinetic modelling in virtual populations.
Ogawa, SI; Shimizu, M; Yamazaki, H, 2020
)
0.56
"A rapid and sensitive chiral liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the enantioseparation and determination of clopidogrel bisulfate enantiomers in beagle plasma was established and successfully applied to a stereoselective pharmacokinetic study."( Development and validation of a LC-MS/MS method for the enantioseparation and determination of clopidogrel bisulfate in beagle plasma and its application to a stereoselective pharmacokinetic study.
He, J; Liu, W; Tian, Y; Zhang, Y; Zhang, Z, 2021
)
0.62
" How CKD status affects the pharmacodynamic (PD) and pharmacokinetic (PK) profiles of different ticagrelor maintenance dose regimens in patients with DM is unknown."( Impact of chronic kidney disease on the pharmacodynamic and pharmacokinetic effects of ticagrelor in patients with diabetes mellitus and coronary artery disease.
Abou Jaoude, P; Angiolillo, DJ; Bass, TA; Been, L; Briceno, M; Franchi, F; Jia, S; Lee, CH; Maaliki, N; Pineda, AM; Rivas, A; Rollini, F; Soffer, D; Suryadevara, S; Zenni, MM; Zhou, X, 2022
)
0.72
" Plasma concentrations of clopidogrel were measured at different time points in the absence and presence of the concurrent use of tested herbal products and the pharmacokinetic parameters were calculated."( Clopidogrel-herb Interactions: A Pharmacokinetic and Pharmacodynamic Assessment in a Rat Model.
Ahmad, A; Alkharfy, K; Alotaibi, A; Alotaibi, K; Alqahtani, S; Jan, B; Raish, M, 2021
)
0.62
" Treatment with black seed also caused an increase in clopidogrel Cmax by 31."( Clopidogrel-herb Interactions: A Pharmacokinetic and Pharmacodynamic Assessment in a Rat Model.
Ahmad, A; Alkharfy, K; Alotaibi, A; Alotaibi, K; Alqahtani, S; Jan, B; Raish, M, 2021
)
0.62
"This investigation was a substudy analysis conducted in selected cohorts of patients with stable atherosclerotic disease enrolled from a larger prospective, open-label, parallel-group pharmacodynamic (PD) study."( Platelet P2Y12 inhibiting therapy in adjunct to vascular dose of rivaroxaban or aspirin: a pharmacodynamic study of dual pathway inhibition vs. dual antiplatelet therapy.
Angiolillo, DJ; Bass, TA; Been, L; Franchi, F; Galli, M; Geisler, T; Jaoude, PA; Jennings, LK; Jia, S; Lee, CH; Maaliki, N; Pineda, AM; Rivas, A; Rollini, F; Soffer, D; Suryadevara, S; Zenni, MM; Zhou, X, 2022
)
0.72
" Pharmacokinetic (PK) profiles and the influence of CYP2C19 polymorphisms were explored in subgroup analysis."( Antiplatelet effect, safety, and pharmacokinetics of vicagrel in patients with coronary artery disease undergoing percutaneous coronary intervention.
Gong, Y; Han, Y; Jiang, H; Kang, Y; Lai, X; Li, J; Li, Y; Liu, B; Liu, Y; Ma, S; Qi, Z; Ren, L; Sun, H; Tang, C; Tang, Y; Zhao, X; Zheng, M, 2022
)
0.72
" This study aimed to develop a semi-mechanistic population pharmacokinetic (PopPK) model to characterize the pharmacokinetic (PK) profile of M15-2, the active metabolite of vicagrel and clopidogrel, and to evaluate the influence of CYP2C19 polymorphisms and other covariates in healthy subjects and patients with acute coronary syndrome (ACS) after oral administration."( Semi-mechanistic population pharmacokinetics analysis reveals distinct CYP2C19 dependency in the bioactivation of vicagrel and clopidogrel to active metabolite M15-2.
Gong, Y; He, Y; Lai, X; Li, YG; Liu, X; Liu, Y; Sun, H; Yan, X; Zhang, EY; Zhang, L, 2022
)
0.72
" The effects of SAI on the pharmacokinetic and pharmacodynamic behaviors of clopidogrel were investigated in rats."( Interaction study of salvianolic acids for injection on pharmacokinetics of clopidogrel in rats using LC-MS/MS.
Chu, Y; Ju, A; Li, D; Li, W; Li, X; Li, Y; Wu, Y; Xie, Y; Zheng, D, 2022
)
0.72
"This was a prospective, randomised, double-blind, placebo-controlled pharmacodynamic study in patients with ASCVD on clopidogrel treatment and with LDL-C levels ≥70 mg/dL despite a maximally tolerated statin dose."( Impact of evolocumab on the pharmacodynamic profiles of clopidogrel in patients with atherosclerotic cardiovascular disease: a randomised, double-blind, placebo-controlled study.
Angiolillo, DJ; Been, L; Franchi, F; Maaliki, N; Ortega-Paz, L; Pineda, AM; Rivas, A; Rollini, F; Soffer, D; Suryadevara, S; Zenni, M; Zhou, X, 2023
)
0.91

Compound-Compound Interactions

Clopidogrel and ticlopidine, sometimes in combination with ASA, are associated with a low risk of bleeding during renal transplantation. This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective.

ExcerptReferenceRelevance
"to investigate the effect of clopidogrel combined with aspirin or aspirin alone on fibromyointimal hyperplasia (FIMH) in a bypass model with native vein grafts (NVG) and biocompound grafts (BCG)."( Prevention of venous graft sclerosis with clopidogrel and aspirin combined with a mesh tubing in a dog model of arteriovenous bypass grafting.
Gutersohn, A; Hetzer, R; Mülling, C; Musci, M; Sänger, S; Schaffner, T; Wellnhofer, E; Zurbrügg, HR, 2001
)
0.31
"Clopidogrel in combination with aspirin, given before percutaneous coronary intervention, has become the standard for stent thrombosis prevention."( The effect of clopidogrel in combination with aspirin when given before coronary artery bypass grafting.
Dick, SE; Hongo, RH; Ley, J; Yee, RR, 2002
)
0.31
"Clopidogrel in combination with aspirin before CABG is associated with higher postoperative bleeding and morbidity."( The effect of clopidogrel in combination with aspirin when given before coronary artery bypass grafting.
Dick, SE; Hongo, RH; Ley, J; Yee, RR, 2002
)
0.31
"To review systematically the clinical effectiveness and the cost-effectiveness of clopidogrel used in combination with standard therapy including aspirin, compared with standard therapy alone for the treatment of non-ST-segment elevation acute coronary syndromes (ACS)."( Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.
Griffin, S; Hawkins, N; Henderson, R; Jones, L; Main, C; Orton, V; Palmer, S; Riemsma, R; Sculpher, M; Sudlow, C, 2004
)
0.32
" The clinical effectiveness and cost-effectiveness of clopidogrel in combination with standard therapy compared with standard therapy alone were synthesised through a narrative review with full tabulation of the results of the included studies."( Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.
Griffin, S; Hawkins, N; Henderson, R; Jones, L; Main, C; Orton, V; Palmer, S; Riemsma, R; Sculpher, M; Sudlow, C, 2004
)
0.32
"The results of the CURE trial indicate that clopidogrel in combination with aspirin was significantly more effective than placebo combined with aspirin in a wide range of patients with ACS."( Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.
Griffin, S; Hawkins, N; Henderson, R; Jones, L; Main, C; Orton, V; Palmer, S; Riemsma, R; Sculpher, M; Sudlow, C, 2004
)
0.32
" To date, evidence supporting antiplatelet drug resistance are pharmacokinetic response variability, drug-drug interaction through competitive inhibition a specific enzymatic pathway, genetic variability, and variability in the induction of enzymatic pathway in metabolic activation of prodrugs, like clopidogrel."( Antiplatelet drug resistance and drug-drug interactions: Role of cytochrome P450 3A4.
Gurbel, PA; Lau, WC, 2006
)
0.33
" Low-dose razaxaban was useful in combination with sub-optimal doses of aspirin and/or clopidogrel for the prevention of occlusive arterial thrombosis without excessive bleeding."( Razaxaban, a direct factor Xa inhibitor, in combination with aspirin and/or clopidogrel improves low-dose antithrombotic activity without enhancing bleeding liability in rabbits.
Crain, EJ; Knabb, RM; Lam, PY; Quan, ML; Watson, CA; Wexler, RR; Wong, PC, 2007
)
0.34
"A patient admitted for coronary angioplasty received a loading dose of Clopidogrel 600 mg, in combination with an infusion of Tirofiban and one prophylactic dose of Enoxaparin."( Cerebellar hematoma complicating 600 mg loading dose of clopidogrel in combination with tirofiban.
Aoun, N; Azar, R; Kadri, Z; Moussa, R; Sarkis, A, 2008
)
0.35
" However, drug-drug interactions may lead to a greatly increased risk of gastrointestinal bleeding when these drugs are combined."( Drug drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding.
Brophy, JM; Delaney, JA; Opatrny, L; Suissa, S, 2007
)
0.34
"To investigate the effect of removing phlegm and dispelling stasis method (RPDSM) combined with Western medicine for treatment of cerebrovascular stenosis."( [Removing phlegm and dispelling stasis method combined with Western medicine for treatment of cerebrovascular stenosis].
Gao, L; Liu, Q; Wang, PP, 2008
)
0.35
" We evaluated apixaban, a direct and highly selective factor Xa inhibitor, in combination with clinically relevant doses of aspirin and/or clopidogrel for prevention of arterial thrombosis in rabbits."( Arterial antithrombotic and bleeding time effects of apixaban, a direct factor Xa inhibitor, in combination with antiplatelet therapy in rabbits.
Crain, EJ; Watson, CA; Wong, PC, 2008
)
0.35
" The current review focuses distinctly on three aspects: (a) an in-depth coverage on the bioanalytical methods for the quantification of clopidogrel and its inactive carboxylic acid metabolite as well as the active metabolite in pre-clinical and clinical samples; (b) an overview of the pharmacokinetic/pharmacodynamic aspects of clopidogrel; and (c) enumerating the key findings from drug-drug interaction studies of clopidogrel with various co-substrates such as lanzoprazole, fluvastatin, atorvastatin, pravastatin, digoxin, ketoconazole, donezepil and theophylline."( Clopidogrel: review of bioanalytical methods, pharmacokinetics/pharmacodynamics, and update on recent trends in drug-drug interaction studies.
Mullangi, R; Srinivas, NR, 2009
)
0.35
" In situations in which both clopidogrel and a PPI are indicated, pantoprazole should be used since it is the PPI least likely to interact with clopidogrel."( Drug-drug interaction between clopidogrel and the proton pump inhibitors.
Mathews, KD; Norgard, NB; Wall, GC, 2009
)
0.35
" This article reviews the metabolism of various PPIs and existing data regarding the drug-drug interaction between PPIs and clopidogrel."( Drug interaction between clopidogrel and proton pump inhibitors.
Cheng-Lai, A; Khalique, SC,
)
0.13
"We investigated whether clopidogrel combined with aspirin affects local thrombin formation and platelet activation triggered by vascular injury."( Thrombin formation and platelet activation at the site of vascular injury in patients with coronary artery disease treated with clopidogrel combined with aspirin.
Branicka, A; Stepień, E; Tracz, W; Undas, A; Wołkow, P; Zmudka, K, 2009
)
0.35
"Our study shows that clopidogrel combined with aspirin does not reduce thrombin formation following vascular injury, but attenuates platelet sCD40L and P-selectin release."( Thrombin formation and platelet activation at the site of vascular injury in patients with coronary artery disease treated with clopidogrel combined with aspirin.
Branicka, A; Stepień, E; Tracz, W; Undas, A; Wołkow, P; Zmudka, K, 2009
)
0.35
" In the forth communication we consider data of randomized studies in which efficacy and safety of clopidogrel in combination with has acetylsalicylic acid (ASA) been assessed in comparison with (ASA) in various acute coronary syndromes (ACS), as well as before, during, and after percutaneous coronary interventions (PCI)."( [Thienopyridines in the treatment and prevention of cardiovascular diseases. Part IV. therapeutic application of clopidogrel in combination with acetylsalicylic acid in acute coronary syndromes and percutaneous coronary interventions].
Avsar, O; Batyraliev, TA; Fettser, DV; Islek, M; Preobrazhenskiĭ, DV; Sidorenko, BA; Vural, A, 2009
)
0.35
"To evaluate the long-term therapeutic effects of atorvastatin via cytochrome P450 (CYP)3A4 pathway or a non-CYP 3A4 pathway statin, pravastatin, combined with clopidogrel for the patients undergoing coronary stenting."( [Comparison on long-term effects of atorvastatin or pravastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial].
Han, YL; Jing, QM; Li, Y; Wang, DM; Wang, SL; Wang, ZL; Zhang, ZL, 2009
)
0.35
"The 12 month clinical outcomes were similar between patients receiving atorvastatin 20 mg/d or pravastatin 20 mg/d combined with clopidogrel after coronary stenting."( [Comparison on long-term effects of atorvastatin or pravastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial].
Han, YL; Jing, QM; Li, Y; Wang, DM; Wang, SL; Wang, ZL; Zhang, ZL, 2009
)
0.35
"The efficacy of Danggui, Honghua alone or combination with clopidogrel was determined in three experimental models."( Antithrombotic effects of Danggui, Honghua and potential drug interaction with clopidogrel.
Li, Y; Wang, N, 2010
)
0.36
" However, studies have found decreased efficacy of clopidogrel when concurrently administered with a PPI."( Drug interaction between clopidogrel and proton pump inhibitors.
Jackevicius, CA; Liu, TJ, 2010
)
0.36
" Moreover, unwanted drug-drug pharmacokinetic interactions influencing CYP2C19 activity and clopidogrel bioactivation such as with proton pump inhibitors remain a matter of intense controversy."( Impact of genetic polymorphisms and drug-drug interactions on clopidogrel and prasugrel response variability.
Ancrenaz, V; Besson, M; Daali, Y; Dayer, P; Desmeules, J; Fontana, P; Samer, C, 2010
)
0.36
"This study evaluated the risk of upper gastrointestinal bleeding (UGIB) associated with use of low-dose acetylsalicylic acid (ASA) alone and in combination with other gastrotoxic medications."( Risk of upper gastrointestinal bleeding with low-dose acetylsalicylic acid alone and in combination with clopidogrel and other medications.
García Rodríguez, LA; Hernández-Díaz, S; Johansson, S; Lin, KJ, 2011
)
0.37
"Multidrug therapy increases the risk for drug-drug interactions."( Clopidogrel-drug interactions.
Angiolillo, DJ; Bates, ER; Lau, WC, 2011
)
0.37
" This review will provide an overview of the mechanisms underlying thienopyridine-associated drug-drug interactions, and highlight the most recent developments in the field and propose guidance for the practitioner."( Thienopyridine-associated drug-drug interactions: pharmacologic mechanisms and clinical relevance.
Collet, JP; Hulot, JS; Montalescot, G, 2011
)
0.37
" In this article, the authors review the current studies that reported a possible drug-drug interaction between clopidogrel and PPIs, particularly omeprazole."( Clopidogrel and proton pump inhibitors: is there a significant drug-drug interaction?
Azab, AN; Friger, M; Gilutz, H; Shmulevich, E, 2011
)
0.37
"An analysis of a case-control study of rhabdomyolysis was conducted to screen for previously unrecognized cytochrome P450 enzyme (CYP) 2C8 inhibitors that may cause other clinically important drug-drug interactions."( A screening study of drug-drug interactions in cerivastatin users: an adverse effect of clopidogrel.
Floyd, JS; Heckbert, SR; Kaspera, R; Kwok, PY; Lumley, T; Marciante, KD; Psaty, BM; Tamraz, B; Totah, RA; Weiss, NS; Wiggins, KL, 2012
)
0.38
"Our results indicate that PAR antagonists used in combination with aspirin provide a potent yet safe antithrombotic strategy in mice and provide insights into the safety and efficacy of using PAR antagonists for the prevention of acute coronary syndromes in humans."( Safety and efficacy of targeting platelet proteinase-activated receptors in combination with existing anti-platelet drugs as antithrombotics in mice.
Hamilton, JR; Jackson, SP; Lee, H; Mountford, JK; Sturgeon, SA, 2012
)
0.38
"To compare the effects of clopidogrel combined with dihydropyridine calcium-channel blockers (CCBs) or non-dihydropyridine CCBs on coronary artery disease (CAD) in elderly patients."( [Effect of clopidogrel combined with calcium-channel blocker on coronary artery disease in elderly patients: a propensity score-based retrospective cohort study].
Cao, J; Fan, L; Gao, Y; Liu, X; Lu, X; Ma, C, 2012
)
0.38
"A total of 1021 patients were enrolled, among whom 402 patients were prescribed with clopidogrel and 619 with clopidogrel combined with CCB (dihydropyridine in 547 and non-dihydropyridine in 72)."( [Effect of clopidogrel combined with calcium-channel blocker on coronary artery disease in elderly patients: a propensity score-based retrospective cohort study].
Cao, J; Fan, L; Gao, Y; Liu, X; Lu, X; Ma, C, 2012
)
0.38
"Compared with clopidogrel without CCB, clopidogrel with CCB does not increase the mortality or composite thromboembolic events in elderly CAD patients, but clopidogrel combined with non-dihydropyridine CCB is associated with significantly increased composite thromboembolic events in comparison with dihydropyridine CCB."( [Effect of clopidogrel combined with calcium-channel blocker on coronary artery disease in elderly patients: a propensity score-based retrospective cohort study].
Cao, J; Fan, L; Gao, Y; Liu, X; Lu, X; Ma, C, 2012
)
0.38
" Clopidogrel, an antiplatelet drug, is widely prescribed either alone or in combination with aspirin as dual antiplatelet therapy for the prevention of vascular occlusive events."( Genetic polymorphisms and drug interactions leading to clopidogrel resistance: why the Asian population requires special attention.
Basri, HB; Hasan, MS; Hin, LP; Stanslas, J, 2013
)
0.39
"SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care."( Long-term results of plaque excision combined with aggressive pharmacotherapy in high-risk patients with advanced peripheral artery disease (SAVE a LEG registry).
Buszman, PE; Buszman, PP; Kiesz, RS; Konkolewska, MD; Martin, JL; Radvany, MG; Szymanski, R; Wiernek, BK; Wiernek, SL, 2013
)
0.39
" This study assessed whether high-dose aspirin: a) provides additional anti-platelet efficacy, assessed in vivo and ex vivo, when combined with P2Y12 inhibition; and/or b) has a negative effect on vascular function."( High-dose aspirin in dogs increases vascular resistance with limited additional anti-platelet effect when combined with potent P2Y12 inhibition.
Björkman, JA; Forsberg, GB; Hansson, GI; Nylander, S; von Bahr, H; Warner, TD; Zachrisson, H, 2013
)
0.39
"We sought to compare the effects of clopidogrel combined with warfarin with clopidogrel alone in the prevention of restenosis after endovascular treatment (EVT) of the femoropopliteal artery."( A prospective randomized controlled clinical trial on clopidogrel combined with warfarin versus clopidogrel alone in the prevention of restenosis after endovascular treatment of the femoropopliteal artery.
Feng, Y; Guo, M; Li, H; Liang, G; Luo, X; Zhang, C; Zhang, F, 2013
)
0.39
"Between June 2008 and May 2009, 88 consecutive patients referred for EVT were randomly divided into a clopidogrel group (42 cases) and a clopidogrel combined with warfarin group (46 cases) before the procedure."( A prospective randomized controlled clinical trial on clopidogrel combined with warfarin versus clopidogrel alone in the prevention of restenosis after endovascular treatment of the femoropopliteal artery.
Feng, Y; Guo, M; Li, H; Liang, G; Luo, X; Zhang, C; Zhang, F, 2013
)
0.39
" The objective of this study was to evaluate the prevalence and clinical consequences of potential drug-drug interactions of clopidogrel with drugs affecting CYP3A4 activity."( Epidemiology of CYP3A4-mediated clopidogrel drug-drug interactions and their clinical consequences.
Heikkilä, P; Huupponen, R; Laine, K; Tirkkonen, T; Vahlberg, T, 2013
)
0.39
" A loading dose of clopidogrel combined with other antithrombotic therapy might be an effective treatment for CWS."( Loading dose of clopidogrel in combination with other antithrombotic therapy for capsular warning syndrome.
Ando, Y; Inatomi, Y; Kawano, H; Nakajima, M; Yonehara, T,
)
0.13
"Clopidogrel and ticlopidine, sometimes in combination with ASA, are associated with a low risk of bleeding during renal transplantation and does not seem to be a contraindication for renal transplant surgery."( Ticlopidine and clopidogrel, sometimes combined with aspirin, only minimally increase the surgical risk in renal transplantation: a case-control study.
Abramowicz, D; Benahmed, A; Broeders, N; Donckier, V; Ghisdal, L; Hoang, AD; Kianda, M; Le Moine, A; Lemy, A; Madhoun, P; Massart, A; Mikhalski, D; Racapé, J; Sadis, C; Wissing, M, 2014
)
0.4
"Based on real world research the circumstances of the clinical use of usual drugs combined with salvianolate injection are surveyed."( [Analysis of salvianolate injection combined with usual drugs in treatment of coronary heart disease in real world].
Chang, YP; Hu, J; Xie, YM; Zeng, XB; Zhang, H; Zhuang, Y, 2013
)
0.39
"In 1 605 patients with coronary heart disease (CHD), salvianolate injection was most frequently (51%) combined with clopidogrel and isosorbide dinitrate."( [Analysis of salvianolate injection combined with usual drugs in treatment of coronary heart disease in real world].
Chang, YP; Hu, J; Xie, YM; Zeng, XB; Zhang, H; Zhuang, Y, 2013
)
0.39
"In the real world, salvianolate injection combined with usual treatment was found to be more effective than other treatment combinations."( [Analysis of salvianolate injection combined with usual drugs in treatment of coronary heart disease in real world].
Chang, YP; Hu, J; Xie, YM; Zeng, XB; Zhang, H; Zhuang, Y, 2013
)
0.39
"Patients in nursing homes are often treated with many drugs concurrently (polypharmacy), which increases the risk of drug-drug interactions."( [Drug-drug interactions in nursing home patients].
Slørdal, L; Spigset, O; Staurset, HB; Søraas, IA, 2014
)
0.4
"The incidence of serious drug-drug interactions among nursing home patients in Trondheim Municipality is low."( [Drug-drug interactions in nursing home patients].
Slørdal, L; Spigset, O; Staurset, HB; Søraas, IA, 2014
)
0.4
"The treatment with Valsartan combined with Clopidogrel and Leflunomide can reduce the urinary proteins loss and renal function deterioration for IgA nephropathy patients and cause minimal adverse reactions."( Valsartan combined with clopidogrel and/or leflunomide for the treatment of progressive immunoglobulin A nephropathy.
Chen, F; Cheng, G; Fang, Y; Guo, Y; Li, H; Liu, D; Liu, F; Liu, L; Liu, Z; Margetts, P; Tang, L; Zhao, Z, 2015
)
0.42
" Mechanisms through which polypharmacy may increase adverse health outcomes include decreased adherence, increased drug side effects, higher use of potentially inappropriate medications, and more frequent drug-drug interactions."( Appropriate prescribing and important drug interactions in older adults.
Paauw, DS; Wallace, J, 2015
)
0.42
" Accordingly, potential drug-drug interactions associated with the concomitant use of these agents present an area of concern."( Carboxylesterase 1-mediated drug-drug interactions between clopidogrel and simvastatin.
Markowitz, JS; Wang, X; Zhu, HJ, 2015
)
0.42
" Importantly, these drug-drug interactions have prognostic implications, since patients with high on-treatment platelet reactivity associated with reduced clopidogrel metabolism have an increased risk of ischemia."( Drug-drug interactions between clopidogrel and novel cardiovascular drugs.
Angiolillo, DJ; Gaudio, C; Greco, C; Marazzi, G; Pelliccia, F; Rollini, F, 2015
)
0.42
" The purpose of this study was to compare the efficacy and safety of clopidogrel combined with aspirin (CA) versus sarpogrelate combined with aspirin (SA) treatment in carotid endarterectomy (CEA) patients."( Effects of Sarpogrelate Combined with Aspirin in Patients Undergoing Carotid Endarterectomy in China: A Single-Center Retrospective Study.
Gu, Y; Guo, J; Guo, L; Qi, L; Tong, Z; Wang, Z; Yu, H; Zhang, J, 2016
)
0.43
" The objective of this study was to determine the efficacy and safety of endoscopy combined with the administration of antiplatelet and/or anticoagulant agents to stimulate bleeding in order to define a source."( Pharmacologic provocation combined with endoscopy in refractory cases of GI bleeding.
Adler, DG; Jex, KT; Nicaud, MJ; Raines, DL, 2017
)
0.46
"Provocative testing combined with endoscopy can be justified as an option in the diagnostic algorithm of complex cases of GI bleeding when intermittent bleeding related to a vascular lesion, such as an angioectasia or Dieulafoy, is suspected."( Pharmacologic provocation combined with endoscopy in refractory cases of GI bleeding.
Adler, DG; Jex, KT; Nicaud, MJ; Raines, DL, 2017
)
0.46
" The objective of the present study was to identify the mechanism of clopidogrel-mediated drug-drug interactions (DDIs) on the pharmacokinetics of OATP1B1 and/or CYP2C8 substrates in vivo."( Clarification of the Mechanism of Clopidogrel-Mediated Drug-Drug Interaction in a Clinical Cassette Small-dose Study and Its Prediction Based on In Vitro Information.
Ieiri, I; Irie, S; Kim, SJ; Kimura, M; Kusuhara, H; Maeda, K; Sugiyama, Y; Yoshikado, T, 2016
)
0.43
"Uncertainty regarding clopidogrel effectiveness attenuation because of a drug-drug interaction with proton pump inhibitors (PPI) has led to conflicting guidelines on concomitant therapy."( Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis.
Guzauskas, GF; Serbin, MA; Veenstra, DL, 2016
)
0.43
"The risk and benefit of GP-IIb/IIIa Inhibition (GPI) in combination with recent antiplatelet regimens in acute coronary syndromes (ACS) remain unassessed."( Safety and efficacy of IIb/IIIa inhibitors in combination with highly active oral antiplatelet regimens in acute coronary syndromes: A meta-analysis of pivotal trials.
Agueznai, M; Ardouin, P; Beygui, F; Blanchart, K; Collet, JP; Lemaître, A; Milliez, P; Montalescot, G; Roule, V; Sabatier, R, 2017
)
0.46
" CYP2C19 genotyping combined with platelet reactivity is an independent and additive predictor of 1-year MACE in Chinese patients undergoing stenting with clopidogrel treatment, which is better than either test alone."( CYP2C19 genotyping combined with on-clopidogrel platelet reactivity in predicting major adverse cardiovascular events in Chinese patients with percutaneous coronary intervention.
Chen, J; Chen, JL; Gao, RL; Gao, Z; Han, YL; He, C; Qiao, SB; Tang, XF; Wang, J; Wu, Y; Xu, B; Yang, YJ; Yao, Y; Yuan, JQ; Zhang, JH, 2016
)
0.43
"Dasabuvir, a nonnucleoside NS5B polymerase inhibitor, is a sensitive substrate of cytochrome P450 (CYP) 2C8 with a potential for drug-drug interaction (DDI) with clopidogrel."( Physiologically Based Pharmacokinetic Modeling Suggests Limited Drug-Drug Interaction Between Clopidogrel and Dasabuvir.
Badri, P; Bow, D; Fischer, V; Fu, W; Shebley, M, 2017
)
0.46
" This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective to address the potential for a significant drug-drug interaction (DDI) between clopidogrel and VIEKIRA PAK."( Utilizing PBPK Modeling to Evaluate the Potential of a Significant Drug-Drug Interaction Between Clopidogrel and Dasabuvir: A Scientific Perspective.
Arya, V; Mishra, P; Reynolds, KS; Younis, IR; Zhao, P, 2017
)
0.46
"The study aimed to investigate the impact of clopidogrel combined with proton pump inhibitors (PPI) pantoprazole treatment on the prognosis of patients with transient ischemic attack (TIA)."( Report: Impact of drug combination of clopidogrel and pantoprazole In the prognosis of patients with transient ischemic attack.
Lu, M, 2017
)
0.46
" This study aimed to investigate the influences of dual-dose clopidogrel, clopidogrel combined with tongxinluo, and ticagrelor on the platelet activity and MACE events of patients with CYP2C19*2 gene function deficiency and poor clopidogrel response after PCI."( Effects of Dual-Dose Clopidogrel, Clopidogrel Combined with Tongxinluo Capsule, and Ticagrelor on Patients with Coronary Heart Disease and CYP2C19*2 Gene Mutation After Percutaneous Coronary Interventions (PCI).
Chen, S; Geng, Y; Gu, J; Hao, Q; Qi, P; Wang, H; Wang, L; Zhang, Y, 2017
)
0.46
"We aimed to develop a mathematical model describing a drug-drug interaction between clopidogrel and omeprazole in humans."( A pharmacokinetic model of drug-drug interaction between clopidogrel and omeprazole at CYP2C19 in humans.
Lohitnavy, M; Lohitnavy, O; Morasuk, T; Tangamornsuksan, W; Thiansupornpong, P, 2017
)
0.46
"To investigate temporal trends in the use of non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) in combination with aspirin and/or clopidogrel in patients with atrial fibrillation (AF) following acute myocardial infarction (MI) and/or percutaneous coronary intervention (PCI)."( Use of oral anticoagulants in combination with antiplatelet(s) in atrial fibrillation.
Berger, JS; Bjerring Olesen, J; Gerds, TA; Gislason, GH; Hansen, ML; Lamberts, M; Langtved Pallisgaard, J; Nissen Bonde, A; Sindet-Pedersen, C; Staerk, L; Torp-Pedersen, C, 2018
)
0.48
"From 2011 to 2016, the use of NOAC in combination with antiplatelet(s) increased in patients with AF following MI/PCI and exceeded the use of VKA in combination with antiplatelet(s) by 2016."( Use of oral anticoagulants in combination with antiplatelet(s) in atrial fibrillation.
Berger, JS; Bjerring Olesen, J; Gerds, TA; Gislason, GH; Hansen, ML; Lamberts, M; Langtved Pallisgaard, J; Nissen Bonde, A; Sindet-Pedersen, C; Staerk, L; Torp-Pedersen, C, 2018
)
0.48
" Three months later, he was noted to have elevated creatine kinase (CK), thought to be related to a potential drug-drug interaction between ticagrelor and atorvastatin."( Elevated Creatine Kinase due to Potential Drug Interaction With Ticagrelor and Atorvastatin.
Beavers, JC, 2019
)
0.51
"A probable drug-drug interaction occurred with concomitant ticagrelor and atorvastatin."( Elevated Creatine Kinase due to Potential Drug Interaction With Ticagrelor and Atorvastatin.
Beavers, JC, 2019
)
0.51
"56%) was the most common triple Western medicine therapy, often combined with antibiotics and blood stasis drugs in use."( [Drug combination characteristics of Shenxiong glucose injection in treating ischemic cerebrovascular disease in real world].
Jia, PP; Liu, H; Wang, GQ; Xie, YM; Zhang, Y; Zhuang, Y, 2017
)
0.46
"Previous studies have found that Panax quinquefolius saponins (PQS) combined with dual antiplatelet therapy (DAPT) of aspirin and clopidogrel enhances antithrombotic effects while reducing gastric mucosal injury induced by DAPT."( Panax quinquefolius saponins combined with dual antiplatelet drug therapy alleviate gastric mucosal injury and thrombogenesis through the COX/PG pathway in a rat model of acute myocardial infarction.
Kou, N; Miao, Y; Qu, H; Shi, DZ; Wang, MM; Xue, M; Yang, B; Yang, L; Zang, MX, 2018
)
0.48
"The case-crossover design may be useful for evaluating the clinical impact of drug-drug interactions in electronic healthcare data; however, experience with the design in this context is limited."( The Case-Crossover Design for Drug-Drug Interactions: Considerations for Implementation.
Bykov, K; Gagne, JJ; Glynn, RJ; Mittleman, MA; Schneeweiss, S, 2019
)
0.51
"The three-parameter model assumes a common drug-drug interaction effect, whereas the saturated model is useful for identifying potential effect heterogeneity or differential confounding across strata."( The Case-Crossover Design for Drug-Drug Interactions: Considerations for Implementation.
Bykov, K; Gagne, JJ; Glynn, RJ; Mittleman, MA; Schneeweiss, S, 2019
)
0.51
"Few population-based studies have examined bleeding associated with clopidogrel drug-drug interactions (DDIs)."( Clopidogrel Drug Interactions and Serious Bleeding: Generating Real-World Evidence via Automated High-Throughput Pharmacoepidemiologic Screening.
Bilker, WB; Brensinger, CM; Cohen, JB; Hennessy, S; Leonard, CE; Nam, YH; Pham Nguyen, TP; Soprano, SE; Zhou, M, 2019
)
0.51
"To study the clinical effect and safety of clopidogrel combined with aspirin in antithrombotic therapy for children with Kawasaki disease (KD) complicated by coronary artery aneurysm (CAA)."( [Clinical effect and safety of clopidogrel combined with aspirin in antithrombotic therapy for children with Kawasaki disease complicated by small/medium-sized coronary artery aneurysms].
Chen, TT; Guo, YH; Li, Y; Liu, YL; Lu, YH; Shi, K; Wang, XM, 2019
)
0.51
"Clopidogrel combined with low-dose aspirin is safe and effective in antithrombotic therapy for children with KD complicated by CAA."( [Clinical effect and safety of clopidogrel combined with aspirin in antithrombotic therapy for children with Kawasaki disease complicated by small/medium-sized coronary artery aneurysms].
Chen, TT; Guo, YH; Li, Y; Liu, YL; Lu, YH; Shi, K; Wang, XM, 2019
)
0.51
"Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the only option for complete revascularization in some patients with diffuse coronary artery disease."( Comparison of dual antiplatelet therapies after coronary endarterectomy combined with coronary artery bypass grafting: a cohort study.
Feng, W; Song, Y; Tiemuerniyazi, X; Xu, F; Yan, H, 2020
)
0.56
" Polypharmacy increases the probability of drug-drug interactions (DDIs)."( Clopidogrel drug interactions: a review of the evidence and clinical implications.
Angiolillo, DJ; Franchi, F; Lee, CH, 2020
)
0.56
" Here, we confirmed the protective effect and mechanism of XST combined with DAPT (XST+ASA+CLP) on cerebral ischemia/reperfusion injury, exploring their better pharmacological action for clinical patients."( Xuesaitong injection (lyophilized) combined with aspirin and clopidogrel protect against focal cerebral ischemic/reperfusion injury in rats by suppressing oxidative stress and inflammation and regulating the NOX2/IL-6/STAT3 pathway.
Dong, DX; Meng, XB; Qu, MW; Sun, GB; Sun, XB; Zhao, LY; Zhu, T, 2021
)
0.62
"Tirofiban can be used to treat patients with acute ischemic stroke (AIS), this study was to evaluate the efficacy and safety of tirofiban combined with heparin in the treatment of mild to moderate AIS."( Tirofiban combined with heparin's effect and safety in the treatment of mild to moderate acute ischemic stroke.
Chen, M; Dai, X; Deng, X; Fu, S; Gong, Q; He, W; Huang, L; Li, C; Luo, Q; Qiu, T; Wang, J; Wang, M; Xiao, H, 2021
)
0.62
"Our objective was to systematically evaluate the efficacy and safety of proton pump inhibitors combined with clopidogrel in patients undergoing percutaneous coronary intervention and to provide an evidence basis for clinical treatment decision-making."( Efficacy and safety of proton pump inhibitors combined with clopidogrel in patients undergoing percutaneous coronary intervention: a meta-analysis.
Duan, R; Han, YY; Li, ZX, 2021
)
0.62
" Our findings showed that antiplatelet therapies (aspirin/clopidogrel cocktail and atopaxar) combined with anastrozole failed to prevent hypercoagulation and induced evidence of a partial EMT."( Antiplatelet Therapy Combined with Anastrozole Induces Features of Partial EMT in Breast Cancer Cells and Fails to Mitigate Breast-Cancer Induced Hypercoagulation.
Augustine, TN; Xulu, KR, 2021
)
0.62
"This study assessed the efficacy and safety of tirofiban in combination with dual-antiplatelet therapy (DAPT) in progressive ischemic stroke."( Assessing the Efficacy and Safety of Tirofiban in Combination With Dual-antiplatelet Therapy in Progressive Ischemic Stroke Patients.
Chang, W; Li, L; Lin, F; Liu, H; Yin, J; Zhang, H; Zhao, Y, 2021
)
0.62
"To investigate the effect of ticagrelor combined with tirofiban versus clopidogrel combined with tirofiban on inflammation response and prognosis of patients with unstable angina pectoris (UA)."( Comparison of the effect of ticagrelor combined with tirofiban versus clopidogrel combined with tirofiban on inflammation response and prognosis of patients with unstable angina pectoris in long term follow-up.
Deng, L; Jia, HZ; Li, MC; Zhu, W, 2021
)
0.62
" Many drug-drug interactions (DDIs) are caused by perpetrator drugs inhibiting or inducing cytochrome P450 (CYP) enzymes, resulting in alterations of the plasma concentrations of a victim drug."( Translational aspects of cytochrome P450-mediated drug-drug interactions: A case study with clopidogrel.
Backman, JT; Filppula, AM; Tornio, A, 2022
)
0.72
"Ischemic stroke combined with hypertension can increase risks of stroke recurrence and death."( The Clinical Efficacy of Clopidogrel Bisulfate Tablets Combined with Olmesartan Medoxomil for Ischemic Stroke with Hypertension and the Effect of Angiotensin II Type 1 Receptor Level on Prognosis.
Fang, W; Guo, X; Jiang, H; Jin, X; Liu, Y; Sun, P; Yu, J, 2021
)
0.62
"Clopidogrel bisulfate tablets combined with olmesartan medoxomil has prominent clinical effects in the treatment of ischemic stroke patients with hypertension, evidently improving the prognosis."( The Clinical Efficacy of Clopidogrel Bisulfate Tablets Combined with Olmesartan Medoxomil for Ischemic Stroke with Hypertension and the Effect of Angiotensin II Type 1 Receptor Level on Prognosis.
Fang, W; Guo, X; Jiang, H; Jin, X; Liu, Y; Sun, P; Yu, J, 2021
)
0.62
"This study aimed to explore the clinical study of clopidogrel combined with Huoxue Tongluo prescription in improving transient ischemic attack (TIA) and the effect on MMP-9, Hcy, and CRP."( Clinical Study of Clopidogrel Combined with Huoxue Tongluo Prescription in Improving Transient Ischemic Attack and the Effect on MMP-9, Hcy, and CRP.
Chen, Z; Li, Y; Ma, L; Ma, Y; Meng, X, 2022
)
0.72
"Clopidogrel combined with Huoxue Tongluo prescription can significantly improve the therapeutic effect and reduce the levels of MMP-9, Hcy, and CRP in patients with TIA."( Clinical Study of Clopidogrel Combined with Huoxue Tongluo Prescription in Improving Transient Ischemic Attack and the Effect on MMP-9, Hcy, and CRP.
Chen, Z; Li, Y; Ma, L; Ma, Y; Meng, X, 2022
)
0.72
"This study aimed to estimate how prevalent potential drug-drug interactions (pDDIs) were in patients with cardiovascular diseases who were hospitalized for more than 24 hours, and to determine the risk factors associated with these pDDIs."( Detection and analysis of potential drug-drug interactions among patients admitted to the cardiac care unit in a tertiary care hospital.
Almaghaslah, D; Khaled, A; Makki, S; Nagib, R; Siddiqua, A, 2023
)
0.91
"To assess the antiplatelet effect of cilostazol clinically, we compared the effects of cilostazol in combination with clopidogrel on various platelet function tests."( Differential inhibition of platelet function by cilostazol in combination with clopidogrel.
Dahlen, JR; Hosokawa, K; Kitagawa, K; Ohnishi, T; Shirai, Y; Yamazaki, M, 2023
)
0.91

Bioavailability

Clopidogrel bioavailability may lead to acute consequences including stent thrombosis (ST) Genetic polymorphisms are thought to affect conversion of the prodrug to the active metabolite. FDA has recently added a black-box warning to clopidOGrel.

ExcerptReferenceRelevance
"Two open, randomized, crossover bioavailability studies were carried out to assess the influence of concurrent antacid medication and food on the bioavailability of clopidogrel."( Clopidogrel bioavailability: absence of influence of food or antacids.
Dickinson, JP; McEwen, J; Moreland, TE; Necciari, J; Perles, P; Pritchard, G; Strauch, G, 1999
)
0.3
" The rate of absorption of extended-release dipyridamole is considerably slower than that of immediate-release dipyridamole, while similar plasma concentrations are maintained to optimise antiplatelet efficacy."( Clinical pharmacokinetics of antiplatelet agents used in the secondary prevention of stroke.
Lenz, T; Wilson, A, 2003
)
0.32
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Quantification of clopidogrel in human plasma by sensitive liquid chromatography/tandem mass spectrometry.
Boosi, R; Kandikere, VN; Maurya, S; Mudigonda, K; Nirogi, RV; Shukla, M, 2006
)
0.33
"Clopidogrel improves endothelial nitric oxide bioavailability and diminishes biomarkers of oxidant stress and inflammation in patients with symptomatic coronary artery disease, suggesting that beyond inhibition of platelet aggregation, adenosine phosphate receptor blockade may also have promising vasoprotective effects."( Clopidogrel improves systemic endothelial nitric oxide bioavailability in patients with coronary artery disease: evidence for antioxidant and antiinflammatory effects.
Baldus, S; Böger, R; Heitzer, T; Karstens, M; Meinertz, T; Ortak, M; Rudolph, V; Schwedhelm, E; Sydow, K; Tschentscher, P, 2006
)
0.33
" We tested the hypothesis that the intestinal efflux transporter P-glycoprotein (P-gp) limits the oral bioavailability of clopidogrel and that variance in the MDR1 gene encoding P-gp predicts absorption variability."( Impact of P-glycoprotein on clopidogrel absorption.
Goeser, T; Grimberg, G; Jung, N; Kastrati, A; Lazar, A; Schömig, A; Schömig, E; Taubert, D; von Beckerath, N, 2006
)
0.33
"The present study aimed at investigating the effects of concomitant food intake on the bioavailability of a single oral dose of clopidogrel (CAS 113665-84-2)."( Effect of food on bioavailability of a single oral dose of clopidogrel in healthy male subjects.
Kandikere, VN; Mudigonda, K; Nirogi, RV, 2006
)
0.33
" In contrast to aspirin, the response to clopidogrel is highly variable and reflects the bioavailability of the active metabolite and not "resistance" of the receptor to inhibition."( Aspirin and clopidogrel resistance.
Fitzgerald, DJ; Maree, A, 2007
)
0.34
" It is applied to study the bioavailability of 75 mg clopidogrel mesylate tablets in 16 human subjects with satisfactory results."( Rapid LC-ESI-MS-MS method for the simultaneous determination of clopidogrel and its carboxylic acid metabolite in human plasma.
Kundlik, M; Patel, NK; Shah, H; Shrivastav, PS; Subbaiah, G,
)
0.13
" The relative bioavailability of the active metabolites of prasugrel and clopidogrel calculated by the ratio of active metabolite AUC (prodrug oral administration/active metabolite intravenous administration) were 25% and 7%, respectively, in rats, and 25% and 10%, respectively, in dogs."( Comparison of formation of thiolactones and active metabolites of prasugrel and clopidogrel in rats and dogs.
Farid, NA; Fusegawa, K; Hagihara, K; Ikeda, T; Ikenaga, H; Kazui, M; Kurihara, A; Nanba, T; Okazaki, O; Takahashi, M, 2009
)
0.35
"A 300 mg loading dose of crushed clopidogrel administered via NG tube provides faster and greater bioavailability than an equal dose taken orally as whole tablets."( Crushed clopidogrel administered via nasogastric tube has faster and greater absorption than oral whole tablets.
Chesebro, JH; Farkouh, ME; Fuster, V; Zafar, MU, 2009
)
0.35
"The aim of the presented comparative study was to evaluate the bioavailability of clopidogrel (CAS 113665-84-2) formulations containing clopidogrel bisulfate (CAS 135046-48-9, CBS) 75 mg based on the parent compound (CBS) and its metabolite SR 26334 - clopidogrel carboxylic acid (CAS 144457-28-3, CCA) determination."( Usefulness of the parent compound determination in bioequivalence evaluation of clopidogrel generic products.
Bogiel, M; Duda, J; Marzec, A; Pawłowska, M; Sieradzki, E; Tejchman-Małecka, B, 2009
)
0.35
"Genetic C3435T polymorphism of the multidrug resistance gene-1 (MDR-1) limits oral bioavailability of clopidogrel and influences prognosis in patients with myocardial infarction."( Influence of C3435T multidrug resistance gene-1 (MDR-1) polymorphism on platelet reactivity and prognosis in patients with acute coronary syndromes.
Filipiak, KJ; Kisiel, B; Kostrzewa, G; Małek, ŁA; Opolski, G; Płoski, R; Serafin, A; Spiewak, M, 2009
)
0.35
" The validated method was applied in bioavailability and bioequivalence study."( Development and validation of high-throughput liquid chromatography-tandem mass spectrometric method for simultaneous quantification of clopidogrel and its metabolite in human plasma.
Chandiran, IS; Jayaveera, KN; Naidu, YK; Rao Divi, K; Reddy S, R; Reddy, MP, 2010
)
0.36
" If a substrate drug with oral bioavailability is equal to or less than 80%, an intravenous drug interaction study at low dose along with a few key oral drug interaction studies could be useful for achieving this objective with the aid of modeling and simulations."( Ongoing challenges in drug interaction safety: from exposure to pharmacogenomics.
Bai, JP, 2010
)
0.36
" Prasugrel is more potent than clopidogrel with a better bioavailability and lower pharmacodynamic variability."( Impact of genetic polymorphisms and drug-drug interactions on clopidogrel and prasugrel response variability.
Ancrenaz, V; Besson, M; Daali, Y; Dayer, P; Desmeules, J; Fontana, P; Samer, C, 2010
)
0.36
"Clopidogrel bisulphate has quite low bioavailability (40-50%)."( Development of sustained release formulation of an antithrombotic drug and application of Fuzzy logic.
Degim, İT; Tan, C,
)
0.13
" In conclusion, clopidogrel improved endothelial function and NO bioavailability in heart failure."( Clopidogrel improves endothelial function and NO bioavailability by sensitizing adenylyl cyclase in rats with congestive heart failure.
Bauersachs, J; Fraccarollo, D; Loch, E; Neuser, J; Pförtsch, S; Schäfer, A; Vogt, C, 2011
)
0.37
" To improve the solubility of clopidogrel napadisilate, a novel clopidogrel napadisilate-loaded solid dispersion was prepared by the spray-drying technique using HPMC and colloidal silica, and the physicochemical properties, dissolution and bioavailability in beagle dogs were evaluated compared to the clopidogrel bisulphate-loaded commercial product."( New clopidogrel napadisilate salt and its solid dispersion with improved stability and bioequivalence to the commercial clopidogrel bisulphate salt in beagle dogs.
Choi, HG; Kim, KS; Kim, YI; Shanmugam, S; Suh, KH; Woo, JS; Yong, CS, 2011
)
0.37
"FA was rapidly absorbed with a low bioavailability after a single oral administration."( Pharmacokinetics of ferulic acid and potential interactions with Honghua and clopidogrel in rats.
Li, Y; Liu, C; Mi, S; Wang, N; Zhang, Y, 2011
)
0.37
" Genetic polymorphisms are thought to affect conversion of the prodrug to the active metabolite, and the FDA has recently added a black-box warning to clopidogrel to highlight the effects of these polymorphisms on drug bioavailability and to inform prescribers about the availability of genetic testing."( Laboratory evaluation of clopidogrel responsiveness by platelet function and genetic methods.
Johari, V; Rodgers, GM; Saunders, PJ; Smock, KJ, 2011
)
0.37
"The bioavailability of clopidogrel bisulfate (CAS 135046-48-9) form I was compared with that of clopidogrel bisulfate form II in 12 male Sprague-Dawley rats."( Study on bioavailability difference between clopidogrel bisulfate form I and form II using liquid chromatography/tandem mass spectrometry.
Che, WJ; Ou-Yang, PK; Tan, XH; Wei, P; Zhang, ZJ; Zou, QG, 2011
)
0.37
" Some patients do not respond to the drug; this condition can be due to patient-related factors (poor compliance, genetic factors, cardiovascular risk profile) or to drug-related factors (reduced bioavailability or absorption, drug-drug interactions)."( Responsiveness to P2Y12 receptor inhibitors.
Esposito, G, 2011
)
0.37
"The ABCB1 C3435T polymorphism limits oral bioavailability of clopidogrel and may influence prognosis of patients treated with clopidogrel."( ABCB1 C3435T polymorphism and risk of adverse clinical events in clopidogrel treated patients: a meta-analysis.
Li, J; Luo, M; Sheng, W; Sun, X; Xu, X, 2012
)
0.38
"The present study was performed to compare the bioavailability of two clopidogrel 75 mg film-coated tablet formulations (test formulation and reference formulation)."( Bioequivalence study of two clopidogrel film-coated tablet formulations in healthy volunteers.
Handayani, LR; Santoso, ID; Setiawati, A; Setiawati, E; Tjandrawinata, RR; Yunaidi, DA, 2011
)
0.37
" Preliminary pharmacokinetic study results showed that the bioavailability of clopidogrel thiolactone generated from 9a was 6-fold higher than that generated from clopidogrel, implying a much lower clinically effective dose for 9a in comparison with clopidogrel."( Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
Gong, Y; Jiao, B; Lv, F; Qi, X; Shan, J; Sun, H; Yuan, F; Zhang, B; Zheng, W; Zhu, Y, 2012
)
0.38
" Similarly, clopidogrel bioavailability remained unchanged by chronic administration of dabigatran etexilate (part 3: ratio test/reference for AUC(0-24) was 103%; 90% CI 80."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013
)
0.39
"The bioavailability of clopidogrel in critically ill patients after cardiopulmonary resuscitation is significantly impaired compared with stable patients."( Impaired bioavailability and antiplatelet effect of high-dose clopidogrel in patients after cardiopulmonary resuscitation (CPR).
Čundrle, I; Hlinomaz, O; Opatřilová, R; Pavlík, M; Součková, L; Šrámek, V; Suk, P; Zvoníček, V, 2013
)
0.39
" When possible, the use of alternative drugs with more uniform and predictable bioavailability and with favorable profiles in terms of risk/benefit and cost/benefit ratios should be preferred."( Diagnosis and management of high platelet reactivity on treatment with clopidogrel.
Cattaneo, M, 2012
)
0.38
" Following the oral administration of clopidogrel with or without the P-gp inhibitors, quercetin (250 mg/kg), telmisartan (8 mg/kg), and cyclosporine A (10 mg/kg), in rats and dogs, the plasma concentration-time profiles of clopidogrel carboxylic acid, a surrogate marker for the bioavailability of clopidogrel, were determined."( Pharmacokinetic interactions of clopidogrel with quercetin, telmisartan, and cyclosporine A in rats and dogs.
Lee, JH; Lee, YJ; Oh, JH; Shin, YJ, 2012
)
0.38
" Clopidogrel resistance is likely to develop as a result of a decreased bioavailability of the active metabolite, due to genetic variation or concomitant drug treatment."( Aspirin and clopidogrel resistance: possible mechanisms and clinical relevance. Part II: Potential causes and laboratory tests.
Sas, K; Sztriha, LK; Vadász, D; Vécsei, L, 2013
)
0.39
" In particular, spiropiperidine indoline-substituted diaryl ureas are described as potent, orally bioavailable small-molecule P2Y1 antagonists with improved activity in functional assays and improved oral bioavailability in rats."( Conformationally constrained ortho-anilino diaryl ureas: discovery of 1-(2-(1'-neopentylspiro[indoline-3,4'-piperidine]-1-yl)phenyl)-3-(4-(trifluoromethoxy)phenyl)urea, a potent, selective, and bioavailable P2Y1 antagonist.
Abell, LM; Bostwick, JS; Bouthillier, G; Chang, M; Gao, Q; Hiebert, S; Hua, J; Huang, CS; L'Heureux, A; Lam, PY; Liu, E; Lloyd, J; Ma, B; McDonnell, PA; Pi, Z; Price, LA; Qiao, JX; Rehfuss, R; Ruel, R; Schnur, DM; Schumacher, WA; Spronk, SA; Steinbacher, TE; Thibeault, C; Wang, TC; Wexler, RR; Wu, Q; Zheng, J, 2013
)
0.39
" However, unlike other medications, subtle differences in clopidogrel bioavailability may lead to acute consequences including stent thrombosis (ST)."( Clustering of acute and subacute stent thrombosis related to the introduction of generic clopidogrel.
Baber, U; Badimon, JJ; Hulot, JS; Kini, A; Kovacic, JC; Krishnan, P; Li, JR; Mehran, R; Moreno, P; Sharma, SK; Sweeny, J, 2014
)
0.4
" The C3435T polymorphism in this gene affects the bioavailability of clopidogrel, however, its effects on clinical outcomes are inconclusive."( Genetic and nongenetic factors influencing the response to clopidogrel.
Bontardelli, F; Merlini, PA; Notarangelo, MF, 2013
)
0.39
" SAR studies were conducted to improve PK and potency, resulting in the identification of compound 3e, a potent, orally bioavailable P2Y1 antagonist with a suitable PK profile in preclinical species."( Identification of 1-{2-[4-chloro-1'-(2,2-dimethylpropyl)-7-hydroxy-1,2-dihydrospiro[indole-3,4'-piperidine]-1-yl]phenyl}-3-{5-chloro-[1,3]thiazolo[5,4-b]pyridin-2-yl}urea, a potent, efficacious and orally bioavailable P2Y(1) antagonist as an antiplatelet
Bostwick, JS; Chacko, SA; Chen, BC; Chen, XQ; Clark, CG; Hiebert, S; Hua, J; Huang, CS; Jeon, YT; Lam, PY; Levesque, PC; Li, D; Li, L; Liu, Y; Malley, M; Mathur, A; Price, LA; Qiao, JX; Rehfuss, R; Ruel, R; Schumacher, WA; Seiffert, DA; Shen, H; Stewart, AB; Sun, D; Thibeault, C; Wang, TC; Wang, Y; Wexler, RR; Wong, HS; Wu, DR; Yang, W; Zhu, J, 2014
)
0.4
" These findings indicate low-dose aspirin coadministration may decrease clopidogrel bioavailability but does not decrease its efficacy."( Aspirin decreases systemic exposure to clopidogrel through modulation of P-glycoprotein but does not alter its antithrombotic activity.
Cho, JY; Chu, K; Hong, KS; Jang, IJ; Ji, SC; Jung, KH; Lee, H; Lee, S; Lim, KS; Oh, J; Shin, D; Shin, KH; Yoon, SH; Yu, KS, 2014
)
0.4
"Two randomized, single dose, 2-period, 2-sequence crossover studies were conducted to evaluate the comparative bioavailability of two clopidogrel formulations under fasting and fed conditions."( Comparative bioavailability of two oral formulations of clopidogrel: determination of clopidogrel and its carboxylic acid metabolite (SR26334) under fasting and fed conditions in healthy subjects.
Breznik, M; Brvar, N; Cvitkovič Marčič, L; Grabnar, I; Lachance, S; Lévesque, A; Mateovič-Rojnik, T; Merslavič, M, 2014
)
0.4
"The intention of this study was to compare the physicochemical properties, stability and bioavailability of a clopidogrel napadisilate (CN)-loaded solid dispersion (SD) and solid self-microemulsifying drug delivery system (solid SMEDDS)."( Comparison of a solid SMEDDS and solid dispersion for enhanced stability and bioavailability of clopidogrel napadisilate.
Balakrishnan, P; Choi, HG; Kim, DS; Kim, DW; Kim, JO; Kwon, MS; Lee, BJ; Park, JH; Park, YJ; Yong, CS; Yousaf, AM, 2014
)
0.4
" Its dissolution profiles and oral bioavailability in rats were also compared with that of CNM and clopidogrel bisulfate (CB)."( Clopidogrel Napadisilate Monohydrate Loaded Surface-Modified Solid Dispersion: Physicochemical Characterization and in Vivo Evaluation.
Cho, KH; Choi, HG; Kim, DW; Kim, JO; Kim, YH; Kwon, MS; Yong, CS, 2015
)
0.42
" Since the bioavailability of 30d was low in rat and dog, we developed the bis((isopropoxycarbonyl)oxy)methyl ester prodrug (ACT-281959, 45)."( 4-((R)-2-{[6-((S)-3-Methoxypyrrolidin-1-yl)-2-phenylpyrimidine-4-carbonyl]amino}-3-phosphonopropionyl)piperazine-1-carboxylic Acid Butyl Ester (ACT-246475) and Its Prodrug (ACT-281959), a Novel P2Y12 Receptor Antagonist with a Wider Therapeutic Window in
Caroff, E; Gnerre, C; Hess, P; Hilpert, K; Hubler, F; Meyer, E; Renneberg, D; Rey, M; Riederer, MA; Steiner, B; Treiber, A, 2015
)
0.42
"ESSENTIALS: The reliability of platelet tests as markers of the variable bioavailability of clopidogrel is not yet defined."( Relationship between pharmacokinetics and pharmacodynamics of clopidogrel in patients undergoing percutaneous coronary intervention: comparison between vasodilator-stimulated phosphoprotein phosphorylation assay and multiple electrode aggregometry.
Beltrame, F; Benati, M; Calabria, S; Cattaneo, M; Danese, E; Fava, C; Gelati, M; Gottardo, R; Guidi, GC; Minuz, P; Tagliaro, F; Tavella, D, 2016
)
0.43
" VASP-P could be useful in studies aimed at investigating relations between CAM bioavailability and clinical events."( Relationship between pharmacokinetics and pharmacodynamics of clopidogrel in patients undergoing percutaneous coronary intervention: comparison between vasodilator-stimulated phosphoprotein phosphorylation assay and multiple electrode aggregometry.
Beltrame, F; Benati, M; Calabria, S; Cattaneo, M; Danese, E; Fava, C; Gelati, M; Gottardo, R; Guidi, GC; Minuz, P; Tagliaro, F; Tavella, D, 2016
)
0.43
" It has poor oral bioavailability due to poor dissolution and possible premature degradation in the intestine."( Enhancement of Dissolution Rate and Intestinal Stability of Clopidogrel Hydrogen Sulfate.
Bali, DE; El Maghraby, GM; Osman, MA, 2016
)
0.43
" The relative bioavailability of the formulation was 101."( Bioequivalence of clopidogrel hydrogen sulfate tablets in healthy Chinese volunteers.
Di, XH; Jiang, N; Song, LX; Xu, J; Xu, L; Xu, XT; Yang, YG; Zhang, M; Zhao, GT, 2015
)
0.42
"Prasugrel exhibits beneficial mid-term effects on endothelial nitric oxide bioavailability and inflammatory markers."( Prasugrel as opposed to clopidogrel improves endothelial nitric oxide bioavailability and reduces platelet-leukocyte interaction in patients with unstable angina pectoris: A randomized controlled trial.
Baldus, S; Friedrichs, K; Fuchs, A; Hellmich, M; Klinke, A; Mollenhauer, M; Rudolph, TK; Rudolph, V; Schlichting, A; Schwedhelm, E, 2017
)
0.46
"In the present investigation, oral dissolving/dispersible/disintegrating tablets (ODTs) of clopidogrel were designed with a view to enhance the bioavailability and patient compliance by two different methods, namely, direct compression and effervescent methods using directly compressible excipient and treated agar (TAG)."( Effect of directly compressible excipient and treated agar on drug release of clopidogrel oral disintegrating tablets.
Kumar Reddy, BK; Nirosha, M; Sai Kiran, BS; Venkateswarlu, K, 2017
)
0.46
" Although generally well tolerated, its efficacy varies among individuals, with the main hypothesis that its bioavailability relies on its bioconversion to the active compound, which, in turn, depends on the genetic background and/or interactions with other drugs."( CYP2C19 or CYP3A5 Genotyping Does Not Predict Clinical Response to Clopidogrel.
Garay-Sánchez, P; Martínez-Quintana, E; Medina-Gil, JM; Riaño, M; Rodríguez-González, F; Saavedra, P; Tugores, A, 2018
)
0.48
"This study demonstrates that the bioavailability of these 4 generic clopidogrel products authorised in Serbia is very similar."( Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.
García-Arieta, A; Miljković, B; Pejčić, Z; Vučićević, K, 2019
)
0.51
"Clopidogrel bisulfate (CB) is a golden antiplatelet treatment, yet its benefits are limited by its low bioavailability (<50%) caused by poor intestinal solubility and absorption."( Stabilizing excipients for engineered clopidogrel bisulfate procubosome derived in situ cubosomes for enhanced intestinal dissolution: Stability and bioavailability considerations.
Abdelmalak, NS; Badawi, A; El-Laithy, HM; Elsayyad, NME, 2019
)
0.51
"Clopidogrel (CLOP) is an antiplatelet drug with poor solubility in intestinal fluid, which limits its bioavailability after oral administration."( Probing the effect of various lipids and polymer blends on clopidogrel encapsulated floating microcarriers.
Ali, A; Asghar, S; Hussain, T; Irfan, M; Irshad, S; Khalid, I; Khalid, SH; Khan, AN; Khan, IU; Sabir, N; Shahzad, Y; Yousaf, AM, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
"Variability in P-glycoprotein (P-gp) efflux transporting activity was supposed to be involved in altered intestinal absorption and bioavailability of clopidogrel in patients; however, reliable evidence is still lacking."( P-glycoprotein deficiency enhances metabolic activation of and platelet response to clopidogrel through marked up-regulation of Cyp3a11 in mice: Direct evidence for the interplay between P-glycoprotein and Cyp3a.
Ge, PX; Ji, JZ; Jiang, LP; Li, YF; Mi, QY; Tai, T; Xie, HG; Zhu, T, 2021
)
0.62
" The therapeutic effects of drug molecules are majorly dependent on the bioavailability and, in essence, on the solubility of the used drug molecules."( Exploration on the drug solubility enhancement in aqueous medium with the help of endo-functionalized molecular tubes: a computational approach.
Paul, R; Paul, S, 2021
)
0.62
"The therapeutic efficacy of clopidogrel as an antiplatelet drug varies among individuals, being the mainstream hypothesis that its bioavailability depends on the individual genetic background and/or interactions with other drugs."( Clinical and Pharmacological Parameters Determine Relapse During Clopidogrel Treatment of Acute Coronary Syndrome.
Martínez-Quintana, E; Medina-Gil, JM; Rodríguez-González, F; Saavedra-Santana, P; Santana-Mateos, M; Tugores, A, 2022
)
0.72
"Despite being a first-line clinical drug, thienopyridines have many unsatisfactory aspects, including the low bioavailability of clopidogrel(CLP) and the high bleeding risk of prasugrel."( Evaluation of efficacy and safety after replacement of methyl hydrogen with deuterium at methyl formate of Clopidogrel.
Cai, D; Cao, X; Chen, C; Chen, L; Gao, M; Gu, J; Li, X; Liu, S; Liu, Y; Miao, Y; Niu, J; Sun, Y; Wu, T; Xu, Z, 2022
)
0.72
"The study aimed to increase the intestinal solubility and absorption of orally bioavailable clopidogrel-bisulfate (CPB) by complexing with hydroxypropyl-β-cyclodextrin (HCD) to form a binary inclusion complex that was stabilized by Tween 80 (T80) resulting into mixed inclusion complex."( Preparation and Characterization of Clopidogrel Bisulfate-hydroxypropyl-β-Cyclodextrin Mixed Inclusion Complex for Improved Intestinal Solubility and Anti-Thrombotic Efficacy.
Chaudhary, S; Rana, V; Sharma, R; Singh, A, 2023
)
0.91

Dosage Studied

The developed method was successfully applied for the determination of clopidogrel bisulfate (CPS), aspirin (ASP), together with salicylic acid (SA) A total of 119 patients undergoing PCI were blindly randomized in 2:1 fashion.

ExcerptRelevanceReference
" From a dose-response showing that the administration of increasing doses of tissue thromboplastin resulted in a subsequent progressive increase of thrombus weight, two concentrations of tissue thromboplastin were chosen: a high dose (550 microL/kg, IV) where thrombus formation was optimal and a concentration (7 microL/kg, IV) where tissue thromboplastin-hypercoagulability was intermediate."( Importance of platelets in experimental venous thrombosis in the rat.
Bernat, A; Herbert, JM; Maffrand, JP, 1992
)
0.28
" Furthermore, the simpler dosing regimen, the absence of neutropenia, and the lower frequency of other side effects make it a safe alternative to ticlopidine."( Effectiveness of clopidogrel and aspirin versus ticlopidine and aspirin in preventing stent thrombosis after coronary stent implantation.
Collins, M; Colombo, A; Iyer, S; Kreps, E; Maida, R; Moses, JW; Moussa, I; Oetgen, M; Roubin, G; Wang, X, 1999
)
0.3
" This review article examines research on both monotherapy and combination antiplatelet therapy for secondary stroke prevention, with an emphasis on lessons learned about dosage schedules, treatment protocols, and side-effect profiles."( Antiplatelet therapy for secondary stroke prevention.
Forbes, CD, 1999
)
0.3
" In both studies, the inhibition of platelet aggregation induced by 5 microM of ADP was measured before dosing (baseline), then at regular intervals during and after treatment."( Repeated-dose pharmacodynamics of clopidogrel in healthy subjects.
Cariou, R; Kieffer, G; Lowe, GD; Nimmo, WS; Thebault, JJ, 1999
)
0.3
" Bleeding time and platelet aggregation induced by 5 microM of ADP were measured before treatment (baseline) and at regular intervals after dosing during treatment."( Clopidogrel and drug metabolism: absence of effect on hepatic enzymes in healthy volunteers.
Dickinson, JP; Houle, JM; Kieffer, G; Kindermans, M; Necciari, J; Pierce, CH; Serre-Lacroix, E, 1999
)
0.3
" Platelet aggregation induced by 5 microM of ADP was measured in plasma samples taken at screening, 2 hours after dosing on day 1 to day 9; 2, 5, and 24 hours after dosing on day 10; and on alternate days until day 24."( Clopidogrel antiplatelet activity is independent of age and presence of atherosclerosis.
Denninger, MH; Necciari, J; Serre-Lacroix, E; Sissmann, J, 1999
)
0.3
" Tests of hemostasis (ADP-induced platelet aggregation and bleeding time) were carried out 2 hours after clopidogrel dosing on days 5, 7, 9, 11, and 14."( Clopidogrel does not affect the pharmacokinetics of theophylline.
Caplain, H; Necciari, J; Thebault, JJ, 1999
)
0.3
" Therefore, no dosage adjustment of clopidogrel is required in patients with Child-Pugh Class A or B cirrhosis."( Cirrhosis does not affect the pharmacokinetics and pharmacodynamics of clopidogrel.
Much, DR; Necciari, J; Nichola, P; Slugg, PH; Smith, WB; Vargas, R, 2000
)
0.31
" Despite the growing use of GP IIb/IIIa antagonists, much information remains unknown as to the proper dosing and the effects these agents have on other elements of the hemostatic and vascular systems."( Antithrombotic therapy in the cardiac catheterization laboratory: focus on antiplatelet agents.
Frelinger III, AL; Furman, MI; Michelson, AD, 2000
)
0.31
" Because of better side-effect profile and simpler dosing regime, clopidogrel has largely replaced ticlopidine."( Isolated profound thrombocytopenia associated with clopidogrel.
Elmi, F; Peacock, T; Schiavone, J, 2000
)
0.31
"To review the efficacy and dosage of aspirin in stroke prevention, and to review the benefits and risks of the newer strategies, compared with aspirin."( Newer antiplatelet therapies in stroke prevention.
Davis, SM; Donnan, GA, 2001
)
0.31
" It is indicated, at a dosage of 75 mg/day, for the reduction of atherosclerotic events including myocardial infarction, ischaemic stroke and vascular death in patients with atherosclerosis manifested by recent stroke, myocardial infarction or established peripheral vascular disease."( [Pharmacy clinics. Medication of the month. Clopidogrel (Plavix)].
Scheen, AJ, 2001
)
0.31
" We present several illustrative cases in which platelet monitoring with the Rapid Platelet Function Assay (RPFA, Accumetrics) was used to guide dosing of a glycoprotein (GP) IIb/IIIa inhibitor for coronary and peripheral intervention among patients at increased bleeding risk."( Clinical application of procedural platelet monitoring during percutaneous coronary intervention among patients at increased bleeding risk.
Chew, DP; Moliterno, DJ; Mukherjee, D; Raymond, RE; Robbins, M; Yadav, JS, 2001
)
0.31
"5 mg/kg intravenous (IV), and eptifibatide using the ESPIRIT dosing (180 g/kg bolus IV, immediately followed by a 2 g/kg/minute continuous IV infusion, and then a second 180 g/kg bolus IV ten minutes after the first bolus)."( Use of clopidogrel loading, enoxaparin, and double-bolus eptifibatide in the setting of early percutaneous coronary intervention for acute coronary syndromes.
Bertolet, BD; Gupta, A; Miller, L, 2002
)
0.31
"A stability indicating, reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of clopidogrel in pharmaceutical dosage forms."( A validated LC method for the determination of clopidogrel in pharmaceutical preparations.
Mitakos, A; Panderi, I, 2002
)
0.31
" This may have implications regarding the need for separate heparin dosing algorithms for patients undergoing PCI in the setting of different GPIIb-IIIa inhibitors."( Activated clotting times in the setting of eptifibatide use during percutaneous coronary intervention.
Ball, SA; Dauerman, HL; Desourdy, MA; Furman, MI; Goldberg, RJ, 2002
)
0.31
" This rabbit model with a high dosage of clopidogrel and aspirin, and a short-time exposure of the heart valve leaflets to rabbit blood under laminar flow, should be further evaluated with respect to whether it can give information about antithrombotic regimens in patients after mechanical heart valve replacement."( Effects of combined therapy of clopidogrel and aspirin in preventing thrombus formation on mechanical heart valves in an ex vivo rabbit model.
Bickel, C; Buerke, M; Hauroeder, B; Hundt, F; Meyer, J; Peetz, D; Rupprecht, HJ; Schlitt, A; Victor, A, 2002
)
0.31
"Better tolerability, reduced toxicity (particularly hematologic), and the convenience of once-daily dosing have resulted in the replacement of ticlopidine with clopidogrel."( Clopidogrel-associated leukopenia.
Kockler, DR; McCarthy, MW, 2003
)
0.32
" We sought to establish an optimal clopidogrel dosing regimen for sustained platelet inhibition in stented patients."( Onset and extent of platelet inhibition by clopidogrel loading in patients undergoing elective coronary stenting: the Plavix Reduction Of New Thrombus Occurrence (PRONTO) trial.
Alford, AB; Bell, CR; Cummings, CC; Gurbel, PA; Meister, AF; Serebruany, VL, 2003
)
0.32
" Therefore, despite improved outcomes, further studies are required to determine the optimal duration and dosage regimen of such combination therapy to maximize its risk-benefit ratio."( Clopidogrel in the management of ischemic heart disease.
Bhatt, R; Cavusoglu, E; Cheng, J; Eng, C; Kunamneni, PB; Marmur, JD,
)
0.13
" Intravenous glycoprotein IIb/IIIa inhibitors effectively prevent periprocedural thrombotic complications, but their short duration of action and parenteral dosing don't allow for long-term protection."( What is the role for improved long-term antiplatelet therapy after percutaneous coronary intervention?
Berger, P; Steinhubl, S, 2003
)
0.32
" On the other hand, ASA has even to be applied at a dosage that almost completely inhibits thromboxane synthesis in order to act on platelet aggregation at all."( [Platelet aggregation disorders].
Patscheke, H, 2003
)
0.32
" Moreover, ximelagatran has rapid onset and offset of action, fixed oral dosing without the need for anticoagulation monitoring, low potential for food and drug interactions, and a therapeutic margin wider than that of warfarin."( New possibilities in anticoagulant management of atrial fibrillation.
Waldo, AL, 2004
)
0.32
" If the international normalized ratio (INR) was kept > 2 for a long period, by means of frequent check-ups and effective dosage adjustment, the chance of death, recurrent myocardial infarction or stroke was 30-50% lower than when acetylsalicylic acid only was used."( [Antithrombotic therapy after myocardial infarction: arguments for the use of acetylsalicylic acid and coumarin derivatives].
Brouwer, A; Verheugt, FW; Waskowsky, WM, 2005
)
0.33
" Specifically, there was no difference in the tirofiban dose-response curves with either platelet agonist for any of the three time points (before, and three and six hours after, clopidogrel administration)."( Does clopidogrel increase the degree of platelet inhibition when a platelet glycoprotein IIb/IIIa inhibitor has been given? Insights from an optical platelet aggregometry study.
Berger, PB; DiBattiste, PM; Lennon, R; Lubbe, D; Orford, JL; Talreja, D, 2004
)
0.32
" The objective of this study was to conduct a detailed time-resolved analysis of the effects of the GPIIb/IIIa inhibitor tirofiban with concomitant clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI) to improve the dosing regimen of these two commonly used antiplatelet drugs."( Pharmacodynamics and pharmacokinetics of the platelet GPIIb/IIIa inhibitor tirofiban in patients undergoing percutaneous coronary intervention: implications for adjustment of tirofiban and clopidogrel dosage.
Badar, J; Covic, L; Jacques, S; Kimmelstiel, C; Kuliopulos, A; Waxman, S; Weintraub, A, 2005
)
0.33
"This study shows that the currently utilized tirofiban dosage is suboptimal and suggests that patients may benefit from a higher dose regimen."( Pharmacodynamics and pharmacokinetics of the platelet GPIIb/IIIa inhibitor tirofiban in patients undergoing percutaneous coronary intervention: implications for adjustment of tirofiban and clopidogrel dosage.
Badar, J; Covic, L; Jacques, S; Kimmelstiel, C; Kuliopulos, A; Waxman, S; Weintraub, A, 2005
)
0.33
"We determined the effect of clopidogrel dosing on the incidence of nonresponsiveness (NR) and high post-treatment platelet aggregation (post-PA)."( The relation of dosing to clopidogrel responsiveness and the incidence of high post-treatment platelet aggregation in patients undergoing coronary stenting.
Bliden, KP; Gurbel, PA; Hayes, KM; Herzog, WR; Tantry, US; Yoho, JA, 2005
)
0.33
" Higher dosing strategies and methods to confirm platelet inhibition should be further investigated in order to optimally use clopidogrel in patients undergoing stenting."( The relation of dosing to clopidogrel responsiveness and the incidence of high post-treatment platelet aggregation in patients undergoing coronary stenting.
Bliden, KP; Gurbel, PA; Hayes, KM; Herzog, WR; Tantry, US; Yoho, JA, 2005
)
0.33
" Patients were randomized to either standard dosing with clopidogrel or 1 of 3 prasugrel regimens."( Randomized comparison of prasugrel (CS-747, LY640315), a novel thienopyridine P2Y12 antagonist, with clopidogrel in percutaneous coronary intervention: results of the Joint Utilization of Medications to Block Platelets Optimally (JUMBO)-TIMI 26 trial.
Antman, EM; Behounek, BD; Braunwald, E; Carney, RJ; Lazzam, C; McCabe, CH; McKay, RG; Murphy, SA; Weerakkody, G; Winters, KJ; Wiviott, SD, 2005
)
0.33
"To review a pediatric experience with the antiplatelet agent clopidogrel and suggest a dosage regimen."( Clopidogrel use in children.
Avner, M; Benson, LN; Finkelstein, Y; Koren, G; Nurmohamed, L, 2005
)
0.33
" In addition, AYPGKF- and thrombin-induced TXA2 generation was significantly reduced in platelets from mice dosed with clopidogrel, confirming the results obtained with the human platelets."( P2Y12 receptor-mediated potentiation of thrombin-induced thromboxane A2 generation in platelets occurs through regulation of Erk1/2 activation.
Garcia, A; Kim, S; Kunapuli, SP; Prabhakar, J; Shankar, H, 2006
)
0.33
" AZD6140 (100 and 200 mg bid, 400 mg qd) rapidly and nearly completely inhibited ADP-induced platelet aggregation after initial dosing (day 1) and at day 28."( Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin.
Emanuelsson, H; Heptinstall, S; Husted, S; Peters, G; Sandset, PM; Wickens, M, 2006
)
0.33
" Changes in total thrombus area (TTA) under low shear rate (LSR; 212 s(-1)) and high shear rate (HSR; 1690 s(-1)) conditions were measured, using the ex vivo Badimon perfusion chamber model pre-dose and 2 and 5 hours after dosing on Day 6, and capillary bleeding times (CBT) were determined."( Antithrombotic effects of ximelagatran plus acetylsalicylic acid (ASA) and clopidogrel plus ASA in a human ex vivo arterial thrombosis model.
Badimon, JJ; Bylock, A; Elg, M; Eriksson, UG; Eriksson-Lepkowska, M; Kalies, I; Nyström, P; Sarich, TC; Wåhlander, K, 2006
)
0.33
" It was shown that standard dosing of tirofiban is insufficient for optimal platelet inhibition."( Single high-dose bolus tirofiban with high-loading-dose clopidogrel in primary coronary angioplasty.
Akbulut, T; Akgoz, H; Bilsel, T; Ciloglu, F; Dayi, SU; Ergelen, M; Sayar, N; Terzi, S; Yesilcimen, K, 2006
)
0.33
" Multiple mechanisms likely contribute to clopidogrel variability of response, including inappropriate dosing or underdosing of clopidogrel, drug-drug interactions, and genetic polymorphisms."( Variability of response to clopidogrel: possible mechanisms and clinical implications.
Frishman, WH; Lerner, RG; Nawarskas, J; Nguyen, T,
)
0.13
" In the triple therapy group, the international normalized ratio or aspirin dosage did not influence the bleeding risk."( Combination therapy with aspirin, clopidogrel and warfarin following coronary stenting is associated with a significant risk of bleeding.
Bergman, G; Chou, E; Hong, MK; Khurram, Z; Minutello, R; Naidu, S; Parikh, M; Wong, SC, 2006
)
0.33
"At the dosing regimens chosen in the JUMBO trial, it seems that prasugrel is a more potent antiplatelet agent than clopidogrel."( Platelet inhibition with prasugrel (CS-747) compared with clopidogrel in patients undergoing coronary stenting: the subset from the JUMBO study.
Lowry, DR; Malinin, AI; Meilman, H; Midei, MG; Serebruany, VL, 2006
)
0.33
" Thirteen patients required a higher dosage of aspirin and/or an additional anti-platelet agent to achieve therapeutic adequacy."( Use of whole blood platelet lumi-aggregometry to optimize anti-platelet therapy in patients with chronic myeloproliferative disorders.
Gemmell, R; Hartwell, T; Manoharan, A, 2006
)
0.33
" This study examined the degree of PI after a high-dose load of clopidogrel compared with standard dosing and the time course of functional recovery after the discontinuation of daily therapy."( Onset and offset of platelet inhibition after high-dose clopidogrel loading and standard daily therapy measured by a point-of-care assay in healthy volunteers.
Cannon, CP; Coleman, JL; Price, MJ; Steinhubl, SR; Teirstein, PS; Wong, GB, 2006
)
0.33
" A significant dose-response was also observed for the vasodilator-stimulated phosphoprotein index, a measure of P2Y(12) receptor inhibition."( A randomized comparison of high clopidogrel loading doses in patients with non-ST-segment elevation acute coronary syndromes: the ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) t
Bal-dit-Sollier, C; Beygui, F; Collet, JP; Drouet, L; Henry, P; Lellouche, N; Meuleman, C; Milleron, O; Montalescot, G; Sideris, G; Slama, M; Steg, PG, 2006
)
0.33
"This double-blind, placebo-controlled trial was designed to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of prasugrel (CS-747, LY640315), a novel thienopyridine P2Y(12) ADP receptor antagonist compared with clopidogrel, during multiple oral dosing in healthy subjects."( A multiple dose study of prasugrel (CS-747), a novel thienopyridine P2Y12 inhibitor, compared with clopidogrel in healthy humans.
Asai, F; Brandt, JT; Freestone, S; Hirota, T; Jakubowski, JA; Matsushima, N; Naganuma, H; Winters, KJ, 2007
)
0.34
" Whether platelet inhibition can be enhanced by increasing clopidogrel maintenance dosage in T2DM patients is unknown."( Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study.
Angiolillo, DJ; Bass, TA; Bernardo, E; Charlton, RK; Costa, MA; Desai, B; Guzman, LA; Shoemaker, SB; Yuan, H; Zenni, MM, 2007
)
0.34
"Although appropriate anticoagulation is essential to maximize the efficacy and safety of primary PCI, the optimal dosing of enoxaparin in this setting is unclear."( A novel enoxaparin regime for ST elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: a WEST sub-study.
Armstrong, PW; Buller, CE; Gordon, P; O'Neill, B; Welsh, RC; Westerhout, CM, 2007
)
0.34
" Recent studies have left clinicians with many questions regarding the role and dosing regimens of clopidogrel in STEMI, PCI, and primary or secondary prevention."( Contemporary issues in clopidogrel therapy: new evidence shaping clinical practice.
Emmons, KL; Taylor, NR, 2007
)
0.34
"Clopidogrel is an established alternative to ticlopidine in addition to aspirin after coronary stenting because of its safety, but its optimal initial dosing is unclear."( Benefits of clopidogrel in patients undergoing coronary stenting significantly depend on loading dose: evidence from a meta-regression.
Abbate, A; Agostoni, P; Biondi-Zoccai, GG; Lotrionte, M; Moretti, C; Sangiorgi, G; Sheiban, I; Valgimigli, M, 2007
)
0.34
" Within the limitations of the study, prasugrel was found to be well tolerated when dosed as LD followed by MD in the presence of ASA and provided greater platelet inhibition than ASA alone."( Dose-dependent inhibition of human platelet aggregation by prasugrel and its interaction with aspirin in healthy subjects.
Brandt, JT; Farid, NA; Jakubowski, JA; Lachno, DR; Li, YG; Naganuma, H; Payne, CD; Weerakkody, GJ; Winters, KJ, 2007
)
0.34
" However, further studies are needed to validate the dose-response relationship and further support the clinical utility of factor VIIa in this life-threatening situation."( Recombinant activated factor VII treatment of retroperitoneal hematoma in a patient with renal failure receiving enoxaparin and clopidogrel.
Al Askar, A; Al Shimemeri, A; Arabi, Y; Cherfan, A, 2007
)
0.34
" Failure to reduce the dose of a GP IIb/IIIa for patients with renal insufficiency resulting in excessive dosing of GP IIb/IIIa inhibitors increases the risk of major bleeding and is particularly common among the elderly, women, and patients with renal insufficiency."( Managing acute coronary syndrome: evidence-based approaches.
Spinler, SA, 2007
)
0.34
" Dosing of aspirin in the first 24 hours was as follows: 17."( Patterns of aspirin dosing in non-ST-elevation acute coronary syndromes in the CRUSADE Quality Improvement Initiative.
Cannon, CP; Gibler, WB; Milford-Beland, S; Ohman, EM; Peterson, ED; Pollack, CV; Roe, MT; Tickoo, S, 2007
)
0.34
" The model identified a clopidogrel poor responder as a subject who failed to achieve and maintain an IPA >or= 25% (or DeltaMPA >or= 20%) with 5 microM ADP at 4-5 and 24 hours after dosing or who failed to achieve and maintain an IPA >or= 20% (or DeltaMPA >or= 15%) with 20 microM ADP at 4-5 and 24 hours after dosing."( Clopidogrel poor responders: an objective definition based on Bayesian classification.
Brandt, JT; Jakubowski, JA; Naganuma, H; Payne, CD; Weerakkody, GJ; Winters, KJ, 2007
)
0.34
" Elderly patients (> or = 75 years of age) received a novel enoxaparin dosing regimen and when compared with UFH, benefited from a lower relative bleeding risk than younger patients without compromising efficacy in preventing death or MI."( ExTRACT-TIMI 25 trial: clarifying the role of enoxaparin in patients with ST-elevation myocardial infarction receiving fibrinolysis.
Gabriel, RS; White, HD, 2007
)
0.34
"In the majority of potentially adverse clopidogrel exposures reported to poison control centers the doses are twice the recommended dosage or less."( Pattern of clopidogrel exposures reported to Texas poison centers during 1998-2004.
Forrester, MB, 2007
)
0.34
" For aspirin, the median dosage per week was 1300 mg and median ARU was 410."( Prevalence and risk factors for aspirin and clopidogrel resistance in cerebrovascular stenting.
Flaherty, CA; Lee, VH; Lopes, DK; Prabhakaran, S; Wells, KR, 2008
)
0.35
"Antiplatelet and antithrombotic activity of multiple oral dosing of prasugrel were evaluated in several animal species."( Repeat oral dosing of prasugrel, a novel P2Y12 receptor inhibitor, results in cumulative and potent antiplatelet and antithrombotic activity in several animal species.
Asai, F; Hashimoto, M; Isobe, T; Jakubowski, JA; Niitsu, Y; Ogawa, T; Otsuguro, K; Sugidachi, A, 2008
)
0.35
" Prasugrel is orally more potent and acts more rapidly than clopidogrel, allowing lower oral dosing despite of similar in vitro activity of the active metabolites."( [Prasugrel, a new thienopyridine].
Huber, K; Schrör, K, 2007
)
0.34
" Despite the unambiguous clinical benefit associated with clopidogrel, accumulating experience with this drug has also led to identification of some of its drawbacks, which are related to inadequate platelet inhibition with standard dosage regimens as well as to its irreversible antiplatelet effects."( ADP receptor antagonism: what's in the pipeline?
Angiolillo, DJ, 2007
)
0.34
"Platelet inhibition as measured by vasodilator-stimulated phosphoprotein (VASP) and light transmission aggregometry (LTA) have shown concordance following dosing of clopidogrel."( A comparison of the antiplatelet effects of prasugrel and high-dose clopidogrel as assessed by VASP-phosphorylation and light transmission aggregometry.
Brandt, JT; Farid, NA; Jakubowski, JA; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
" Investigation of alternative clopidogrel dosing regimens to reduce ischaemic events in high-risk patients identified by this assay is warranted."( Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation.
Endemann, S; Ernst, A; Gollapudi, RR; Levisay, JP; Price, MJ; Sawhney, NS; Schatz, RA; Stinis, CT; Teirstein, PS; Valencia, R, 2008
)
0.35
" One hundred sixty-one patients on 100 mg of aspirin co-medication underwent elective coronary stenting and were given an initial dosage of 600 mg clopidogrel, followed by 75 mg clopidogrel daily."( How to optimise clopidogrel therapy? Reducing the low-response incidence by aggregometry-guided therapy modification.
Engelhardt, A; Lask, S; Mügge, A; Neubauer, H, 2008
)
0.35
" The specific dosing and its clinical usefulness of each medication are considered."( [Platelet aggregation inhibition in acute coronary syndrome. Facts and expectations].
Keltai, M, 2008
)
0.35
" Hyporesponsive patients might benefit from different dosing strategies or additional antiplatelet therapies."( Investigating the mechanisms of hyporesponse to antiplatelet approaches.
Angiolillo, D; Bates, E; Berger, PB; Bhatt, D; Braunwald, E; Cannon, CP; Furman, MI; Gurbel, P; Michelson, AD; Peterson, E; Wiviott, S, 2008
)
0.35
" In recent years, clopidogrel dosing strategies among such patients have evolved considerably, with newer approaches involving loading doses prior to PCI and increases in the time interval and loading dosage in an effort to overcome variable responsiveness/hyporesponsiveness to platelet inhibition."( Clinical considerations with the use of antiplatelet therapy in patients undergoing percutaneous coronary intervention.
Angiolillo, D; Bates, E; Berger, PB; Bhatt, D; Braunwald, E; Cannon, CP; Furman, MI; Gurbel, P; Michelson, AD; Peterson, E; Wiviott, S, 2008
)
0.35
" Since prasugrel is still under investigation, an official recommended dosage regimen has yet to be determined."( Prasugrel: a novel antiplatelet agent.
Haber, SL; Riley, AB; Tafreshi, MJ, 2008
)
0.35
" Future studies with prasugrel should determine its optimal dosage regimen to minimize bleeding risks and evaluate its outcomes in ACS and safety profile in special patient populations."( Prasugrel: a novel antiplatelet agent.
Haber, SL; Riley, AB; Tafreshi, MJ, 2008
)
0.35
" Clopidogrel at 3 mg kg(-1) was dosed orally once daily for three days, with the last dose given 2 h before injury."( Arterial antithrombotic and bleeding time effects of apixaban, a direct factor Xa inhibitor, in combination with antiplatelet therapy in rabbits.
Crain, EJ; Watson, CA; Wong, PC, 2008
)
0.35
" A total of 119 patients undergoing PCI were blindly randomized in 2:1 fashion to receive clopidogrel loading 600 mg on the table immediately before PCI and 75 mg 2 times/day for 1 month (high-dose group) versus standard dosing (300 mg loading and 75 mg/day; low-dose group)."( Comparison of higher clopidogrel loading and maintenance dose to standard dose on platelet function and outcomes after percutaneous coronary intervention using drug-eluting stents.
Abuzahra, M; Bobek, J; Caldera, A; Dokainish, H; Gonzalez, R; Hartley, WB; Lakkis, N; Pillai, M, 2008
)
0.35
" Decision to increase clopidogrel dosage may vary on the basis of the assay used, thus highlighting the need for unambiguous guidelines with respect to assay selection, as platelet function assays are not interchangeable."( Comparison of four tests to assess inhibition of platelet function by clopidogrel in stable coronary artery disease patients.
Diodati, JG; Lordkipanidzé, M; Nguyen, TA; Palisaitis, DA; Pharand, C; Schampaert, E, 2008
)
0.35
" Currently, efficiency, dosing and indications of established antiplatelet substances are being re-evaluated, whilst new, so far unrecognized molecular targets for inhibition of platelet activity come up front."( Antiplatelet drugs in cardiological practice: established strategies and new developments.
Klauss, V; Krötz, F; Sohn, HY, 2008
)
0.35
" The ExTRACT-TIMI 25 trial employed a novel dosing regimen for enoxaparin adjusted for age and renal function, which was designed to minimize bleeding risk while maintaining the beneficial effects of enoxaparin."( ExTRACT-TIMI 25 in perspective: key lessons regarding enoxaparin as an adjunct to fibrinolytic therapy.
Giugliano, RP; Thomas, D, 2009
)
0.35
" These results indicate that further studies are needed to determine the optimal dosing and timing of antiplatelet therapies for patients undergoing primary PCI."( Patterns of upstream antiplatelet therapy use before primary percutaneous coronary intervention for acute ST-elevation myocardial infarction (from the CRUSADE National Quality Improvement Initiative).
Alexander, D; Gibler, WB; Mann, N; Ohman, EM; Ou, FS; Peterson, ED; Roe, MT, 2008
)
0.35
" The drug was given as monotherapy for 10 days, and after a 6-day run-in period with atorvastatin 80 mg/day, the same dosage of atorvastatin was continued with the respective thienopyridine for 10 days."( Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects.
Brandt, JT; Ernest, CS; Farid, NA; Jakubowski, JA; Konkoy, CS; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
"Blood samples were collected before and at various time points after dosing on days 1 and 11 for determination of plasma concentrations of metabolites and for measurement of platelet aggregation induced by adenosine 5'-diphosphate 20 microM and vasodilator-stimulated phosphoprotein (VASP)."( Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects.
Brandt, JT; Ernest, CS; Farid, NA; Jakubowski, JA; Konkoy, CS; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
" The lack of a clinically meaningful effect of high-dose atorvastatin on the pharmacodynamic response to prasugrel after the loading or maintenance dose indicates that no dosage adjustment should be necessary in patients receiving these drugs concomitantly."( Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects.
Brandt, JT; Ernest, CS; Farid, NA; Jakubowski, JA; Konkoy, CS; Li, YG; Payne, CD; Salazar, DE; Small, DS; Winters, KJ, 2008
)
0.35
"The CURRENT-OASIS 7 trial will help to define optimal dosing regimens for clopidogrel and ASA in patients with ST and non-ST-segment-elevation ACS treated with an early invasive strategy."( Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy.
Bassand, JP; Chrolavicius, S; Diaz, R; Fox, KA; Granger, CB; Jolly, S; Mehta, SR; Rupprecht, HJ; Widimsky, P; Yusuf, S, 2008
)
0.35
" In view of all this it is not surprising that in the past years the indications, application and dosage of anticoagulant and platelet aggregation inhibitor drugs have changed."( [Current issues of anticoagulation therapy in the course of dental treatment and oral surgery].
Barabás, JB; Horváth, C; Joób-Fancsaly, A; Kalmár, G; Koppány, F, 2008
)
0.35
" If planned immediate PCI after thrombolytic therapy is not indicated, PCI immediately after high dosage of glycoprotein IIb/IIIa-Inhibitors in combination with a high dose of clopidogrel may give good results."( [Acute intervention for ST-elevation myocardial infarction].
Heintzen, MP, 2008
)
0.35
"Despite a lack of clear recommendations to guide decision-making, reductions in enoxaparin sodium dosage in the elderly and in patients with mild and moderate renal dysfunction are common in patients with acute coronary syndrome."( Factors associated with bleeding in elderly hospitalized patients treated with enoxaparin sodium : a prospective, open-label, observational study.
Beckerman, P; Ben-Artzi, M; Ben-Yehuda, A; Haber, G; Levin, A; Muszkat, M; Varon, D, 2009
)
0.35
" Recent data have demonstrated limitations with the currently approved dosing regimen of clopidogrel (loading dose, 300 mg; maintenance dose, 75 mg daily) in a significant number of patients during the first few hours-days of treatment (Gurbel et al, Circulation."( Antiplatelet therapy in percutaneous coronary intervention: integration of prasugrel into clinical practice.
Giugliano, RP; Thomas, D, 2009
)
0.35
" The proposed methods have been successfully applied to the analysis of CLP in pharmaceutical dosage forms without interference from other dosage form additives and the results were statistically compared with the official method."( Spectrophotometric and spectrodensitometric determination of Clopidogrel Bisulfate with kinetic study of its alkaline degradation.
Abbas, SS; Abdelkawy, M; Abdelrahman, MM; Zaazaa, HE, 2009
)
0.35
" The dose-response effect as studied by platelet aggregometry showed that the required molar concentration to block the interactive effect in the case of YH was less than that of MRS2179."( Platelet responsiveness to yohimbine hydrochloride and MRS2179 in the context of the interaction between collagen and epinephrine in acute coronary syndrome.
Chakrabarti, P; Chaudhuri, U; Dasgupta, AK; Deb, S; Guha, P; Guha, S; Lahiri, P; Roy, S; Sardar, P,
)
0.13
" However, these studies are limited by varying antiplatelet drug dosing regimens, heterogeneous laboratory assessments for ex vivo platelet function, and wide interindividual variation in platelet responses."( Antiplatelet drug 'resistance'. Part 1: mechanisms and clinical measurements.
Fuster, V; Gorog, DA; Sweeny, JM, 2009
)
0.35
" A clopidogrel maintenance dosage of 150 mg daily for 1 week resulted in greater platelet inhibition than 75 mg daily (50 +/- 28% vs."( The antiplatelet effect of higher loading and maintenance dose regimens of clopidogrel: the PRINC (Plavix Response in Coronary Intervention) trial.
Armstrong, G; Dahl, ML; El-Jack, S; Farrell, H; Gladding, P; Gunes, A; Kay, P; Ormiston, J; Ruygrok, P; Scott, D; Stewart, J; Webster, M; Zeng, I, 2008
)
0.35
" A maintenance dosage of 150 mg daily produces greater platelet inhibition than 75 mg daily."( The antiplatelet effect of higher loading and maintenance dose regimens of clopidogrel: the PRINC (Plavix Response in Coronary Intervention) trial.
Armstrong, G; Dahl, ML; El-Jack, S; Farrell, H; Gladding, P; Gunes, A; Kay, P; Ormiston, J; Ruygrok, P; Scott, D; Stewart, J; Webster, M; Zeng, I, 2008
)
0.35
"Recurrent ischemic events occurred even during routine use of 75 mg clopidogrel in addition to aspirin, that indicated a potentially insufficient maintenance dosage of clopidogrel."( A high maintenance dose of clopidogrel improves short-term clinical outcomes in patients with acute coronary syndrome undergoing drug-eluting stent implantation.
Han, YL; Jing, QM; Li, Y; Ma, YY; Wang, B; Wang, DM; Wang, G; Wang, SL; Wang, ZL; Xu, K, 2009
)
0.35
" It is quickly absorbed and exhibits a rapid antiplatelet effect, with higher and more consistent levels of inhibition of platelet aggregation (IPA) being maintained across the dosing interval than with clopidogrel."( Ticagrelor: the first reversibly binding oral P2Y12 receptor antagonist.
Husted, S; van Giezen, JJ, 2009
)
0.35
"The study was conducted as a monocentric, open, randomized, single-dose, two-period crossover trial in 48 healthy volunteers with a duration of hospitalization of approximately 24 h after dosing on day 1 and with a real wash-out period of 7 days."( Bioequivalence study of two different clopidogrel bisulfate film-coated tablets.
Emritte, N; Erenmemisoglu, A; Koytchev, R; Richter, W; Tuncay, E; Van der Meer, MJ, 2009
)
0.35
" When patients were further stratified into 4 groups according to the timing and dosage of clopidogrel loading, the incidence of the primary outcome was 16% and 27% in those receiving 600 and 300 mg before and 28% and 39% in those receiving 600 and 300 mg after PPCI, respectively (p for trend <0."( Usefulness of pretreatment with high-dose clopidogrel in patients undergoing primary angioplasty for ST-elevation myocardial infarction.
Behar, S; Beinart, R; Boyko, V; Fefer, P; Hammerman, H; Hod, H; Matetzky, S; Segev, A, 2009
)
0.35
" This study evaluated the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI in a randomized, prospective, double-blind, and placebo-controlled design."( Week-long high-maintenance dose clopidogrel regimen achieves better platelet aggregation inhibition than a standard loading dose before percutaneous coronary intervention: results of a double-blind, randomized clinical trial.
Diodati, JG; Lordkipanidzé, M; Nguyen, TA; Palisaitis, DA; Pharand, C; Schampaert, E; Turgeon, J, 2009
)
0.35
" HCPR as measured with the novel INNOVANCE P2Y cartridge was associated with clinical determinants such as BMI, female gender, impaired LVEF (left ventricular ejection fraction), renal failure and dosing of clopidogrel."( The influence of clinical characteristics, laboratory and inflammatory markers on 'high on-treatment platelet reactivity' as measured with different platelet function tests.
Berg, JM; Bouman, HJ; Elsenberg, EH; Hackeng, CM; van de Wal, RM; van Werkum, JW; Verheugt, FW; Zomer, AC, 2009
)
0.35
" Thus, two major paradoxes in cardiovascular medicine today are: 1) despite the overwhelming evidence that platelet reactivity strongly influences the development of potentially catastrophic events including myocardial infarction and stent thrombosis in the PCI patient, no measurement is made in clinical practice to assess the presence of blood vulnerability (platelet reactivity) and 2) despite the overwhelming evidence that the effect of dual antiplatelet therapy with aspirin and P2Y12 receptor blockers is variable, the guidelines largely recommend a uniform, "one size fits all" dosing of these agents in the PCI patient without any confirmation of an adequate antiplatelet effect."( Platelet monitoring for PCI: is it really necessary?
Gurbel, PA; Tantry, US, 2009
)
0.35
" Personalizing clopidogrel dosing using pharmacogenomics may be an effective method of optimizing treatment."( Pharmacogenetic testing for clopidogrel using the rapid INFINITI analyzer: a dose-escalation study.
Baak, R; Bvaldivia, B; Gladding, P; Ormiston, J; Ruygrok, P; Stewart, J; Voss, J; Webster, M; White, C; White, H, 2009
)
0.35
" (2) Clopidogrel may be under dosed in obese patients."( Clopidogrel affects leukocyte dependent platelet aggregation by P2Y12 expressing leukocytes.
Bode, C; Diehl, P; Halscheid, C; Helbing, T; Moser, M; Olivier, C, 2010
)
0.36
" The improved efficacy of multiple-drug therapy is associated with an increased risk of bleeding, which raises the issue of the dosing of these drugs."( Antiplatelet agents.
Spectre, G; Varon, D, 2009
)
0.35
" The improved efficacy of multiple drug therapy is associated with an increased risk of bleeding, which raises the issue of the dosing of these drugs."( Frontiers in platelet inhibition.
Shai, E; Spectre, G; Varon, D, 2009
)
0.35
"A novel stability-indicating normal phase liquid chromatographic (NP-LC) method was developed for the determination of purity of clopidogrel drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products."( A validated stability-indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and pharmaceutical dosage form.
Durga Rao, D; Kalyanaraman, L; Sait, SS; Venkata Rao, P, 2010
)
0.36
" Some recent studies have suggested that a higher clopidogrel maintenance dosage could enhance ex vivo platelet inhibition and thereby overcome resistance to clopidogrel."( High maintenance dosage of clopidogrel is associated with a reduced risk of stent thrombosis in clopidogrel-resistant patients.
Carrie, D; Galinier, M; Lapeyre-Mestre, M; Montastruc, JL; Pathak, A; Tavassoli, N; Voisin, S, 2010
)
0.36
"To investigate whether a higher clopidogrel maintenance dosage is associated with a reduced risk of stent thrombosis after percutaneous coronary intervention (PCI) in clopidogrel-resistant patients and to evaluate the frequency of hemorrhagic accidents that could be associated with a high clopidogrel maintenance dosage."( High maintenance dosage of clopidogrel is associated with a reduced risk of stent thrombosis in clopidogrel-resistant patients.
Carrie, D; Galinier, M; Lapeyre-Mestre, M; Montastruc, JL; Pathak, A; Tavassoli, N; Voisin, S, 2010
)
0.36
" All patients received a clopidogrel loading dose of 300 mg, then 32 patients received a clopidogrel maintenance dosage of 75 mg/day (patients admitted between 2004 and 2005) and 20 patients received 150 mg/day (patients admitted in 2006)."( High maintenance dosage of clopidogrel is associated with a reduced risk of stent thrombosis in clopidogrel-resistant patients.
Carrie, D; Galinier, M; Lapeyre-Mestre, M; Montastruc, JL; Pathak, A; Tavassoli, N; Voisin, S, 2010
)
0.36
"Our data suggest that a high maintenance dosage of clopidogrel (150 mg/day) is associated with a reduced risk of definite stent thrombosis and MACE compared with a maintenance dosage of 75 mg/day."( High maintenance dosage of clopidogrel is associated with a reduced risk of stent thrombosis in clopidogrel-resistant patients.
Carrie, D; Galinier, M; Lapeyre-Mestre, M; Montastruc, JL; Pathak, A; Tavassoli, N; Voisin, S, 2010
)
0.36
" Optimal dosing strategy as determined by ticagrelor's pharmacokinetic and pharmacodynamic profile is a loading dose of 180 mg followed by 90 mg by mouth twice daily."( Efficacy and safety of ticagrelor: a reversible P2Y12 receptor antagonist.
Anderson, SD; Epstein, BJ; Shah, NK; Yim, J, 2010
)
0.36
" Twenty-four hours after a 300 mg loading dose of clopidogrel, one group received a dosage of 75 mg/day of clopidogrel and a placebo for 14 days, followed 3 weeks later by the same protocol but with coadministration of 75 mg/day clopidogrel and 20 mg/day omeprazole instead."( Effects of omeprazole on the antiplatelet activity of clopidogrel.
Jeong, JW; Kim, NH; Oh, SK; Park, HY; Rhee, SJ; Yoo, NJ; Yun, KH, 2010
)
0.36
" While there is some established evidence for an induction strategy and design of chemical structure, the proposed dosing input strategy is speculative in nature."( Genetic CYP2C19 polymorphism dependent non-responders to clopidogrel therapy--does structural design, dosing and induction strategies have a role to play?
Srinivas, NR,
)
0.13
" In a research study using an earlier four-color version of the assay, it was demonstrated that warfarin dosing can be influenced by a cytochrome P450 (CYP) 4F2 variant."( DMET microarray technology for pharmacogenomics-based personalized medicine.
Burmester, JK; Mansfield, E; Sedova, M; Shapero, MH, 2010
)
0.36
" After a washout period of > 2 weeks, the subjects underwent a platelet aggregation test before and after dosing with 75 mg of clopidogrel for 7 days."( [13C]pantoprazole breath test as a predictor of the anti-platelet function of clopidogrel.
Furuta, T; Iwaki, T; Umemura, K, 2010
)
0.36
" The large clinical trials COAG and EU-PACT will define the extent to which pharmacogenetic dosing affects the safety and efficacy of warfarin and coumarin derivatives."( Implementing genotype-guided antithrombotic therapy.
Duconge, J; Ruaño, G; Seip, RL, 2010
)
0.36
" We review the recent data on efficacy and safety of dosing strategies for antiplatelet therapy in PCI."( Dosing strategies for antiplatelet therapy in percutaneous coronary intervention.
Bauters, C; Bonello, L; Delhaye, C; Lablanche, JM; Lemesle, G; Maluenda, G; Sudre, A, 2010
)
0.36
" East and Southeast Asian patients (N = 715) with moderate- to high-risk ACS undergoing PCI will be randomized to one of three prasugrel dosing regimens (60 mg LD/10 mg MD; 30 mg LD/7."( Prasugrel versus clopidogrel in Asian patients with acute coronary syndromes: design and rationale of a multi-dose, pharmacodynamic, phase 3 clinical trial.
Boonbaichaiyapruck, S; Ge, J; Goh, YS; Hong, BK; Hou, CJ; Pinton, P; Zhu, J, 2010
)
0.36
"This study assesses the optimal dosing schedule for ticagrelor in healthy volunteers and compares the degree of IPA with clopidogrel."( Pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of ticagrelor in healthy volunteers.
Butler, K; Teng, R, 2010
)
0.36
"Multiple dosing provided predictable pharmacokinetics of ticagrelor and its metabolite over the dose range of 50-600 mg once daily and 50-300 mg twice daily with C(max) and AUC(0,t) increasing approximately dose-proportionally."( Pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of ticagrelor in healthy volunteers.
Butler, K; Teng, R, 2010
)
0.36
" This article provides an overview of ADP P2Y₁₂ receptor-inhibiting strategies, including high clopidogrel dosing regimens and novel agents under advanced clinical development."( Platelet P2Y₁₂ receptor inhibition: an update on clinical drug development.
Angiolillo, DJ; Vivas, D, 2010
)
0.36
" Additionally, it provides an overview of tirofiban's pharmacology and summary of the clinical efficacy and safety data of two dosing regimens."( Safety evaluation of tirofiban.
Tebaldi, M; Valgimigli, M, 2010
)
0.36
" * We tested whether the separate dosing of a PPI and clopidogrel decreased the risk of attenuation of clopidogrel efficacy."( Influences of different proton pump inhibitors on the anti-platelet function of clopidogrel in relation to CYP2C19 genotypes.
Furuta, T; Iwaki, T; Umemura, K, 2010
)
0.36
" A less than 30% inhibition of platelet aggregation (IPA) during clopidogrel dosing was defined as a 'low responder'."( Influences of different proton pump inhibitors on the anti-platelet function of clopidogrel in relation to CYP2C19 genotypes.
Furuta, T; Iwaki, T; Umemura, K, 2010
)
0.36
" Morning and evening dosing of omeprazole were both associated with lower IPA in DMs."( Influences of different proton pump inhibitors on the anti-platelet function of clopidogrel in relation to CYP2C19 genotypes.
Furuta, T; Iwaki, T; Umemura, K, 2010
)
0.36
" Multiple gastroduodenal biopsies were performed during 2 esophagogastroduodenoscopy in subjects dosed with aspirin enteric-coated 81 mg once daily or clopidogrel 75 mg once daily."( Is gastroduodenal biopsy safe in patients receiving aspirin and clopidogrel?: a prospective, randomized study involving 630 biopsies.
Aisenberg, J; Bamji, ND; Bodian, CA; Cohen, LB; Desai, JC; Dikman, AE; Harpaz, N; Kornacki, S; Miller, KM; Sanyal, S; von Althann, C; Whitson, MJ, 2011
)
0.37
" Regarding the postoperative course, significant results could be demonstrated for: adrenaline dosage (0."( Mid-term outcomes of patients with PCI prior to CABG in comparison to patients with primary CABG.
Adamczak, M; Boulesteix, AL; Eifert, S; Kilian, E; Lamm, P; Mair, H; Reichart, B, 2010
)
0.36
" However, evidence-based guidelines for dosing have not been established for either agent."( Dose comparisons of clopidogrel and aspirin in acute coronary syndromes.
Afzal, R; Bassand, JP; Chrolavicius, S; Diaz, R; Eikelboom, JW; Fox, KA; Granger, CB; Jolly, S; Joyner, CD; Mehta, SR; Pogue, J; Rupprecht, HJ; Widimsky, P; Yusuf, S, 2010
)
0.36
"Four randomized, placebo-controlled, crossover studies were conducted among 282 healthy subjects to investigate whether an interaction exists between clopidogrel (300-mg loading dose/75-mg/day maintenance dose) and the proton-pump inhibitor (PPI) omeprazole (80 mg) when they are administered simultaneously (study 1); whether the interaction, if any, can be mitigated by administering clopidogrel and omeprazole 12 h apart (study 2) or by increasing clopidogrel to 600-mg loading/150-mg/day maintenance dosing (study 3); and whether the interaction applies equally to the PPI pantoprazole (80 mg) (study 4)."( Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies.
Angiolillo, DJ; Bergougnan, L; Cheng, S; Dubar, M; Gibson, CM; Hurbin, F; LaCreta, FP; Nicolas, O; Ollier, C; Perrin, L, 2011
)
0.37
" Until further reliable controlled data are available, this potential, but currently unproven, clinical interaction can be minimized by widely separating the dosing of clopidogrel and PPI."( NSAID-induced gastrointestinal and cardiovascular injury.
Chan, FK; Ng, SC, 2010
)
0.36
"Absorption is a critical component of the pharmacokinetics for solid dosage forms administered orally."( Role of drug absorption in the pharmacokinetics of therapeutic interventions for stroke.
Conrado, DJ; Derendorf, H; Gonzalez, D, 2010
)
0.36
" Alternative dosing regimens might enhance platelet inhibition."( Pilot study of the antiplatelet effect of increased clopidogrel maintenance dosing and its relationship to CYP2C19 genotype in patients with high on-treatment reactivity.
Barker, CM; Kandzari, DE; Murray, SS; Price, MJ; Teirstein, PS; Topol, EJ, 2010
)
0.36
" If both Clopidogrel and PPI need to be prescribed, a split dosage regimen of PPI in the morning and clopidogrel in the evening can be recommended."( [Dilemma between gastroprotection and cardiovascular prevention].
Kandulski, A; Malfertheiner, P; Venerito, M, 2010
)
0.36
" Management is currently limited to dosing alteration and introduction of other antiplatelet agents."( Resistance to aspirin and clopidogrel therapy.
Alam, S; Assaad, S; Beresian, J; Bitar, A; Charafeddine, K; Khoury, M; Musallam, KM; Taher, AT, 2011
)
0.37
" It was aimed to increase its bioavailability by designing a controlled release dosage form of clopidogrel, which is different from available current dosage forms in the market."( Development of sustained release formulation of an antithrombotic drug and application of Fuzzy logic.
Degim, İT; Tan, C,
)
0.13
" The serum thromboxane levels in mice (n = 3) dosed with clopidogrel and prasugrel were decreased by 83."( Antagonism of P2Y₁₂ reduces physiological thromboxane levels.
Bhavaraju, K; Gartner, TK; Georgakis, A; Jin, J; Kunapuli, SP; Nurden, A; Nurden, P; Tomiyama, Y, 2010
)
0.36
" The present article reviews data on the clinical impact of enhanced P2Y12 inhibition with either higher clopidogrel dosing or new oral antiplatelet agents, including prasugrel and ticagrelor, in the setting of STEMI, focusing on results in the setting of primary PCI."( Clinical impact of enhanced inhibition of P2Y12-mediated platelet aggregation in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.
Capranzano, P; Dangas, G; Mehran, R; Stone, GW; Tamburino, C, 2010
)
0.36
" One hour after the last dosing of clopidogrel, all subjects received 15-mg of sibutramine."( Effects of clopidogrel on the pharmacokinetics of sibutramine and its active metabolites.
Bae, JW; Jang, CG; Lee, SY, 2011
)
0.37
"A rapid, simple, and easy method for the simultaneous determination of clopidogrel and aspirin from bulk material and dosage formulations in the presence of meloxicam as internal standard has been developed."( Simultaneous determination of clopidogrel and aspirin by RP-HPLC from bulk material and dosage formulations using multivariate calibration technique.
Ali, KA; Arayne, MS; Nawaz, M; Sultana, N, 2011
)
0.37
" 75-mg daily maintenance dosage of clopidogrel on clinical and laboratory end-points in patients undergoing PCI."( Clopidogrel 150 vs. 75 mg day(-1) in patients undergoing percutaneous coronary intervention: a meta-analysis.
Chen, YG; Hao, PP; Li, RJ; Wang, JL; Yang, JM; Zhang, MX; Zhang, Y, 2011
)
0.37
"As compared with the currently recommended 75-mg day(-1) maintenance dosage of clopidogrel, the 150-mg day(-1) dosage can reduce major adverse cardiac and/or cerebrovascular events but may increase the risk of minor bleeding."( Clopidogrel 150 vs. 75 mg day(-1) in patients undergoing percutaneous coronary intervention: a meta-analysis.
Chen, YG; Hao, PP; Li, RJ; Wang, JL; Yang, JM; Zhang, MX; Zhang, Y, 2011
)
0.37
" Until further data is available, some clinical strategies can be recommended: (1) individual gastrointestinal risk assessment, with PPIs administration only to patients on dual anti-platelet therapy with additional GI risk factors; (2) preferential use of PPIs that have shown less interference with clopidogrel efficacy; (3) wide separation of PPI and clopidogrel dosing to minimize the risk of interaction (PPI may be given before breakfast and clopidogrel at bedtime); (4) or alternative use of histamine-2-receptor antagonist therapy, in patients at low GI risk."( [Clopidogrel--proton pump inhibitors drug interaction: implications to clinical practice].
Albuquerque, A; Fontes-Carvalho, R, 2010
)
0.36
"The aim of this work was a preliminary study of the "in-process" amorphization of clopidogrel hydrogensulfate (CLP) as model drug during the production of tablets as dosage form."( Formulation of tablets containing an 'in-process' amorphized active pharmaceutical ingredient.
Jójárt-Laczkovich, O; Szabó-Révész, P, 2011
)
0.37
" In order to achieve the desired results and, as with all medications, PPIs should always be used appropriately taking care never to exceed correct dosage and duration."( Proton pump inhibitors in rheumatic diseases: clinical practice, drug interactions, bone fractures and risk of infections.
Ferraccioli, GF; Gremese, E; Laria, A; Zoli, A, 2011
)
0.37
" However, it needs to be shown that the higher dosage is associated with a beneficial clinical outcome in these patients."( A high maintenance dose increases the inhibitory response to clopidogrel in patients with high on-treatment residual platelet reactivity.
Gremmel, T; Kopp, CW; Koppensteiner, R; Panzer, S; Seidinger, D; Steiner, S, 2012
)
0.38
" We examined potential associations between high on treatment platelet reactivity and the risk of ST and assessed the effects of increased antiplatelet dosage on platelet inhibition."( High on treatment platelet reactivity and stent thrombosis.
French, JK; Juergens, CP; Parikh, D; Rajendran, S; Shugman, I, 2011
)
0.37
" Further study is required to determine optimal dosing and proper patient selection with prasugrel treatment."( Emerging antiplatelet therapies in percutaneous coronary intervention: a focus on prasugrel.
Martin, MT; Nutescu, EA; Spinler, SA, 2011
)
0.37
" Blood samples were collected before dosing and at 0, 2, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180 and 210 min after drug administration to determine the plasma drug concentration of FA."( Pharmacokinetics of ferulic acid and potential interactions with Honghua and clopidogrel in rats.
Li, Y; Liu, C; Mi, S; Wang, N; Zhang, Y, 2011
)
0.37
"A double-blind crossover study was conducted in four CYP2C19 genotype-defined metabolizer groups to assess whether increase in clopidogrel dosing can overcome reduced pharmacodynamic response in CYP2C19 poor metabolizers (PMs)."( Genetic polymorphisms and the impact of a higher clopidogrel dose regimen on active metabolite exposure and antiplatelet response in healthy subjects.
Bergougnan, L; Bhatt, DL; Dubar, M; Farenc, C; Hurbin, F; Lacreta, F; Pearson, K; Perrin, L; Simon, T; Vicaut, E, 2011
)
0.37
" Doubling clopidogrel dosage to 150 mg restored the basal response."( Doubling the dose of clopidogrel restores the loss of antiplatelet effect induced by esomeprazole.
Cerboni, P; Doyen, D; Ferrari, E; Moceri, P, 2011
)
0.37
" The effect of aspirin dosing was evaluated using χ(2) , Cochran-Mantel-Haenszel, and homogeneity testing."( Influence of low-dose aspirin (81 mg) on the incidence of definite stent thrombosis in patients receiving bare-metal and drug-eluting stents.
Columbo, J; Cui, J; Davis, M; Giugliano, GR; Lotfi, A; Mulvey, S; Schweiger, M; Wartak, S, 2011
)
0.37
" A "one size fits all" approach to clopidogrel dosing is probably flawed."( Clopidogrel "resistance": where are we now?
Hobson, AR; Qureshi, Z, 2013
)
0.39
" PM103 is an intravenous formulation of clopidogrel being developed as an alternative to oral clopidogrel to provide for dosing flexibility in the emergent clinical setting."( Pharmacokinetics and platelet aggregation inhibitory effects of a novel intravenous formulation of clopidogrel in humans.
Adams, MP; Cooper, WD; Cushing, DJ; Kowey, PR; Machatha, S; Mosher, GL; Souney, PF; Zhang, B, 2012
)
0.38
"All patients received 325 mg of aspirin and a loading dose of 600 mg of clopidogrel followed by a maintenance dosage of 325 mg/d of aspirin and 75 mg/d of clopidogrel for at least 6 months."( High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI.
Abbate, R; Antoniucci, D; Buonamici, P; Gensini, GF; Giusti, B; Gori, AM; Marcucci, R; Migliorini, A; Parodi, G; Valenti, R, 2011
)
0.37
"In HD patients exhibiting HTPR following standard clopidogrel treatment, prasugrel 10 mg day(-1) is significantly more efficient than doubling the clopidogrel dosage in achieving adequate platelet inhibition."( Antiplatelet effects of prasugrel vs. double clopidogrel in patients on hemodialysis and with high on-treatment platelet reactivity.
Alexopoulos, D; Davlouros, P; Fourtounas, C; Goumenos, D; Kassimis, G; Komninakis, D; Panagiotou, A; Xanthopoulou, I, 2011
)
0.37
" Adjusted dosing according to weight may help achieve adequate therapeutic platelet inhibition and reactivity while decreasing thromboembolic complications."( Body weight: a risk factor for subtherapeutic antithrombotic therapy in neurovascular stenting.
Alexander, MJ; Choulakian, A; Drazin, D; Kornbluth, P; Nuño, M, 2011
)
0.37
" Blood samples were drawn just before the first clopidogrel intake on day 1, and after the last dosing (day 7)."( Effect of clopidogrel on circulating biomarkers of angiogenesis and endothelial activation.
Azizi, M; Blanchard, A; Bura, A; Gaussem, P; Remones, V; Smadja, DM; Szymezak, J, 2012
)
0.38
"Compared with the rational loading dosage, the tailored loading dosage better inhibited platelet aggregation based on a > 50% decrease in adenosine phosphate-mediated platelet aggregation (rational loading dosage vs."( Use of tailored loading-dose clopidogrel in patients undergoing selected percutaneous coronary intervention based on adenosine diphosphate-mediated platelet aggregation.
Chen, X; Ge, CJ; Lü, SZ; Meng, K; Song, XT; Zhu, HG, 2010
)
0.36
" Twenty-nine healthy volunteers had platelet studies performed before and 1 week after 75 mg daily dosing of clopidogrel."( Immature platelet fraction (IPF) determined with an automated method predicts clopidogrel hyporesponsiveness.
DeLao, T; Guthikonda, S; Ibrahim, H; Kleiman, NS; Nadipalli, S, 2012
)
0.38
" Whether this is worth both the risk of non-compliance with twice-a-day dosing in real-life patients lacking the same motivation as their trial-volunteer counterparts, and the 2000-fold difference in incremental cost, is the remaining matter for debate."( Quantitative comparison of clopidogrel 600 mg, prasugrel and ticagrelor, against clopidogrel 300 mg on major adverse cardiovascular events and bleeding in coronary stenting: synthesis of CURRENT-OASIS-7, TRITON-TIMI-38 and PLATO.
Davies, JE; Francis, DP; Nijjer, SS, 2012
)
0.38
" In the management of bleeding ulcer patients with high-risk stigmata of recent hemorrhage, resuming antiplatelet agents at 3-5 days after the last dosing is a reasonable strategy."( New look at antiplatelet agent-related peptic ulcer: an update of prevention and treatment.
Hsu, PI, 2012
)
0.38
"This study sought to assess the presence of a dose-response effect of cigarette smoking and its impact on high on-treatment platelet reactivity (HPR) in patients with diabetes mellitus treated with clopidogrel."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
" If cigarette smoking is associated with a dose-response effect on pharmacodynamic measures in clopidogrel-treated patients is unknown."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
"A dose-response effect was observed for all pharmacodynamic parameters tested."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
"Cigarette smoking is associated with a dose-response effect on clopidogrel-induced antiplatelet effects and lower rates of HPR in diabetes mellitus patients."( Cigarette smoking is associated with a dose-response effect in clopidogrel-treated patients with diabetes mellitus and coronary artery disease: results of a pharmacodynamic study.
Angiolillo, DJ; Bass, TA; Capodanno, D; Capranzano, P; Charlton, RK; Desai, B; Dharmashankar, K; Ferreiro, JL; Kodali, M; Tello-Montoliu, A; Tomasello, SD; Ueno, M, 2012
)
0.38
"Testing platelet function makes clopidogrel dosing safer, and simplifies therapy adjustments in long-term treatment."( Prophylactic use of clopidogrel in paediatric cardiac patients.
Grohmann, J; Hanke, CA; Nakamura, L; Stiller, B; Zieger, B, 2012
)
0.38
" In RESPOND, ticagrelor mean C(max) and AUC(8) following 2-week dosing were comparable between clopidogrel responders (724 ng/mL and 3983 ng · h/mL, respectively) and non-responders (764 ng/mL and 3986 ng · h/mL, respectively)."( Pharmacokinetics and pharmacodynamics of ticagrelor in patients with stable coronary artery disease: results from the ONSET-OFFSET and RESPOND studies.
Bliden, K; Butler, K; Gurbel, PA; Husted, SE; Høimark, L; Storey, RF; Tantry, US; Teng, R; Wei, C, 2012
)
0.38
" However, the reversible binding of ticagrelor to the P2Y(12) receptor requires a twice-daily dosing regimen."( Comparative pharmacokinetics and pharmacodynamics of platelet adenosine diphosphate receptor antagonists and their clinical implications.
Ferro, A; Floyd, CN; Passacquale, G, 2012
)
0.38
"In patients undergoing elective PCI, using bivalirudin as a bolus only dosing may be as effective and less costly when compared with bolus followed by an infusion for the duration of the intervention."( Comparison of bolus only with bolus plus infusion of bivalirudin in patients undergoing elective percutaneous coronary intervention: a retrospective observational study.
Ghosn, S; Sheikh-Taha, M, 2012
)
0.38
" The emergence of new anticoagulants that offer equal or superior efficacy, greater safety and the convenience of fixed oral dosing may make warfarin the less preferred option."( Prevention of stroke in patients with atrial fibrillation: anticoagulant and antiplatelet options.
Halperin, JL; Varughese, CJ, 2012
)
0.38
"This substudy of the Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability and Efficacy in Nonurgent Percutaneous Coronary Intervention patients (INNOVATE-PCI) trial evaluated the pharmacokinetic and pharmacodynamic effects of two dosing regimens of IV followed by oral elinogrel (120 mg IV plus 100 mg oral twice daily; 120 mg IV plus 150 mg oral twice daily) versus standard clopidogrel therapy (300-600 mg oral loading dose plus 75 mg oral maintenance dose) in 56 patients undergoing nonurgent PCI."( Pharmacokinetic and pharmacodynamic effects of elinogrel: results of the platelet function substudy from the intravenous and oral administration of elinogrel to evaluate tolerability and efficacy in nonurgent percutaneous coronary intervention patients (I
Angiolillo, DJ; Broderick, S; Buerke, M; Conley, PB; Dabrowski, M; Gurbel, PA; Harrington, RA; Jennings, LK; Kochman, J; McClure, MW; Neumann, FJ; Rao, SV; Saucedo, JF; Stephens, G; Stumpf, J; Trenk, D; Welsh, RC; Wójcik, J, 2012
)
0.38
"Compared with clopidogrel, the combination of IV and oral elinogrel achieves more rapid and enhanced antiplatelet effects that were sustained through the transition to oral elinogrel in the peri-PCI period, but these were not significant during chronic dosing in this pilot investigation."( Pharmacokinetic and pharmacodynamic effects of elinogrel: results of the platelet function substudy from the intravenous and oral administration of elinogrel to evaluate tolerability and efficacy in nonurgent percutaneous coronary intervention patients (I
Angiolillo, DJ; Broderick, S; Buerke, M; Conley, PB; Dabrowski, M; Gurbel, PA; Harrington, RA; Jennings, LK; Kochman, J; McClure, MW; Neumann, FJ; Rao, SV; Saucedo, JF; Stephens, G; Stumpf, J; Trenk, D; Welsh, RC; Wójcik, J, 2012
)
0.38
" To assist in estimating therapeutic warfarin doses, the warfarin label provides a pharmacogenomic dosing table and various warfarin pharmacogenomic dosing algorithms are available."( Clinical pharmacogenomics of warfarin and clopidogrel.
Shin, J, 2012
)
0.38
" Twenty-week-old mice (n = 10-12) were ovariectomized or sham treated and dosed orally with clopidogrel (1 mg/kg) or vehicle (NaCl) daily for 4 weeks."( Clopidogrel (Plavix), a P2Y12 receptor antagonist, inhibits bone cell function in vitro and decreases trabecular bone in vivo.
Arnett, TR; Brandao-Burch, A; Hajjawi, M; Jorgensen, NR; Orriss, IR; Patel, JJ; Schwarz, P; Syberg, S, 2012
)
0.38
" Therefore the optimal dosage and duration of clopidogrel therapy is of utmost importance."( Clinical use of clopidogrel.
Byrne, RA; Sarafoff, N; Sibbing, D, 2012
)
0.38
" Therefore, several new antiplatelet treatment strategies have been developed in order to optimize platelet inhibition: a) modification of dosing of commonly used agents; b) use of new agents; and c) addition of a third antiplatelet drug (triple therapy)."( Challenges and perspectives of antiplatelet therapy in patients with diabetes mellitus and coronary artery disease.
Angiolillo, DJ; Ferreiro, JL, 2012
)
0.38
"Six trials and one meta-analysis were identified; aspirin dosage was identified as a potential confounder."( Investigating incoherence gives insight: clopidogrel is equivalent to extended-release dipyridamole plus aspirin in secondary stroke prevention.
Dewilde, S; Hawkins, N, 2012
)
0.38
" Steady-state dosing of clopidogrel 75 mg qd and dabigatran etexilate 150 mg bid (part 2) demonstrated minor effects on dabigatran pharmacokinetics (AUC(τ,ss) ratio test/reference: 91."( Pharmacokinetic and pharmacodynamic effects of comedication of clopidogrel and dabigatran etexilate in healthy male volunteers.
Baumann, S; Friedman, J; Fritsch, H; Härtter, S; Schepers, C; Sennewald, R, 2013
)
0.39
"Six male dogs all received 7 different dosing regimens separated by 1-5week washout periods: cangrelor (1μg/kg/min, intravenous infusion); ticagrelor (0."( Evaluation of ticagrelor pharmacodynamic interactions with reversibly binding or non-reversibly binding P2Y(12) antagonists in an ex-vivo canine model.
Emanuelsson, BM; Ravnefjord, A; van Giezen, JJ; Weilitz, J, 2012
)
0.38
" With clopidogrel dosed 3hours after ticagrelor, IPA was reduced after washout of ticagrelor to 38% at 24hrs vs."( Evaluation of ticagrelor pharmacodynamic interactions with reversibly binding or non-reversibly binding P2Y(12) antagonists in an ex-vivo canine model.
Emanuelsson, BM; Ravnefjord, A; van Giezen, JJ; Weilitz, J, 2012
)
0.38
"Regardless of dose, adjusted odds ratios associating clopidogrel use with the study endpoint were statistically significant and followed a dose-response pattern."( Gastrointestinal events with clopidogrel: a nationwide population-based cohort study.
Grove, EL; Jørgensen, NR; Schwarz, P; Vestergaard, P; Würtz, M, 2013
)
0.39
" The dosage of anti-platelet drugs, combination with any other drugs, clinical characters in baseline of all enrolled patients were analyzed."( [Clinical application of VerifyNow-P2Y12 assay in evaluation of platelet inhibition efficacy of clopidogrel].
Chen, XM; Cui, HB; DU, WP; Feng, MJ; Hu, YW; Lin, SY; Pan, WM; Wang, SH; Wang, SQ; Wang, Y; Yang, R; Ye, HH; Zhou, HL, 2012
)
0.38
" In consideration for prescribing DAPT (drug, dosage and duration) the clinician will have to weigh the potential benefits (reduction in death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke) and risks (severe or life-threatening bleeding) for each and every patient."( Dual antiplatelet therapy for primary and secondary prevention.
Dhruvakumar, S; Gerula, C; Kaluski, E; Klapholz, M; Maher, J; Mathur, AP; Mazza, V; Waller, AH, 2012
)
0.38
" There was a nonsignificant decrease in thromboembolic complications in patients whose clopidogrel dosage was tailored to the assay."( Clopidogrel resistance is associated with thromboembolic complications in patients undergoing neurovascular stenting.
Bennet, H; Berenstein, A; Brockington, C; Chong, J; Ewing, SL; Fifi, JT; Leesch, W; Narang, J, 2013
)
0.39
" The comparator was standard dosage of clopidogrel."( Comparing newer oral anti-platelets prasugrel and ticagrelor in reduction of ischemic events-evidence from a network meta-analysis.
Chatterjee, S; Frankel, R; Ghose, A; Guha, G; Mukherjee, D; Sharma, A, 2013
)
0.39
" Regulatory agencies as well as major cardiac societies suggest the use of other anti-platelet medications or alternative dosing strategies for clopidogrel in patients with reduced effectiveness of clopidogrel."( High on-treatment platelet reactivity and P2Y12 antagonists in clinical trials.
Hochholzer, W; Kristensen, SD; Neumann, FJ; Trenk, D, 2013
)
0.39
" At steady-state ticagrelor (50 mg bid, or 200 mg bid), concomitant aspirin (300 mg qd) had no effect on mean maximum plasma concentration (Cmax), median time to Cmax (tmax), or mean area under the plasma concentration-time curve for the dosing interval (AUC0-τ) for ticagrelor and its primary metabolite, AR-C124910XX."( Evaluation of the pharmacokinetics and pharmacodynamics of ticagrelor co-administered with aspirin in healthy volunteers.
Butler, K; Maya, J; Teng, R, 2013
)
0.39
" Following this randomized pilot study, it may be justified to perform a large-scale randomized study comparing 50- and 75-mg dosing of clopidogrel in Japanese patients undergoing coronary stent implantation."( Efficacy and safety of low-dose clopidogrel in Japanese patients after drug-eluting stent implantation: a randomized pilot trial.
Fujimoto, Y; Iwata, Y; Kadohira, T; Kitahara, H; Kobayashi, Y; Morino, T; Ohkubo, K; Sugimoto, K, 2014
)
0.4
" Additionally, CES1 genetic variants have the potential to serve as a biomarker to predict clopidogrel response and individualize clopidogrel dosing regimens in clinical practice."( Carboxylesterase 1 as a determinant of clopidogrel metabolism and activation.
Angiolillo, DJ; Brinda, BJ; Gawronski, BE; Markowitz, JS; Wang, X; Zhu, HJ, 2013
)
0.39
" Larger studies are urgently needed to validate a clinically useful threshold to define clopidogrel hyper-response and to examine the clinical effects of antiplatelet dosage adjustment."( Clopidogrel hyper-response and bleeding risk in neurointerventional procedures.
Churilov, L; Dowling, R; Goh, C; Mitchell, P; Yan, B, 2013
)
0.39
" Two 7-day treatments were separated by 14-day washout periods: (a) PA32540 + clopidogrel (300 mg loading/75 mg maintenance) 10 hours later and (b) synchronous dosing of clopidogrel + EC aspirin (81 mg) + EC omeprazole (40 mg)."( Spaced administration of PA32540 and clopidogrel results in greater platelet inhibition than synchronous administration of enteric-coated aspirin and enteric-coated omeprazole and clopidogrel.
Antonino, M; Bliden, KP; Chai, S; Fort, JG; Gesheff, M; Gesheff, T; Gurbel, PA; Jeong, YH; Shuldiner, A; Tantry, US; Zhang, Y, 2013
)
0.39
" Moreover, inappropriate statin dosing restrictions (underdosing of simvastatin and lovastatin) were deliberately utilized in PLATO, potentially contributing to the beneficial effect of ticagrelor."( Exploring the ticagrelor-statin interplay in the PLATO trial.
Dinicolantonio, JJ; Serebruany, VL, 2013
)
0.39
" Dosage was maintained as 75mg clopidogrel daily, 250mg ticlopidine twice daily, and 250mg ticlopidine plus 80mg Gingko Biloba extract twice daily."( Ticlopidine with Ginkgo Biloba extract: a feasible combination for patients with acute cerebral ischemia.
Hong, JM; Joo, IS; Lee, JS; Lim, YA; Shin, DH, 2013
)
0.39
" A review of data regarding aspirin use for secondary prevention of events in ACS demonstrated that low aspirin doses (75 to 160 mg/day) are consistently favored for short- and long-term use because of the lack of a dose-response relationship between increasing aspirin dose and improved efficacy, and a higher incidence of gastrointestinal bleeding with increasing aspirin dose."( Aspirin, clopidogrel, and ticagrelor in acute coronary syndromes.
Berger, JS, 2013
)
0.39
" In study 2, 35 healthy subjects were treated with LDA 100 mg (regimen A), and then 20 randomly selected subjects were dosed clopidogrel 75 mg (regimen C), LDA/clopidogrel (regimen AC), or LDA/clopidogrel/rabeprazole 10 mg for 7 days."( Antiplatelet drugs are a risk factor for esophageal mucosal injury.
Furuta, T; Miyajima, H; Nishino, M; Osawa, S; Sahara, S; Sugimoto, K; Sugimoto, M; Umemura, K; Uotani, T; Watanabe, H; Yamada, T; Yamade, M, 2013
)
0.39
" A combined formulation of ASA and clopidogrel has been developed to provide dosing convenience and improve adherence."( The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, si
Huh, W; Jung, JA; Kim, JR; Kim, MJ; Kim, TE; Ko, JW; Lee, SY; Park, KM, 2013
)
0.39
" Serial blood samples were collected immediately before and after dosing for 24 hours."( The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, si
Huh, W; Jung, JA; Kim, JR; Kim, MJ; Kim, TE; Ko, JW; Lee, SY; Park, KM, 2013
)
0.39
" Dans certaines situations de risque par contre, une adaption du dosage est conseillée pour minimiser les effets secondaires négatifs: Chez les patients de plus de 75 ans, et/ou d'un poids corporel de moins de 60 kg, une réduction du dosage de prasugrel est conseillée en raison d'un risque élevé d'hémorragie."( [Thrombocyte aggregation inhibitors: what are the risks?].
Curkovic, I; Egbring, M; Kullak-Ublick, GA, 2013
)
0.39
" For warfarin, no significant sex difference was seen regarding bleeding event reports, suggesting individualised dosing being an important factor."( Sex differences in spontaneous reports on adverse bleeding events of antithrombotic treatment.
Holm, L; Loikas, D; Malmström, RE; Mejyr, S; Rydberg, DM; Schenck-Gustafsson, K; von Euler, M; Wettermark, B, 2014
)
0.4
" In this situation, a number of alternatives to conventional dosing of clopidogrel have been investigated, including increasing the dosage of clopidogrel, switching from clopidogrel to either prasugrel or ticagrelor, or adding cilostazol to clopidogrel therapy."( Treatment options for patients with poor clopidogrel response.
Nawarskas, JJ; Roberts, DI,
)
0.13
"Optimal aspirin dosing after acute coronary syndromes remains uncertain."( Discharge aspirin dose and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel: an analysis from the TRITON-TIMI 38 study (trial to assess improvement in therapeutic outcomes by optimizing platelet inhibit
Antman, EM; Braunwald, E; Cannon, CP; Kohli, P; Murphy, SA; Udell, JA; Wiviott, SD, 2014
)
0.4
" To observe whether antithrombin agents affect the pharmacokinetic and pharmacodynamic properties of batifiban in combination therapy and optimize clinical administration dosage of batifiban, an open-label and parallel study was conducted."( Pharmacokinetic and pharmacodynamic properties of batifiban coadministered with antithrombin agents in Chinese healthy volunteers.
Chen, H; Chen, K; He, XM; Jia, MM; Li, J; Li, SF; Li, WY; Liu, MZ; Wang, YH; Wu, SL; Zhou, Y, 2013
)
0.39
" The developed model may serve as the foundation for further exploration of pharmacogenetic-based dosing of EFV."( Population pharmacogenetic-based pharmacokinetic modeling of efavirenz, 7-hydroxy- and 8-hydroxyefavirenz.
Abdelhady, AM; Desta, Z; Jiang, F; Overholser, BR; Shin, JG; Yeo, CW, 2014
)
0.4
" In conclusion, in non-diabetic obese patients with CAD, standard prasugrel dosing achieved more potent PD effects than high-dose clopidogrel in the acute phase of treatment, but this was not sustained during maintenance phase treatment."( Pharmacodynamic effects of standard dose prasugrel versus high dose clopidogrel in non-diabetic obese patients with coronary artery disease.
Angiolillo, DJ; Bass, TA; Darlington, A; Desai, B; Ferreiro, JL; Guzman, LA; Patel, R; Rollini, F; Tello-Montoliu, A; Ueno, M, 2014
)
0.4
" Electronically compiled multidrug dosing histories allowed the concomitant intake of high-dose lipophilic statins to be identified as a risk factor of impaired response to clopidogrel and revealed that exposure to further potential drug-drug interactions (DDIs) was too low for analysis."( Antiplatelet resistance in outpatients with monitored adherence.
Arnet, I; Hersberger, KE; Romanens, M; Tsakiris, DA; Walter, PN, 2014
)
0.4
" To overcome the problem some authors have suggested to increase the dosage of the drug, to use other drugs, to genotype patients, and not to use proton pomp inhibitors in patients on double antiplatelet therapy."( What's new about clopidogrel.
Biasucci, LM; Camaioni, C; Cialdella, P; Gustapane, M, 2013
)
0.39
"Warfarin is among the ten drugs most commonly involved in adverse drug reactions, has a narrow therapeutic index and complex dosage regimen, exhibits enormous variability dose-response and high risk drug-drug interactions."( Pharmacoepidemiologic study of warfarin prescription in a Brazilian tertiary hospital.
Guidoni, CM; Obreli-Neto, PR; Pereira, LR, 2014
)
0.4
" pylori-positive and 10-negative subjects) with 100 mg aspirin plus 75 mg clopidogrel (AC) once-daily dosing and AC plus 20 mg famotidine twice-daily dosing (ACH)."( Prevention of gastric mucosal injury induced by anti-platelet drugs by famotidine.
Furuta, T; Ichikawa, H; Iwaizumi, M; Miyajima, H; Nishino, M; Osawa, S; Sahara, S; Sugimoto, K; Sugimoto, M; Umemura, K; Uotani, T; Watanabe, H; Yamada, T; Yamade, M, 2014
)
0.4
" Clopidogrel dosing regimens have evolved over time, enabling us to evaluate platelet reactivity in real-life ACS patients undergoing percutaneous coronary intervention and treated with three different clopidogrel doses."( Evaluation of platelet response to different clopidogrel dosing regimens in patients with acute coronary syndrome in clinical practice.
Beigel, R; Fefer, P; Gannot, S; Hod, H; Matetzky, S; Rosenberg, N; Savion, N; Shechter, M; Varon, D, 2015
)
0.42
" The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing (on day 0 and day 14), and the grade of gastric mucosal injury was assessed according to the modified Lanza score."( A randomized, double-blind, placebo-controlled study of rebamipide for gastric mucosal injury taking aspirin with or without clopidogrel.
Fukui, H; Hida, N; Hori, K; Miwa, H; Nakamura, S; Ogawa, T; Ohda, Y; Okugawa, T; Oshima, T; Tomita, T; Tozawa, K; Watari, J, 2014
)
0.4
" The developed methods were applied for simultaneous analysis of aspirin, atorvastatin and clopedogrel in capsule dosage forms and results were in good concordance with alternative liquid chromatography."( Comparative study of three modified numerical spectrophotometric methods: an application on pharmaceutical ternary mixture of aspirin, atorvastatin and clopedogrel.
Hegazy, ND; Issa, MM; Nejem, RM; Shanab, AA; Stefan-van Staden, RI, 2014
)
0.4
" After discontinuation of the CCBs, angiotensin receptor blockers were newly administered to the patients or dosed up for control of blood pressure."( Antiplatelet effect of clopidogrel can be reduced by calcium-channel blockers.
Kim, JY; Kim, YD; Lee, KY; Seo, KD; Yoon, YW, 2014
)
0.4
"This is the largest population-scale genetic epidemiology study that provides a high-resolution map of variants associated with clopidogrel response that could be potentially valuable to clinicians to rationally plan appropriate dosage for therapy in resource poor conditions based on population level allele frequencies."( Pharmacogenetic landscape of clopidogrel in north Indians suggest distinct interpopulation differences in allele frequencies.
Basu, A; Bharadwaj, D; Giri, AK; Khan, NM; Scaria, V; Tandon, N, 2014
)
0.4
"Twice daily dosing is often perceived as inferior to once daily dosing due to a higher likelihood of missing a dose."( Projected inhibition of platelet aggregation with ticagrelor twice daily vs. clopidogrel once daily based on patient adherence data (the TWICE project).
Claeys, MJ; Legrand, V; Van de Werf, F; Vandendriessche, E; Vrijens, B, 2014
)
0.4
"Drug dosing histories of 5014 patients prescribed cardiovascular medications (primarily antihypertensive medicines) were extracted from an electronically compiled dosing history database."( Projected inhibition of platelet aggregation with ticagrelor twice daily vs. clopidogrel once daily based on patient adherence data (the TWICE project).
Claeys, MJ; Legrand, V; Van de Werf, F; Vandendriessche, E; Vrijens, B, 2014
)
0.4
" This modelling and simulation study suggests a therapeutic benefit of ticagrelor over clopidogrel when taking into account the most common dosing omissions."( Projected inhibition of platelet aggregation with ticagrelor twice daily vs. clopidogrel once daily based on patient adherence data (the TWICE project).
Claeys, MJ; Legrand, V; Van de Werf, F; Vandendriessche, E; Vrijens, B, 2014
)
0.4
" Medication use was compared between transfer and direct-arrival patients to determine if these therapies were delayed or dosed in excess."( The quality of antiplatelet and anticoagulant medication administration among ST-segment elevation myocardial infarction patients transferred for primary percutaneous coronary intervention.
Alexander, KP; Li, S; Magid, DJ; Peterson, ED; Roe, MT; Ting, HH; Wang, TY, 2014
)
0.4
"ST-segment elevation myocardial infarction patients transferred for primary PCI in community practice are at risk for delayed and excessively dosed antithrombotic therapy, highlighting the need for continued quality improvement to maximize the appropriate use of these important adjunctive therapies."( The quality of antiplatelet and anticoagulant medication administration among ST-segment elevation myocardial infarction patients transferred for primary percutaneous coronary intervention.
Alexander, KP; Li, S; Magid, DJ; Peterson, ED; Roe, MT; Ting, HH; Wang, TY, 2014
)
0.4
" Even a 12-hour separation of dosing does not appear to prevent drug interactions between omeprazole and clopidogrel."( Proton-pump inhibitors in patients requiring antiplatelet therapy: new FDA labeling.
Chilton, R; Johnson, DA; Liker, HR, 2014
)
0.4
" At the end of the dosing interval on day 28, mean final-extent IPA was 10."( Pharmacodynamics, pharmacokinetics and safety of ticagrelor in Asian patients with stable coronary artery disease.
Emanuelsson, H; Hiasa, Y; Teng, R, 2014
)
0.4
" A loading dosage of aspirin (500 mg) and/or clopidogrel (300 mg) was given 24 hours before the procedure to patients naïve to antiplatelet agents, whereas the usual dosage (aspirin 100 mg and clopidogrel 75 mg) was continued for patients who had previously been taking these agents for more than a week."( Association between silent embolic cerebral infarction and continuous increase of P2Y12 reaction units after neurovascular stenting.
Jung, JM; Kang, DW; Kim, BJ; Kim, JS; Kwon, JY; Kwon, SU; Lee, DH, 2014
)
0.4
" One of the most widely studied drugs with regard to genomics-guided dosing options is the oral anticoagulant, warfarin."( Is personalized medicine a dream or a reality?
Kim, RB; Morse, BL, 2015
)
0.42
" PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel's active metabolite (Clop-AM)."( Impaired responsiveness to the platelet P2Y12 receptor antagonist clopidogrel in patients with type 2 diabetes and coronary artery disease.
Angiolillo, DJ; Bass, TA; Darlington, A; Desai, B; Ferreiro, JL; Franchi, F; Guzman, LA; Jakubowski, JA; Moser, BA; Rollini, F; Sugidachi, A; Tello-Montoliu, A; Ueno, M, 2014
)
0.4
" The PRASugrel For Japanese PatIenTs with Coronary Artery Diseases Undergoing Elective PCI (PRASFIT-Elective) study investigated the efficacy and safety of different prasugrel dosing regimens in Japanese patients undergoing elective PCI."( Prasugrel, a third-generation P2Y12 receptor antagonist, in patients with coronary artery disease undergoing elective percutaneous coronary intervention.
Ikeda, Y; Isshiki, T; Kimura, T; Kitagawa, K; Miyazaki, S; Nakamura, M; Nanto, S; Nishikawa, M; Ogawa, H; Saito, S; Takayama, M; Yokoi, H, 2014
)
0.4
"These results support the risk-benefit profile of an adjusted dosing regimen of prasugrel in Japanese patients undergoing PCI."( Prasugrel, a third-generation P2Y12 receptor antagonist, in patients with coronary artery disease undergoing elective percutaneous coronary intervention.
Ikeda, Y; Isshiki, T; Kimura, T; Kitagawa, K; Miyazaki, S; Nakamura, M; Nanto, S; Nishikawa, M; Ogawa, H; Saito, S; Takayama, M; Yokoi, H, 2014
)
0.4
" In this paper, we have described a rapid and convenient method of verification which polymorph of HSCL is present in its final solid dosage form."( Solid-state NMR as an effective method of polymorphic analysis: solid dosage forms of clopidogrel hydrogensulfate.
Kolodziejski, W; Mazurek, A; Pindelska, E; Pisklak, DM; Szeleszczuk, L, 2015
)
0.42
"The study involved 209 non-cardiogenic ischemic stroke patients who were administered oral clopidogrel at a dosage of 75 mg/day for at least 1 week."( Relationship between smoking and responsiveness to clopidogrel in non-cardiogenic ischemic stroke patients.
Deguchi, I; Fukuoka, T; Hayashi, T; Horiuchi, Y; Kato, Y; Maruyama, H; Nagamine, Y; Ohe, Y; Sano, H; Sehara, Y; Tanahashi, N, 2014
)
0.4
" CYP2C19 was the covariate in the final pharmacokinetic model, and the model was to design a prior dosage regimen."( [Population pharmacokinetics and pharmacodynamics of clopidogrel in patients with acute coronary syndrome].
Ding, XL; Gao, J; Hang, YF; Jiang, B; Miao, LY; Xie, C; Xue, L, 2014
)
0.4
"This study aimed to validate a loading and maintenance clopidogrel dosing scheme for the inhibition of platelet function, measured by whole blood impedance aggregometry in healthy adult horses."( Inhibition of platelet function with clopidogrel, as measured with a novel whole blood impedance aggregometer in horses.
Failing, K; Moritz, A; Roscher, KA, 2015
)
0.42
"Evaluate the impact of salt and counterion identity on performance of solid immediate release dosage forms of miconazole and clopidogrel, respectively, in fasted upper gastrointestinal lumen using in-vitro methodologies."( In-vitro evaluation of performance of solid immediate release dosage forms of weak bases in upper gastrointestinal lumen: experience with miconazole and clopidogrel salts.
Dimopoulou, M; Mourouti, CS; Reppas, C; Symillides, M; Vertzoni, M, 2016
)
0.43
"Miconazole data indicate that salts may adversely affect performance of immediate release dosage forms of weak bases."( In-vitro evaluation of performance of solid immediate release dosage forms of weak bases in upper gastrointestinal lumen: experience with miconazole and clopidogrel salts.
Dimopoulou, M; Mourouti, CS; Reppas, C; Symillides, M; Vertzoni, M, 2016
)
0.43
" Point-of-care genetic testing for CYP2C19*2, ABCB1 TT and CYP2C19*17 was performed with carriers of either the CYP2C19*2 allele or ABCB1 TT genotype randomly assigned to a strategy of prasugrel 10 mg daily or an augmented dosing strategy of clopidogrel (150 mg daily for 6 days then 75 mg daily)."( A prospective randomized evaluation of a pharmacogenomic approach to antiplatelet therapy among patients with ST-elevation myocardial infarction: the RAPID STEMI study.
Bernick, J; Dick, AJ; Froeschl, M; Glover, C; Gollob, MH; Hibbert, B; Labinaz, M; Le May, MR; Marquis, JF; McPherson, R; Roberts, JD; So, DY; Tran, L; Wells, GA, 2016
)
0.43
" Investigators have therefore sought to "escalate" clopidogrel dosing to overcome HTPR to reduce ischemic/thrombotic events."( Review of clopidogrel dose escalation in the current era of potent P2Y12 inhibitors.
Howell, LA; Polasek, M; Rossi, JS; Stouffer, GA, 2015
)
0.42
" We sought to evaluate platelet reactivity during loading and maintenance dosing of ticagrelor versus clopidogrel, and the pharmacokinetic profile of ticagrelor and its metabolite AR-C124910XX, in black patients with stable CAD taking low-dose aspirin (acetylsalicylic acid)."( Ticagrelor Versus Clopidogrel in Black Patients With Stable Coronary Artery Disease: Prospective, Randomized, Open-Label, Multiple-Dose, Crossover Pilot Study.
Angiolillo, DJ; Caplan, RJ; Carlson, GF; Ferdinand, KC; Maya, J; Teng, R; Waksman, R, 2015
)
0.42
" All patients received low-molecular-weight heparin in prophylactic dosage starting 24 hours after aneurysm treatment."( Ventriculostomy-Related Hemorrhage After Treatment of Acutely Ruptured Aneurysms: The Influence of Anticoagulation and Antiplatelet Treatment.
Bruder, M; El-Fiki, A; Güresir, E; Konczalla, J; Lescher, S; Schuss, P; Seifert, V; Vatter, H, 2015
)
0.42
" Study results suggest that there is no benefit to dosing clopidogrel twice daily when compared to either prasugrel or once daily clopidogrel dosing."( Comparing prasugrel to twice daily clopidogrel post percutaneous coronary intervention in a Veterans Affairs population.
Khatri, S; Pierce, T, 2015
)
0.42
"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, dosage and administration, cost, and place in therapy of vorapaxar in the secondary prevention of atherosclerotic events are reviewed."( Vorapaxar for reduction of thrombotic cardiovascular events in myocardial infarction and peripheral artery disease.
Arif, SA; D'Souza, J; Gil, M; Gim, S, 2015
)
0.42
" All of the incorrect interpretations were for patients with test results indicating a dosing or drug change (6/19; 32%)."( Community pharmacists' experience with pharmacogenetic testing.
Haga, SB; Mills, R; Moaddeb, J,
)
0.13
" Therefore, clopidogrel napadisilate is a useful alternative option for the dosing of ischemic stroke patient populations."( Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in stroke patients: multicenter, randomized, open-label, phase 4, non-inferiority clinical trial.
Kang, K; Kim, BK; Kim, HJ; Koh, SH; Lee, SJ, 2016
)
0.43
"Clopidogrel (Plavix®), is a widely used antiplatelet agent, which shows high inter-individual variability in treatment response in patients following the standard dosing regimen."( Development of a physiology-directed population pharmacokinetic and pharmacodynamic model for characterizing the impact of genetic and demographic factors on clopidogrel response in healthy adults.
Horenstein, RB; Jiang, XL; Lesko, LJ; Lewis, JP; Peletier, LA; Samant, S; Schmidt, S; Shuldiner, AR; Yerges-Armstrong, LM, 2016
)
0.43
" A sigmoid dose-response curve defined the relations between CAMCmax and PRI after 3 to 24 h (IC50 , 459."( Relationship between pharmacokinetics and pharmacodynamics of clopidogrel in patients undergoing percutaneous coronary intervention: comparison between vasodilator-stimulated phosphoprotein phosphorylation assay and multiple electrode aggregometry.
Beltrame, F; Benati, M; Calabria, S; Cattaneo, M; Danese, E; Fava, C; Gelati, M; Gottardo, R; Guidi, GC; Minuz, P; Tagliaro, F; Tavella, D, 2016
)
0.43
" Therefore, the ABCB1 C3435T genotyping should be one of the parameters taken into account when deciding about the dosing regimen of clopidogrel."( P-Glycoprotein Polymorphism C3435T Is Associated with Dose-Adjusted Clopidogrel and 2-Oxo-Clopidogrel Concentration.
Apostolovic, SR; Jankovic, SM; Jevtovic-Stoimenov, T; Konstantinovic, SS; Lilic, J; Nikolic, VN; Pavlovic, M; Stokanovic, D; Zivkovic, VS; Zvezdanovic, JB, 2016
)
0.43
" The use of novel and more potent drug or high clopidogrel maintenance dosing before stent implantation may be beneficial treatment options for antiplatelet therapy in CYP2C19*2 carriers."( Effects of genetic factors to stent thrombosis due to clopidogrel resistance after coronary stent placement.
Avcilar, T; Cetin, SE; Emre, A; Erdem, A; Guney, AI; Isbir, T; Kaspar, EC; Kirac, D; Terzi, S; Yazici, S; Yesilcimen, K, 2016
)
0.43
"The deformation behavior of particles under pressure dominates the mechanical properties of solid dosage forms."( Visualization and quantification of deformation behavior of clopidogrel bisulfate polymorphs during tableting.
Gui, SY; Guo, T; Li, HY; Li, Y; Nangia, A; Wu, L; Xiao, TQ; Yin, XZ; York, P; Zhang, JW, 2016
)
0.43
"Randomized patients with available aspirin dosing information in COGENT (N = 3,752) were divided into "low-dose" (≤ 100 mg) and "high-dose" (>100 mg) aspirin groups."( Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy.
Bhatt, DL; Cannon, CP; Cohen, M; Cryer, BL; Doros, G; Goldsmith, MA; Hsieh, WH; Laine, L; Lanas, A; Lapuerta, P; Liu, Y; Schnitzer, TJ; Shook, TL; Vaduganathan, M, 2016
)
0.43
" Platelet activation markers were measured by flow cytometry on unstimulated or stimulated (adenosine diphosphate (ADP) 20 μM) platelets, before and after each dosing period."( Prasugrel 5 mg inhibits platelet P-selectin and GPIIb-IIIa expression in very elderly and non elderly: results from the GENERATIONS trial, a pharmacodynamic study in stable CAD patients.
Borna, C; Brown, P; Erlinge, D; Gidlöf, O; Jakubowski, JA; Lood, C; Truedsson, L; Wagner, H; Winters, K; Zhou, C, 2016
)
0.43
" A study of the ability of the compounds to inhibit ADP-induced platelet aggregation in fresh rat whole blood collected 2 h after oral dosing of rats with the compounds (7."( Significant Improvement of Metabolic Characteristics and Bioactivities of Clopidogrel and Analogs by Selective Deuteration.
Fawcett, JP; Gu, J; Liu, M; Meng, X; Su, C; Wang, H; Xu, X; Yang, Y; Yang, Z; Zhao, X, 2016
)
0.43
" The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations."( The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study.
Bolek, T; Fedor, M; Fedorová, J; Galajda, P; Kovář, F; Kubisz, P; Mokáň, M; Samoš, M; Stančiaková, L; Staško, J, 2016
)
0.43
"The dosing regimen of prasugrel adjusted for Japanese patients was compared with that of clopidogrel by analyzing the pharmacokinetics and pharmacodynamics in 40 healthy Japanese subjects in a randomized, single-blind crossover study."( The Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Healthy Japanese Volunteers.
Iwaki, T; Umemura, K, 2016
)
0.43
"High interindividual variability in clinical outcomes following clopidogrel's standard dosing regimen continues to be a challenge even two decades after its approval."( Identifying clinically relevant sources of variability: The clopidogrel challenge.
Horenstein, RB; Jiang, XL; Lesko, LJ; Lewis, JP; Peletier, LA; Samant, S; Schmidt, S; Shuldiner, AR, 2017
)
0.46
" A fixed-dose combination (FDC) capsule (HCP0911) has been developed to provide dosing convenience and improve adherence."( Pharmacodynamic effects of a new fixed-dose clopidogrel-aspirin combination compared with separate administration of clopidogrel and aspirin in patients treated with coronary stents: The ACCEL-COMBO trial.
Ahn, JH; Gurbel, PA; Hwang, JY; Hwang, SJ; Jang, JY; Jeong, YH; Kang, MG; Kim, K; Koh, JS; Kwak, CH; Park, HW; Park, JR; Park, Y; Tantry, US, 2017
)
0.46
" Dosage should be individualized in these populations."( Effect of obesity and serum leptin level on clopidogrel resistance.
Çiftçi, C; Doğan, A; Görmüş, U; Kahraman, S; Özdemir, E; Usta, E, 2016
)
0.43
" Newer P2Y12 antagonists with faster onset and greater inhibition of platelet activity have improved cardiovascular outcomes but have created uncertainty with the appropriate dosing when switching between agents."( In-stent thrombosis when switching ticagrelor to clopidogrel after percutaneous coronary intervention.
Brice, AE; Haynick, M; Hernandez, GA; Mendoza, CE; Sanchez, M, 2017
)
0.46
"The antiplatelet drug clopidogrel is widely used for prophylaxis of arterial thromboses in cats in a standard dosage of 18."( Influence of a low dosage of clopidogrel on platelet function in cats as measured by the platelet function analyser PFA-100 and the multiplate analyser.
Mischke, R; Teuber, M, 2016
)
0.43
" These prerequisites resulted in working out a recommended algorithm of individual dosing of clopidogrel (based on the analysis of case histories of patients with atherosclerosis of lower limb arteries by the level of platelet aggregation to a series of inducers) and correction of the dose of the drug based on the results of molecular-genetic testing of the cytochrome CYPC19 gene."( [Algorithm for selection of individual therapy with clopidogrel in vascular surgical practice].
Lifshits, GI; Seredina, TA; Shevela, AI; Slepukhina, AA; Zelenskaya, EM,
)
0.13
"Various strategies are emerging for dosing antiplatelet therapies in preparation for pipeline stent embolization in adults."( Optimal pediatric dosing of anti-platelet agents for pipeline stent embolization -a case report and review of the literature.
Cobb, MIH; Fernando Gonzalez, L; Hauck, EF; Smith, TP; Zomorodi, AR, 2017
)
0.46
" The clopidogrel dosage was adjusted to double the maintenance dose for the ineffective patients."( Impact of the CYP2C19 Gene Polymorphism on Clopidogrel Personalized Drug Regimen and the Clinical Outcomes.
Chen, K; Guo, X; Li, P; Liu, H; Liu, X; Zhang, R, 2016
)
0.43
"For percutaneous coronary intervention in postoperative patients, research data is still lacking regarding clopidogrel dosage on the basis of different CYP2C19 genotypes."( Impact of the CYP2C19 Gene Polymorphism on Clopidogrel Personalized Drug Regimen and the Clinical Outcomes.
Chen, K; Guo, X; Li, P; Liu, H; Liu, X; Zhang, R, 2016
)
0.43
" However, a substantial number of patients do not respond to clopidogrel despite a standardized dosage regimen, and this is directly associated with poor prognosis."( Effects of four novel genetic polymorphisms on clopidogrel efficacy in Chinese acute coronary syndromes patients.
Cao, S; Chen, BL; Fan, L; Liu, M; Liu, ZQ; Xiao, FY; Zhang, W; Zhou, G; Zhou, HH, 2017
)
0.46
"The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians."( A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.
Bang, J; Jin, C; Kim, MH; Serebruany, V,
)
0.13
" There was no difference in primary outcome between the loading dosage group 16."( Clopidogrel loading dose versus maintenance dose to treat patients with acute ischaemic stroke in China (CLASS-China): results from a prospective double-blind randomised clinical trial.
Tan, Z; Wang, W; Xiao, W; Xu, A; Yang, W; Zeng, J; Zhao, Y, 2017
)
0.46
" This suggests that clopidogrel dosing in patients with acute coronary syndromes should be personalized, taking into consideration both ischemic and bleeding risk."( Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention.
Bossard, M; Faxon, DP; Fox, KAA; Gao, P; Granger, CB; Jolly, SS; Mehta, SR; Montalescot, G; Natarajan, MK; Niemela, K; Steg, PG; Tanguay, JF; Widimsky, P; Yusuf, S, 2017
)
0.46
" The dosage of clopidogrel therapy should be adjusted based on its polymorphisms."( [Influence of CYP2C19 gene polymorphisms on the efficacy of clopidogrel treatment for the prevention of ischemic stroke following coronary stent implantation].
Chen, J; Ding, N; Li, G; Peng, L; Shao, Y; Wang, Y; Xu, Z; Zhang, C, 2017
)
0.46
" The genetic variants of vitamin K expoxide reductase might account for the universally lower warfarin dosage used in Chinese population."( Integrative Medicine on Optimizing Clopidogrel and Aspirin Therapy.
Chen, H, 2019
)
0.51
" Decreased trend of negative outcomes could be observed in patients with double dosage of clopidogrel, but the difference was not significant."( Randomized Comparisons of Double-Dose Clopidogrel or Adjunctive Cilostazol Versus Standard Dual Antiplatelet in Patients With High Posttreatment Platelet Reactivity: Results of the CREATIVE Trial.
Chen, J; Gao, R; Huang, X; Qiao, S; Tang, YD; Wang, W; Wu, Y; Xu, B; Yan, H; Yang, M; Yang, Y; Zhang, K, 2018
)
0.48
"This was a prospective, randomized, open-label study conducted in patients on maintenance dosing (MD) of aspirin (81 mg/d) and clopidogrel (75 mg/d)."( Pharmacodynamic Effects of Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease: Results of the SWAP-4 Study.
Agarwal, M; Angiolillo, DJ; Bass, TA; Been, L; Briceno, M; Franchi, F; Kureti, M; Moon, JY; Nagaraju, D; Nawaz, A; Rivas Rios, J; Rivas, A; Rollini, F; Shaikh, Z; Soffer, D; Suryadevara, S; Wali, M; Zenni, MM, 2018
)
0.48
" As a result, a substantial number of patients (20-30%) with ACS show an inadequate response to clopidogrel despite a standardized dosing regimen."( Role of CYP2C19 genotype testing in clinical use of clopidogrel: is it really useful?
Bella, J; Krim, N; Zeb, I, 2018
)
0.48
"Long-term evidence shows an increased risk of cardiovascular events in the morning hours and recent studies in aspirin-treated patients have shown increased platelet reactivity at the end of the dosing interval."( Twenty-four-hour time dependency of clopidogrel effects in patients with acute coronary syndromes: The CiCAD-Study.
Egger, F; Freynhofer, MK; Gruber, SC; Huber, K; Hübl, W; Weiss, TW; Willheim, M, 2019
)
0.51
" Dosing starts at 10 mg dose and with 60 min intervals between doses, this now becomes a 4 h desensitization protocol."( Clopidogrel Desensitization: Background and Recommendations for Use of a Rapid (4 Hour) Protocol.
Bulva, J; Simon, RA, 2019
)
0.51
" For emergent reversal of P2Y12 inhibitors, test method can affect platelet dosing recommendations, as different methods may give different results."( Laboratory Monitoring of Platelet P2Y12 Receptor Inhibitors and Reversal of Antiplatelet Agents.
Ahmed, T; Senzel, L; Spitzer, ED, 2019
)
0.51
" There were two treatment phases during which cats received either Plavix or generic clopidogrel at a dosage of 18."( Comparison of metabolomics and platelet aggregometry between Plavix and generic clopidogrel in cats: a pilot study.
Court, MH; Hogan, DF; Lee, PM; Malkawi, M; Moore, GE; Woolcock, AD, 2019
)
0.51
"Long-term evidence supports a clustering of cardiovascular events in the early morning and smaller mechanistic studies in aspirin-treated patients have shown increased platelet reactivity at the end of the dosing interval."( Diurnal Variability of On-Treatment Platelet Reactivity in Clopidogrel versus Prasugrel Treated Acute Coronary Syndrome Patients: A Pre-Specified TROPICAL-ACS Sub-Study.
Aradi, D; Dézsi, DA; Freynhofer, MK; Geisler, T; Gross, L; Haller, PM; Hein-Rothweiler, R; Huber, K; Huczek, Z; Massberg, S; Orban, M; Sibbing, D; Toth-Gayor, GG; Trenk, D, 2019
)
0.51
" 63 patients were divided into four groups with different dosage regimen and the serum samples were collected for the analysis."( Interaction of clopidogrel and fufang danshen dripping pills assay in coronary heart disease based on non-target metabolomics.
Chang, H; Guo, MZ; Ji, S; Tang, DQ; Wang, TY; Yang, J, 2019
)
0.51
"In order to mimic the standard dosing regimen for DAPT in human, various Sprague-Dawley rats treatment groups were received a bolus oral dose of DAPT on day 1 followed by DAPT for consecutive 13 days in absence and presence of orally co-administered four TCM herbs (Danshen, Gegen, Danggui and Chuanxiong) at their low and high doses."( Impact of the Chinese herbal medicines on dual antiplatelet therapy with clopidogrel and aspirin: Pharmacokinetics and pharmacodynamics outcomes and related mechanisms in rats.
Lee, P; Luo, X; Mok, C; Qian, C; Wu, C; Xiao, M; Yang, M; Zhang, Y; Zuo, Z, 2019
)
0.51
" Dosing for neuroendovascular conditions is often extrapolated from the cardiac literature, although outcomes in cardiac patients may not be relevant to neurologic patients, making prophylactic treatment recommendations challenging for these patients."( Periprocedural Neuroendovascular Antiplatelet Strategies for Thrombosis Prevention in Clopidogrel-Hyporesponsive Patients.
Barra, ME; Berger, K; Brophy, GM; Tesoro, EP, 2019
)
0.51
" Since patients with different genetic variations respond quite differently to clopidogrel therapy, the related genetic testing plays a vital role in its dosage and genetic testing related to clopidogrel therapy is currently considered as routine test worldwide."( Comparison between MassARRAY and pyrosequencing for CYP2C19 and ABCB1 gene variants of clopidogrel efficiency genotyping.
Dai, S; Jiang, Y; Li, Y; Liu, J; Pan, J; Xu, Z, 2019
)
0.51
" Modified dosing strategies were shown to increase the final PRU values and to decrease the percentage of platelet inhibition (137."( Dose adjustment of clopidogrel in hyper-responder patients with unruptured intracranial aneurysms treated with stents.
Cayuela, A; de Albóniga-Chindurza, A; García-Lozano, JR; González, A; Luque Vega, MI; Ortega-Quintanilla, J; Zapata-Arriaza, E, 2020
)
0.56
" Integrating pharmacogenomics into clinical practice to assist in drug selection and dosing has the potential to improve the outcomes of treatment, reduce the risk of drug-induced morbidity and death, and be cost-effective."( Pharmacogenomics: An evolving clinical tool for precision medicine.
Eng, C; Erwin, AL; Hicks, JK; Hockings, JK; Mason, NT; Pasternak, AL, 2020
)
0.56
" Here we describe the results of 3 studies that evaluated the safety and tolerability of DS-1040 along with the effect on DS-1040 pharmacokinetic (PK) parameters, when dosed alone or when coadministered with aspirin (NCT02071004), clopidogrel (NCT02560688), or enoxaparin in healthy subjects."( Safety and Pharmacokinetics of DS-1040 Drug-Drug Interactions With Aspirin, Clopidogrel, and Enoxaparin.
Dishy, V; Kobayashi, F; Kochan, J; Limsakun, T; McPhillips, P; Mendell, J; Orihashi, Y; Pav, J; Pizzagalli, F; Rambaran, C; Vandell, AG; Warren, V; Zhou, J, 2020
)
0.56
"To allow for tailored dosing and overcome swallowing difficulties, compounded liquid medication is often required in pediatric patients."( Stability of Azathioprine, Clonidine Hydrochloride, Clopidogrel Bisulfate, Ethambutol Hydrochloride, Griseofulvin, Hydralazine Hydrochloride, Nitrofurantoin, and Thioguanine Oral Suspensions Compounded with SyrSpend SF pH4.
Anagnostou, K; Cunha, CN; da Silva, SL; Dijkers, E; Ferreira, AO; Polonini, H,
)
0.13
" PK modelling and simulation were conducted to support dosing recommendations."( Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects.
Axelsen, LN; Bruderer, S; Perez Ruixo, JJ; Poggesi, I; Rasschaert, F, 2021
)
0.62
"This review aimed to evaluate the clinical success of clopidogrel dosing based on CYP2C19 genotype and to identify the relevant additional factors that may be useful for consideration by the clinician when dosing individuals with clopidogrel."( Clopidogrel Dosing: Current Successes and Emerging Factors for Further Consideration.
Chetty, M; Manchandani, P; Ravenstijn, P, 2021
)
0.62
"Our results demonstrated the impact of clopidogrel on the pharmacokinetics of selexipag and its active metabolite and suggested that selexipag should be carefully prescribed with clopidogrel with dose adjustment or reducing the dosing frequency in Japanese clinical settings."( Clinical evaluation of drug-drug interactions between the cytochrome P450 substrates selexipag and clopidogrel in Japanese volunteers.
Hakamata, A; Inui, N; Kamiya, C; Katayama, N; Namiki, N; Odagiri, K; Tanaka, S; Tatsumi, K; Uchida, S; Watanabe, H, 2021
)
0.62
"Patients bearing polymorphisms termed CYP2C19 loss of function (LoF) alleles and ABCB1-C3435T may do not properly respond to standard dosage of clopidogrel and have an increased risk of thrombosis."( The need of a multicomponent guiding approach to personalize clopidogrel treatment.
Amelia, F; Carmine, S; Giancarlo, A; Giovanna, N; Graziamaria, C; Maria, C; Martina, T; Teresa, I; Valentina, M; Valeria, C, 2021
)
0.62
" Of which, there were 2 cases which changed the dosage of clopidogrel to 75 mg BID, 14 cases who changed clopidogrel to ticagrelor."( Effects of individualized antiplatelet therapy based on CYP2C19 genotype and platelet function on the prognosis of patients after PCI.
Gao, M; Hou, YL; Jia, XM; Ma, LP; Ren, MY; Wang, JR; Zhang, M; Zhang, P; Zhang, Y, 2020
)
0.56
" To improve adherence to DAPT, the FDC (fixed dose combination) of Acetylsalicylic acid (ASA) and clopidogrel was developed into a single pill instead of two separate pills thus facilitating the dosage and administration of the therapy and increasing compliance."( Adherence and persistence analysis in patients treated with double antiplatelet therapy (DAPT) at two years in real life.
Costantini, A; Romagnoli, A; Santoleri, F, 2021
)
0.62
" Compared with a standard clopidogrel-based dual antiplatelet therapy (DAPT) regimen, an intensified dosing strategy appears to offer no additional benefit with a signal of possible harm."( Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease.
Boden, W; Bossard, M; Budaj, A; Di Pasquale, G; Faxon, D; Flather, M; Gao, P; Granger, CB; Joyner, C; Kastrati, A; Mehta, SR; Moccetti, T; Pais, P; Steg, G; Tanguay, JF; Valentin, V; Yusuf, S, 2021
)
0.62
" Patients received alternative drug dosing or antiplatelet agents other than clopidogrel only if this was prescribed for another diagnosis or they had a preexisting contraindication."( Comparison of Aspirin Monotherapy versus Dual Antiplatelet Therapy Following Coronary Artery Bypass Grafting.
Hess, NR; Kilic, A; Sultan, I; Thoma, F; Wang, Y, 2021
)
0.62
" Clopidogrel hyper-responsive patients received reduced dosing according to the values of follow-up PRUs before and 7, 14, 30, and 90 days after the procedure."( Active management of the target P2Y12 reaction unit range in patients undergoing stent-assisted coil embolization for unruptured cerebral aneurysms.
Furuta, T; Kotsugi, M; Myouchin, K; Nakagawa, I; Nakase, H; Nakase, K; Park, HS; Yamada, S; Yokoyama, S, 2021
)
0.62
" This modified dosage regimen has been established in studies conducted in Japan; however, the efficacy and safety of switching from clopidogrel to prasugrel DAPT among Taiwanese patients remain to be explored."( Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy.
Cheng, LC; Chu, PH; Huang, CL; Kuo, FY; Lan, WR; Lee, CH; Lee, WL; Lin, WS; Liu, PY; Lo, PH; Lu, TM; Nikolajsen, C; Rafael, V; Su, CH; Tsukiyama, S; Wang, YC; Yang, WC; Yin, WH, 2022
)
0.72
" The impact of proactive regulatory action, such as recommended dosing and therapeutic drug monitoring (TDM), was also observable within the global database."( The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.
Aoki, Y; Chandler, RE; Lönnstedt, IM; Wakao, R, 2021
)
0.62
" A decreased MACCE rate was also observed in patients administered the double dosage of clopidogrel, but the bleeding risk was increased compared with the control group."( Efficacy and safety of ticagrelor versus clopidogrel with different dosages in acute coronary syndrome patients with high GRACE and CRUSADE scores.
Lan, Y; Xiao, P; Xie, F,
)
0.13
"Liquisolid compact is a novel dosage form in which a liquid medication (liquid drug, drug solution/dispersion in non-volatile solvent/solvent system) is converted to a dry, free flowing powder and compressed."( Evaluation of the effect of carrier material on modification of release characteristics of poor water soluble drug from liquisolid compacts.
Ali, B; Alyami, HS; Badshah, M; Khan, A; Naz, A; Ullah, M; Wahab, A, 2021
)
0.62
"Obesity attenuated metabolic activation of clopidogrel and increased counts of circulating reticulated and mature platelets, leading to impaired platelet responsiveness to the drug in mice, suggesting that clopidogrel dosage may need to be adjusted adequately in overweight or obese patients."( Is platelet responsiveness to clopidogrel attenuated in overweight or obese patients and why? A reverse translational study in mice.
Ge, PX; Ji, JZ; Jiang, LP; Li, YF; Mi, QY; Tai, T; Xie, HG; Zhu, T, 2022
)
0.72
" We investigated whether alternate-day dosing of vonoprazan might avoid this interaction with clopidogrel while providing sufficient gastric acid inhibition."( Influence of daily versus alternate-day dosing of vonoprazan on intragastric pH, serum gastrin, and the antiplatelet function of clopidogrel : Influence of alternate-day dosing of vonoprazan.
Furuta, T; Hamaya, Y; Higuchi, T; Iwaizumi, M; Kagami, T; Osawa, S; Sugimoto, K; Takahashi, S; Tamura, S; Tani, S; Uotani, T; Yamade, M, 2022
)
0.72
"In the present work, we report a method based on micellar liquid chromatography coupled with ultraviolet detection (MLC/UV), for the simultaneous quantification of combined anti-platelet therapy namely, clopidogrel bisulfate (CPS), aspirin (ASP), together with salicylic acid (SA), in their pharmaceutical dosage form."( Micelle-Incorporated Liquid Chromatography in the Light of Green Chemistry: An Application for the Quality Control Analysis of Anti-Platelet Fixed-Dose Combinations.
Abdulwahab, S; Eissa, MS; Elsonbaty, A; Hassan, WS, 2022
)
0.72
"The MLC/UV method was successfully applied to the quantitative analysis of CPS, ASP together with SA-as a main degradation product of ASP-in their pharmaceutical dosage form."( Micelle-Incorporated Liquid Chromatography in the Light of Green Chemistry: An Application for the Quality Control Analysis of Anti-Platelet Fixed-Dose Combinations.
Abdulwahab, S; Eissa, MS; Elsonbaty, A; Hassan, WS, 2022
)
0.72
"The developed method was successfully applied for the determination of clopidogrel bisulfate (CPS), aspirin (ASP), together with salicylic acid (SA), in their pharmaceutical dosage form."( Micelle-Incorporated Liquid Chromatography in the Light of Green Chemistry: An Application for the Quality Control Analysis of Anti-Platelet Fixed-Dose Combinations.
Abdulwahab, S; Eissa, MS; Elsonbaty, A; Hassan, WS, 2022
)
0.72
" We therefore titrate clopidogrel dosing to maintain a moderate level of platelet inhibition using the VerifyNow P2Y12 assay."( Excessive platelet inhibition following Pipeline embolization of intracranial aneurysms.
Anders, M; Beitelshees, AL; Caffes, N; Cannarsa, G; Cherian, J; Gandhi, D; Jindal, G; Khunte, M; Malhotra, A; Miller, TR; Rock, P; Simard, JM, 2023
)
0.91
" Advantages in both PK and pharmacogenetics suggest that vicagrel may reduce the complexity of currently recommended CYP2C19-based dosage adjustment for clopidogrel."( Semi-mechanistic population pharmacokinetics analysis reveals distinct CYP2C19 dependency in the bioactivation of vicagrel and clopidogrel to active metabolite M15-2.
Gong, Y; He, Y; Lai, X; Li, YG; Liu, X; Liu, Y; Sun, H; Yan, X; Zhang, EY; Zhang, L, 2022
)
0.72
" Clopidogrel was the most difficult medication to consistently administer, and twice a day dosing was the highest frequency of medication administration most owners could achieve."( A multicenter prospective evaluation of owner medication adherence for feline cardiovascular disease in the referral setting.
Allen, JW; Chapel, EH; Murphy, LA; Nakamura, RK; O'Malley, B; Russell, NJ; Schrope, DP; Sloan, CQ; Wang, ML; Zimmerman, SA, 2022
)
0.72
" We aimed to evaluate the dose-response relationship of milvexian in participants treated with dual antiplatelets."( Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention.
Amarenco, P; Bereczki, D; Czlonkowska, A; Diener, HC; Donovan, M; Endres, M; Gailani, D; Hankey, GJ; Kahl, A; Kasner, SE; Li, D; Lutsep, HL; Molina, CA; Ntaios, G; Perera, V; Sharma, M; Shuaib, A; Toyoda, K; Tsivgoulis, G, 2022
)
0.72
"The AXIOMATIC-SSP trial will evaluate the dose-response of milvexian for ischemic stroke occurrence in participants with ischemic stroke or TIA."( Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention.
Amarenco, P; Bereczki, D; Czlonkowska, A; Diener, HC; Donovan, M; Endres, M; Gailani, D; Hankey, GJ; Kahl, A; Kasner, SE; Li, D; Lutsep, HL; Molina, CA; Ntaios, G; Perera, V; Sharma, M; Shuaib, A; Toyoda, K; Tsivgoulis, G, 2022
)
0.72
" In addition, PGx-guided dosing guidelines are now available for multiple CVD drugs, including clopidogrel, warfarin, and statins."( Pharmacogenomics implementation in cardiovascular disease in a highly diverse population: initial findings and lessons learned from a pilot study in United Arab Emirates.
Al-Mahayri, ZN; Al-Maskari, F; Ali, BR; AlKaabi, J; Alqasrawi, MN; Altoum, SM; AlZaabi, A; Badawi, S; George, L; Hamza, D; Jamil, G; Khasawneh, LQ; Ouda, H; Patrinos, GP, 2022
)
0.72
" Regarding warfarin, only 20% of the participants exhibited reference alleles at VKORC1-1639G > A, CYP2C9*2, and CYP2C9*3, leaving 80% with alternative genotypes at any of the two genes that can be integrated into the warfarin dosing algorithms and can be used whenever the patient receives a warfarin prescription."( Pharmacogenomics implementation in cardiovascular disease in a highly diverse population: initial findings and lessons learned from a pilot study in United Arab Emirates.
Al-Mahayri, ZN; Al-Maskari, F; Ali, BR; AlKaabi, J; Alqasrawi, MN; Altoum, SM; AlZaabi, A; Badawi, S; George, L; Hamza, D; Jamil, G; Khasawneh, LQ; Ouda, H; Patrinos, GP, 2022
)
0.72
"10]), compared with never use, and there was no evidence of a dose-response relation."( Antiplatelet drugs and breast cancer risk in a large nationwide Danish case-control study.
Cairat, M; Dossus, L; Fournier, A; Hicks, B; Olesen, M; Pottegård, A, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
platelet aggregation inhibitorA drug or agent which antagonizes or impairs any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system.
anticoagulantAn agent that prevents blood clotting.
P2Y12 receptor antagonistAn antagonist at the P2Y12 receptor
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
thienopyridineAny organic heterobicyclic compound whose skeleton results from the formal ortho-fusion of any bond of a pyridine with any bond of a thiophene.
monochlorobenzenesAny member of the class of chlorobenzenes containing a mono- or poly-substituted benzene ring in which only one substituent is chlorine.
methyl esterAny carboxylic ester resulting from the formal condensation of a carboxy group with methanol.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (2)

PathwayProteinsCompounds
Clopidogrel Action Pathway98
Clopidogrel Metabolism Pathway98

Protein Targets (12)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
EWS/FLI fusion proteinHomo sapiens (human)Potency35.19730.001310.157742.8575AID1259253; AID1259256
nonstructural protein 1Influenza A virus (A/WSN/1933(H1N1))Potency19.95260.28189.721235.4813AID2326
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
parathyroid hormone/parathyroid hormone-related peptide receptor precursorHomo sapiens (human)Potency89.12513.548119.542744.6684AID743266
gemininHomo sapiens (human)Potency25.11890.004611.374133.4983AID624297
Rap guanine nucleotide exchange factor 4Homo sapiens (human)Potency79.43283.981146.7448112.2020AID720708
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cytochrome P450 2C8Homo sapiens (human)Ki14.30000.00180.38733.3000AID705605
Cytochrome P450 2B6Homo sapiens (human)Ki1.10000.00041.416010.0000AID589245
Sodium-dependent serotonin transporterHomo sapiens (human)IC50 (µMol)0.56200.00010.86458.7096AID625222
Sodium-dependent serotonin transporterHomo sapiens (human)Ki0.29900.00000.70488.1930AID625222
Cytochrome P450 2C19Homo sapiens (human)Ki14.30000.00010.830010.0000AID705605
P2Y purinoceptor 12Homo sapiens (human)IC50 (µMol)2.40000.00041.048910.0000AID1850679
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (97)

Processvia Protein(s)Taxonomy
lipid hydroxylationCytochrome P450 2C8Homo sapiens (human)
organic acid metabolic processCytochrome P450 2C8Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C8Homo sapiens (human)
steroid metabolic processCytochrome P450 2C8Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C8Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C8Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C8Homo sapiens (human)
retinol metabolic processCytochrome P450 2C8Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 2C8Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C8Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C8Homo sapiens (human)
oxidative demethylationCytochrome P450 2C8Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C8Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2B6Homo sapiens (human)
steroid metabolic processCytochrome P450 2B6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2B6Homo sapiens (human)
cellular ketone metabolic processCytochrome P450 2B6Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2B6Homo sapiens (human)
cholesterol biosynthetic processLiver carboxylesterase 1Homo sapiens (human)
cholesterol metabolic processLiver carboxylesterase 1Homo sapiens (human)
response to toxic substanceLiver carboxylesterase 1Homo sapiens (human)
positive regulation of cholesterol effluxLiver carboxylesterase 1Homo sapiens (human)
negative regulation of cholesterol storageLiver carboxylesterase 1Homo sapiens (human)
epithelial cell differentiationLiver carboxylesterase 1Homo sapiens (human)
cholesterol homeostasisLiver carboxylesterase 1Homo sapiens (human)
reverse cholesterol transportLiver carboxylesterase 1Homo sapiens (human)
medium-chain fatty acid metabolic processLiver carboxylesterase 1Homo sapiens (human)
regulation of bile acid biosynthetic processLiver carboxylesterase 1Homo sapiens (human)
cellular response to cholesterolLiver carboxylesterase 1Homo sapiens (human)
cellular response to low-density lipoprotein particle stimulusLiver carboxylesterase 1Homo sapiens (human)
cholesterol ester hydrolysis involved in cholesterol transportLiver carboxylesterase 1Homo sapiens (human)
positive regulation of cholesterol metabolic processLiver carboxylesterase 1Homo sapiens (human)
regulation of bile acid secretionLiver carboxylesterase 1Homo sapiens (human)
lipid catabolic processLiver carboxylesterase 1Homo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 2C19Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C19Homo sapiens (human)
steroid metabolic processCytochrome P450 2C19Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C19Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C19Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
adaptive immune responseRap guanine nucleotide exchange factor 4Homo sapiens (human)
G protein-coupled receptor signaling pathwayRap guanine nucleotide exchange factor 4Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayRap guanine nucleotide exchange factor 4Homo sapiens (human)
calcium-ion regulated exocytosisRap guanine nucleotide exchange factor 4Homo sapiens (human)
regulation of exocytosisRap guanine nucleotide exchange factor 4Homo sapiens (human)
insulin secretionRap guanine nucleotide exchange factor 4Homo sapiens (human)
positive regulation of insulin secretionRap guanine nucleotide exchange factor 4Homo sapiens (human)
regulation of synaptic vesicle cycleRap guanine nucleotide exchange factor 4Homo sapiens (human)
Ras protein signal transductionRap guanine nucleotide exchange factor 4Homo sapiens (human)
regulation of insulin secretionRap guanine nucleotide exchange factor 4Homo sapiens (human)
G protein-coupled adenosine receptor signaling pathwayP2Y purinoceptor 12Homo sapiens (human)
monoatomic ion transportP2Y purinoceptor 12Homo sapiens (human)
substrate-dependent cell migration, cell extensionP2Y purinoceptor 12Homo sapiens (human)
G protein-coupled receptor signaling pathwayP2Y purinoceptor 12Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayP2Y purinoceptor 12Homo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayP2Y purinoceptor 12Homo sapiens (human)
hemostasisP2Y purinoceptor 12Homo sapiens (human)
calcium-mediated signalingP2Y purinoceptor 12Homo sapiens (human)
cerebral cortex radial glia-guided migrationP2Y purinoceptor 12Homo sapiens (human)
cell projection organizationP2Y purinoceptor 12Homo sapiens (human)
lamellipodium assemblyP2Y purinoceptor 12Homo sapiens (human)
platelet activationP2Y purinoceptor 12Homo sapiens (human)
positive regulation of integrin activation by cell surface receptor linked signal transductionP2Y purinoceptor 12Homo sapiens (human)
positive regulation of cell adhesion mediated by integrinP2Y purinoceptor 12Homo sapiens (human)
G protein-coupled purinergic nucleotide receptor signaling pathwayP2Y purinoceptor 12Homo sapiens (human)
positive regulation of monoatomic ion transportP2Y purinoceptor 12Homo sapiens (human)
response to axon injuryP2Y purinoceptor 12Homo sapiens (human)
regulation of chemotaxisP2Y purinoceptor 12Homo sapiens (human)
positive regulation of chemotaxisP2Y purinoceptor 12Homo sapiens (human)
establishment of localization in cellP2Y purinoceptor 12Homo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionP2Y purinoceptor 12Homo sapiens (human)
platelet aggregationP2Y purinoceptor 12Homo sapiens (human)
cellular response to ATPP2Y purinoceptor 12Homo sapiens (human)
visual system developmentP2Y purinoceptor 12Homo sapiens (human)
positive regulation of ruffle assemblyP2Y purinoceptor 12Homo sapiens (human)
regulation of microglial cell migrationP2Y purinoceptor 12Homo sapiens (human)
positive regulation of microglial cell migrationP2Y purinoceptor 12Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (48)

Processvia Protein(s)Taxonomy
monooxygenase activityCytochrome P450 2C8Homo sapiens (human)
iron ion bindingCytochrome P450 2C8Homo sapiens (human)
protein bindingCytochrome P450 2C8Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C8Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 2C8Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C8Homo sapiens (human)
aromatase activityCytochrome P450 2C8Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 2C8Homo sapiens (human)
heme bindingCytochrome P450 2C8Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C8Homo sapiens (human)
monooxygenase activityCytochrome P450 2B6Homo sapiens (human)
iron ion bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-alpha-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
heme bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-beta-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2B6Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2B6Homo sapiens (human)
sterol esterase activityLiver carboxylesterase 1Homo sapiens (human)
methylumbelliferyl-acetate deacetylase activityLiver carboxylesterase 1Homo sapiens (human)
carboxylesterase activityLiver carboxylesterase 1Homo sapiens (human)
carboxylic ester hydrolase activityLiver carboxylesterase 1Homo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
iron ion bindingCytochrome P450 2C19Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxygen bindingCytochrome P450 2C19Homo sapiens (human)
enzyme bindingCytochrome P450 2C19Homo sapiens (human)
heme bindingCytochrome P450 2C19Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
aromatase activityCytochrome P450 2C19Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C19Homo sapiens (human)
guanyl-nucleotide exchange factor activityRap guanine nucleotide exchange factor 4Homo sapiens (human)
protein bindingRap guanine nucleotide exchange factor 4Homo sapiens (human)
cAMP bindingRap guanine nucleotide exchange factor 4Homo sapiens (human)
protein-macromolecule adaptor activityRap guanine nucleotide exchange factor 4Homo sapiens (human)
small GTPase bindingRap guanine nucleotide exchange factor 4Homo sapiens (human)
G protein-coupled adenosine receptor activityP2Y purinoceptor 12Homo sapiens (human)
G protein-coupled ADP receptor activityP2Y purinoceptor 12Homo sapiens (human)
guanyl-nucleotide exchange factor activityP2Y purinoceptor 12Homo sapiens (human)
G protein-coupled purinergic nucleotide receptor activityP2Y purinoceptor 12Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (22)

Processvia Protein(s)Taxonomy
endoplasmic reticulum membraneCytochrome P450 2C8Homo sapiens (human)
plasma membraneCytochrome P450 2C8Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C8Homo sapiens (human)
cytoplasmCytochrome P450 2C8Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C8Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2B6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2B6Homo sapiens (human)
cytoplasmCytochrome P450 2B6Homo sapiens (human)
cytoplasmLiver carboxylesterase 1Homo sapiens (human)
endoplasmic reticulumLiver carboxylesterase 1Homo sapiens (human)
endoplasmic reticulum lumenLiver carboxylesterase 1Homo sapiens (human)
lipid dropletLiver carboxylesterase 1Homo sapiens (human)
cytosolLiver carboxylesterase 1Homo sapiens (human)
lipid dropletLiver carboxylesterase 1Homo sapiens (human)
endoplasmic reticulumLiver carboxylesterase 1Homo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C19Homo sapiens (human)
plasma membraneCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
cytoplasmCytochrome P450 2C19Homo sapiens (human)
cytosolRap guanine nucleotide exchange factor 4Homo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 4Homo sapiens (human)
membraneRap guanine nucleotide exchange factor 4Homo sapiens (human)
hippocampal mossy fiber to CA3 synapseRap guanine nucleotide exchange factor 4Homo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 4Homo sapiens (human)
plasma membraneP2Y purinoceptor 12Homo sapiens (human)
cell surfaceP2Y purinoceptor 12Homo sapiens (human)
membraneP2Y purinoceptor 12Homo sapiens (human)
cell projection membraneP2Y purinoceptor 12Homo sapiens (human)
cell body membraneP2Y purinoceptor 12Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (202)

Assay IDTitleYearJournalArticle
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1493927Antagonist activity at P2Y12 in human platelet rich plasma assessed as inhibition of collagen-induced platelet aggregation at 10 uM pretreated for 30 mins followed by collagen addition measured after 5 mins by light transmission aggregometric analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Thieno[2,3-b]pyridine derivatives are potent anti-platelet drugs, inhibiting platelet activation, aggregation and showing synergy with aspirin.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1217728Intrinsic clearance for reactive metabolites formation per mg of protein based on cytochrome P450 (unknown origin) inactivation rate by TDI assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID700805Drug metabolism in human liver microsomes assessed as CYP2D6-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1186087Ex vivo inhibition of platelet aggregation in po dosed Sprague-Dawley rat after 2 hrs2014Journal of medicinal chemistry, Sep-11, Volume: 57, Issue:17
N-[6-(4-butanoyl-5-methyl-1H-pyrazol-1-yl)pyridazin-3-yl]-5-chloro-1-[2-(4-methylpiperazin-1-yl)-2-oxoethyl]-1H-indole-3-carboxamide (SAR216471), a novel intravenous and oral, reversible, and directly acting P2Y12 antagonist.
AID700809Drug metabolism in human liver microsomes assessed as CYP1A2-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1339045Toxicity in Swiss albino mouse assessed as bleeding time at 70 umol/kg, po
AID1217712Time dependent inhibition of CYP2C8 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1068712Displacement of UDP-[14C]GlcNAc from TarO (unknown origin) after 2.5 hrs by scintillation counting analysis2014Bioorganic & medicinal chemistry letters, Feb-01, Volume: 24, Issue:3
Designing analogs of ticlopidine, a wall teichoic acid inhibitor, to avoid formation of its oxidative metabolites.
AID1656368Drug metabolism in human plasma assessed as acid metabolite formation at 75 mg, po after 1 hr using radiolabelled compound2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Designing around Structural Alerts in Drug Discovery.
AID1212912Inhibition of CYP2B6 variant in human liver microsomes harboring CYP2B6*6/*6 genotype assessed as 8-hydroxyefavirenz formation using efavirenz as substrate after 15 mins by LC/MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Effects of the CYP2B6*6 allele on catalytic properties and inhibition of CYP2B6 in vitro: implication for the mechanism of reduced efavirenz metabolism and other CYP2B6 substrates in vivo.
AID1217711Metabolic activation in human liver microsomes assessed as [3H]GSH adduct formation rate measured per mg of protein at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID667509Drug metabolism in rat liver microsomes assessed as NADPH-dependent active metabolite glutathione adducts 2 formation at 20 uM after 30 mins by LC-MS/MS analysis2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID1277732Toxicity in Swiss albino mouse assessed as bleeding time at 70 umol/kg, po administered as single dose measured up to 24 hrs (Rvb = 3.5 +/- 0.3 mins)2016European journal of medicinal chemistry, Mar-03, Volume: 110Synthesis and evaluation of dual antiplatelet activity of bispidine derivatives of N-substituted pyroglutamic acids.
AID1062236Antithrombotic activity in FeCl2-induced Sprague-Dawley rat carotid artery thrombosis model assessed as reduction of thrombus weight at 20 mg/kg, po after 60 mins relative to vehicle-treated control2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Conformationally constrained ortho-anilino diaryl ureas: discovery of 1-(2-(1'-neopentylspiro[indoline-3,4'-piperidine]-1-yl)phenyl)-3-(4-(trifluoromethoxy)phenyl)urea, a potent, selective, and bioavailable P2Y1 antagonist.
AID1493931Antagonist activity at P2Y12 in human platelet rich plasma assessed as inhibition of ADP-induced CD62P expression pretreated for 30 mins followed by ADP addition measured after 5 mins by flow cytometric analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Thieno[2,3-b]pyridine derivatives are potent anti-platelet drugs, inhibiting platelet activation, aggregation and showing synergy with aspirin.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1656369Protein binding in human platelets using radiolabelled compound2020Journal of medicinal chemistry, 06-25, Volume: 63, Issue:12
Designing around Structural Alerts in Drug Discovery.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1339042Anti-thrombotic activity in Swiss albino mouse assessed as protection against collagen/epinephrine-induced pulmonary thromboembolism at 70 umol/kg, po administered 60 mins prior to thrombotic challenge measured 5 hrs post dose
AID1179966Antithrombotic activity in rabbit model of electrically-induced carotid artery thrombosis assessed as reduction in thrombus formation dosed 30 mins before electrical stimulation2014Journal of medicinal chemistry, Jul-24, Volume: 57, Issue:14
Discovery of 4-aryl-7-hydroxyindoline-based P2Y1 antagonists as novel antiplatelet agents.
AID700802Drug metabolism in human liver microsomes assessed as decrease in CYP3A4/5-mediated (S)-5-(1-(2-chlorophenyl)-2-methoxy-2-oxoethyl)-6,7-dihydrothieno[3,2-c]pyridin-5-ium formation at 20 uM in presence of ketoconazole2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1892492Antithrombotic activity in po dosed cynomolgus monkey electrolytic mediated carotid arterial thrombosis model assessed as reduction in weight of carotid artery thrombus2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Discovery of Two Novel Antiplatelet Clinical Candidates (BMS-986120 and BMS-986141) That Antagonize Protease-Activated Receptor 4.
AID1151460Antithrombotic activity in pentobarbital anesthetized rat assessed as reduction in FeCl2-induced thrombus weight at 10 mg/kg, po administered 1 hr prior to FeCl2 challenge2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
Identification of 1-{2-[4-chloro-1'-(2,2-dimethylpropyl)-7-hydroxy-1,2-dihydrospiro[indole-3,4'-piperidine]-1-yl]phenyl}-3-{5-chloro-[1,3]thiazolo[5,4-b]pyridin-2-yl}urea, a potent, efficacious and orally bioavailable P2Y(1) antagonist as an antiplatelet
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID700811Prodrug activation in human liver microsomes assessed as CYP2D6-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1143853Prolongation of bleeding time in mouse at 70 uM/kg, po administered as single dose by tail excision method relative to control2014European journal of medicinal chemistry, Jun-23, Volume: 81Synthesis and identification of chiral aminomethylpiperidine carboxamides as inhibitor of collagen induced platelet activation.
AID700813Prodrug activation in human liver microsomes assessed as CYP2B6-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1871460Lipophilicity, logP of compound
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1064263Antiplatelet activity against New Zealand white rabbit platelets assessed as inhibition of ADP-induced platelet aggregation preincubated at 30 uM for 2 mins before challenge measured after 2 mins by spectrophotometry2014Journal of natural products, Jan-24, Volume: 77, Issue:1
Lignans from the aerial parts of Saururus chinensis: isolation, structural characterization, and their effects on platelet aggregation.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID667508Drug metabolism in rat liver microsomes assessed as NADPH-dependent active metabolite glutathione adducts 4 formation at 20 uM after 30 mins by LC-MS/MS analysis2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1727519Antithrombotic activity in cynomolgus monkey model of electrolytic carotid artery thrombosis assessed as increase in bleeding time in provoked kidney at 0.3 mg/kg, PO administered once daily for 3 days measured at 2 hrs post last dose2021European journal of medicinal chemistry, Jan-01, Volume: 209Protease activated receptor 4 (PAR4) antagonists: Research progress on small molecules in the field of antiplatelet agents.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID705605Time dependent inhibition of CYP2C192012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID1339041Anti-thrombotic activity in Swiss albino mouse assessed as protection against collagen/epinephrine-induced pulmonary thromboembolism at 70 umol/kg, po administered 60 mins prior to thrombotic challenge measured up to 5 hrs post dose
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1277741Antithrombotic activity in Swiss albino mouse assessed as protection against collagen-epinephrine induced pulmonary thromboembolism at 70 umol/kg, po after 4 hrs2016European journal of medicinal chemistry, Mar-03, Volume: 110Synthesis and evaluation of dual antiplatelet activity of bispidine derivatives of N-substituted pyroglutamic acids.
AID589247Mechanism based inhibition of human cytochrome P450 2C192005Current drug metabolism, Oct, Volume: 6, Issue:5
Cytochrome p450 enzymes mechanism based inhibitors: common sub-structures and reactivity.
AID1217708Time dependent inhibition of CYP2D6 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID667515Half life in Sprague-Dawley rat assessed as clopidogrel thioacetate level at 24 umol/kg, po2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1727522Antithrombotic activity in cynomolgus monkey model of electrolytic carotid artery thrombosis assessed as increase in mesenteric bleeding time at 1 mg/kg, PO administered once daily for 3 days measured at 2 hrs post last dose2021European journal of medicinal chemistry, Jan-01, Volume: 209Protease activated receptor 4 (PAR4) antagonists: Research progress on small molecules in the field of antiplatelet agents.
AID766345Therapeutic index, ratio of ED50 for antithrombotic activity in Beagle dog modified Folts model to dose required to increase in bleeding time by 3.5 fold in Beagle dog modified Folts model2013Journal of medicinal chemistry, Sep-12, Volume: 56, Issue:17
Lead optimization of ethyl 6-aminonicotinate acyl sulfonamides as antagonists of the P2Y12 receptor. separation of the antithrombotic effect and bleeding for candidate drug AZD1283.
AID1217710Covalent binding in human liver microsomes measured per mg of protein using radiolabelled compound at 10 uM after 1 hr incubation by liquid scintillation counting2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1217727Intrinsic clearance for reactive metabolites formation per mg of protein in human liver microsomes based on [3H]GSH adduct formation rate at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1517825Antithrombotic activity in Wistar rat plasma assessed as wet weight of thrombus at 22 umol/kg, po measured after 1 hr (Rvb = 0.403 +/- 0.183 g)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1068713Ratio of MIC for community acquired methicillin-resistant Staphylococcus aureus USA300 in presence of targocil to MIC for community acquired methicillin-resistant Staphylococcus aureus USA300 by checkerboard broth microdilution assay2014Bioorganic & medicinal chemistry letters, Feb-01, Volume: 24, Issue:3
Designing analogs of ticlopidine, a wall teichoic acid inhibitor, to avoid formation of its oxidative metabolites.
AID1217709Time dependent inhibition of CYP3A4 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID456232Activity at human recombinant CES1 expressed in baculovirus-infected Spodoptera frugiperda Sf21 cells assessed as substrate hydrolysis by fluorescence assay2010Bioorganic & medicinal chemistry, Jan-01, Volume: 18, Issue:1
In silico prediction of human carboxylesterase-1 (hCES1) metabolism combining docking analyses and MD simulations.
AID1217707Time dependent inhibition of CYP2C19 in human liver microsomes at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1450602In vivo drug metabolism in human assessed as CYP2C8-mediated 2-oxoclopidogrel formation2017Journal of medicinal chemistry, 11-09, Volume: 60, Issue:21
Glucuronides as Potential Anionic Substrates of Human Cytochrome P450 2C8 (CYP2C8).
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID705583Time dependent inhibition of CYP2B6 in human liver microsomes2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID1143852Antithrombotic activity in mouse assessed as protection against collagen-epinephrine-induced pulmonary thromboembolism at 70 uM/kg, po administered 60 mins prior to thrombotic challenge measured for up to 5 hrs post-drug dose2014European journal of medicinal chemistry, Jun-23, Volume: 81Synthesis and identification of chiral aminomethylpiperidine carboxamides as inhibitor of collagen induced platelet activation.
AID1517826Antithrombotic activity in Wistar rat plasma assessed as dry weight of thrombus at 22 umol/kg, po measured after 1 hr (Rvb = 0.120 +/- 0.045 g)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1151458Toxicity in rat assessed as prolongation of cuticle bleeding time at 10 mg/kg, po relative to control2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
Identification of 1-{2-[4-chloro-1'-(2,2-dimethylpropyl)-7-hydroxy-1,2-dihydrospiro[indole-3,4'-piperidine]-1-yl]phenyl}-3-{5-chloro-[1,3]thiazolo[5,4-b]pyridin-2-yl}urea, a potent, efficacious and orally bioavailable P2Y(1) antagonist as an antiplatelet
AID700810Prodrug activation in human liver microsomes assessed as CYP3A4/5-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1217704Time dependent inhibition of CYP1A2 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID635594Antiplatelet activity against New Zealand white rabbit platelets assessed as inhibition of ADP-induced platelet aggregation at 9.6 ug/mL treated 2 mins before ADP challenge measured after 4 mins by turbidimetric analysis2011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Structure-activity relationships of chalcone analogs as potential inhibitors of ADP- and collagen-induced platelet aggregation.
AID1068714Ratio of MIC for community acquired methicillin-resistant Staphylococcus aureus USA300 in presence of cefuroxime to MIC for community acquired methicillin-resistant Staphylococcus aureus USA300 by checkerboard broth microdilution assay2014Bioorganic & medicinal chemistry letters, Feb-01, Volume: 24, Issue:3
Designing analogs of ticlopidine, a wall teichoic acid inhibitor, to avoid formation of its oxidative metabolites.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID635595Antiplatelet activity against New Zealand white rabbit platelets assessed as inhibition of collagen-induced platelet aggregation at 9.6 ug/mL treated 2 mins before collagen challenge measured after 4 mins by turbidimetric analysis2011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Structure-activity relationships of chalcone analogs as potential inhibitors of ADP- and collagen-induced platelet aggregation.
AID705590Inhibition of CYP2B6 in human assessed as decrease of hydroxybupropion metabolite systemic exposure2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID700800Prodrug activation in human liver microsomes assessed as increase in Cytochrome P450-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 20 uM in presence of ketoconazole2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1892498Antithrombotic activity in cynomolgus monkey assessed as prolongation of kidney bleeding time at 3 mg/kg2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Discovery of Two Novel Antiplatelet Clinical Candidates (BMS-986120 and BMS-986141) That Antagonize Protease-Activated Receptor 4.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID667510Drug metabolism in rat liver microsomes assessed as NADPH-dependent active metabolite glutathione adducts 3 formation at 20 uM after 30 mins by LC-MS/MS analysis2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID1151457Toxicity in rat assessed as prolongation of mesentric bleeding time at 10 mg/kg, po relative to control2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
Identification of 1-{2-[4-chloro-1'-(2,2-dimethylpropyl)-7-hydroxy-1,2-dihydrospiro[indole-3,4'-piperidine]-1-yl]phenyl}-3-{5-chloro-[1,3]thiazolo[5,4-b]pyridin-2-yl}urea, a potent, efficacious and orally bioavailable P2Y(1) antagonist as an antiplatelet
AID1493932Antagonist activity at P2Y12 in human platelet rich plasma assessed as inhibition of ADP-induced PAC1 expression pretreated for 30 mins followed by ADP addition measured after 5 mins by flow cytometric analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Thieno[2,3-b]pyridine derivatives are potent anti-platelet drugs, inhibiting platelet activation, aggregation and showing synergy with aspirin.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1450601In vivo drug metabolism in human assessed as CYP2C8-mediated 2-(1-((S)-1-(2-chlorophenyl)-2-methoxy-2-oxoethyl)-4-mercaptopiperidin-3-ylidene)acetic acid formation2017Journal of medicinal chemistry, 11-09, Volume: 60, Issue:21
Glucuronides as Potential Anionic Substrates of Human Cytochrome P450 2C8 (CYP2C8).
AID1277719Antithrombotic activity in Swiss albino mouse assessed as protection against collagen-epinephrine induced pulmonary thromboembolism at 70 umol/kg, po after 1 hr2016European journal of medicinal chemistry, Mar-03, Volume: 110Synthesis and evaluation of dual antiplatelet activity of bispidine derivatives of N-substituted pyroglutamic acids.
AID1441772Drug metabolism assessed as CES1 (unknown origin)-mediated SR26334 formation2017European journal of medicinal chemistry, Mar-31, Volume: 129Strategies in the designing of prodrugs, taking into account the antiviral and anticancer compounds.
AID1727523Antithrombotic activity in cynomolgus monkey model of electrolytic carotid artery thrombosis assessed as increase in provoked kidney bleeding time at 1 mg/kg, PO administered once daily for 3 days measured at 2 hrs post last dose2021European journal of medicinal chemistry, Jan-01, Volume: 209Protease activated receptor 4 (PAR4) antagonists: Research progress on small molecules in the field of antiplatelet agents.
AID589245Mechanism based inhibition of human cytochrome P450 2B6 using recombinant CYP2B62005Current drug metabolism, Oct, Volume: 6, Issue:5
Cytochrome p450 enzymes mechanism based inhibitors: common sub-structures and reactivity.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1892497Antithrombotic activity in cynomolgus monkey assessed as prolongation of kidney bleeding time at 1 mg/kg2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Discovery of Two Novel Antiplatelet Clinical Candidates (BMS-986120 and BMS-986141) That Antagonize Protease-Activated Receptor 4.
AID1727535Antithrombotic activity in cynomolgus monkey model of electrolytic carotid artery thrombosis assessed as increase in bleeding time in provoked kidney at 0.3 mg/kg, PO administered once daily for 3 days measured at 2 hrs post last dose relative to control2021European journal of medicinal chemistry, Jan-01, Volume: 209Protease activated receptor 4 (PAR4) antagonists: Research progress on small molecules in the field of antiplatelet agents.
AID1212911Inhibition of CYP2B6 variant in human liver microsomes harboring CYP2B6*1/*1 genotype assessed as 8-hydroxyefavirenz formation using efavirenz as substrate after 15 mins by LC/MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 40, Issue:4
Effects of the CYP2B6*6 allele on catalytic properties and inhibition of CYP2B6 in vitro: implication for the mechanism of reduced efavirenz metabolism and other CYP2B6 substrates in vivo.
AID1493928Antagonist activity at P2Y12 in human whole blood assessed as inhibition of ADP-induced platelet-aggregation at 10 uM pretreated for 30 mins followed by ADP addition measured after 5 mins by FITC staining-based flow cytometric analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Thieno[2,3-b]pyridine derivatives are potent anti-platelet drugs, inhibiting platelet activation, aggregation and showing synergy with aspirin.
AID1331279Antiplatelet aggregatory activity against New Zealand white rabbit platelets at 150 uM preincubated for 2 to 3 mins followed by ADP-addition measured after 4 mins by turbidometric method relative to vehicle control2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Bioactive chemical constituents from the root bark of Morus australis.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1727536Antithrombotic activity in cynomolgus monkey model of electrolytic carotid artery thrombosis assessed as increase in mesentric bleeding time at 0.3 mg/kg, PO administered once daily for 3 days measured at 2 hrs post last dose relative to control2021European journal of medicinal chemistry, Jan-01, Volume: 209Protease activated receptor 4 (PAR4) antagonists: Research progress on small molecules in the field of antiplatelet agents.
AID640615Clearance in human liver microsomes at 1 uM measured after 60 mins by HPLC analysis2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Capture hydrolysis signals in the microsomal stability assay: molecular mechanisms of the alkyl ester drug and prodrug metabolism.
AID700801Prodrug activation in human liver microsomes assessed as increase in Cytochrome P450-mediated 2-oxo-clopidogrel formation at 20 uM in presence of ketoconazole2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1062235Induction of mesenteric bleeding time in Sprague-Dawley rat at 20 mg/kg, po measured over 10 mins relative to vehicle-treated control2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Conformationally constrained ortho-anilino diaryl ureas: discovery of 1-(2-(1'-neopentylspiro[indoline-3,4'-piperidine]-1-yl)phenyl)-3-(4-(trifluoromethoxy)phenyl)urea, a potent, selective, and bioavailable P2Y1 antagonist.
AID667506Tmax in Sprague-Dawley rat assessed as clopidogrel thioacetate level at 24 umol/kg, po2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID589244Mechanism based inhibition of human cytochrome P450 2B6 using human liver microsomes2005Current drug metabolism, Oct, Volume: 6, Issue:5
Cytochrome p450 enzymes mechanism based inhibitors: common sub-structures and reactivity.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1450603In vivo drug metabolism in human assessed as carboxylesterase-mediated clopidogrel carboxylic acid formation in blood2017Journal of medicinal chemistry, 11-09, Volume: 60, Issue:21
Glucuronides as Potential Anionic Substrates of Human Cytochrome P450 2C8 (CYP2C8).
AID700807Drug metabolism in human liver microsomes assessed as CYP2C9-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID705606Inhibition of CYP2B6 in human assessed as increase of bupropion systemic exposure2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
Mechanism-based inactivation (MBI) of cytochrome P450 enzymes: structure-activity relationships and discovery strategies to mitigate drug-drug interaction risks.
AID700803Drug metabolism in human liver microsomes assessed as CYP3A4/5-mediated (S)-5-(1-(2-chlorophenyl)-2-methoxy-2-oxoethyl)-6,7-dihydrothieno[3,2-c]pyridin-5-ium formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1217706Time dependent inhibition of CYP2C9 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID700815Prodrug activation in human liver microsomes assessed as CYP1A2-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID700812Prodrug activation in human liver microsomes assessed as CYP2C19-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID700806Drug metabolism in human liver microsomes assessed as CYP2C19-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID667516AUC (0 to infinity) in Sprague-Dawley rat assessed as clopidogrel thioacetate level at 24 umol/kg, po2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID667507Cmax in Sprague-Dawley rat assessed as clopidogrel thioacetate level at 24 umol/kg, po2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID700808Drug metabolism in human liver microsomes assessed as CYP2B6-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1217729Intrinsic clearance for reactive metabolites formation assessed as summation of [3H]GSH adduct formation rate-based reactive metabolites formation and cytochrome P450 (unknown origin) inactivation rate-based reactive metabolites formation2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID766347In vivo antithrombotic activity in Beagle dog modified Folts model assessed as increase in blood flow administered as bolus infusion measured after 30 mins2013Journal of medicinal chemistry, Sep-12, Volume: 56, Issue:17
Lead optimization of ethyl 6-aminonicotinate acyl sulfonamides as antagonists of the P2Y12 receptor. separation of the antithrombotic effect and bleeding for candidate drug AZD1283.
AID1179967Induction of bleeding time in rabbit model of electrically-induced carotid artery thrombosis at 80% antithrombotic dose administered 30 mins before electrical stimulation (Rvb = 1 +/- 0.05 No_unit)2014Journal of medicinal chemistry, Jul-24, Volume: 57, Issue:14
Discovery of 4-aryl-7-hydroxyindoline-based P2Y1 antagonists as novel antiplatelet agents.
AID1517827Antithrombotic activity in Wistar rat plasma assessed as thrombus formation time at 22 umol/kg, po measured after 1 hr (Rvb = 9.4 +/- 8.9 mins)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID667511Drug metabolism in rat liver microsomes assessed as NADPH-dependent active metabolite glutathione adducts 1 formation at 20 uM after 30 mins by LC-MS/MS analysis2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID1217733Time dependent inhibition of CYP2B6 (unknown origin) at 0.3 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID667512Drug metabolism in rat liver microsomes assessed as NADPH-dependent active metabolite glutathione adducts formation at 20 uM after 30 mins by LC-MS/MS analysis in presence of NADPH and GSH2012Journal of medicinal chemistry, Apr-12, Volume: 55, Issue:7
Overcoming clopidogrel resistance: discovery of vicagrel as a highly potent and orally bioavailable antiplatelet agent.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1517824Anticoagulant activity in Wistar rat plasma assessed as ADP-induced platelet aggregation at 22 umol/kg, po measured after 1 hr by Born's method (Rvb = 66.8 +/- 15.8 %)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1143851Antithrombotic activity in mouse assessed as protection against collagen-epinephrine-induced pulmonary thromboembolism at 70 uM/kg, po administered 60 mins prior to thrombotic challenge2014European journal of medicinal chemistry, Jun-23, Volume: 81Synthesis and identification of chiral aminomethylpiperidine carboxamides as inhibitor of collagen induced platelet activation.
AID1404801Antiplatelet activity in Wistar rat platelet rich plasma assessed as inhibition of ADP-induced platelet aggregation pretreated for 1 min followed by ADP addition by turbidimetric method2018European journal of medicinal chemistry, Jun-25, Volume: 154Discovery of phenylsulfonylfuroxan derivatives as gamma globin inducers by histone acetylation.
AID700814Prodrug activation in human liver microsomes assessed as CYP2C9-mediated 2-oxo-clopidogrel formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1850679Inhibition of P2Y12 (unknown origin)2022Bioorganic & medicinal chemistry letters, 09-01, Volume: 71Strategies for targeting the P2Y
AID1493926Antagonist activity at P2Y12 in human platelet rich plasma assessed as inhibition of ADP-induced platelet aggregation at 10 uM pretreated for 30 mins followed by ADP addition measured after 5 mins by light transmission aggregometric analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Thieno[2,3-b]pyridine derivatives are potent anti-platelet drugs, inhibiting platelet activation, aggregation and showing synergy with aspirin.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID700804Drug metabolism in human liver microsomes assessed as CYP3A4/5-mediated (2S)-methyl 2-(2-chlorophenyl)-2-(3-hydroxy-2,3,6,7-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate formation at 50 uM2012ACS medicinal chemistry letters, Oct-11, Volume: 3, Issue:10
Identification of the Significant Involvement and Mechanistic Role of CYP3A4/5 in Clopidogrel Bioactivation.
AID1277739Antithrombotic activity in ferric chloride-induced Swiss albino mouse arterial thrombosis model assessed as prolonged time to occlusion at 70 umol/kg, po (Rvb = 9.5 +/- 0.4 mins)2016European journal of medicinal chemistry, Mar-03, Volume: 110Synthesis and evaluation of dual antiplatelet activity of bispidine derivatives of N-substituted pyroglutamic acids.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (9,793)

TimeframeStudies, This Drug (%)All Drugs %
pre-19905 (0.05)18.7374
1990's170 (1.74)18.2507
2000's2971 (30.34)29.6817
2010's5379 (54.93)24.3611
2020's1268 (12.95)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,918 (18.77%)5.53%
Reviews1,795 (17.56%)6.00%
Case Studies849 (8.31%)4.05%
Observational309 (3.02%)0.25%
Other5,350 (52.34%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (707)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Re [NCT00385944]Phase 256 participants (Actual)Interventional2007-03-31Completed
A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention [NCT01603082]Phase 4343 participants (Actual)Interventional2012-07-31Completed
A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention [NCT00097591]Phase 313,619 participants (Actual)Interventional2004-11-30Completed
A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus Clopidogrel in Subjects With Acute Coronary Syndrome Who Are Receiving Clopidogrel [NCT00356135]Phase 2139 participants (Actual)Interventional2006-07-31Completed
Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19 [NCT03942458]Phase 150 participants (Actual)Interventional2019-04-03Completed
Assessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications in Patients With High Bleeding Risk Beyond One Month Aft [NCT05577988]Phase 32,468 participants (Anticipated)Interventional2023-04-30Not yet recruiting
Randomized Double-Blind Placebo-Controlled Study of Pyrazinoylguanidine Hydrochloride (Amiloride) in Subjects With Coronary Artery Disease [NCT01228214]Phase 2/Phase 3100 participants (Actual)Interventional2011-03-31Active, not recruiting
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given With Ome [NCT01129388]Phase 172 participants (Actual)Interventional2009-03-31Completed
The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma [NCT01264640]25 participants (Anticipated)Interventional2010-07-31Active, not recruiting
Randomized, Prospective , Open Label, Phase 4 Trial of Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention With Drug-eluting Stent [NCT01261832]Phase 4951 participants (Anticipated)Interventional2011-07-31Active, not recruiting
A Trial of Evaluating Additional Benefit of Cilostazol to Dual Antiplatelet Therapy in Patients With Long or Multi-vessel Coronary Artery Disease Underwent Biolimus-Eluting Stent Implantation [NCT01192724]Phase 4630 participants (Actual)Interventional2010-03-31Completed
Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit) [NCT01371058]Phase 4350 participants (Actual)Interventional2011-03-31Completed
Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty. [NCT01109784]Phase 370 participants (Anticipated)Interventional2010-04-30Completed
Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial [NCT01113372]Phase 43,119 participants (Actual)Interventional2010-04-30Completed
A Randomized, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 m [NCT01123824]Phase 140 participants (Actual)Interventional2009-04-30Completed
Efficacy and Safety of Sequential Monotherapy of Ticagrelor and Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention With Acute Coronary Syndrome [NCT04937699]Phase 42,690 participants (Anticipated)Interventional2023-03-28Recruiting
Bivalirudin Plus Prasugrel vs Abciximab Plus Clopidogrel. Optimizing Ischemic Protection and Bleeding Risk in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT01158846]Phase 4800 participants (Anticipated)Interventional2010-08-31Not yet recruiting
Comparison of the Efficacy and Safety of New Platform Everolimus-eluting Coronary Stent System (Promus Element) With Zotarolimus-eluting Coronary Stent System (Endeavor Resolute) and Triple Anti-platelet Therapy With Double-dose Clopidogrel Anti-platelet [NCT01267734]Phase 43,750 participants (Anticipated)Interventional2010-06-30Recruiting
Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events [NCT01186146]Phase 45,000 participants (Actual)Interventional2010-08-31Completed
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment [NCT01304472]Phase 325 participants (Anticipated)Interventional2011-02-28Completed
Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS [NCT03775746]Phase 4150 participants (Anticipated)Interventional2019-01-08Recruiting
Impact of Type 2 Diabetes on Outcomes Associated With Antiplatelet Drugs: A Retrospective Analysis [NCT05053828]173,464 participants (Actual)Observational2021-09-20Completed
Low-dose Prasgurel Versus Clopidogrel on the Dual Antiplatelet Regimen for Intracranial Stenting or Flow Diverter Treatment for Unruptured Cerebral Aneurysms: a Multi-center Randomized Controlled Trial [NCT05359224]Phase 4406 participants (Anticipated)Interventional2022-06-13Recruiting
Use of Recombinant FVIIa to Mitigate Clopidogrel Anti-platelet Therapy-Mediated Bleeding in a Single Centre, Randomized, Placebo-controlled, Double-blind Clinical Trial [NCT01561950]Phase 191 participants (Actual)Interventional2008-05-31Terminated
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inh [NCT00391872]Phase 318,624 participants (Actual)Interventional2006-10-31Completed
[NCT01094457]Phase 4840 participants (Actual)Interventional2009-03-31Completed
"Prevalence of clOpidogrel resIstaNce in a Selected Population of Patients Undergoing Elective Percutaneous Coronary Intervention at a Tertiary Cardiovascular Center in Trinidad: The POINT Pilot Study" [NCT03667066]40 participants (Actual)Observational2017-09-01Completed
A Randomized, Placebo-controlled, Two-sequence, Two-period Crossover Study, to Investigate a Potential Food Effect on the Pharmacodynamic and Bioavailability of Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) in Healthy Male [NCT01129271]Phase 172 participants (Actual)Interventional2009-04-30Completed
A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial [NCT03947229]Phase 43,200 participants (Actual)Interventional2019-08-14Active, not recruiting
PREDICT: Scripps Pilot Study on the Effect of High Clopidogrel Maintenance Dosing and Its Relationship to Cytochrome P450 2C19 Polymorphism Status [NCT01118793]41 participants (Actual)Observational2008-12-31Completed
Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin [NCT02034292]Phase 116 participants (Actual)Interventional2014-02-28Terminated(stopped due to Sponsor Decision)
Prasugrel in Comparison to High Clopidogrel Dose for Inhibition of Platelet Reactivity as Assessed With a Point-of-Care Platelet Function Assay in Patients Undergoing Chronic Hemodialysis Presenting Resistance to the Usual Clopidogrel Dose [NCT01155765]Phase 370 participants (Anticipated)Interventional2010-05-31Completed
Randomized Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography ( [NCT02833948]Phase 3231 participants (Actual)Interventional2016-05-31Completed
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed [NCT01338909]Phase 335 participants (Anticipated)Interventional2011-04-30Completed
Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM): a Randomized Pharmacodynamic Study [NCT02457130]Phase 430 participants (Anticipated)Interventional2015-04-30Recruiting
A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects [NCT02439190]Phase 142 participants (Actual)Interventional2015-09-30Completed
The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease(AURORA): A Prospective Cohort Study [NCT03691688]2,000 participants (Anticipated)Observational [Patient Registry]2018-12-01Recruiting
Impact of Genetic Variation in CES1 on Antiplatelet Therapy [NCT03161678]Phase 489 participants (Actual)Interventional2017-08-22Completed
Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo [NCT03664388]8,000 participants (Anticipated)Observational2016-02-01Recruiting
Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome [NCT02379676]Phase 438 participants (Anticipated)Interventional2015-01-31Recruiting
Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study) [NCT00799396]Phase 4682 participants (Actual)Interventional2006-07-31Completed
A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Clopidogrel Plus Acetylsalicylic Acid (ASA) Versus ASA Alone in Subjects With Acute ST Elevation Myocardial Infarction (STEMI) Treated With Fibrinolytic Therapy [NCT00714961]Phase 33,491 participants (Actual)Interventional2003-02-28Completed
A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study) [NCT03649711]Phase 376 participants (Actual)Interventional2018-11-01Completed
Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial [NCT05320926]3,744 participants (Anticipated)Interventional2022-03-11Recruiting
Influence of Vorapaxar on Thrombin Generation and Coagulability [NCT03207451]Phase 481 participants (Actual)Interventional2016-01-01Completed
Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination (PFA-100, LTA and VerifyNOW) in Acute Myocardial Infarction [NCT01381185]Phase 4154 participants (Actual)Interventional2011-05-31Completed
A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation [NCT03204695]27 participants (Actual)Interventional2017-05-29Terminated(stopped due to Study closed due to device design modifications.)
[NCT02037412]Phase 4148 participants (Actual)Interventional2014-01-31Terminated(stopped due to The patient registration was not successful.)
Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in Patients With Non ST Elevation Acute Coronary Syndromes [NCT02071966]Phase 455 participants (Anticipated)Interventional2012-11-30Terminated(stopped due to slow enrollment)
The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man [NCT02120092]Phase 289 participants (Actual)Interventional2010-10-31Completed
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug [NCT05418556]Phase 43,944 participants (Anticipated)Interventional2022-10-21Recruiting
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation [NCT02247128]Phase 41,016 participants (Actual)Interventional2014-01-31Completed
Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients [NCT02048228]Phase 2/Phase 3200 participants (Anticipated)Interventional2014-10-31Not yet recruiting
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®) [NCT02060786]Phase 490 participants (Actual)Interventional2010-10-31Completed
Optimal Dose of Ticagrelor(90 mg qd)and Double Standard-dose Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With Coronary Heart Disease [NCT03614832]Phase 4100 participants (Anticipated)Interventional2018-05-01Recruiting
The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction [NCT05210595]Phase 4120 participants (Anticipated)Interventional2022-01-01Recruiting
[NCT02032290]Phase 488 participants (Anticipated)Interventional2014-02-28Not yet recruiting
Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®) [NCT01349777]Phase 41,056 participants (Actual)Interventional2010-03-15Completed
Evaluation of the Benefit/Risk Ratio of Restarting or Avoiding Antiplatelet Drugs in Patients Who Had a Spontaneous Intracerebral Hemorrhage While Treated With Antithrombotic Drugs : RESTART-FR Study [NCT02966119]Phase 323 participants (Actual)Interventional2016-12-07Terminated(stopped due to Recruitment difficulties)
Clopidogrel Versus Aspirin Monotherapy Beyond Twelve Months After Percutaneous Coronary Intervention in Patients at High Risk for Recurrent Ischemic Events [NCT04418479]Phase 45,000 participants (Anticipated)Interventional2020-08-10Recruiting
Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT) [NCT04014803]Phase 43,500 participants (Anticipated)Interventional2020-01-13Recruiting
Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention. [NCT01930773]Phase 3150 participants (Anticipated)Interventional2013-03-31Recruiting
An Open-label, Randomized, 4-treatment, 3-period, Crossover Interaction Study, Evaluating the Effect of Esomeprazole 40 mg, Omeprazole 80 mg or Lansoprazole 60 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel in Healthy Volunteers [NCT01147588]Phase 1149 participants (Actual)Interventional2010-05-31Completed
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study. [NCT01175200]82 participants (Actual)Interventional2010-09-30Completed
Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial [NCT05671276]Phase 4150 participants (Anticipated)Interventional2022-02-01Recruiting
A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers [NCT03814642]Phase 125 participants (Actual)Interventional2019-01-21Completed
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis [NCT00153062]Phase 420,332 participants (Actual)Interventional2003-08-31Completed
Effect of Clopidogrel on Allergen Challenge in Asthma [NCT01955512]Phase 224 participants (Anticipated)Interventional2013-05-31Completed
A Single-center, Open-label, Two-treatment, One-sequence, Cross-over Study to Investigate the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite, ACT-333679, in Healthy Male Subjects [NCT03496506]Phase 122 participants (Actual)Interventional2018-03-05Completed
A Randomized Controlled Trial of Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy and Oral Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: OVER-TIME [NCT05233124]Phase 260 participants (Anticipated)Interventional2021-09-01Recruiting
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II [NCT04078737]Phase 36,412 participants (Actual)Interventional2019-09-23Completed
An Open-label Study Evaluating the Acute Efficacy of Treatment With Ticagrelor Versus Clopidogrel on Myocardial Tissue-level Perfusion Assessed by TMPFC and MRI in Patients With High-risk NSTE-ACS Undergoing Early PCI(EARLY-MYO II) [NCT02201667]Phase 4444 participants (Anticipated)Interventional2014-08-31Not yet recruiting
Peripheral Endothelial Function Assessment of Patients on Ticagrelor vs. Clopidogrel Who Have Undergone Percutaneous Coronary Intervention - a Randomised, Crossover Study. [NCT02469740]Phase 461 participants (Actual)Interventional2015-07-31Completed
Randomized Comparison of Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus a Common Antiplatelet Treatment for Intracranial Aneurysm Stent-assisted Coiling [NCT02224131]Phase 41,856 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis [NCT03289520]Phase 3877 participants (Actual)Interventional2003-01-07Completed
The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention [NCT02925923]Phase 2100 participants (Actual)Interventional2016-11-01Completed
A comParison on Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Study Among SeVerE Chronic Kidney Disease/ End-Stage-Renal-Disease Patients With Recent Acute Coronary Syndrome. [NCT02459288]Phase 480 participants (Anticipated)Interventional2014-01-31Recruiting
"High on Treatment Platelet Reactivity in the Intensive Care Unit" [NCT02285751]Phase 2200 participants (Anticipated)Interventional2012-11-30Recruiting
A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent [NCT02446730]Phase 41,400 participants (Anticipated)Interventional2014-09-30Recruiting
Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Temanogrel Co-administered With Aspirin and Clopidogrel [NCT02419820]Phase 1104 participants (Actual)Interventional2015-03-31Terminated(stopped due to Sponsor Decision)
A Multicenter Randomized Trial Evaluating the Efficacy of Sarpogrelate on Ischemic Heart Disease After Drug-eluting Stent Implantation in Patients With Diabetes Mellitus or Renal Impairment [NCT02294643]Phase 3220 participants (Actual)Interventional2009-04-30Completed
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction [NCT05744804]150 participants (Anticipated)Interventional2023-03-01Not yet recruiting
A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Antithrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants [NCT03698513]Phase 1113 participants (Actual)Interventional2018-10-04Completed
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial [NCT03463317]Phase 41,512 participants (Anticipated)Interventional2018-02-28Recruiting
Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention [NCT02334254]Phase 4420 participants (Anticipated)Interventional2013-08-31Recruiting
Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement. [NCT02866175]Phase 31,506 participants (Actual)Interventional2017-02-24Completed
[NCT02817789]Phase 350 participants (Actual)Interventional2016-05-09Completed
Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention [NCT02327624]Phase 4180 participants (Actual)Interventional2015-06-30Completed
Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity [NCT05080478]50 participants (Anticipated)Observational2018-11-01Recruiting
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial [NCT05611242]Phase 3404 participants (Anticipated)Interventional2023-11-01Recruiting
Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study. [NCT02198300]Phase 4202 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-blind, Active-Controlled Trial Comparing the Safety and Efficacy of Aspirin Versus Clopidogrel in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency [NCT04088513]Phase 4440 participants (Anticipated)Interventional2020-01-22Recruiting
Relative Bioavailability of Telmisartan and SR26334, the Main Metabolite of Clopidogrel, After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After p.o. Administration of 80 mg Telmisartan and 75 mg Clopidogrel Alone. A Four- [NCT02262650]Phase 124 participants (Actual)Interventional2004-04-30Completed
Comparison of Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Undergoing PPCI Evaluated by SPECT [NCT02233790]Phase 4600 participants (Anticipated)Interventional2014-12-31Not yet recruiting
The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry [NCT02264912]2,016 participants (Actual)Observational [Patient Registry]2008-07-31Completed
Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Controlled, Feasibility Study [NCT04738097]Phase 390 participants (Actual)Interventional2021-08-08Completed
Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI) [NCT04695106]Phase 42,230 participants (Anticipated)Interventional2021-10-25Recruiting
Effect of the Genetic Variant 2C19*2 on Clopidogrel Biological Response in Patients With Premature Coronary Artery Disease [NCT00822666]Phase 3109 participants (Actual)Interventional2008-10-31Completed
Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve [NCT02108808]Phase 476 participants (Actual)Interventional2014-04-30Completed
Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt [NCT02118870]Phase 41,500 participants (Actual)Interventional2014-06-10Completed
Comparison of The Influence of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function For Patients With ST-Segment Elevation Myocardial Infarction Receiving Emergency Percutaneous Coronary Intervention [NCT02123004]Phase 4350 participants (Anticipated)Interventional2014-04-30Not yet recruiting
A Randomized, Open-Label, Parallel, Multi-Center, Phase IV Study to Assess the Effect of Ticagrelor vs Clopidogrel on Adenosine-Induced Myocardial Blood Flow in Peripheral Artery Disease (PAD)Patients [NCT02121288]Phase 40 participants (Actual)Interventional2014-12-31Withdrawn
Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients : A Consortium From Multi-centered Registries [NCT04734028]13,160 participants (Actual)Observational2003-07-09Completed
PANDDA Study: Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients [NCT02302508]Phase 40 participants (Actual)Interventional2019-09-01Withdrawn(stopped due to Funding)
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After Undergoing Percutaneous Coronary Intervention:The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) - 2 Study [NCT04483583]Phase 480 participants (Anticipated)Interventional2020-12-08Recruiting
Combined Effect of Diabetes and cyp2c19 Polymorphism on Clopidogrel VS Ticagrelor Antiplatelet Activity in Patients of Anterior ST Elevation Myocardial Infarction Undergoing Primary PCI [NCT03613857]1,022 participants (Actual)Observational [Patient Registry]2017-04-15Completed
A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure [NCT03088072]Phase 475 participants (Anticipated)Interventional2017-03-23Recruiting
Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy [NCT03072082]Phase 4440 participants (Anticipated)Interventional2017-06-30Not yet recruiting
Platelet Reactivity in Patients With End Stage Renal Disease Receiving Clopidogrel Compared With Ticagrelor [NCT02163954]Phase 316 participants (Actual)Interventional2013-01-31Completed
Randomised, Open Label, 3-way Cross Over Phase I Study to Investigate the Impact of Concomitant Use of Multiple Doses of Clopidogrel (75 mg qd After a Loading Dose of 300 mg) With Multiple Doses of Dabigatran Etexilate (150 mg Bid) on the Pharmacokinetic [NCT02171598]Phase 144 participants (Actual)Interventional2009-02-28Completed
Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease [NCT02209350]Phase 1202 participants (Actual)Interventional2014-08-02Active, not recruiting
A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours [NCT02048085]Phase 40 participants (Actual)Interventional2014-01-02Withdrawn(stopped due to unable to get study up and enrolling)
CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study) [NCT03783351]4,009 participants (Anticipated)Interventional2019-05-27Recruiting
Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography [NCT02070159]Phase 343 participants (Actual)Interventional2011-12-31Completed
The Efficacy and Safety of Clopidogrel Combined With Rivaroxaban and Aspirin in Patients With Coronary Heart Disease and Gastrointestinal Diseases Undergoing PCI:a Randomized Controlled Study [NCT04805710]Phase 41,020 participants (Anticipated)Interventional2021-03-17Not yet recruiting
A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial [NCT02094963]Phase 4800 participants (Actual)Interventional2014-07-05Completed
Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study - ARMYDA-AMULET [NCT05554822]Phase 3574 participants (Anticipated)Interventional2021-06-14Recruiting
CSP #571 - Drug-eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) [NCT01121224]Phase 4597 participants (Actual)Interventional2012-01-11Completed
Clopidogrel Response and CYP2C19 Genotype in Ischemic Stroke Patients [NCT03385538]Phase 4103 participants (Actual)Interventional2015-11-01Completed
[NCT02309970]90 participants (Anticipated)Observational2014-12-31Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays [NCT01108588]Phase 115 participants (Anticipated)Interventional2010-06-30Completed
Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel [NCT01328470]Phase 485 participants (Actual)Interventional2009-09-30Completed
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (600 mg Loading Dose Followed by 150 mg/Day) Alone or Given Concomi [NCT01129414]Phase 172 participants (Actual)Interventional2009-06-30Completed
Single-Dose Food In Vivo Bioequivalence Study of Clopidogrel Bisulfate Tablets (75 mg; Mylan) to Plavix® Tablets (75 mg; Bristol-Myers Squibb/Sanofi) in Healthy Volunteers [NCT00650169]Phase 147 participants (Actual)Interventional2004-12-31Completed
Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation [NCT02224066]Phase 465 participants (Actual)Interventional2016-01-31Completed
High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial. [NCT02224534]Phase 4326 participants (Anticipated)Interventional2014-10-31Recruiting
Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects [NCT04945616]Phase 152 participants (Actual)Interventional2021-07-13Completed
Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure [NCT01112137]Phase 446 participants (Actual)Interventional2005-01-31Completed
A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12 Inhibitor, vs Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent PCI [NCT00751231]Phase 2652 participants (Actual)Interventional2008-12-31Completed
An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers [NCT01210339]Phase 158 participants (Actual)Interventional2010-11-30Completed
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study [NCT04001894]Phase 450 participants (Actual)Interventional2019-07-02Completed
An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects [NCT01129063]Phase 132 participants (Actual)Interventional2009-03-31Completed
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomit [NCT01129375]Phase 172 participants (Actual)Interventional2009-02-28Completed
Use of the Smart Nitinol Stent System for the Treatment of Severe Atherosclerotic Carotid Stenosis: Study Protocol for a Retrospective, Non-randomized, Long-term Parallel Controlled Trial [NCT02800174]103 participants (Actual)Interventional2006-06-30Completed
Ticagrelor Versus Clopidogrel in Ischemic Stroke. a Randomized Double-blinded Controlled Trial [NCT05553613]Phase 3900 participants (Actual)Interventional2022-10-01Completed
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches [NCT04100135]150 participants (Anticipated)Interventional2021-02-05Recruiting
Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With S [NCT02298088]Phase 33,799 participants (Actual)Interventional2015-08-31Completed
Comparative Randomized Single-blind Trial of Amiloride in Coronary Heart Disease [NCT01231165]Phase 2/Phase 370 participants (Actual)Interventional2009-02-28Completed
Test of Efficacy and Safety of the Dual Antiplatelet Therapy Compared to the Combination of Oral Anticoagulant Therapy + Dual Antiplatelet Therapy in Patients With Atrial Fibrillation With Low-moderate Risk Submitted to Coronary Stent Implantation [NCT01141153]Phase 4304 participants (Anticipated)Interventional2010-06-30Active, not recruiting
Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly [NCT02317198]Phase 41,011 participants (Actual)Interventional2013-06-30Active, not recruiting
Does the Magnitude of Platelet Inhibition Inversely Correlate With the Number of TCD-detected Microemboli in Asymptomatic Patients Undergoing Carotid Artery Stenting Prior to Cardiac Surgery Who Are Being Pre-treated With 300 mg or 600 mg Loading Dose of [NCT01146301]Phase 40 participants Interventional2008-03-31Completed
Stroke Imaging Package Study of Intracranial Atherosclerosis [NCT03719820]550 participants (Anticipated)Observational [Patient Registry]2018-11-14Recruiting
Clinical Trial Program of a Medical Instrument Product [NCT01157455]Phase 41,900 participants (Anticipated)Interventional2010-05-31Recruiting
Dual Antiplatelet Therapy in Patients With Aspirin Resistance Following Coronary Artery Bypass Grafting [NCT01159639]Phase 4200 participants (Actual)Interventional2010-06-30Completed
Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping [NCT01174693]Phase 4795 participants (Actual)Interventional2010-03-31Completed
PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents [NCT01103843]1,000 participants (Anticipated)Interventional2010-04-30Recruiting
Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent [NCT01102439]Phase 482 participants (Actual)Interventional2010-04-30Completed
[NCT01584791]Phase 4148 participants (Actual)Interventional2010-10-31Completed
Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent [NCT00910299]Phase 2423 participants (Actual)Interventional2009-07-31Terminated(stopped due to Due to the low rate of primary endpoint events experienced in the study to date)
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomit [NCT01129427]Phase 166 participants (Actual)Interventional2009-08-31Completed
Benefits and Risks Evaluation of Different Anti-platelet Strategies Beyond a 12-month Period Inpatients Receiving Sirolimus Drug-eluting Stent Implantation [NCT01233167]5,232 participants (Anticipated)Interventional2011-08-31Not yet recruiting
Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention [NCT01135667]Phase 4106 participants (Actual)Interventional2010-09-30Completed
Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets [NCT03787927]Phase 1/Phase 260 participants (Anticipated)Interventional2018-12-03Active, not recruiting
A Prospective, Randomized, Active-controlled, Double-blind, Parallel, Multi-center, Phase IV, Exploratory Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke [NCT05445895]Phase 4500 participants (Anticipated)Interventional2022-12-16Recruiting
Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris [NCT03759067]511 participants (Actual)Interventional2010-10-18Completed
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial [NCT05166538]Phase 4204 participants (Anticipated)Interventional2022-02-01Not yet recruiting
Comparison of the Generic and Original Formulation of Clopidogrel Regarding the Potency of Platelet Inhibition in Patients After PCI [NCT01147133]Phase 475 participants (Actual)Interventional2009-11-30Completed
Comparison Between Ticagrelor and Clopidogrel Effect on Endothelial, Platelet and Inflammation Parameters in Patients With Stable Coronary Artery Disease and Chronic Obstructive Pulmonary Disease Undergoing PCI [NCT02519608]Phase 244 participants (Actual)Interventional2015-09-30Completed
TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome. [NCT03357874]Phase 3514 participants (Anticipated)Interventional2018-10-28Recruiting
The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial [NCT04501900]Phase 42,106 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity [NCT01335048]Phase 450 participants (Anticipated)Interventional2011-04-30Completed
Evaluating the Benefit of Additional Platelet Inhibition in Acute Coronary Syndrome Patients With High Platelet Reactivity Undergoing PCI [NCT01339026]Phase 444 participants (Actual)Interventional2012-02-29Terminated(stopped due to Change in guidelines favouring newer antiplatelet drugs in ACS)
Role of Clopidogrel in Preventing Exacerbations in Patients With Severe COPD: An Open-label Randomized Controlled Trial. [NCT06021990]Phase 3162 participants (Anticipated)Interventional2023-10-01Recruiting
Multicenter, Randomized, Non-inferiority Trial to Evaluate the Safety and Efficacy of Rivaroxaban Compared to Warfarin for Thromboprophylaxis in Children With Giant Coronary Aneurysms After Kawasaki Disease [NCT05643651]Phase 3332 participants (Anticipated)Interventional2023-03-01Not yet recruiting
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination and to Evaluate Single Dose Pharmacokinetics of MK0524A in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia [NCT01012219]Phase 136 participants (Actual)Interventional2009-11-30Completed
Effects of Different Doses of Ticagrelor and Standard-dose Clopidogrel on Platelet Aggregation and Endothelial Function in Diabetic Patients With Stable Coronary Artery Disease [NCT02889549]Phase 2/Phase 360 participants (Anticipated)Interventional2016-08-31Recruiting
Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of R-130964, the Active Metabolite of Clopidogrel, in Healthy Subjects [NCT01263093]Phase 147 participants (Actual)Interventional2010-12-31Completed
Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI [NCT02888652]1,500 participants (Actual)Observational [Patient Registry]2015-09-30Completed
COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary Syndromes(OPT-CKD Trial) [NCT02578537]Phase 460 participants (Anticipated)Interventional2015-10-31Recruiting
MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers [NCT02570581]Phase 116 participants (Actual)Interventional2014-06-30Completed
Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm [NCT02675205]Phase 3100 participants (Actual)Interventional2015-12-31Completed
Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting [NCT04091074]Phase 126 participants (Anticipated)Interventional2022-01-01Not yet recruiting
Effects of Edoxaban on the Cellular and Protein Phase of Coagulation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel (EDOX-APT): A Prospective Randomized Study [NCT02567461]Phase 480 participants (Actual)Interventional2016-03-31Completed
The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis [NCT02594410]Phase 4149 participants (Actual)Interventional2011-09-30Completed
Optimization of Antiplatelet Therapy With Clopidogrel on the Basis of the Extent of Platelet Inhibition in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy Undergoing PCI With Stent Implantation [NCT00774475]Phase 3442 participants (Anticipated)Interventional2008-11-30Not yet recruiting
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial) [NCT00781573]167 participants (Actual)Interventional2008-09-11Completed
A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study [NCT02618733]120 participants (Actual)Interventional2014-12-31Completed
Clopidogrel On Top of Aspirin For the Prevention of New Onset Migraine Headache Occurrence Following Transcatheter Closure of Atrial Septal Defects: A Prospective Randomized Trial (the CANOA Study) [NCT00799045]Phase 4220 participants (Actual)Interventional2008-10-31Completed
Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions [NCT00698607]Phase 41,466 participants (Anticipated)Interventional2008-06-30Active, not recruiting
A Randomised, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of Ticagrelor Compared With Clopidogrel in Patients With Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-responders or Responders [RESPOND] [NCT00642811]Phase 298 participants (Actual)Interventional2008-05-31Completed
Clopidogrel Pharmacogenetics Bench to Bedside - A Practical Application [NCT01341600]18 participants (Actual)Interventional2010-07-31Completed
STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within [NCT00623623]Phase 31,899 participants (Actual)Interventional2008-03-01Completed
Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age [NCT00833703]Phase 349 participants (Actual)Interventional2009-01-31Completed
[NCT00857155]200 participants (Anticipated)Interventional2009-01-31Recruiting
Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT [NCT00858715]46 participants (Actual)Interventional2008-05-31Completed
Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance [NCT05978726]325 participants (Actual)Observational2017-07-01Completed
Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium [NCT00859885]1,500 participants (Anticipated)Observational2008-09-08Recruiting
Chinese People's Liberation Army General Hospital [NCT02798874]240 participants (Anticipated)Interventional2016-05-31Enrolling by invitation
Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study) [NCT02792712]Phase 4200 participants (Anticipated)Interventional2016-01-31Recruiting
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial [NCT00882739]Phase 4168 participants (Actual)Interventional2009-04-30Completed
Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients: A Cohort Study [NCT05504330]100 participants (Anticipated)Observational2022-08-15Recruiting
A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention With the CYPHER® Sirolimus-eluting Cor [NCT00954707]Phase 42,509 participants (Actual)Interventional2009-08-31Active, not recruiting
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial. [NCT02265289]Phase 114 participants (Actual)Interventional1999-01-31Completed
Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding [NCT05223335]Phase 4121 participants (Actual)Interventional2022-03-29Completed
TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial [NCT02505399]Phase 4180 participants (Actual)Interventional2015-11-30Completed
The Carotid and Middle Cerebral Artery Occlusion Surgery Study [NCT01758614]Phase 3330 participants (Actual)Interventional2013-06-06Completed
A Phase ⅢB, Prospective, Randomized, Open Label, Blinded-endpoint, Multicenter Trial of the Efficacy and Safety of Urokinase Thrombolysis Comparing With Antiplatelet Agents for Patients With Minor Stroke. [NCT04420351]Phase 31,005 participants (Actual)Interventional2020-10-04Completed
XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT) [NCT01106534]Phase 4870 participants (Actual)Interventional2009-08-31Completed
Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects [NCT02086903]Phase 312 participants (Actual)Interventional2014-02-28Completed
RIsk of Apoplexia Cerebri in CLOpidogrel Non-responders [NCT02093299]165 participants (Actual)Observational [Patient Registry]2012-12-31Terminated(stopped due to Lack of feasiability)
Effect of Continuous Clopidogrel Dosing Targeted After Platelet Function Testing in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention With High On-treatment Platelet Reactivity [NCT02096419]Phase 487 participants (Actual)Interventional2012-02-29Completed
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study) [NCT03073850]Phase 448 participants (Actual)Interventional2017-02-23Terminated(stopped due to Majority of enrolled patients have withdrawn.)
An Open-label, Blinded, Randomized Crossover Four Period Single Dose Full Replicative Bioequivalence Study of Two Formulations Clopidogrel Film-coated Tablets 75 mg (Pharmtechnology LLC, Republic of Belarus) and Plavix® Film-coated Tablets 75 mg (Manufact [NCT05934799]Phase 160 participants (Actual)Interventional2023-06-16Completed
Half-dose Ticagrelor Overcomes High-dose Clopidogrel in Acute Coronary Syndrome Patients With High On-Clopidogrel Platelet Reactivity [NCT03062462]Phase 2/Phase 380 participants (Anticipated)Interventional2017-02-10Recruiting
Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not? The CAPITAL OPTI-CROSS Study. [NCT02054663]Phase 460 participants (Actual)Interventional2013-12-31Completed
A Randomised, Open-label, Parallel Group, Multi-center Study Using OCT to Comparing the Efficacy and Safety of Ticagrelor With Clopidogrel in the Prevention of Subclinical Thrombus in Patients After Drug-eluting Stent Implantation [NCT02140801]Phase 4352 participants (Actual)Interventional2014-05-01Completed
A Prospective Randomised Controlled Trial [NCT02086019]250 participants (Actual)Interventional2014-05-01Completed
A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study [NCT02429271]Phase 3336 participants (Actual)Interventional2015-08-31Completed
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study [NCT06165068]Phase 3174 participants (Anticipated)Interventional2023-12-31Recruiting
Dual Anti-platelet Therapy in Chronic Obstructive Pulmonary Disease Study [NCT05567562]Phase 230 participants (Anticipated)Interventional2023-12-08Recruiting
Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects [NCT04809818]Phase 164 participants (Anticipated)Interventional2021-03-21Recruiting
Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement [NCT02133989]Phase 386 participants (Anticipated)Interventional2014-06-30Recruiting
Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention [NCT02410083]Phase 4448 participants (Actual)Interventional2012-11-30Completed
A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention [NCT05638867]Phase 43,944 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Single-center, Randomized, Open-label, Controlled, Dose-escalating, Parallel-group Study to Assess the Anti-platelet Effect of Berberine in Patients Receiving Aspirin and Clopidogrel After Percutaneous Coronary Intervention [NCT03378934]Phase 464 participants (Anticipated)Interventional2018-09-26Recruiting
Targeting Platelets in Chronic HIV Infection [NCT02578706]Phase 227 participants (Actual)Interventional2015-10-31Completed
Safety and Efficacy of Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After Drug-coated Balloons for Coronary Small Vessel Disease: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation, Single-center Study [NCT06088433]Phase 4292 participants (Anticipated)Interventional2023-11-15Not yet recruiting
Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia [NCT06053021]1,200 participants (Anticipated)Interventional2023-09-15Recruiting
Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases. [NCT00734123]Phase 42,948 participants (Anticipated)Interventional2008-04-30Recruiting
Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT) [NCT06037889]Phase 3516 participants (Anticipated)Interventional2023-11-09Recruiting
MPD-RC 108: Phase II, Randomized, Double-Blind, Placebo Controlled International Study of Clopidogrel and Aspirin for the Treatment of Polycythemia Vera [NCT00940784]Phase 20 participants (Actual)Interventional2009-06-30Withdrawn(stopped due to Could not get drug)
Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI [NCT00976092]Phase 4548 participants (Actual)Interventional2009-09-30Active, not recruiting
Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome [NCT00684203]Phase 2120 participants (Actual)Interventional2006-12-01Completed
[NCT00776477]Phase 3300 participants (Anticipated)Interventional2007-12-31Recruiting
Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting [NCT00776633]Phase 4614 participants (Actual)Interventional2008-09-30Active, not recruiting
Role of CYP2C19 Polymorphism in the Drug Interaction Between Clopidogrel and Omeprazole [NCT01094275]75 participants (Actual)Observational [Patient Registry]2010-01-31Completed
A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing [NCT00778193]Phase 4125 participants (Actual)Interventional2007-10-31Completed
A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention [NCT00059215]Phase 2905 participants (Actual)Interventional2003-04-30Completed
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707]Phase 310,000 participants (Anticipated)Interventional2016-04-11Recruiting
ETAMI-Study: Early Thienopyridine Treatment to Improve Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction [NCT01327534]Phase 363 participants (Actual)Interventional2011-05-31Completed
To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy A [NCT05186129]Phase 136 participants (Actual)Interventional2018-04-06Completed
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial. [NCT02222987]Phase 114 participants (Actual)Interventional1999-02-28Completed
A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coron [NCT02748330]Phase 440 participants (Actual)Interventional2016-06-30Completed
Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly [NCT04219774]Phase 233 participants (Actual)Interventional2020-05-01Active, not recruiting
Enrichment of CES1 Carriers in the Pharmacogenomics Anti-Platelet Intervention Study [NCT03188705]Phase 46 participants (Actual)Interventional2019-10-14Completed
Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study [NCT05193071]Phase 41,022 participants (Anticipated)Interventional2022-07-08Recruiting
PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY [NCT00611286]Phase 41,700 participants (Anticipated)Interventional2006-12-31Completed
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb [NCT04229264]Phase 3200 participants (Anticipated)Interventional2020-01-09Recruiting
Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit [NCT02762864]200 participants (Anticipated)Interventional2016-05-31Enrolling by invitation
Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI [NCT02696330]Phase 4150 participants (Anticipated)Interventional2015-09-30Recruiting
Effect of Plavix Treatment on NO Production Measured by Laser Doppler Method Referring to Endothelial Function in Patients With Severe Coronary Heart Disease [NCT00648453]Phase 439 participants (Actual)Interventional2002-12-31Completed
Influence of Platelet Reactivity in Peripheral Arterial Disease Patients Undergoing Percutaneous Angioplasty on Mid-term Outcomes [NCT04165629]450 participants (Anticipated)Observational2020-01-01Recruiting
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation [NCT00620646]80 participants (Anticipated)Interventional2008-02-29Completed
A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix® [NCT00620802]Phase 160 participants (Actual)Interventional2007-11-30Completed
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction [NCT02777580]Phase 4609 participants (Actual)Interventional2017-08-01Active, not recruiting
GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety [NCT00645918]2,800 participants (Actual)Interventional2008-06-30Completed
A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients [NCT04409834]Phase 4390 participants (Actual)Interventional2020-08-05Completed
Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent [NCT00661206]Phase 44,005 participants (Actual)Interventional2008-09-30Active, not recruiting
Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function [NCT00693069]Phase 3120 participants (Actual)Interventional2004-09-30Completed
30-d Rand, Eval-blind, Controlled, Multi-centre, Parallel, ph III Study to Evaluate Effect of a Low Maint Dose Ticagrelor Regimen vs Standard Dose Clopidogrel on Coronary Flow Reserve in DM Patients With Impaired Microvascular Function Without Prior MI or [NCT04069234]Phase 30 participants (Actual)Interventional2019-09-15Withdrawn(stopped due to Sponsor decided to stop the study due to commercial reasons.)
Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting [NCT00827411]Phase 42,500 participants (Actual)Interventional2009-01-31Completed
Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection [NCT00839345]0 participants Expanded AccessTemporarily not available
Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy [NCT06013020]Phase 4374 participants (Anticipated)Interventional2023-08-28Recruiting
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial [NCT03568890]Phase 4510 participants (Anticipated)Interventional2018-09-01Recruiting
Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial [NCT05493657]230 participants (Anticipated)Interventional2023-02-02Recruiting
Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy. [NCT00335452]Phase 325,086 participants (Actual)Interventional2006-06-30Completed
The MAgnitude of Platelet Inhibition and the Pharmacokinetics of a 600 mg Loading Dose of Clopidogrel, in Different Patient CATegories (Stable Angina Versus Acute-coronary Syndromes Versus ST-elevated Myocardial Infarction). [NCT01012544]Phase 4187 participants (Actual)Interventional2009-04-30Completed
Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT00947843]Phase 4306 participants (Actual)Interventional2013-11-30Completed
"Second Generation Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy" [NCT00944333]Phase 31,378 participants (Actual)Interventional2009-07-31Terminated(stopped due to STOP due to recent data in literature questioning the need to continue DAP beyond six months in patients with stable coronary artery stenting with DES.)
Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay [NCT01023360]Phase 430 participants (Anticipated)Interventional2008-05-31Recruiting
Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke [NCT00979589]Phase 35,100 participants (Actual)Interventional2009-12-31Completed
Study of the Potentiation of the Effects of Clopidogrel by Rifampicin in Healthy Volunteers [NCT00696566]Phase 112 participants (Actual)Interventional2007-11-30Completed
Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial [NCT02689037]Phase 3394 participants (Anticipated)Interventional2016-04-30Not yet recruiting
Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent [NCT00640679]Phase 4782 participants (Actual)Interventional2008-04-30Terminated(stopped due to Due to slow enrollment the study was stopped prematurely.)
Single-Dose Fasting In Vivo Bioequivalence Study of Clopidogrel Bisulfate Tablets (75 mg; Mylan) to Plavix® Tablets (75 mg; Bristol-Myers Squibb/Sanofi) in Healthy Volunteers [NCT00648947]Phase 146 participants (Actual)Interventional2004-12-31Completed
Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel [NCT00749710]100 participants (Anticipated)Interventional2008-09-30Not yet recruiting
[NCT02606552]Phase 49 participants (Actual)Interventional2016-07-20Terminated(stopped due to The number of patients registered for the study was low and it was expected to be difficult to derive the study results.)
Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients [NCT00669149]Phase 499 participants (Actual)Interventional2008-06-30Terminated(stopped due to recruitment difficulties)
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions [NCT00823212]Phase 31,530 participants (Actual)Interventional2009-01-31Completed
GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO) - The Gore REDUCE Clinical Study [NCT00738894]664 participants (Actual)Interventional2008-12-10Completed
[NCT00775762]Phase 3213 participants (Anticipated)Interventional2008-11-30Not yet recruiting
Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial [NCT02628587]Phase 460 participants (Anticipated)Interventional2016-02-29Not yet recruiting
The Effect of Ticagrelor on 15-Epi-Lipoxin A4 and Inflammation [NCT02626169]Phase 40 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Pharmaceutical company sponsor withdrew support prior to enrollment of subjects.)
The Effect of Ticagrelor on the Inflammatory Response to Human Endotoxemia [NCT02612480]40 participants (Actual)Interventional2015-10-31Completed
Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial) [NCT00797056]Early Phase 132 participants (Actual)Interventional2008-04-30Completed
Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function and Other Circulating Biomarkers in Humans [NCT02587260]Phase 454 participants (Actual)Interventional2015-12-17Completed
A Comparison of Platelet Inhibition Following Prasugrel or Clopidogrel Administration in Asian Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention [NCT00830960]Phase 3720 participants (Actual)Interventional2009-02-28Completed
Apixaban Versus Antiplatelet Drugs or no Antithrombotic Drugs After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation: A Randomised Phase II Clinical Trial [NCT02565693]Phase 2101 participants (Actual)Interventional2014-09-30Completed
Randomized Comparison of Adenosin Intracoronary Infusion and Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI [NCT00751491]Phase 360 participants (Anticipated)Interventional2008-09-30Recruiting
Prevention of Cerebral Ischaemia in Stent Treatment for Carotid Artery Stenosis - A Randomised Multi-centre Phase II Trial Comparing Ticagrelor Versus Clopidogrel With Outcome Assessment on MRI (PRECISE-MRI) [NCT02677545]Phase 2210 participants (Actual)Interventional2016-12-31Completed
A Randomized, Pharmacodynamic Comparison of Low Dose Ticagrelor to Clopidogrel in Patients With Prior Myocardial Infarction [NCT02663713]Phase 420 participants (Actual)Interventional2017-01-31Completed
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers [NCT04171687]Phase 136 participants (Actual)Interventional2019-10-21Completed
Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the Infarct-related Artery in STEMI Patients: A Prospective Randomized Trial of Ticagrelor Versus Clopidogrel [NCT02639143]Phase 450 participants (Actual)Interventional2015-12-31Completed
Comparison of Ulcer Healing in Patients Taking Rabeprazole Plus Aspirin Versus Rabeprazole Plus Clopidogrel for Acute Peptic Ulcer [NCT01037491]200 participants (Anticipated)Interventional2009-10-31Recruiting
Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery. A Prospective Randomized Controlled Study [NCT00724880]Phase 4135 participants (Actual)Interventional2006-06-30Completed
A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks [NCT00862420]Phase 3431 participants (Actual)Interventional2009-02-28Completed
Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine [NCT00732290]Phase 110 participants (Actual)Interventional2009-02-28Completed
SMart Angioplasty Research Team: Comparison Between P2Y12 Inhibitor MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary BiorEsorbable Scaffold II: (SMART-CHOICE II) Trial [NCT03119012]Phase 41,520 participants (Anticipated)Interventional2017-04-19Suspended(stopped due to cannot use bioabsorbable scaffold)
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study (AFIRE Study) [NCT02642419]Phase 42,200 participants (Anticipated)Interventional2015-01-31Recruiting
Warfarin After Anterior ST-Elevation Myocardial Infarction [NCT00662467]20 participants (Actual)Interventional2006-11-30Completed
[NCT02831218]70 participants (Actual)Interventional2016-12-31Terminated(stopped due to This study was merged into HOWTO-BRS study.)
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Very Elderly Versus Non-Elderly Aspirin-Treated Subjects With Stable Coronary Artery Disease [NCT01107912]Phase 1155 participants (Actual)Interventional2010-03-31Completed
Validation of Adjunctive Cilostazol According to CYP2C19 Polymorphism: Prospective, Randomized, Single-Center Trial: [NCT00891670]Phase 380 participants (Anticipated)Interventional2009-05-31Not yet recruiting
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed [NCT00699998]Phase 39,326 participants (Actual)Interventional2008-06-30Completed
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention [NCT04060914]Phase 4225 participants (Anticipated)Interventional2019-08-30Not yet recruiting
A Pharmacoepidemiological Study on the Risk of Bleeding in New Users of Low-dose Aspirin (ASA) in The Health Improvement Network (THIN), UK [NCT02550717]398,158 participants (Actual)Observational2015-09-01Completed
Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel [NCT00882388]Phase 440 participants (Actual)Interventional2005-03-31Completed
Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI [NCT00697021]Phase 350 participants (Anticipated)Interventional2008-06-30Recruiting
International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt [NCT00396877]Phase 3906 participants (Actual)Interventional2006-11-30Completed
The Influence of CYP2C19 Polymorphism on Antiplatelet Effects and Clinical Outcomes in Non-acute Stroke Patients Treated With Clopidogrel: The Contribution of Genetic Analysis to the Efficacy of Clopidogrel (Cognac) Study [NCT02711410]518 participants (Actual)Observational2009-10-31Completed
Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects [NCT00935506]Phase 115 participants (Actual)Interventional2009-07-31Completed
Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris [NCT02548611]Phase 4795 participants (Actual)Interventional2015-09-30Terminated(stopped due to Due to low recruitment)
Recovery of Platelet Function After a Loading Dose of Prasugrel or Clopidogrel in Aspirin-Treated Subjects Presenting With Symptoms of Acute Coronary Syndromes [NCT01107899]Phase 129 participants (Actual)Interventional2009-10-31Terminated(stopped due to Terminated due to Enrollment futility)
Recovery of Platelet Function Following Discontinuation of Prasugrel or Clopidogrel Maintenance Dosing in Aspirin-Treated Subjects With Stable Coronary Disease [NCT01014624]Phase 456 participants (Actual)Interventional2010-02-28Completed
A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5 [NCT04116931]Phase 480 participants (Anticipated)Interventional2020-06-22Recruiting
Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions: an Open-label, Multicenter, Randomized, Non-inferiority Trial [NCT05209412]370 participants (Anticipated)Interventional2022-02-01Recruiting
Single-center, Prospective, Controlled Study of the Safety and Efficacy of Aspirin and Clopidogrel in Ischemic Cardiovascular and Cerebrovascular Patients Complications With CAA [NCT04654026]43 participants (Anticipated)Observational2021-02-20Not yet recruiting
EndothelIal progeNitor Cell Capture steNt With 1-mOnth Dual Antiplatelet Therapy Versus eVerolimus-eluting Stent With stAndard 12-month Dual anTIplatelet Therapy in Elderly (≥ 70 Year) With Stable corONary Artery Disease - INNOVATION Trial [NCT01394848]Phase 41 participants (Actual)Interventional2011-10-31Terminated(stopped due to Previous other study including EPC capture stent raised the issue of safety (significant high incidence of instent restenosis))
A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State [NCT01409616]Phase 1100 participants (Actual)Interventional2009-04-30Completed
Prasugrel Versus Adjusted High-dose Clopidogrel to TREAT High On-clopidogrel Platelet Reactivity in Acute Coronary Syndrome Patients After PCI [NCT01493999]Phase 4147 participants (Actual)Interventional2011-09-30Completed
Comparative Pharmacokinetics After Single Oral Administration of YH14659, a Fixed Dose Combination Versus Coadministration of Separate Constituents in Healthy Male Volunteers [NCT01422109]Phase 144 participants (Actual)Interventional2011-07-31Completed
Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet With Plavix® 75 mg In Healthy Subjects Under Fed Conditions [NCT01512485]Phase 151 participants (Actual)Interventional2006-10-31Completed
The Effect of an Acute Dose of Ticagrelor or Clopidogrel and of Treatment for 14 Days on Ischemia-reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects. [NCT02580149]Phase 424 participants (Actual)Interventional2015-10-31Completed
Trial for Efficacy and Safety of Cilostazol on the Progression of Symptomatic Intracranial Stenosis Comparing Clopidogrel [NCT00130039]Phase 4457 participants (Actual)Interventional2005-08-31Completed
A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disea [NCT00528411]Phase 2123 participants (Actual)Interventional2007-10-31Completed
Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease [NCT02798913]Phase 3300 participants (Anticipated)Interventional2016-01-31Recruiting
Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND Randomized Study [NCT03729401]Phase 4390 participants (Anticipated)Interventional2019-08-22Suspended(stopped due to Testing supplies unavailable.)
Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease [NCT00816166]Phase 2/Phase 3125 participants (Actual)Interventional2008-10-31Terminated
A Phase 1, Open-label, 2-period, Fixed-sequence Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion Coadministered With Clopidogrel in Healthy Subjects [NCT02560688]Phase 122 participants (Actual)Interventional2015-12-31Completed
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial [NCT02601157]Phase 42,173 participants (Actual)Interventional2016-01-18Completed
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy) [NCT02767401]Phase 4200 participants (Actual)Interventional2015-09-15Completed
Anticoagulation Using Rivaroxaban on Top of Aspirin in Recent Stroke/Transient Ischemic Attack Patients With Intracranial Atherosclerotic Stenosis (AA-ICAS) [NCT05700266]Phase 2/Phase 31,180 participants (Anticipated)Interventional2023-12-30Not yet recruiting
A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus High Dose Clopidogrel in Subjects With Type 2 Diabetes Mellitus and Coronary Artery Disease. [NCT00642174]Phase 235 participants (Actual)Interventional2008-04-30Completed
A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial [NCT02609698]Phase 4906 participants (Anticipated)Interventional2015-08-31Recruiting
TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition [NCT00914368]Phase 2450 participants (Anticipated)Interventional2009-01-31Completed
Platelet Function Monitoring in Patients Treated With Clopidogrel at the Time of Primary Percutaneous Coronary Angioplasty [NCT00827346]Phase 2/Phase 3100 participants (Anticipated)Interventional2009-01-31Completed
Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging [NCT05845489]Phase 49,930 participants (Anticipated)Interventional2023-03-09Recruiting
Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA) [NCT01325935]Phase 41,187 participants (Actual)Interventional2011-04-30Completed
The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial. [NCT01930591]Phase 3140 participants (Actual)Interventional2014-05-31Completed
Reassessment of Anti-Platelet Therapy Using InDividualized Strategies - Modifying Acute CoroNary Syndrome Algorithms Based on Genetic and Demographic Evaluation: The RAPID-MANAGE Study [NCT02044146]Phase 2/Phase 3120 participants (Actual)Interventional2014-09-30Completed
Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation [NCT02044250]Phase 45,530 participants (Actual)Interventional2014-02-28Completed
A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft. [NCT00174759]Phase 31,460 participants (Anticipated)Interventional2004-09-30Completed
An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes [NCT02944123]Phase 3120 participants (Actual)Interventional2016-09-30Completed
Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI [NCT00889044]Phase 330 participants (Anticipated)Interventional2009-04-30Recruiting
COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial [NCT00814268]Phase 4358 participants (Actual)Interventional2008-12-31Completed
The Effects of Physical Training, Aspirin, and Clopidogrel on the Walking Capacity of Patients With Stage II Peripheral Arterial Disease [NCT00189618]Phase 4250 participants (Anticipated)Interventional2005-05-31Completed
A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to [NCT00821834]Phase 31,003 participants (Actual)Interventional2008-12-31Completed
Retinal Blood Flow and Microthrombi in Type 1 Diabetes [NCT00406991]Phase 2100 participants Interventional2003-06-30Completed
Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation [NCT00822536]Phase 41,798 participants (Actual)Interventional2009-01-31Completed
[NCT01032668]Phase 3192 participants (Actual)Interventional2008-09-30Completed
A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation [NCT00249873]Phase 37,554 participants (Actual)Interventional2003-06-30Completed
ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery(TEG-CABG Trial):Does Intensified Postoperative Antiplatelet Therapy in Preoperatively Identified Hypercoagulable Patients Improve Outcome After CABG [NCT01046942]Phase 3250 participants (Anticipated)Interventional2008-11-30Recruiting
The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients [NCT00263211]Phase 248 participants (Actual)Interventional2006-01-31Terminated(stopped due to Stopped due to low percentage of patients with detectable CTCs at baseline.)
Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass? [NCT00228423]Phase 2113 participants (Actual)Interventional2006-05-31Completed
Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44 [NCT00357968]Phase 2201 participants (Actual)Interventional2006-08-31Completed
Methods to Augment the Efficacy of Aspirin and Clopidogrel in Healthy Subjects (ASA Only) and Patients With Stable Coronary Artery Disease (Taking Clopidogrel Only) or (Taking Clopidogrel & ASA) With an Elevated Platelet Turnover (Reticulated Platelets). [NCT01011257]Phase 40 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to No funding secured.)
CYP 2C19 Polymorphism and Response to Adjunctive Cilostazol and High Maintenance-dose Clopidogrel in Patients Undergoing Elective Percutaneous Coronary Intervention [NCT01012193]Phase 4134 participants (Actual)Interventional2008-01-31Completed
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan [NCT01069302]Phase 4106 participants (Actual)Interventional2010-02-28Completed
The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes. [NCT01475552]Phase 4130 participants (Actual)Interventional2010-09-30Completed
Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study [NCT01887704]240 participants (Actual)Interventional2010-01-31Completed
ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study [NCT01894789]Phase 2/Phase 336 participants (Actual)Interventional2013-03-31Completed
Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta [NCT01905566]Phase 450 participants (Actual)Interventional2013-09-30Completed
Clopidogrel Or Metoprolol in Myocardial Infarction Trial [NCT00222573]Phase 446,000 participants Interventional1999-07-31Completed
Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis [NCT01950416]Phase 456 participants (Actual)Interventional2013-03-31Completed
Intensified Antiplatelet Therapy in Post-PCI Patients With High On-treatment Platelet Reactivity: the OPTIMA-2 Trial [NCT01955200]Phase 41,724 participants (Actual)Interventional2013-10-05Completed
Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke : Role of Platelet alpha2-adrenergic Receptors [NCT01955642]91 participants (Actual)Observational2013-09-30Completed
[NCT01959191]859 participants (Actual)Observational2008-01-31Completed
Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI [NCT01959451]Phase 42,600 participants (Actual)Interventional2013-09-30Completed
Platelet Reactivity After Ticagrelor Loading Dose Versus Clopidogrel Loading Dose and Reloading With Ticagrelor, in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention (PCI). [NCT01961856]Phase 374 participants (Actual)Interventional2013-09-30Completed
Genotype Guided Versus Conventional Approach in Selection of Oral P2Y12 Receptor Blocker in Chinese Patients Suffering From Acute Coronary Syndrome [NCT01994941]Phase 4133 participants (Actual)Interventional2013-08-31Completed
Cilostazol Stroke Prevention Study for Antiplatelet Combination [NCT01995370]Phase 41,884 participants (Actual)Interventional2013-12-13Completed
POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy [NCT05926271]Phase 2200 participants (Anticipated)Interventional2023-07-15Recruiting
Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study [NCT02869009]Phase 33,000 participants (Actual)Interventional2016-11-30Completed
A Prospective, Multicenter, Randomized, Open-label Trial to Compare Efficacy and Safety of Clopidogrel vs Ticagrelor in Stabilized Patients With Acute Myocardial Infarction After Percutaneous Coronary Intervention; TicAgrelor Versus CLOpidogrel in Stabili [NCT02018055]Phase 42,590 participants (Actual)Interventional2014-02-14Completed
The Effect of Prasugrel as Compared to Clopidogrel on Platelet Function Immediately Following the Termination of Intravenous Bivalirudin in Patients Undergoing Percutaneous Coronary and Structural Cardiac Intervention [NCT01789814]Phase 424 participants (Actual)Interventional2013-07-31Completed
The Influence of Smoking Status on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Aspirin-treated Subjects With Stable Coronary Artery Disease [NCT01260584]Phase 4110 participants (Actual)Interventional2010-11-30Completed
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study) [NCT02026219]Phase 476 participants (Actual)Interventional2013-10-31Completed
A Phase 3, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Standard Medical Treatment for Acute Ischemic Stroke Due to [NCT05141305]Phase 3516 participants (Anticipated)Interventional2022-04-09Recruiting
Influence of CYP2C19 Genetic Variants on Clopidogrel in Healthy Subjects [NCT00413608]Phase 1140 participants (Actual)Interventional2007-01-31Completed
COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale [NCT05546320]Phase 41,000 participants (Anticipated)Interventional2022-10-15Recruiting
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH) [NCT00007683]Phase 31,587 participants (Anticipated)Interventional1998-10-31Completed
Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke, a Randomized Controlled Trial [NCT06120725]Phase 3580 participants (Actual)Interventional2021-09-01Completed
Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [NCT00562289]Phase 3664 participants (Actual)Interventional2007-12-31Completed
Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel [NCT04619381]0 participants (Actual)Observational2021-03-19Withdrawn(stopped due to The study funding was dropped with no patients enrolled)
Safety of High-dose Tirofiban in Patient Undergoing Coronary Angioplasty. [NCT00566891]Phase 42,000 participants (Actual)Interventional2007-12-31Completed
[NCT00589862]Phase 40 participants (Actual)Interventional2007-10-31Withdrawn(stopped due to Failure to secure adequate funding)
Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events [NCT00590174]Phase 41,175 participants (Actual)Interventional2007-10-31Completed
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization [NCT02211066]Phase 459 participants (Actual)Interventional2014-10-31Completed
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) [NCT02486367]Phase 460 participants (Actual)Interventional2015-06-30Completed
PHASE IV Study of Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After Percutaneous Aortic Valve Implantation. Multicenter Randomized Clinical Trial [NCT01642134]Phase 4124 participants (Actual)Interventional2013-04-30Completed
Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention. [NCT01641510]Phase 370 participants (Actual)Interventional2013-10-31Completed
Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial [NCT05885932]472 participants (Anticipated)Interventional2023-08-25Recruiting
The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome [NCT02484924]5,225 participants (Actual)Observational2010-06-30Completed
Comparison of Prasugrel and Clopidogrel Reloading on High Platelet Reactivity in Clopidogrel-loaded Patients Undergoing Percutaneous Coronary Intervention [NCT01609647]Phase 376 participants (Actual)Interventional2012-09-30Completed
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight Aspirin-Treated Subjects With Stable Coronary Artery Disease [NCT01107925]Phase 172 participants (Actual)Interventional2010-03-31Completed
Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting [NCT00302913]120 participants Interventional2005-12-31Completed
Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP) [NCT02893280]0 participants (Actual)Observational2015-04-30Withdrawn(stopped due to Due to an incompatibility with the local procedures)
Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study [NCT00716924]Phase 3155 participants (Actual)Interventional2004-05-31Completed
A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA [NCT00853450]Phase 128 participants (Anticipated)Interventional2009-02-28Completed
Assessment of Platelet-dependent Thrombosis by an ex Vivo Arterial Injury Model: a Placebo Controlled Trial of Clopidogrel as Antiplatelet Therapy in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease [NCT00728156]Phase 490 participants (Actual)Interventional2009-08-31Completed
A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms [NCT03989557]Phase 4314 participants (Actual)Interventional2019-07-01Completed
Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards Valve. A Randomized Study (the ARTE Trial) [NCT02640794]Phase 4222 participants (Actual)Interventional2015-01-31Completed
Prospective, Multi-centre, Randomized, Parallel Comparison to Evaluate the Safety and Efficacy of the Abluminal Sirolimus Coated Bio-engineered Stent (COMBO Stent) in Association With Short-term Single Antiplatelet Therapy in Patients With Coronary Artery [NCT02723981]Phase 40 participants (Actual)Interventional2016-04-30Withdrawn(stopped due to Regulatory authority approval for the initial study design could not be obtained)
Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting: The ALPHEUS Study [NCT02617290]Phase 31,900 participants (Actual)Interventional2017-01-09Completed
Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients [NCT02707445]5,000 participants (Actual)Interventional2011-09-30Completed
A Randomised, Double-Blind, Parallel Group, Asian, Multicenter Study, to Assess Pharmacokinetic and Pharmacodynamic Profile of 2 Doses of Ticagrelor on Top of Low Dose Acetyl Salicylic Acid (ASA) Therapy on Platelet Aggregation in Japanese and Asian Patie [NCT01118325]Phase 2146 participants (Actual)Interventional2010-04-30Completed
Ticagrelor in Remote Ischemic Preconditioning Study [NCT04174261]Phase 4245 participants (Actual)Interventional2017-01-29Completed
VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA Trial) [NCT04654052]Phase 4634 participants (Anticipated)Interventional2021-07-02Recruiting
Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO) [NCT02776540]Phase 4188 participants (Actual)Interventional2016-06-01Completed
High On-treatment Platelet Reactivity to Adenosine Diphosphate Identified by Multiple Platelet Function Assay Guide to Modify Anti-platelet Strategy in Patients Undergoing Percutaneous Coronary Intervention [NCT02699008]477 participants (Actual)Interventional2014-01-31Completed
150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention [NCT00638326]Phase 3500 participants (Anticipated)Interventional2008-03-31Terminated(stopped due to Greater differences between randomized patients than previously anticipated)
A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal S [NCT00977938]Phase 425,682 participants (Actual)Interventional2009-10-31Completed
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus [NCT04305587]Phase 166 participants (Actual)Interventional2020-03-16Completed
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56 [NCT01235351]Phase 2335 participants (Actual)Interventional2010-10-31Completed
TRansferring From ClopIdogrel Loading Dose to Prasugrel Loading Dose in Acute Coronary Syndrome PatiEnTs: TRIPLET [NCT01115738]Phase 2282 participants (Actual)Interventional2010-05-31Completed
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China. [NCT00664846]4,000 participants (Anticipated)Interventional2008-04-30Completed
A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke [NCT03122002]1,200 participants (Actual)Observational2018-03-03Terminated(stopped due to Limited number of participants enrolled.)
COmparison of Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy [NCT03198741]Phase 4783 participants (Actual)Interventional2017-07-13Completed
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study) [NCT02829151]Phase 4390 participants (Anticipated)Interventional2017-02-21Recruiting
Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial [NCT04661709]Phase 4502 participants (Anticipated)Interventional2021-03-01Not yet recruiting
A Randomized, Open-label, Single-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a Tablet Containing 75 mg of Clopidogrel and 100 mg of Aspirin and The Simultaneous Administration of The Separate Formulations of [NCT01388660]Phase 160 participants (Anticipated)Interventional2011-06-30Recruiting
Evaluation of Exercise Capacity as Measured by Peak Oxygen Uptake, Before and After Percutaneous Revascularization of Chronic Total Occlusion [NCT02499666]15 participants (Actual)Observational2015-06-29Terminated(stopped due to difficulty recruiting patients)
Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism [NCT01421706]Phase 120 participants (Actual)Interventional2008-07-31Completed
Clinical Assessment of Pidogrel® Versus Plavix® [NCT01431495]Phase 4219 participants (Actual)Interventional2010-04-30Completed
Effect of Ticagrelor on Endothelial Function [NCT01805596]Phase 345 participants (Anticipated)Interventional2013-04-30Completed
PhaRmacodynamic Effects of Switching thErapy in paTients With High on Treatment Platelet Reactivity and Genotype Variation: High Clopidogrel Dose Versus Prasugrel RESET GENE Trial [NCT01465828]Phase 330 participants (Actual)Interventional2011-10-31Completed
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03961334]Phase 3620 participants (Anticipated)Interventional2019-12-05Recruiting
Comparison of Platelet Inhibitory Effect With Adjunctive Cilostazol Versus High Maintenance-dose ClopidogrEL in Acute Myocardial Infarction Patients According to CYP2C19 Polymorphism [NCT00915733]Phase 480 participants (Actual)Interventional2009-05-31Completed
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) [NCT05047172]Phase 31,683 participants (Anticipated)Interventional2022-08-02Recruiting
MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting [NCT05566301]1,140 participants (Anticipated)Observational2021-09-02Recruiting
ANTIPLATELET TREATMENT IN ACUTE CORONARY SYNDROMES. SAFETY AND EFFICACY OF ANTIPLATELET SWITCHING Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome [NCT04630288]1,900 participants (Actual)Observational2019-07-02Active, not recruiting
Pragmatic Randomized Controlled Trial Comparing Treatment Effectiveness of Guideline Indicated Anti-platelet Therapy for Acute Coronary Syndrome in Patients With Chronic Kidney Disease [NCT03150667]Phase 4220 participants (Anticipated)Interventional2017-04-10Recruiting
PROCLAIM: Pilot Study Examining Effects of Clopidogrel Compared to Placebo on Markers of Inflammation in Subjects With Metabolic Syndrome [NCT00296803]Phase 4216 participants Interventional2005-11-30Completed
[NCT02953405]1,000 participants (Anticipated)Observational2015-12-31Recruiting
Evaluation the Effect of Ticagrelor and Clopidogrel in Stable Coronary Syndrome A Randomized Clinical Trial [NCT05858918]476 participants (Actual)Interventional2022-10-01Completed
A Phase 1, Open-label, Randomized, Multiple-dose, Crossover Pharmacokinetic/Pharmacodynamic Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Phenotypes [NCT05162053]Phase 1128 participants (Actual)Interventional2021-12-09Completed
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study [NCT01860105]Phase 137 participants (Actual)Interventional2012-09-30Completed
RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI [NCT04688723]Phase 41,000 participants (Anticipated)Interventional2020-12-23Recruiting
A Single Center, Open-Label, Drug Interaction Study of MGL-3196 With Clopidogrel in Healthy Subjects [NCT04671069]Phase 120 participants (Actual)Interventional2019-07-26Completed
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects [NCT00368238]Phase 296 participants Interventional2005-10-31Completed
CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction [NCT00372216]Phase 3337 participants (Actual)Interventional2006-10-31Completed
Evaluation of the Effect of the H2 Haplotype and CYP3As Polymorphisms on the Antiplatelet Response to Clopidogrel Given Before Elective Percutaneous Coronary Intervention [NCT00433784]Phase 4120 participants Interventional2004-09-30Completed
A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: [NCT03437044]Phase 440 participants (Actual)Interventional2018-03-14Completed
Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries [NCT00494156]0 participants (Actual)Interventional2003-07-31Withdrawn(stopped due to Study halted prematurely prior to enrollment of first participant.)
A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt [NCT02938182]Phase 450 participants (Anticipated)Interventional2016-10-31Recruiting
[NCT02922465]Phase 120 participants (Actual)Interventional2016-09-30Completed
Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease [NCT04824911]Phase 2424 participants (Anticipated)Interventional2021-03-23Recruiting
A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese [NCT01294462]Phase 3801 participants (Actual)Interventional2011-02-28Completed
A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease [NCT00557921]Phase 35,000 participants (Anticipated)Interventional2007-12-31Terminated(stopped due to Terminated by Sponsor)
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Long Lesion Sub-trial [NCT01500434]Phase 3102 participants (Actual)Interventional2009-02-28Completed
The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction [NCT05045274]300 participants (Anticipated)Interventional2021-12-31Not yet recruiting
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial [NCT00991029]Phase 34,881 participants (Actual)Interventional2010-05-28Terminated(stopped due to The trial was halted by the DSMB.)
[NCT00004564]0 participants InterventionalRecruiting
Platelet Reactivity With Clopidogrel Versus Prasugrel in Patients With Systolic Heart Failure [NCT01765400]Phase 430 participants (Actual)Interventional2013-05-15Completed
The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers [NCT01469416]Phase 110 participants (Actual)Interventional2012-03-31Completed
Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers [NCT01482117]28 participants (Actual)Interventional2011-11-30Completed
A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation [NCT00243178]Phase 36,706 participants (Actual)Interventional2003-07-31Terminated
Which Early ST Elevation Myocardial Infarction Therapy? The WEST Study [NCT00121446]Phase 2/Phase 3300 participants Interventional2003-07-31Completed
Impact of Chronic Kidney Disease (CKD) on Pharmacodynamic Profiles of the P2Y12 Receptor Inhibitor Clopidogrel in the Setting of Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease (CAD) [NCT03774394]Phase 461 participants (Actual)Interventional2019-08-22Completed
Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention [NCT00325390]Phase 3800 participants Interventional2004-07-31Completed
Pilot Study of Preoperative Aspirin and Postoperative Clopidogrel's Effects on Graft Patency and Cardiac Events in Coronary Artery Bypass Surgery [NCT00330772]Phase 3150 participants (Anticipated)Interventional2006-07-31Completed
Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-P [NCT04006288]Phase 490 participants (Actual)Interventional2019-09-06Completed
Effects of Clopidogrel vs Prasugel vs Ticagrelor on Endothelial Function, Inflammatory and Oxidative Stress Parameters and Platelet Function in Patients Undergoing Coronary Artery Stenting. A Randomised, Prospective Study. [NCT01700322]Phase 4126 participants (Actual)Interventional2012-08-31Completed
A Single Center, Double-Blind, Randomized Trial to Evaluate the Effects of Aspirin 325 mg + Clopidogrel 75 mg v. Aspirin 325 mg + Placebo on Plasma Concentration of C-Reactive Protein: The CATER Trial Protocol [NCT00343876]Phase 4100 participants (Anticipated)Interventional2005-07-31Completed
Impact of Pre-treatment With 600mg of Clopidogrel (Plavix) on the Incidence of Ischemic and Hemorrhagic Complications in Patients Undergoing Elective Percutaneous Coronary Revascularization.--Prospective Randomized Trial. [NCT00421252]Phase 418 participants (Actual)Interventional2007-01-31Terminated(stopped due to Difficult to enroll patients; limited resources available)
A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension [NCT00105209]Phase 220 participants Interventional2002-04-30Completed
Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER) [NCT00109382]Phase 2/Phase 3500 participants (Anticipated)Interventional2003-05-31Completed
Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes [NCT00404781]Phase 4305 participants (Actual)Interventional2006-06-30Completed
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial [NCT02959606]Phase 4272 participants (Anticipated)Interventional2016-12-31Recruiting
Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects. [NCT00152646]Phase 436 participants (Anticipated)Interventional2005-03-31Recruiting
Etude de la Reserve Vasomotrice Microcirculatoire cutanée [NCT00152724]85 participants (Actual)Observational1996-01-31Completed
A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2) [NCT00140465]Phase 460 participants (Actual)Interventional2004-10-31Completed
Recombinant Human Prourokinase(rhPro-UK)for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS≤5) Within 4.5 Hours After Symptom Onset [NCT05507645]Phase 31,446 participants (Anticipated)Interventional2022-10-21Recruiting
Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack [NCT00363753]Phase 10 participants (Actual)Interventional2006-08-31Withdrawn
Radix/Rhizoma Notoginseng Extract (Sanchitongtshu) Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Placebo-controlled Study [NCT02975076]120 participants (Anticipated)Interventional2016-12-31Not yet recruiting
Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease [NCT05821062]400 participants (Anticipated)Observational2022-04-14Recruiting
Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting [NCT01163604]Phase 4114 participants (Actual)Interventional2010-08-31Completed
Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes - the TC4 Comparative Effectiveness Study [NCT04057300]Phase 41,038 participants (Actual)Interventional2018-10-01Completed
Aspirin Non-responsiveness and Clopidogrel Endpoint Trial. [NCT00222261]Phase 41,001 participants (Actual)Interventional2003-04-30Completed
Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery [NCT00235248]Phase 3350 participants (Actual)Interventional2002-02-28Completed
A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healt [NCT00942175]Phase 1160 participants (Actual)Interventional2009-12-31Completed
Phase 4 Study of Clopidogrel in Patients With Stable Coronary Artery Disease to Determine Effects on Vascular Function, Biomarkers and Endothelial Progrenitor Cells [NCT01283282]Phase 448 participants (Actual)Interventional2008-01-31Completed
Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiograp [NCT00432120]Phase 30 participants Interventional2006-03-31Completed
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS [NCT00444132]Phase 350 participants (Anticipated)Interventional2005-03-31Completed
Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events [NCT00484926]Phase 42,000 participants (Actual)Interventional2007-03-31Completed
Validation of the Clinical Applicability of Various Platelet Function Assessments in High-Risk Atherothrombotic Patients Undergoing Percutaneous Coronary Angioplasty: Phase 4 Study [NCT00513149]Phase 4150 participants (Anticipated)Interventional2006-07-31Recruiting
A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers [NCT01526122]Phase 165 participants (Actual)Interventional2011-09-30Completed
The ANTARCTIC Study - Assessment of a Normal Versus Tailored Dose of Prasugrel After Stenting in Patients Aged > 75 Years to Reduce the Composite of Bleeding, Stent Thrombosis and Ischemic Complications [NCT01538446]Phase 4880 participants (Actual)Interventional2012-03-31Completed
Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation [NCT01543932]Phase 381 participants (Actual)Interventional2012-07-31Completed
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers) [NCT00115375]Phase 292 participants (Actual)Interventional2004-01-31Completed
Evaluation the Effect of the Double Maintenance Dose of Clopidogrel Versus Single Dose in Patients With Coronary Artery Disease With a BMI ≥ 27 kg.m-2 [NCT01509365]Phase 4116 participants (Actual)Interventional2011-12-31Completed
Open-label Randomized Control Trial to Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome [NCT05573958]Phase 490 participants (Anticipated)Interventional2022-10-01Not yet recruiting
One Year Effects of Different Clopidogrel Maintaining Dosage on Patients With Acute Coronary Syndrome Undergoing Coronary Drug Eluting Stent Implantation [NCT00404053]Phase 40 participants Interventional2004-12-31Completed
Uninterrupted Clopidogrel Therapy Before Elective Colonoscopy Will Increase the Risk of Post-polypectomy Bleeding [NCT01806090]Phase 4216 participants (Actual)Interventional2012-02-29Completed
Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients [NCT03823274]1,011 participants (Actual)Observational [Patient Registry]2019-04-01Completed
Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis [NCT03150680]1,080 participants (Anticipated)Observational [Patient Registry]2017-09-01Recruiting
A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II) [NCT03062826]347 participants (Actual)Observational2017-01-11Active, not recruiting
A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) [NCT00020189]Phase 20 participants Interventional2000-06-30Completed
A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low [NCT00050817]Phase 315,603 participants (Actual)Interventional2002-10-31Completed
Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study [NCT00163267]Phase 2/Phase 380 participants (Actual)Interventional2005-09-30Completed
Secondary Prevention of Small Subcortical Strokes (SPS3) Trial [NCT00059306]Phase 33,020 participants (Actual)Interventional2003-02-28Completed
Functional Mitral Regurgitation in STICH [NCT00224809]250 participants (Anticipated)Interventional2002-09-30Completed
Perioperative Risk Factors for the Development of Aspirin Low Response in Patients Undergoing Vascular Surgery. [NCT03587324]176 participants (Actual)Interventional2013-02-28Completed
PACT (Platelet Activity After Clopidogrel Termination) [NCT00619073]15 participants (Actual)Interventional2008-04-30Completed
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization [NCT00644657]27 participants (Actual)Interventional2007-03-31Completed
A Study of the Transition From Cangrelor to Clopidogrel or Prasugrel in Patients With Coronary Artery Disease. [NCT01979445]Phase 215 participants (Actual)Interventional2013-12-02Completed
The Impact of Grapefruit Juice on the Response to a Loading Dose and Maintenance Dose of Clopidogrel in Healthy Volunteers [NCT00817999]Phase 432 participants (Actual)Interventional2008-11-30Completed
Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens. [NCT05718531]Phase 3200 participants (Anticipated)Interventional2023-02-01Not yet recruiting
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX) [NCT01156571]Phase 311,145 participants (Actual)Interventional2010-09-30Completed
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile Among Coronary Artery Disease (CAD) Patients Undergoing Percutaneous Coronary Intervention (PCI) [NCT05516784]Phase 480 participants (Actual)Interventional2019-09-01Completed
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study) [NCT01612884]Phase 467 participants (Actual)Interventional2011-08-31Terminated(stopped due to Slow enrollment)
Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve [NCT02384070]300 participants (Actual)Interventional2009-01-31Completed
A Multicentre Study Comparing the Efficacy of Rosuvastatin With Atorvastatin When Given for a Period of 16 Wks to Subjects With Coronary Heart Disease & a Previously Performed Percutaneous Coronary Intervention [NCT00235950]Phase 4255 participants Interventional2004-01-31Completed
Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel [NCT00262275]0 participants Interventional2002-07-31Completed
Cervical Artery Dissection in Stroke Study [NCT00238667]Phase 3250 participants (Actual)Interventional2005-11-30Completed
A Sequence-randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetics and Safety After Oral Administration of Clopidogrel and Aspirin in Free Combination and Fixed-dose Combination as HCP0911 in Healthy Male Volunteers [NCT01448330]Phase 164 participants (Actual)Interventional2011-07-31Completed
A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI). [NCT00385138]Phase 35,364 participants (Actual)Interventional2006-09-30Terminated(stopped due to Insufficient evidence of the clinical effectiveness of cangrelor)
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers [NCT01603342]Phase 118 participants (Actual)Interventional2007-12-31Completed
Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Preven [NCT00300339]Phase 2599 participants (Actual)Interventional2006-02-28Completed
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry) [NCT00418860]1,200 participants (Anticipated)Interventional2006-09-30Completed
Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk [NCT02960126]Phase 31,500 participants (Anticipated)Interventional2016-11-30Not yet recruiting
A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel in Healthy Subjects [NCT06164834]Phase 148 participants (Anticipated)Interventional2023-12-05Not yet recruiting
Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy [NCT01495845]Phase 148 participants (Actual)Interventional2011-12-31Completed
Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers [NCT01496261]Phase 160 participants (Actual)Interventional2011-08-31Completed
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers [NCT01503658]Phase 418 participants (Actual)Interventional2012-01-31Completed
Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention [NCT01505790]Phase 3187 participants (Actual)Interventional2011-07-31Completed
Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet With Plavix® 75 mg In Healthy Subjects Under Fasting Conditions [NCT01506713]Phase 153 participants (Actual)Interventional2006-09-30Completed
Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD? [NCT01621451]Phase 4400 participants (Anticipated)Interventional2012-06-30Enrolling by invitation
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Table [NCT01621750]Phase 168 participants (Actual)Interventional2008-08-31Completed
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Clopidogrel 300 mg Tablets of Dr. Reddy's India and Plavix® 300 mg Tablets Under Fed Conditions [NCT01621763]Phase 168 participants (Actual)Interventional2008-09-30Completed
Evaluation of Ticagrelor Anti Platelet and Pleiotropic Effects in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome. [NCT01626534]Phase 3125 participants (Actual)Interventional2012-03-31Completed
Tailored Strategy for Residual Platelet Activity In Advanced Peripheral Artery Disease: New Optimal Management. [NCT01627431]Phase 4410 participants (Anticipated)Interventional2012-07-31Recruiting
An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Bioequivalence Study of Clopidogrel Tablets USP 75mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Plavix® (Clopidogrel Bisulfate Tablets) 75mg [NCT01630642]Phase 10 participants InterventionalCompleted
An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Bioequivalence Study of Clopidogrel Tablets USP 75mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Plavix® (Clopidogrel Bisulfate Tablets) 75mg [NCT01630915]Phase 10 participants InterventionalCompleted
Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment. [NCT01636180]Phase 40 participants (Actual)Interventional2012-03-31Withdrawn
Aspirin Versus Clopidogrel Effect on Uterine Perfusion in Women With Unexplained Recurrent Pregnancy Loss With Decreased Uterine Artery Pulsatility Index: A Randomized Controlled Trial [NCT01635426]Phase 2/Phase 332 participants (Anticipated)Interventional2012-03-31Recruiting
Effect of Modifying Anti-platelet Treatment to Ticagrelor in Patients With Diabetes and Low Response to Clopidogrel [NCT01643031]Phase 4500 participants (Anticipated)Interventional2012-08-31Not yet recruiting
A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healt [NCT01657071]Phase 160 participants (Actual)Interventional2012-03-31Completed
Safety and Efficacy of Intensive Versus Guideline Antiplatelet Therapy in High Risk Patients With Recent Ischaemic Stroke or Transient Ischaemic Attack: a Randomised Controlled Trial [NCT01661322]Phase 33,096 participants (Actual)Interventional2009-04-30Terminated(stopped due to Trial reached a definitive answer ahead of full recruitment.)
Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers [NCT01663038]Phase 160 participants (Actual)Interventional2010-12-31Completed
The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis [NCT01665235]200 participants (Anticipated)Interventional2012-08-31Recruiting
Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial [NCT04624854]Phase 48,250 participants (Anticipated)Interventional2020-10-27Recruiting
A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent. [NCT01684813]Phase 465 participants (Anticipated)Interventional2012-10-31Completed
A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT [NCT05936606]3,434 participants (Anticipated)Interventional2023-08-16Recruiting
Smart Angioplasty Research Team: Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes (SMART-DATE) [NCT01701453]2,712 participants (Actual)Interventional2012-08-31Active, not recruiting
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease [NCT01706510]Phase 428 participants (Actual)Interventional2012-12-31Completed
Effects of Ticagrelor and Intracoronary Morphine on Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT01738100]Phase 2100 participants (Anticipated)Interventional2012-09-30Recruiting
A Prospective, Randomized, Two Period, With an Intermediate Wash Out Period, Cross-over Study to Compare the Effects of Either Combined Therapy With Ramipril and Clopidogrel or Ramipril Monotherapy on Oxidative Stress, Vascular Inflammation and Endothelia [NCT01743014]Phase 460 participants (Anticipated)Interventional2012-07-31Recruiting
A Open Label, Randomized, Crossover and Potential Parallel, Single Dose Study of Ticagrelor 180 mg and Acetylsalicylic Acid (ASA) in Healthy Volunteers Followed by Autologous in Vivo Platelet Transfusion to Determine the Effects of Platelet Supplementatio [NCT01744288]Phase 1258 participants (Actual)Interventional2012-12-31Completed
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine (SPRING): a Multicenter, Random, Case Control Study [NCT04946734]Phase 3440 participants (Anticipated)Interventional2021-08-12Recruiting
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial [NCT02939872]Phase 4238 participants (Actual)Interventional2017-03-09Active, not recruiting
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study [NCT01757262]Phase 30 participants (Actual)Interventional2013-01-31Withdrawn
Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial) [NCT01763749]Phase 491 participants (Actual)Interventional2012-10-31Completed
Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention [NCT01765452]Phase 4285 participants (Actual)Interventional2012-10-31Completed
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome [NCT01774838]Phase 349 participants (Actual)Interventional2014-10-31Completed
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions of Aspirin Co-administration on the PK/PD of Clopidogrel and PK of Digoxin in Healthy Volunteers [NCT01775839]Phase 424 participants (Actual)Interventional2013-01-31Completed
Phase IV: A Comparison of Reduced-dose Prasugrel and Clopidogrel in Elderly Patients With Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention (PCI) [NCT01777503]Phase 42,000 participants (Anticipated)Interventional2012-11-30Recruiting
PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy. [NCT01778842]Phase 368 participants (Anticipated)Interventional2013-03-31Not yet recruiting
Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients. [NCT01779401]1,078 participants (Actual)Interventional2012-09-30Completed
A REAl-life Study on Short-term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or Transient Ischemic Attack [NCT05476081]1,067 participants (Anticipated)Observational [Patient Registry]2021-02-03Recruiting
The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention [NCT01812330]Phase 3180 participants (Anticipated)Interventional2013-01-31Recruiting
Bedside Testing of the CYP2C19 Gene to Asses Effectiveness of Clopidogrel in Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention : Individualized Antiplatelet Drugs Treatment to Improve Prognosis [NCT01823185]Phase 41,500 participants (Anticipated)Interventional2013-03-31Recruiting
Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study [NCT01826175]Phase 40 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to Study terminated mutually by sponsor & PI due to no enrollment)
Study of the Effect of Ticagrelor and Clopidogrel on the Immune Response of Healthy Volunteers [NCT01846559]Phase 430 participants (Actual)Interventional2013-04-30Completed
A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis [NCT04847752]1,000 participants (Anticipated)Observational2021-03-01Recruiting
Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy. [NCT01212302]500 participants (Actual)Interventional2008-10-31Completed
Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) [NCT01742117]Phase 45,276 participants (Actual)Interventional2013-05-31Completed
Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty [NCT02327741]1,010 participants (Actual)Interventional2012-10-31Completed
CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study [NCT02742987]Phase 442 participants (Actual)Interventional2014-03-31Completed
Comparison of Dual-Antiplatelet and Triple-Antiplatelet Preparation Using P2Y12 Assay in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for An Unruptured Intracranial Aneurysm [NCT03581409]Phase 4198 participants (Actual)Interventional2018-10-24Completed
A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System [NCT01589978]Phase 42,681 participants (Actual)Interventional2012-05-31Completed
Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction [NCT02931045]Phase 460 participants (Actual)Interventional2017-12-30Completed
Randomized, Crossover Study of the Antithrombotic Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin When Administered With Bivalirudin [NCT01642238]Phase 415 participants (Actual)Interventional2012-07-31Completed
Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment (A Possible Mechanism of HOTPR:High On- Treatment Platelet Reactivity) [NCT03190005]35 participants (Actual)Observational2017-01-01Completed
A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin [NCT02052635]Phase 434 participants (Actual)Interventional2014-09-30Terminated(stopped due to Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe)
A Phase 2, Open Label, Pilot Study to Examine the Use of Rivaroxaban Plus Aspirin vs. Clopidogrel Plus Aspirin for the Prevention of Restenosis After Infrainguinal Percutaneous Transluminal Angioplasty for Critical Limb Ischemia [NCT02260622]Phase 220 participants (Actual)Interventional2014-10-31Completed
PHARMACOGENOMICS OF ANTI-PLATELET RESPONSE - I [NCT01815008]Phase 419 participants (Actual)Interventional2012-10-31Completed
Comparative Study of the Antithrombotic Effects of Ticagrelor and Clopidogrel in Type 2 Diabetic Patients [NCT01823510]Phase 420 participants (Actual)Interventional2013-07-31Completed
Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy [NCT06175377]660 participants (Anticipated)Interventional2024-03-30Not yet recruiting
Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients With Acute Myocardial Infarction: A Randomized, Placebo-controlled ACCEL-EPISODE Trial [NCT04407312]Phase 460 participants (Actual)Interventional2016-01-01Active, not recruiting
Pharmacokinetics and Pharmacodynamics of Platelet P2Y12 Inhibitors in Patients Undergoing Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction: A Pilot Study [NCT02376283]Phase 487 participants (Actual)Interventional2015-03-09Completed
Tailoring Bleeding Reduction Approaches in Patients Undergoing Percutaneous Coronary Interventions: Comparative Pharmacodynamic Effects of Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy De-escalation [NCT05681702]Phase 490 participants (Anticipated)Interventional2023-02-15Recruiting
Bioavailability of Two Oral Formulations of Clopidogrel: A Randomized, Open Label, Single Dose, Two-Period, Crossover Comparison in Healthy Mexican Volunteers [NCT01447563]Phase 132 participants (Actual)Interventional2008-05-31Terminated
Observational Study on Predictive Value for Vascular Events of Residual Platelet Aggregation in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting [NCT01449617]272 participants (Anticipated)Observational2010-08-31Recruiting
Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial [NCT05960721]4,220 participants (Anticipated)Interventional2023-07-06Recruiting
Replication of the PLATO Antiplatelet Trial in Healthcare Claims Data [NCT04237935]27,960 participants (Actual)Observational2019-09-22Completed
Replication of the TRITON-TIMI Antiplatelet Trial in Healthcare Claims Data [NCT04237922]43,864 participants (Actual)Observational2019-09-22Completed
Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent [NCT01341964]Phase 4302 participants (Actual)Interventional2011-05-31Completed
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI) [NCT01463150]Phase 427 participants (Actual)Interventional2011-10-31Completed
A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary [NCT01864005]Phase 460 participants (Actual)Interventional2013-05-31Completed
Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol [NCT04368377]Phase 25 participants (Actual)Interventional2020-04-06Completed
Efficacy and Safety of Different Ticagrelor Regimens Versus Clopidogrel in Patients With Coronary Artery Disease: a Retrospective Multicenter Study (SUPERIOR) [NCT03381742]Phase 2/Phase 33,043 participants (Actual)Interventional2017-12-13Completed
The Accuracy Of A Novel Platelet Activity Assay In Humans On Antiplatelet Agents: Pharmacodynamics And Comparison With Light Transmission Aggregometry [NCT04822363]Early Phase 1125 participants (Anticipated)Interventional2021-08-20Recruiting
Study of the Efficacy and Safety of Cilostazol in the Prevention of Ischemic Vascular Events in Diabetic Patients With Symptomatic Peripheral Artery Disease. [NCT02983214]Phase 4826 participants (Actual)Interventional2016-11-30Completed
Antiplatelet Therapy in HIV - Antiplatelet and Immune Modulating Effects of Aspirin or Clopidogrel in Subjects With HIV [NCT02559414]Phase 255 participants (Actual)Interventional2015-02-28Completed
Pharmacodynamic Effects of Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus: The Optimizing Anti-Platelet Therapy In Diabetes MellitUS (OPTIMUS)-5 Study [NCT02548650]Phase 466 participants (Actual)Interventional2016-03-25Completed
The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack.10 vs 30 Days of Combination ASA and Clopidogrel Study [NCT02144831]Phase 40 participants (Actual)Interventional2014-07-31Withdrawn(stopped due to Could not get study started)
Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG) [NCT01158703]Phase 420 participants (Actual)Interventional2010-07-31Terminated(stopped due to poor recruitment and reduction in CT surgery support)
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion [NCT04502017]Phase 4360 participants (Anticipated)Interventional2020-08-05Recruiting
Clopidogrel Pharmacogenomics Project [NCT01097343]Phase 250 participants (Actual)Interventional2010-03-31Completed
Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in High-risk Patients With Acute Non-disabling Cerebrovascular Events (ADANCE): Rationale, Objectives, and Design [NCT01924325]Phase 2/Phase 310,000 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, P [NCT03430661]Phase 177 participants (Actual)Interventional2018-01-24Completed
Optimal Duration of Clopidogrel After Implantation of Second-Generation Drug-Eluting Stents (OPTIMA-C) [NCT03056118]Phase 41,368 participants (Actual)Interventional2011-05-02Completed
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial [NCT05910125]Phase 4472 participants (Anticipated)Interventional2023-07-31Not yet recruiting
Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study) [NCT04393025]Phase 450 participants (Actual)Interventional2016-06-30Completed
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry [NCT01515345]Phase 31,008 participants (Actual)Interventional2011-07-31Completed
Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study: A Prospective, Multicenter, Randomized Trial of Genotype-directed (G-D)Versus Standard of Care (SOC)Anti-platelet Therapy [NCT01452152]Phase 49 participants (Actual)Interventional2012-02-29Terminated(stopped due to Terminated by study sponsor.)
Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT [NCT03197298]2,062 participants (Actual)Observational [Patient Registry]2012-12-21Completed
TRIANA: A Randomized Trial to Compare the Efficay and Safety of Thrombolysis With Primary Angioplasty as Initial Reperfusion Therapy in Older Patients (>= 75 Years Old) With Acute Myocardial Infarction [NCT00257309]Phase 4266 participants (Actual)Interventional2005-04-30Terminated(stopped due to Slow recruitment)
A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial [NCT02696226]3 participants (Actual)Interventional2016-02-29Terminated(stopped due to Poor enrollment)
Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel [NCT04431349]1,097 participants (Actual)Observational2016-01-01Completed
Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers [NCT02554721]Phase 177 participants (Actual)Interventional2015-08-31Completed
Evaluation of Platelet Aggregation and Adenosine Levels in Patients With Coronary Artery Disease and Chronic Kidney Dysfunction Taking Dual Antiplatelet Therapy With Aspirin and Clopidogrel or Ticagrelor [NCT03039205]Phase 290 participants (Actual)Interventional2017-11-07Completed
Modulation of the WNT/Beta-Catenin Pathway in Patients With Acute Myocardial Infarction [NCT05122741]50 participants (Anticipated)Observational [Patient Registry]2021-12-01Recruiting
Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial [NCT01830491]Phase 4162 participants (Actual)Interventional2009-03-31Completed
Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention [NCT04981041]Phase 42,334 participants (Anticipated)Interventional2021-12-16Recruiting
A Randomized, Open-Label, Cross-Over, Study to Evaluate the Inhibitory Effect of Clopidogrel, EC Aspirin 81 mg and EC Omeprazole 40 mg All Dosed Concomitantly and PA32540 and Clopidogrel Dosed Separately on Platelet Aggregation in Healthy Volunteers [NCT01557335]Phase 130 participants (Actual)Interventional2010-11-30Completed
Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards SAPIEN XT Valve. A Randomized Pilot Study (the ARTE Trial) [NCT01559298]Phase 4178 participants (Actual)Interventional2012-03-31Completed
Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary S [NCT01572129]Phase 4240 participants (Anticipated)Interventional2011-11-30Recruiting
Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial. [NCT01572623]Phase 4150 participants (Anticipated)Interventional2011-07-31Recruiting
The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency [NCT01598337]Phase 3200 participants (Anticipated)Interventional2011-04-30Recruiting
A Randomized, Pilot, Single-center Study, Investigator-Initiated Study to Look at an Aggressive Therapeutic Approach in Aspirin Resistant Patients Comparing to Standard for Patient Undergoing Percutaneous Coronary Intervention [NCT01103440]Phase 236 participants (Actual)Interventional2007-04-30Completed
Extended Antiplatelet Therapy With Clopidogrel Alone Versus Clopidogrel Plus Aspirin After Completion of 9- to 12-month Dual Antiplatelet Therapy for ACS Patients With Both High Bleeding and Ischemic Risk. [NCT03431142]Phase 47,700 participants (Anticipated)Interventional2018-02-12Recruiting
Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes [NCT02556203]Phase 31,653 participants (Actual)Interventional2015-12-16Terminated(stopped due to Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator)
A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrom [NCT02293395]Phase 23,037 participants (Actual)Interventional2015-04-20Completed
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia [NCT02230527]Phase 2/Phase 346 participants (Actual)Interventional2014-10-31Terminated(stopped due to Lack of enrollment)
Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities [NCT02217501]Phase 3159 participants (Actual)Interventional2015-11-30Completed
Stroke and Coated-Platelets - A Translational Research Initiative [NCT04698031]Phase 4152 participants (Anticipated)Interventional2022-03-30Recruiting
Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study [NCT01960296]Phase 248 participants (Actual)Interventional2012-01-31Completed
Safety of Ticagrelor Plus Warfarin Versus Clopidogrel+Aspirin+Warfarin in Patients With Persistent or Permanent Atrial Fibrillation and Undergoing PCI-S: A Randomized, Open, Controlled, Parallel Group, Multi-center Trial [NCT02206815]Phase 4296 participants (Actual)Interventional2014-09-19Completed
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions [NCT04744571]200 participants (Anticipated)Interventional2021-02-28Enrolling by invitation
"Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel in Patients Undergoing One-stop Hybrid Coronary Revascularization" [NCT02513004]Phase 460 participants (Anticipated)Interventional2015-06-30Recruiting
Pharmacodynamic Evaluation of Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease [NCT02287909]Phase 487 participants (Actual)Interventional2014-12-31Completed
Intravenous Thrombolysis With Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Acute Non-large Vessel Occlusion in Extended Time Window--A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial [NCT05752916]Phase 4568 participants (Anticipated)Interventional2023-06-02Recruiting
Pembrolizumab in Combination With Anti-platelet Therapy for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck [NCT03245489]Phase 120 participants (Anticipated)Interventional2017-10-20Recruiting
Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis. [NCT00360386]Phase 2110 participants Interventional2004-03-31Completed
Left Atrial Appendage Occlusion Versus Novel Oral Anti-coagulation in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention: a Randomized, Multicentre, Open-label, Non-inferiority Trial [NCT05353140]1,386 participants (Anticipated)Interventional2022-09-01Recruiting
Randomized Clinical Trial Assessing the Value of Beta-Blockers and Antiplatelet Agents in Patients With Spontaneous Coronary Artery Dissection. (The BA-SCAD Randomized Clinical Trial) [NCT04850417]Phase 4600 participants (Anticipated)Interventional2021-04-30Not yet recruiting
The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel [NCT01790997]Phase 3126 participants (Actual)Interventional2012-05-31Completed
A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting [NCT02330640]Phase 4137 participants (Actual)Interventional2016-01-31Completed
Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs [NCT03111420]280 participants (Actual)Interventional2017-01-09Completed
Incidence Des évènements cArdiovasculaires majeurS Chez Les Patients COronariens diabétiques Subissant Une angioPlastie Coronaire et traités Par Clopidogrel à la Dose 150 mg Versus 75 mg [NCT03329261]Phase 4167 participants (Actual)Interventional2017-12-07Completed
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial [NCT03078465]Phase 30 participants (Actual)Interventional2017-06-20Withdrawn(stopped due to Competitive studies were conducted at the same time, and enrollment was suspended.)
Reassessment of Long-Term Dual Anti-Platelet Therapy Using InDividualized Strategies - Using a Novel Combined Demographic and Pharmacogenomic Strategy: The RAPID EXTEND Pilot Study [NCT03224923]Phase 45 participants (Actual)Interventional2017-08-18Terminated(stopped due to Competing study to be started in November 2018)
Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention [NCT04999293]1,505 participants (Actual)Observational2021-07-20Completed
The Association Between Plasma or Platelet microRNAs and Clopidogrel Low Response and Its Mechanism [NCT02447809]Phase 4400 participants (Anticipated)Interventional2015-01-31Recruiting
Impact of Antiretroviral Treatment on Pharmacokinetics and Pharmacodynamics of Thienopyridines in Healthy Volunteers and HIV Patients [NCT03054207]Phase 121 participants (Actual)Interventional2015-06-30Terminated(stopped due to difficulty to recruit)
An Open-label, Randomised, Three-way Crossover Study in Healthy Subjects to Assess the Bioequivalence of European Source Generic Clopidogrel Tablets and US and Japanese Source Branded Clopidogrel (Plavix®) Tablets. [NCT02185534]Phase 1144 participants (Actual)Interventional2014-08-31Completed
Investigating the Changes of the Cognition in Asymptomatic Intracranial Stenosis Patients After 1-Year Standard Medical Treatment Without Stenting [NCT04850001]40 participants (Anticipated)Observational2020-09-10Recruiting
Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization [NCT02433587]Phase 30 participants (Actual)Interventional2019-10-31Withdrawn(stopped due to Never recruited any patients.)
Safety and Efficacy of Low-Dose Ticagrelor in Chinese Patients With Non-ST-Elevation Acute Coronary Syndrome: A Randomized Clinical Trial [NCT02415803]Phase 375 participants (Anticipated)Interventional2014-12-31Recruiting
[NCT02411903]Phase 4160 participants (Anticipated)Interventional2015-03-31Enrolling by invitation
Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction [NCT00386191]Phase 41,110 participants (Actual)Interventional2006-09-30Completed
A Phase III Multi-centre Double-blind Placebo Controlled Study Analysing the Efficacy and Safety of Daily Administration of a P2Y12 Inhibitor (Clopidogrel) for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer [NCT02404363]Phase 339 participants (Actual)Interventional2016-01-11Terminated(stopped due to recruitment problem)
The Relationship Between Genotype and Platelet Reactivity in Patients Treated With Ticagrelor Versus Clopidogrel: PIANO Genotype Study [NCT02394145]Phase 320 participants (Anticipated)Interventional2009-09-30Recruiting
A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Followi [NCT03766581]Phase 22,366 participants (Actual)Interventional2019-01-27Completed
Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure. [NCT03103685]Phase 4428 participants (Anticipated)Interventional2017-05-01Not yet recruiting
[NCT02391883]356 participants (Actual)Observational2011-01-31Completed
The Study of Berberine Affecting Metabolism, Inflammation Status, Endothelial Function and Thrombotic Events in Patients With Coronary Artery Disease by Remodeling Gut Microbiota [NCT04434365]Phase 1/Phase 224 participants (Actual)Interventional2019-06-21Active, not recruiting
Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial [NCT04770012]Phase 3135 participants (Anticipated)Interventional2021-06-28Recruiting
Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients [NCT03078257]Phase 190 participants (Anticipated)Interventional2016-01-01Recruiting
Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator [NCT02331511]100 participants (Anticipated)Interventional2015-10-31Recruiting
24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial [NCT04989257]3,488 participants (Anticipated)Interventional2021-08-31Not yet recruiting
A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI). [NCT00305162]Phase 38,882 participants (Actual)Interventional2006-04-30Terminated(stopped due to Insufficient evidence of the clinical effectiveness of cangrelor)
Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications [NCT01586975]Phase 2/Phase 393 participants (Actual)Interventional2007-07-31Completed
EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy [NCT02244710]109 participants (Actual)Interventional2015-03-31Completed
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-control [NCT03599284]Phase 2279 participants (Actual)Interventional2018-08-30Completed
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel [NCT01456546]Phase 131 participants (Actual)Interventional2011-10-31Completed
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month [NCT03606642]Phase 250 participants (Actual)Interventional2018-11-19Active, not recruiting
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation [NCT01813435]Phase 315,991 participants (Actual)Interventional2013-07-01Completed
"Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention (The ELIMIT Trial)" [NCT00687076]Phase 4102 participants (Actual)Interventional2004-04-30Completed
The Randomized, Double-blind, Placebo-controlled Clinical Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent High-risk Ischemic Stroke Recurrence [NCT04142151]60 participants (Anticipated)Interventional2019-09-01Recruiting
Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction [NCT04369534]Phase 4120 participants (Actual)Interventional2015-12-01Completed
Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study [NCT01896557]Phase 492 participants (Actual)Interventional2011-10-31Completed
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. [NCT04333407]320 participants (Actual)Interventional2020-04-03Terminated(stopped due to Difficulty in recruiting eligible participants)
Body Weight Adjusted Clopidogrel Treatment in Patients With Coronary Artery Disease [NCT05657041]Phase 2/Phase 380 participants (Anticipated)Interventional2023-04-26Recruiting
Fasting, Comparative, Open-label, Randomized, Four-period, Two-sequence, Bioequivalence Study of Сlopidogrel Bisulfate Film-coated Tablets, 75 mg (JSC Farmak, Ukraine) vs Plavix® 75 mg Film-coated Tablets in Healthy Adult Subjects [NCT05125549]Phase 148 participants (Actual)Interventional2018-07-12Completed
Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial [NCT05257824]Phase 4528 participants (Anticipated)Interventional2022-06-23Recruiting
Study of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy [NCT03072121]Phase 4440 participants (Anticipated)Interventional2017-06-30Not yet recruiting
Pharmacodynamic Effects of Different Ticagrelor Maintenance Dosing Regimens With and Without Aspirin in Patients With Diabetes Mellitus: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-7 Study [NCT04484259]Phase 463 participants (Anticipated)Interventional2021-03-31Recruiting
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Pharmacokinetics Sub-trial [NCT01510327]Phase 322 participants (Actual)Interventional2009-10-31Completed
A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease [NCT03008083]Phase 42,446 participants (Anticipated)Interventional2019-01-10Recruiting
[NCT03006835]Phase 4120 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Dapagliflozin Effect in Cognitive Impairment in Stroke Trial [NCT05565976]Phase 2/Phase 3270 participants (Anticipated)Interventional2020-08-01Recruiting
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI) [NCT03001960]Phase 3200 participants (Anticipated)Interventional2017-03-31Not yet recruiting
Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon [NCT05098704]Phase 2/Phase 390 participants (Anticipated)Interventional2022-06-22Recruiting
A Randomized, Open-label, Active-Controlled and Blinded-Endpoint Trial Comparing the Antiplatelet Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin in Chinese Patients With High-risk Transient Ischemic Attack or Minor Stroke. [NCT02506140]Phase 2/Phase 3675 participants (Actual)Interventional2015-08-31Completed
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial [NCT02514642]Phase 430 participants (Anticipated)Interventional2015-07-31Recruiting
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study [NCT02319941]Phase 265 participants (Actual)Interventional2015-05-20Completed
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial [NCT02494284]Phase 4364 participants (Actual)Interventional2015-12-22Terminated(stopped due to Slow enrollment)
Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents (ADAPT AF-DES) [NCT04250116]Phase 4960 participants (Anticipated)Interventional2020-04-28Recruiting
A Prospective, Multicentre, Randomized, Open Label, Blinded Endpoint, Phase 3 Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular E [NCT02989558]Phase 390 participants (Actual)Interventional2016-12-31Completed
Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin [NCT01768637]Phase 148 participants (Actual)Interventional2013-01-31Completed
An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome [NCT04023630]Phase 44,000 participants (Anticipated)Interventional2019-10-01Not yet recruiting
Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous [NCT02320357]Phase 1/Phase 218 participants (Actual)Interventional2015-08-19Completed
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus C [NCT02164864]Phase 32,725 participants (Actual)Interventional2014-07-22Completed
Low-dose of Ticagrelor and Standard-dose Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study [NCT03679091]Phase 436 participants (Actual)Interventional2018-08-29Completed
Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion [NCT03431909]Phase 480 participants (Actual)Interventional2014-01-01Completed
Effects of Edoxaban on Platelet Aggregation in Patients With Stable Coronary Artery Disease [NCT05122455]Phase 2/Phase 370 participants (Anticipated)Interventional2021-09-14Recruiting
Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects [NCT03392051]Phase 118 participants (Actual)Interventional2017-12-28Completed
Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation [NCT06102720]Phase 4200 participants (Anticipated)Interventional2023-01-12Recruiting
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease [NCT01523366]Phase 453 participants (Actual)Interventional2012-04-30Completed
A Randomized, Open-label Single-center Trial of Lipo-prostaglandin E1 Improves Coronary Microcirculation Dysfunction in Patients With Ischemic Heart Disease Combine With Diabetes Mellitus [NCT03159559]Phase 460 participants (Anticipated)Interventional2017-01-31Active, not recruiting
Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study [NCT03661411]Phase 4760 participants (Actual)Interventional2018-10-17Completed
Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Thrombolysis With Low Dose Tenecteplase (TNK-tPA) Versus Standard of Care in Minor Ischemic Stroke With Proven Acute Symptomatic Occlusion [NCT02398656]Phase 31,274 participants (Anticipated)Interventional2015-04-30Recruiting
An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [NCT01830543]Phase 32,124 participants (Actual)Interventional2013-05-10Completed
Pharmacodynamic Outcomes in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention Treated With an Individualized Treatment STRATEGY [NCT05773989]Phase 488 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers [NCT02010632]Phase 132 participants (Actual)Interventional2013-08-31Completed
A Randomized, Open-Label, Parallel-Group, Multi-Center Study Of Adding Edoxaban Or Clopidogrel To Aspirin To Maintain Patency In Subjects With Peripheral Arterial Disease Following Femoropopliteal Endovascular Intervention [NCT01802775]Phase 2203 participants (Actual)Interventional2013-02-06Completed
Effect of Haemodialysis on the Efficacy of Antiplatelet Agents [NCT03330223]60 participants (Anticipated)Observational2017-11-10Recruiting
The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study [NCT03372785]240 participants (Anticipated)Observational [Patient Registry]2018-04-10Enrolling by invitation
Role of Anti-platelet in Treatment of Acute Ischemic Stroke [NCT03266731]120 participants (Anticipated)Interventional2018-01-04Not yet recruiting
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 [NCT04505774]Phase 4880 participants (Actual)Interventional2020-09-04Active, not recruiting
Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction) [NCT02428374]Phase 4300 participants (Anticipated)Interventional2015-05-31Recruiting
A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease [NCT01732822]Phase 313,885 participants (Actual)Interventional2012-12-04Completed
Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia [NCT02224274]Phase 457 participants (Actual)Interventional2014-08-31Completed
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in African American Patients With Stable Coronary Artery Disease [NCT01523392]Phase 450 participants (Actual)Interventional2012-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00059215 (4) [back to overview]Number of Participants With Major Adverse Cardiovascular Events (MACE)
NCT00059215 (4) [back to overview]Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE
NCT00059215 (4) [back to overview]Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
NCT00059215 (4) [back to overview]Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
NCT00097591 (6) [back to overview]Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
NCT00097591 (6) [back to overview]Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
NCT00097591 (6) [back to overview]Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events
NCT00097591 (6) [back to overview]Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke
NCT00097591 (6) [back to overview]Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)
NCT00097591 (6) [back to overview]Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events
NCT00130039 (6) [back to overview]Number of Patients With Ipsilateral Ischemic Stroke Rate
NCT00130039 (6) [back to overview]Numbers of Fatal or Major Bleeding Complications
NCT00130039 (6) [back to overview]Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI
NCT00130039 (6) [back to overview]Number of Participants With Stroke Events
NCT00130039 (6) [back to overview]Number of Participants With Progression of Symptomatic Intracranial Stenosis
NCT00130039 (6) [back to overview]Number of Participants With Overall Cardiovascular Events
NCT00153062 (5) [back to overview]Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
NCT00153062 (5) [back to overview]Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
NCT00153062 (5) [back to overview]Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
NCT00153062 (5) [back to overview]Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
NCT00153062 (5) [back to overview]Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
NCT00228423 (4) [back to overview]Vein Graft Intimal Area
NCT00228423 (4) [back to overview]Vein Graft Angiographic Patency
NCT00228423 (4) [back to overview]Incidence of Major Bleeding Events Within One Year Following Surgery
NCT00228423 (4) [back to overview]Incidence of Major Adverse Coronary Events Within One Year Following Surgery
NCT00249873 (4) [back to overview]Death From Any Cause (Cardiovascular and Noncardiovascular)
NCT00249873 (4) [back to overview]Adjudicated Major Bleedings
NCT00249873 (4) [back to overview]First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication
NCT00249873 (4) [back to overview]Occurrence of Stroke
NCT00257309 (2) [back to overview]Death/Reinfarction/Disabling Stroke at 30 Days
NCT00257309 (2) [back to overview]Incidence of Death or Reinfarction or Disabling Stroke
NCT00263211 (5) [back to overview]Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
NCT00263211 (5) [back to overview]Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
NCT00263211 (5) [back to overview]Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
NCT00263211 (5) [back to overview]Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
NCT00263211 (5) [back to overview]Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
NCT00305162 (17) [back to overview]Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
NCT00305162 (17) [back to overview]Incidence of All Cause Mortality
NCT00305162 (17) [back to overview]Incidence of All-cause Mortality
NCT00305162 (17) [back to overview]Incidence of All-cause Mortality and MI
NCT00305162 (17) [back to overview]Incidence of All-cause Mortality or MI
NCT00305162 (17) [back to overview]Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
NCT00305162 (17) [back to overview]Incidence of GUSTO Severe / Life-threatening Bleeding
NCT00305162 (17) [back to overview]Incidence of IDR
NCT00305162 (17) [back to overview]Incidence of MI
NCT00305162 (17) [back to overview]Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
NCT00305162 (17) [back to overview]Incidence of All-cause Mortality, MI or IDR
NCT00305162 (17) [back to overview]Individual Incidence of All-cause Mortality
NCT00305162 (17) [back to overview]Incidence of ACUITY Major Bleeding
NCT00305162 (17) [back to overview]Incidence of Stroke
NCT00305162 (17) [back to overview]Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
NCT00305162 (17) [back to overview]Incidence of Stroke
NCT00305162 (17) [back to overview]Individual Incidence of IDR
NCT00335452 (7) [back to overview]First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
NCT00335452 (7) [back to overview]First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
NCT00335452 (7) [back to overview]Occurrence of Major Bleeding - ASA Dose Level Comparison
NCT00335452 (7) [back to overview]Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison
NCT00335452 (7) [back to overview]Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
NCT00335452 (7) [back to overview]First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
NCT00335452 (7) [back to overview]First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
NCT00356135 (6) [back to overview]Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week
NCT00356135 (6) [back to overview]Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
NCT00356135 (6) [back to overview]Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
NCT00356135 (6) [back to overview]Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
NCT00356135 (6) [back to overview]Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)
NCT00356135 (6) [back to overview]Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event
NCT00357968 (18) [back to overview]Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
NCT00357968 (18) [back to overview]Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
NCT00357968 (18) [back to overview]Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
NCT00357968 (18) [back to overview]Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
NCT00357968 (18) [back to overview]Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
NCT00357968 (18) [back to overview]Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
NCT00357968 (18) [back to overview]Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
NCT00357968 (18) [back to overview]Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
NCT00357968 (18) [back to overview]Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
NCT00357968 (18) [back to overview]Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
NCT00385138 (20) [back to overview]Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
NCT00385138 (20) [back to overview]Incidence of Stent Thrombosis
NCT00385138 (20) [back to overview]Incidence of Stent Thrombosis
NCT00385138 (20) [back to overview]Incidence of Stroke
NCT00385138 (20) [back to overview]Incidence of Stroke
NCT00385138 (20) [back to overview]Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality or MI
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality, MI, or IDR
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
NCT00385138 (20) [back to overview]Incidence of GUSTO Severe / Life-threatening
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality
NCT00385138 (20) [back to overview]Incidence of IDR
NCT00385138 (20) [back to overview]Incidence of MI
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality
NCT00385138 (20) [back to overview]Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
NCT00385138 (20) [back to overview]Incidence of ACUITY Major Bleeding
NCT00385138 (20) [back to overview]Incidence of IDR
NCT00385138 (20) [back to overview]Incidence of All-cause Mortality or MI
NCT00385138 (20) [back to overview]Incidence of MI
NCT00385944 (18) [back to overview]Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)
NCT00385944 (18) [back to overview]Correlation of MPA to 20 μM ADP and PRU
NCT00385944 (18) [back to overview]Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP
NCT00385944 (18) [back to overview]Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP
NCT00385944 (18) [back to overview]Inhibition Platelet Aggregation (IPA) to 20 μM ADP
NCT00385944 (18) [back to overview]Inhibition Platelet Aggregation (IPA) to 5 μM ADP
NCT00385944 (18) [back to overview]Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)
NCT00385944 (18) [back to overview]Mean Residual Platelet Aggregation (RPA) to 20 µM ADP
NCT00385944 (18) [back to overview]Mean Residual Platelet Aggregation (RPA) to 5 µM ADP
NCT00385944 (18) [back to overview]MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)
NCT00385944 (18) [back to overview]MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)
NCT00385944 (18) [back to overview]MPA to 5 μM ADP
NCT00385944 (18) [back to overview]P2Y12 Reaction Units (PRU)
NCT00385944 (18) [back to overview]Platelet Reactivity Index (PRI)
NCT00385944 (18) [back to overview]Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)
NCT00385944 (18) [back to overview]Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
NCT00385944 (18) [back to overview]Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)
NCT00385944 (18) [back to overview]Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)
NCT00391872 (16) [back to overview]Participants With Major or Minor Bleeding
NCT00391872 (16) [back to overview]Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
NCT00391872 (16) [back to overview]Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
NCT00391872 (16) [back to overview]Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
NCT00391872 (16) [back to overview]Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
NCT00391872 (16) [back to overview]Participants With Any Major Bleeding Event
NCT00391872 (16) [back to overview]Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
NCT00391872 (16) [back to overview]Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
NCT00391872 (16) [back to overview]Participants With Death From Any Cause
NCT00391872 (16) [back to overview]Participants With Death From Vascular Causes
NCT00391872 (16) [back to overview]Participants With MI Event
NCT00391872 (16) [back to overview]Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
NCT00391872 (16) [back to overview]Participants With Non-procedural Major Bleeding
NCT00391872 (16) [back to overview]Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
NCT00391872 (16) [back to overview]Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
NCT00391872 (16) [back to overview]Participants With Stroke
NCT00396877 (3) [back to overview]Number of Participants With Bleeding Events
NCT00396877 (3) [back to overview]Number of Participants According to Bleeding Type/Etiology
NCT00396877 (3) [back to overview]Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
NCT00528411 (45) [back to overview]Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Post 6-week Treatment: FVC
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
NCT00528411 (45) [back to overview]Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: VT
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: VE
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: TLC
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: SpO2
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: RV
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: RR
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: FRC
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: EF
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
NCT00528411 (45) [back to overview]Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
NCT00528411 (45) [back to overview]Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
NCT00619073 (1) [back to overview]Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.
NCT00623623 (25) [back to overview]Number of Patients With All Cause Death and Non-fatal Stroke
NCT00623623 (25) [back to overview]Number of Patients With Total Non-disabling Stroke
NCT00623623 (25) [back to overview]Number of Patients With Cardiac Mortality
NCT00623623 (25) [back to overview]Number of Patients With Cardiogenic Shock
NCT00623623 (25) [back to overview]Number of Patients With Congestive Heart Failure (CHF)
NCT00623623 (25) [back to overview]Number of Patients With Intracranial Haemorrhage
NCT00623623 (25) [back to overview]Number of Patients With Ischaemic Stroke
NCT00623623 (25) [back to overview]Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions
NCT00623623 (25) [back to overview]Number of Patients With Rehospitalisation for Cardiac Reasons
NCT00623623 (25) [back to overview]Number of Patients With Rehospitalisation for Non-cardiac Reasons
NCT00623623 (25) [back to overview]Number of Patients With Serious Repeat Target Vessel Revascularization
NCT00623623 (25) [back to overview]Number of Patients With Serious Resuscitated Ventricular Fibrillation
NCT00623623 (25) [back to overview]Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures
NCT00623623 (25) [back to overview]Number of Patients With Minor Non-intracranial Bleeds
NCT00623623 (25) [back to overview]Number of Patients With Recurrent Myocardial Infarction (Reinfarction)
NCT00623623 (25) [back to overview]Number of Patients With Total Disabling Stroke
NCT00623623 (25) [back to overview]Number of Patients With Total Stroke (All Types)
NCT00623623 (25) [back to overview]Number of Patients With Total Non-intracranial Bleeds
NCT00623623 (25) [back to overview]Number of Patients With Total Fatal Stroke
NCT00623623 (25) [back to overview]Number of Patients With All Cause Death and Shock
NCT00623623 (25) [back to overview]Number of Patients With All Cause Death and Shock and CHF
NCT00623623 (25) [back to overview]Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke
NCT00623623 (25) [back to overview]Number of Patients With All Cause Death and Shock and Reinfarction
NCT00623623 (25) [back to overview]Number of Patients With All Cause Mortality
NCT00623623 (25) [back to overview]Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
NCT00642174 (5) [back to overview]Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate
NCT00642174 (5) [back to overview]Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)
NCT00642174 (5) [back to overview]Platelet Reactivity Index (PRI)
NCT00642174 (5) [back to overview]Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay
NCT00642174 (5) [back to overview]Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay
NCT00642811 (6) [back to overview]Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28
NCT00642811 (6) [back to overview]Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.
NCT00642811 (6) [back to overview]Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)
NCT00642811 (6) [back to overview]Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15
NCT00642811 (6) [back to overview]Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15
NCT00642811 (6) [back to overview]Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28
NCT00644657 (2) [back to overview]The Percentage of Coated Platelets After Coronary Angiography and/or PCI
NCT00644657 (2) [back to overview]The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
NCT00684203 (15) [back to overview]Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI
NCT00684203 (15) [back to overview]Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI
NCT00684203 (15) [back to overview]Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge
NCT00684203 (15) [back to overview]Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion
NCT00684203 (15) [back to overview]Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization
NCT00684203 (15) [back to overview]Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI
NCT00684203 (15) [back to overview]Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI
NCT00684203 (15) [back to overview]Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit
NCT00684203 (15) [back to overview]Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI
NCT00684203 (15) [back to overview]Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI
NCT00684203 (15) [back to overview]Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)
NCT00684203 (15) [back to overview]Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit
NCT00684203 (15) [back to overview]Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI
NCT00684203 (15) [back to overview]Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events
NCT00684203 (15) [back to overview]Mean CD40 Ligand Levels Among Participants Who Underwent PCI
NCT00687076 (2) [back to overview]Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis
NCT00687076 (2) [back to overview]Change in Total Cholesterol (mg/dl) From Baseline to Month 12
NCT00699998 (10) [back to overview]Platelet Aggregation Measures
NCT00699998 (10) [back to overview]Summary of All Deaths
NCT00699998 (10) [back to overview]Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
NCT00699998 (10) [back to overview]Percentage of Participants With a Composite Endpoint of CV Death and MI
NCT00699998 (10) [back to overview]Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
NCT00699998 (10) [back to overview]Genotyping Related to Drug Metabolism
NCT00699998 (10) [back to overview]Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
NCT00699998 (10) [back to overview]Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
NCT00699998 (10) [back to overview]Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
NCT00699998 (10) [back to overview]Economic and Quality of Life Outcomes
NCT00738894 (4) [back to overview]Number of Subjects With Effective Closure in Test (Device) Arm
NCT00738894 (4) [back to overview]Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
NCT00738894 (4) [back to overview]Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)
NCT00738894 (4) [back to overview]Number of Subjects With Study-related Serious Adverse Events
NCT00799396 (2) [back to overview]Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
NCT00799396 (2) [back to overview]Changes in Platelet Function in Response to Clopidogrel
NCT00816166 (1) [back to overview]Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
NCT00817999 (1) [back to overview]% Platelet Inhibition
NCT00823212 (39) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT00823212 (39) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT00823212 (39) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT00823212 (39) [back to overview]Target Lesion Failure (TLF)
NCT00823212 (39) [back to overview]Target Lesion Failure (TLF)
NCT00823212 (39) [back to overview]Target Lesion Revascularization (TLR)
NCT00823212 (39) [back to overview]Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]Target Lesion Revascularization (TLR)
NCT00823212 (39) [back to overview]Target Vessel Failure (TVF)
NCT00823212 (39) [back to overview]Target Vessel Failure (TVF)
NCT00823212 (39) [back to overview]Target Vessel Failure (TVF)
NCT00823212 (39) [back to overview]Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]Non-cardiac Death
NCT00823212 (39) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT00823212 (39) [back to overview]Target Lesion Revascularization (TLR)
NCT00823212 (39) [back to overview]Acute Technical Success
NCT00823212 (39) [back to overview]All Cause Mortality
NCT00823212 (39) [back to overview]All Cause Mortality
NCT00823212 (39) [back to overview]Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]All Cause Mortality
NCT00823212 (39) [back to overview]All Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]All Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]All Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]Cardiac Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]Cardiac Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]Cardiac Death or Myocardial Infarction (MI)
NCT00823212 (39) [back to overview]Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
NCT00823212 (39) [back to overview]Cardiac Death Related to the Target Vessel
NCT00823212 (39) [back to overview]Cardiac Death Related to the Target Vessel
NCT00823212 (39) [back to overview]Cardiac Death Related to the Target Vessel
NCT00823212 (39) [back to overview]Clinical Procedural Success
NCT00823212 (39) [back to overview]Non-cardiac Death
NCT00823212 (39) [back to overview]Non-cardiac Death
NCT00823212 (39) [back to overview]Target Lesion Failure (TLF)
NCT00823212 (39) [back to overview]Target Lesion Failure (TLF)
NCT00823212 (39) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT00823212 (39) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT00830960 (11) [back to overview]Incidence of CABG-related TIMI Major or Minor Bleeding.
NCT00830960 (11) [back to overview]Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort
NCT00830960 (11) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
NCT00830960 (11) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
NCT00830960 (11) [back to overview]Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
NCT00830960 (11) [back to overview]Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
NCT00830960 (11) [back to overview]Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
NCT00830960 (11) [back to overview]Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
NCT00830960 (11) [back to overview]Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
NCT00830960 (11) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort
NCT00830960 (11) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)
NCT00833703 (3) [back to overview]Number of Participants According to Bleeding Type/Etiology
NCT00833703 (3) [back to overview]Number of Participants With Bleeding Events
NCT00833703 (3) [back to overview]Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths
NCT00910299 (3) [back to overview]Number of Participants With Stent Thrombosis (ST)
NCT00910299 (3) [back to overview]Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
NCT00910299 (3) [back to overview]Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
NCT00942175 (5) [back to overview]Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
NCT00942175 (5) [back to overview]Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.
NCT00954707 (13) [back to overview]Rate of Major Adverse Cardiac Events (MACE)
NCT00954707 (13) [back to overview]Rate of Non-cardiac Death
NCT00954707 (13) [back to overview]Rate of Procedure Success
NCT00954707 (13) [back to overview]Rate of Protocol Defined Major Bleeding Complications
NCT00954707 (13) [back to overview]Rate of Protocol Defined Stent Thrombosis (ST)
NCT00954707 (13) [back to overview]Rate of Target Vessel Failure (TVF)
NCT00954707 (13) [back to overview]Phase I: the Rate of Target Lesion Failure (TLF)
NCT00954707 (13) [back to overview]Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
NCT00954707 (13) [back to overview]Rate of Cardiac Death
NCT00954707 (13) [back to overview]Rate of Clinically Driven Target Vessel Revascularization (TVR)
NCT00954707 (13) [back to overview]Rate of Clinically-driven Target Lesion Revascularization (TVR)
NCT00954707 (13) [back to overview]Rate of Device Success
NCT00954707 (13) [back to overview]Rate of Lesion Success
NCT00977938 (14) [back to overview]Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
NCT00977938 (14) [back to overview]Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
NCT00977938 (14) [back to overview]Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
NCT00977938 (14) [back to overview]Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
NCT00977938 (14) [back to overview]Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
NCT00977938 (14) [back to overview]GUSTO Severe or Moderate Bleeding - Randomized DES ITT
NCT00977938 (14) [back to overview]MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
NCT00977938 (14) [back to overview]GUSTO Severe or Moderate Bleeding - Randomized DES ITT
NCT00977938 (14) [back to overview]MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
NCT00977938 (14) [back to overview]MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
NCT00977938 (14) [back to overview]MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
NCT00977938 (14) [back to overview]MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
NCT00977938 (14) [back to overview]GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
NCT00977938 (14) [back to overview]GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
NCT00991029 (13) [back to overview]Minor Hemorrhage
NCT00991029 (13) [back to overview]Ischemic Stroke
NCT00991029 (13) [back to overview]Hemorrhagic Stroke
NCT00991029 (13) [back to overview]Major Hemorrhage Other Than Intracranial Hemorrhage
NCT00991029 (13) [back to overview]Death From Any Cause
NCT00991029 (13) [back to overview]Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
NCT00991029 (13) [back to overview]Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage
NCT00991029 (13) [back to overview]Major Hemorrhage
NCT00991029 (13) [back to overview]Symptomatic Intracerebral Hemorrhage
NCT00991029 (13) [back to overview]Ischemic or Hemorrhagic Stroke
NCT00991029 (13) [back to overview]Myocardial Infarction
NCT00991029 (13) [back to overview]Other Symptomatic Intracranial Hemorrhage
NCT00991029 (13) [back to overview]Death From Ischemic Vascular Causes
NCT01012219 (1) [back to overview]Cutaneous Bleeding Time (BT)
NCT01014624 (8) [back to overview]Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population
NCT01014624 (8) [back to overview]Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population
NCT01014624 (8) [back to overview]Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population
NCT01014624 (8) [back to overview]The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
NCT01014624 (8) [back to overview]The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
NCT01014624 (8) [back to overview]Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population
NCT01014624 (8) [back to overview]Percentage of Inhibition of Platelet Aggregation on Washout Day 1
NCT01014624 (8) [back to overview]Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose
NCT01097343 (1) [back to overview]Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230
NCT01103440 (2) [back to overview]Number of Participants With Elevation of Cardiac Enzyme
NCT01103440 (2) [back to overview]Number of Participants With Major Adverse Cardiac Event (MACE)
NCT01107899 (8) [back to overview]Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
NCT01107899 (8) [back to overview]Platelet Function by LTA at 5 and 20 μM ADP
NCT01107899 (8) [back to overview]Platelet Function by Multiplate® ADP Test and ADP Test HS
NCT01107899 (8) [back to overview]Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD
NCT01107899 (8) [back to overview]Platelet Function 24 Hours Post Loading Dose
NCT01107899 (8) [back to overview]Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
NCT01107899 (8) [back to overview]Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
NCT01107899 (8) [back to overview]Percentage of Participants Returning to Baseline Platelet Function
NCT01107912 (5) [back to overview]Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy
NCT01107912 (5) [back to overview]Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period
NCT01107912 (5) [back to overview]Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy
NCT01107912 (5) [back to overview]Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy
NCT01107912 (5) [back to overview]Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing
NCT01107925 (5) [back to overview]Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)
NCT01107925 (5) [back to overview]Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy
NCT01107925 (5) [back to overview]Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)
NCT01107925 (5) [back to overview]Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy
NCT01107925 (5) [back to overview]Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy
NCT01115738 (9) [back to overview]Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin
NCT01115738 (9) [back to overview]Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit
NCT01115738 (9) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
NCT01115738 (9) [back to overview]Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)
NCT01115738 (9) [back to overview]Percentage of Poor Responders
NCT01115738 (9) [back to overview]Percentage of Inhibition of Platelet Aggregation
NCT01115738 (9) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT01115738 (9) [back to overview]P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
NCT01115738 (9) [back to overview]P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
NCT01118325 (11) [back to overview]AZD6140 (Cmax) at Week 4
NCT01118325 (11) [back to overview]AZD6140 (Tmax) at Week 4
NCT01118325 (11) [back to overview]Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients
NCT01118325 (11) [back to overview]IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients
NCT01118325 (11) [back to overview]IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients
NCT01118325 (11) [back to overview]IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients
NCT01118325 (11) [back to overview]IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients
NCT01118325 (11) [back to overview]AR-C124910XX (Tmax) at Week 4
NCT01118325 (11) [back to overview]AR-C124910XX (AUC0-tau) at Week 4
NCT01118325 (11) [back to overview]AR-C124910XX (Cmax) at Week 4
NCT01118325 (11) [back to overview]AZD6140 (AUC0-tau) at Week 4
NCT01121224 (28) [back to overview]In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.
NCT01121224 (28) [back to overview]Number of Participants With Target Lesion Revascularization (TLR)
NCT01121224 (28) [back to overview]Procedural Success
NCT01121224 (28) [back to overview]Patient-Oriented Composite Endpoint Will be Used as Secondary Outcome
NCT01121224 (28) [back to overview]Number of Participants With Target Vessel Revascularization (TVR)
NCT01121224 (28) [back to overview]Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.
NCT01121224 (28) [back to overview]Device-oriented Composite Endpoint of Target Lesion Failure Will be Used as a Secondary Outcome
NCT01121224 (28) [back to overview]Number of Participants With Target Vessel Myocardial Infarction
NCT01121224 (28) [back to overview]Number of Participants With Stroke
NCT01121224 (28) [back to overview]Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization
NCT01121224 (28) [back to overview]Incremental Cost-effectiveness of DES Relative to BMS
NCT01121224 (28) [back to overview]Procedural Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding)
NCT01121224 (28) [back to overview]Quality Adjusted Life Years of DES Relative to BMS
NCT01121224 (28) [back to overview]Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction
NCT01121224 (28) [back to overview]Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death
NCT01121224 (28) [back to overview]Number of Participants With Stroke
NCT01121224 (28) [back to overview]Number of Participants With Any Revascularization
NCT01121224 (28) [back to overview]Patient-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.
NCT01121224 (28) [back to overview]Number of Participants With Non-Target Revascularization
NCT01121224 (28) [back to overview]Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition
NCT01121224 (28) [back to overview]Number of Participants With Myocardial Infarction (MI)
NCT01121224 (28) [back to overview]Number of Participants With Non-Target Revascularization
NCT01121224 (28) [back to overview]Number of Participants With Target Lesion Revascularization (TLR)
NCT01121224 (28) [back to overview]Number of Participants With Definite or Probable Stent Thrombosis
NCT01121224 (28) [back to overview]In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.
NCT01121224 (28) [back to overview]Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.
NCT01121224 (28) [back to overview]Quality Adjusted Life Years for Subgroups of Patients
NCT01121224 (28) [back to overview]Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.
NCT01156571 (3) [back to overview]Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
NCT01156571 (3) [back to overview]The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
NCT01156571 (3) [back to overview]Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild
NCT01158703 (6) [back to overview]Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
NCT01158703 (6) [back to overview]Incidence of Bleeding Between the Two Treatment Arms
NCT01158703 (6) [back to overview]Number of Angina Events
NCT01158703 (6) [back to overview]Number of Major Adverse Cardiovascular Events With Combination Therapy
NCT01158703 (6) [back to overview]Number of Myocardial Infarction Events
NCT01158703 (6) [back to overview]Number of Thrombotic Events
NCT01163604 (1) [back to overview]Number of Participants With Occlusion and Restenosis at One Year
NCT01212302 (1) [back to overview]Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)
NCT01235351 (2) [back to overview]Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)
NCT01235351 (2) [back to overview]Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)
NCT01260584 (7) [back to overview]Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status
NCT01260584 (7) [back to overview]Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status
NCT01260584 (7) [back to overview]Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
NCT01260584 (7) [back to overview]Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
NCT01260584 (7) [back to overview]Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235
NCT01260584 (7) [back to overview]Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.
NCT01260584 (7) [back to overview]Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%
NCT01263093 (5) [back to overview]Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)
NCT01263093 (5) [back to overview]Percentage Inhibition of Platelet Aggregation
NCT01263093 (5) [back to overview]Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
NCT01263093 (5) [back to overview]Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)
NCT01263093 (5) [back to overview]Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)
NCT01283282 (7) [back to overview]Endothelial Progenitor Cells (EPCs)
NCT01283282 (7) [back to overview]Oxidative Stress Markers
NCT01283282 (7) [back to overview]Inflammatory Marker CD40 Ligand
NCT01283282 (7) [back to overview]Flow-mediated Dilation (FMD)
NCT01283282 (7) [back to overview]Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)
NCT01283282 (7) [back to overview]Pulse Wave Velocity (PWV)
NCT01283282 (7) [back to overview]Nitroglycerin-mediated Vasodilation
NCT01294462 (4) [back to overview]Major Bleeding
NCT01294462 (4) [back to overview]Major and Minor Bleeding
NCT01294462 (4) [back to overview]Major Adverse Cardiac Events (MACE)
NCT01294462 (4) [back to overview]Composite of All-cause Mortality, MI or Stroke
NCT01341600 (4) [back to overview]Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole
NCT01341600 (4) [back to overview]Level of Active Clopidogrel Metabolite
NCT01341600 (4) [back to overview]Change in Platelet Aggregation Following Therapy With Clopidogrel
NCT01341600 (4) [back to overview]Change in Platelet Aggregation Following Therapy With Clopidogrel
NCT01341964 (1) [back to overview]Blood Concentration of the Active Metabolite of Clopidogrel
NCT01452152 (5) [back to overview]Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization
NCT01452152 (5) [back to overview]Post-treatment Platelet Aggregation
NCT01452152 (5) [back to overview]Occurrence of Post-randomization Cardiovascular Events
NCT01452152 (5) [back to overview]Occurrence of Bleeding Events
NCT01452152 (5) [back to overview]Occurrence of Adverse Events
NCT01500434 (26) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT01500434 (26) [back to overview]Target Vessel Failure (TVF)
NCT01500434 (26) [back to overview]All Cause Death
NCT01500434 (26) [back to overview]Target Vessel Revascularization (TVR)
NCT01500434 (26) [back to overview]Target Vessel Revascularization (TVR)
NCT01500434 (26) [back to overview]Target Vessel Revascularization (TVR)
NCT01500434 (26) [back to overview]Acute Technical Success
NCT01500434 (26) [back to overview]Target Vessel Failure (TVF)
NCT01500434 (26) [back to overview]Target Vessel Failure (TVF)
NCT01500434 (26) [back to overview]Target Lesion Revascularization (TLR)
NCT01500434 (26) [back to overview]Target Lesion Revascularization (TLR)
NCT01500434 (26) [back to overview]Target Lesion Failure (TLF)
NCT01500434 (26) [back to overview]Target Lesion Failure (TLF)
NCT01500434 (26) [back to overview]Cardiac Death Related to the Target Vessel
NCT01500434 (26) [back to overview]All Cause Death
NCT01500434 (26) [back to overview]Target Lesion Failure (TLF)
NCT01500434 (26) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT01500434 (26) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT01500434 (26) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT01500434 (26) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT01500434 (26) [back to overview]All Cause Death
NCT01500434 (26) [back to overview]Cardiac Death Related to the Target Vessel
NCT01500434 (26) [back to overview]Cardiac Death Related to the Target Vessel
NCT01500434 (26) [back to overview]Target Lesion Revascularization (TLR)
NCT01500434 (26) [back to overview]Clinical Procedural Success
NCT01500434 (26) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT01510327 (14) [back to overview]Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus
NCT01510327 (14) [back to overview]All Death
NCT01510327 (14) [back to overview]Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus
NCT01510327 (14) [back to overview]Terminal Phase Half-life (t1/2) Everolimus
NCT01510327 (14) [back to overview]Target Vessel Revascularization (TVR)
NCT01510327 (14) [back to overview]Target Lesion Revascularization (TLR)
NCT01510327 (14) [back to overview]Myocardial Infarction (MI) Related to the Target Vessel
NCT01510327 (14) [back to overview]Maximum Observed Everolimus Blood Concentration (Cmax)
NCT01510327 (14) [back to overview]Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
NCT01510327 (14) [back to overview]Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
NCT01510327 (14) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
NCT01510327 (14) [back to overview]Total Blood Clearance - Everolimus (CL)
NCT01510327 (14) [back to overview]Time of Occurrence of Maximum Everolimus Concentration (Tmax)
NCT01510327 (14) [back to overview]Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus
NCT01515345 (3) [back to overview]Any Bleeding Event
NCT01515345 (3) [back to overview]Definite Stent Thrombosis
NCT01515345 (3) [back to overview]Probable Stent Thrombosis
NCT01523366 (5) [back to overview]Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
NCT01523366 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
NCT01523366 (5) [back to overview]AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
NCT01523366 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose
NCT01523366 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
NCT01523392 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose
NCT01523392 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
NCT01523392 (5) [back to overview]Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
NCT01523392 (5) [back to overview]AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
NCT01523392 (5) [back to overview]Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
NCT01586975 (1) [back to overview]PFA1
NCT01589978 (21) [back to overview]Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
NCT01589978 (21) [back to overview]Cardiac Death or Myocardial Infarction (MI) Rate
NCT01589978 (21) [back to overview]ARC ST Rate in PLATINUM-like Population.
NCT01589978 (21) [back to overview]All Death Rate
NCT01589978 (21) [back to overview]All Death or Myocardial Infarction Rate
NCT01589978 (21) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
NCT01589978 (21) [back to overview]Myocardial Infarction (MI) Rate
NCT01589978 (21) [back to overview]Cardiac Death Rate
NCT01589978 (21) [back to overview]Target Vessel Revascularization (TVR) Rate
NCT01589978 (21) [back to overview]Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
NCT01589978 (21) [back to overview]Target Vessel Failure (TVF) Rate
NCT01589978 (21) [back to overview]Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Rate of Longitudinal Stent Deformation
NCT01589978 (21) [back to overview]Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Rate of Cardiac Death Events Related to the PROMUS Element Stent
NCT01589978 (21) [back to overview]Non-cardiac Death Rate
NCT01589978 (21) [back to overview]Major Adverse Cardiac Event Rate (MACE)
NCT01589978 (21) [back to overview]Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
NCT01603082 (2) [back to overview]Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
NCT01603082 (2) [back to overview]Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
NCT01612884 (2) [back to overview]Number of Participants With Ischemic Events
NCT01612884 (2) [back to overview]Thrombelastography (TEG) MA
NCT01642238 (8) [back to overview]Platelet Reactivity
NCT01642238 (8) [back to overview]Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
NCT01642238 (8) [back to overview]Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
NCT01642238 (8) [back to overview]Blood Thrombogenicity
NCT01642238 (8) [back to overview]Blood Thrombogenicity
NCT01642238 (8) [back to overview]Blood Thrombogenicity
NCT01642238 (8) [back to overview]Platelet Reactivity
NCT01642238 (8) [back to overview]Platelet Reactivity
NCT01732822 (24) [back to overview]Changes in Fontaine Stage
NCT01732822 (24) [back to overview]Any Amputation Caused by PAD
NCT01732822 (24) [back to overview]All-cause Mortality
NCT01732822 (24) [back to overview]ALI
NCT01732822 (24) [back to overview]Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)
NCT01732822 (24) [back to overview]Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)
NCT01732822 (24) [back to overview]MI
NCT01732822 (24) [back to overview]Major Amputation Caused by PAD
NCT01732822 (24) [back to overview]Lower Extremity Revascularization
NCT01732822 (24) [back to overview]Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
NCT01732822 (24) [back to overview]CV-related Hospitalization
NCT01732822 (24) [back to overview]CV Death
NCT01732822 (24) [back to overview]Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])
NCT01732822 (24) [back to overview]Composite of CV Death, MI, Ischemic Stroke, and ALI
NCT01732822 (24) [back to overview]Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)
NCT01732822 (24) [back to overview]Change in ABI/TBI From Baseline
NCT01732822 (24) [back to overview]TIMI Major or Minor Bleeding Events
NCT01732822 (24) [back to overview]Changes in Rutherford Classification
NCT01732822 (24) [back to overview]TIMI Major Bleeding Events
NCT01732822 (24) [back to overview]Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event
NCT01732822 (24) [back to overview]PLATO Major Bleeding Events
NCT01732822 (24) [back to overview]Non-CV Death
NCT01732822 (24) [back to overview]Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)
NCT01732822 (24) [back to overview]Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)
NCT01742117 (4) [back to overview]Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
NCT01742117 (4) [back to overview]Thrombolysis in Myocardial Infarction Major or Minor Bleeding
NCT01742117 (4) [back to overview]Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
NCT01742117 (4) [back to overview]Occurrence of the a Major Adverse Cardiovascular Event
NCT01765400 (3) [back to overview]The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication
NCT01765400 (3) [back to overview]The Change in Platelet Activation Assay (VASP)Between Baseline and Each Antiplatelet Medication
NCT01765400 (3) [back to overview]The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication
NCT01768637 (3) [back to overview]Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate
NCT01768637 (3) [back to overview]Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid
NCT01768637 (3) [back to overview]Whole Blood Platelet Aggregation to 2 µg/mL Collagen
NCT01789814 (1) [back to overview]Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
NCT01802775 (6) [back to overview]Percentage of Participants With Clinically Relevant Bleeding During Treatment
NCT01802775 (6) [back to overview]Safety Assessments
NCT01802775 (6) [back to overview]Percentage of Participants With First Re-stenosis / Re-occlusion
NCT01802775 (6) [back to overview]Number of Participants With Amputations
NCT01802775 (6) [back to overview]Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period
NCT01802775 (6) [back to overview]Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment
NCT01813435 (9) [back to overview]Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
NCT01813435 (9) [back to overview]Number of Participants With All-cause Mortality
NCT01813435 (9) [back to overview]Number of Participants With Myocardial Infarction
NCT01813435 (9) [back to overview]Number of Participants With New Q-wave Myocardial Infarction
NCT01813435 (9) [back to overview]Number of Participants With a Stroke
NCT01813435 (9) [back to overview]Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
NCT01813435 (9) [back to overview]Number of Participants With a Definite Stent Thrombosis
NCT01813435 (9) [back to overview]Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
NCT01813435 (9) [back to overview]Number of Participants With a Myocardial Revascularisation
NCT01815008 (4) [back to overview]Difference in Arachidonic Acid-induced Platelet Aggregation
NCT01815008 (4) [back to overview]Difference in ADP-induced Platelet Aggregation
NCT01815008 (4) [back to overview]Changes in Platelet Transcriptome With Clopidogrel
NCT01815008 (4) [back to overview]Difference in Collagen-induced Platelet Aggregation
NCT01823510 (4) [back to overview]Thrombus Formation
NCT01823510 (4) [back to overview]P2Y12 Reaction Unit (PRU)
NCT01823510 (4) [back to overview]Platelet Reactivity Index (PRI)
NCT01823510 (4) [back to overview]Platelet Reactivity
NCT01830543 (9) [back to overview]Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
NCT01830543 (9) [back to overview]Percentage of Participants With Stroke
NCT01830543 (9) [back to overview]Percentage of Participants With Stent Thrombosis
NCT01830543 (9) [back to overview]Percentage of Participants With Myocardial Infarction
NCT01830543 (9) [back to overview]Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
NCT01830543 (9) [back to overview]Percentage of Participants With Clinically Significant Bleeding
NCT01830543 (9) [back to overview]Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
NCT01830543 (9) [back to overview]Percentage of Participants With Cardiovascular Death
NCT01830543 (9) [back to overview]Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
NCT01864005 (5) [back to overview]the Percentage Inhibition of the P2Y12 Receptor
NCT01864005 (5) [back to overview]the Percentage Inhibition of the P2Y12 Receptor
NCT01864005 (5) [back to overview]the Percentage Inhibition of the P2Y12 Receptor
NCT01864005 (5) [back to overview]the Percentage Inhibition of the P2Y12 Receptor
NCT01864005 (5) [back to overview]the Percentage Inhibition of the P2Y12 Receptor
NCT01896557 (4) [back to overview]Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment
NCT01896557 (4) [back to overview]Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.
NCT01896557 (4) [back to overview]Comparison of the Primary Outcome With Bioimpedance Aggregometry
NCT01896557 (4) [back to overview]Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)
NCT01960296 (8) [back to overview]Average Change in Hematocrit
NCT01960296 (8) [back to overview]Average Length of Hospital Stay
NCT01960296 (8) [back to overview]Bleeding-related Re-hospitalization
NCT01960296 (8) [back to overview]Development of Myocardial Infarction or Thrombosis
NCT01960296 (8) [back to overview]Perioperative Bleeding Complications
NCT01960296 (8) [back to overview]Procedure Estimated Blood Loss
NCT01960296 (8) [back to overview]Procedure Time
NCT01960296 (8) [back to overview]Same Day Discharged
NCT01979445 (5) [back to overview]Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay
NCT01979445 (5) [back to overview]Bleeding Events In Accordance With GUSTO Scale
NCT01979445 (5) [back to overview]Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone
NCT01979445 (5) [back to overview]Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay
NCT01979445 (5) [back to overview]Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone
NCT02010632 (1) [back to overview]Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
NCT02052635 (2) [back to overview]P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
NCT02052635 (2) [back to overview]P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
NCT02164864 (13) [back to overview]Time to First Adjudicated ST
NCT02164864 (13) [back to overview]Time to First Adjudicated SE
NCT02164864 (13) [back to overview]Time to First Adjudicated ISTH MBE or CRNMBE
NCT02164864 (13) [back to overview]Time to Adjudicated All Cause Death
NCT02164864 (13) [back to overview]Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
NCT02164864 (13) [back to overview]Time to Composite Endpoint of Death or First Thrombotic Event
NCT02164864 (13) [back to overview]Time to First Adjudicated MI
NCT02164864 (13) [back to overview]Time to Composite Endpoint of Death + MI + Stroke
NCT02164864 (13) [back to overview]Time to Adjudicated Undetermined Cause of Death
NCT02164864 (13) [back to overview]Time to Adjudicated CV
NCT02164864 (13) [back to overview]Time to Adjudicated Non-CV
NCT02164864 (13) [back to overview]Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
NCT02164864 (13) [back to overview]Time to First Adjudicated Stroke
NCT02185534 (3) [back to overview]Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))
NCT02185534 (3) [back to overview]Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)
NCT02185534 (3) [back to overview]Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
NCT02217501 (2) [back to overview]Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death
NCT02217501 (2) [back to overview]Number of Participants With First Occurrence of Bleeding
NCT02224274 (3) [back to overview]VerifyNow P2Y12Test - Platelet Reactivity
NCT02224274 (3) [back to overview]Multiplate ADP Test
NCT02224274 (3) [back to overview]VerifyNow P2Y12Test - % Inhibition
NCT02230527 (1) [back to overview]Absolute Change in TcPO2 From Baseline to Month 6
NCT02260622 (10) [back to overview]TVR
NCT02260622 (10) [back to overview]The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)
NCT02260622 (10) [back to overview]Reintervention, Above Ankle Amputation and Restenosis (RAS)
NCT02260622 (10) [back to overview]Peri-procedure Death
NCT02260622 (10) [back to overview]Number of Participants With 2 Class Improvement on the Rutherford Scale
NCT02260622 (10) [back to overview]Minor Bleeding
NCT02260622 (10) [back to overview]Major Bleeding
NCT02260622 (10) [back to overview]MACE
NCT02260622 (10) [back to overview]Event-free Survival
NCT02260622 (10) [back to overview]Overall Survival
NCT02287909 (1) [back to overview]Platelet Reactivity Unit
NCT02293395 (1) [back to overview]Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
NCT02327741 (7) [back to overview]Number of Patients With Central Vascular Accidents Proved by CT Scan
NCT02327741 (7) [back to overview]Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues
NCT02327741 (7) [back to overview]Number of Patients With Minor Bleeding
NCT02327741 (7) [back to overview]Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
NCT02327741 (7) [back to overview]Number of Patients With Major Bleeding Need Transfusion
NCT02327741 (7) [back to overview]Number of Patients With Death Due to Cardiac Causes
NCT02327741 (7) [back to overview]Number of Patients With Myocardial Infarction Need Hospital Admission
NCT02376283 (3) [back to overview]Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml
NCT02376283 (3) [back to overview]Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
NCT02376283 (3) [back to overview]Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
NCT02384070 (3) [back to overview]Thrombotic Complications
NCT02384070 (3) [back to overview]TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
NCT02384070 (3) [back to overview]Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure
NCT02486367 (8) [back to overview]Change in D-Dimer Levels as Measured by Blood Test
NCT02486367 (8) [back to overview]Change in Mono-CD62P as Measured by Blood Test
NCT02486367 (8) [back to overview]Change in Mono-2b3a as Measured by Blood Test
NCT02486367 (8) [back to overview]Change in IL-6 as Measured by Blood Test.
NCT02486367 (8) [back to overview]Change in IL-8 as Measured by Blood Test
NCT02486367 (8) [back to overview]Platelet Reactivity
NCT02486367 (8) [back to overview]Inflammatory Monocyte Proportion
NCT02486367 (8) [back to overview]Change in sCD14 as Measured by Blood Test.
NCT02548650 (2) [back to overview]Maximal Platelet Aggregation in Non-DM
NCT02548650 (2) [back to overview]Maximal Platelet Aggregation in DM
NCT02554721 (2) [back to overview]Effects On Skin Bleeding Time (BT)
NCT02554721 (2) [back to overview]Ex-vivo Inhibition Of Platelet Aggregation (IPA)
NCT02556203 (8) [back to overview]Number of Participants With Primary Bleeding Event (PBE)
NCT02556203 (8) [back to overview]Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
NCT02556203 (8) [back to overview]Number of Participants With Death or First Thromboembolic Event (DTE)
NCT02556203 (8) [back to overview]Number of Participants With Cardiovascular Death or Thromboembolic Event
NCT02556203 (8) [back to overview]Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
NCT02556203 (8) [back to overview]Number of Participants With Death or First Thromboembolic Event (DTE)
NCT02556203 (8) [back to overview]Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
NCT02556203 (8) [back to overview]Number of Participants With Net-clinical Benefit
NCT02559414 (5) [back to overview]Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min
NCT02559414 (5) [back to overview]Percentage Monocyte-Platelet Aggregates
NCT02559414 (5) [back to overview]Percentage Monocyte-Platelet Aggregates
NCT02559414 (5) [back to overview]Percentage Leukocyte-Platelet Aggregate
NCT02559414 (5) [back to overview]Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min
NCT02578706 (23) [back to overview]Change in Spontaneous Platelet Aggregometry From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in sCD14 From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in sCD40L From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Platelet Aggregometry in Response to ADP 20µM From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Maximum Clot Firmness (MCF) From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in Intermediate Monocyte Subsets From Baseline to Week 24.
NCT02578706 (23) [back to overview]Change in IL-6 From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in D-dimer From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Coagulation Time (CT) From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in Clot Formation Time (CFT) From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in sTNFR I From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in sTNFR II From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Classical Monocyte Subsets From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Alpha Angle From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in Thrombus Formation (High Shear) From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in Thrombus Formation (Low Shear) From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Number of Subjects With at Least One Grade 3 or Higher Sign/Symptom or Laboratory Abnormality
NCT02578706 (23) [back to overview]Change in Monocyte Activation sCD163 From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Monocyte Platelet Aggregates From Baseline to 24 Weeks
NCT02578706 (23) [back to overview]Change in Non-classical Monocyte Subsets From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Platelet Aggregometry in Response to Arachidonic Acid 1500µM From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Platelet Aggregometry in Response to Collagen 2µg/mL From Baseline to Week 24
NCT02578706 (23) [back to overview]Change in Platelet Aggregometry in Response to Epi 5µM From Baseline to Week 24
NCT02742987 (1) [back to overview]Flow-mediated Dilation of the Brachial Artery
NCT02833948 (10) [back to overview]Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.
NCT02833948 (10) [back to overview]Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.
NCT02833948 (10) [back to overview]The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.
NCT02833948 (10) [back to overview]Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.
NCT02833948 (10) [back to overview]Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.
NCT02833948 (10) [back to overview]Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.
NCT02833948 (10) [back to overview]The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan
NCT02866175 (7) [back to overview]Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02866175 (7) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
NCT02925923 (12) [back to overview]Number of Patients With Minor Bleeding Complications
NCT02925923 (12) [back to overview]A Change in Hematocrit Levels
NCT02925923 (12) [back to overview]Heparin Dose, Unit/Kg
NCT02925923 (12) [back to overview]Activated Clotting Time (ACT), Seconds
NCT02925923 (12) [back to overview]Platelet Aggregation Levels
NCT02925923 (12) [back to overview]Number of Patients With Negative Clinical Outcomes
NCT02925923 (12) [back to overview]Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
NCT02925923 (12) [back to overview]Change in Hemoglobin Levels (g/dL)
NCT02925923 (12) [back to overview]Number of Patients With Minor Bleeding Complications
NCT02925923 (12) [back to overview]Number of Patients With Major Bleeding Complications
NCT02925923 (12) [back to overview]Number of Patients With Major Bleeding Complications
NCT02925923 (12) [back to overview]Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
NCT02931045 (1) [back to overview]Concentration of Platelet Extracellular Vesicles/ml
NCT03188705 (2) [back to overview]Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
NCT03188705 (2) [back to overview]Changes in Platelet Function in Response to Clopidogrel
NCT03190005 (1) [back to overview]PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication
NCT03207451 (3) [back to overview]Effects of Vorapaxar on Von Willebrand Factor (vWF).
NCT03207451 (3) [back to overview]Effects of Vorapaxar on Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS)
NCT03207451 (3) [back to overview]Effects of Vorapaxar on 15 μmol/L SFLLRN (PAR-1 Activating Peptide) Induced Platelet Aggregation
NCT03381742 (2) [back to overview]ADP-induced Platelet-fibrin Clot Strength (MA)
NCT03381742 (2) [back to overview]ADP-induced Inhibition of Platelet Aggregation
NCT03437044 (2) [back to overview]Platelet Reactivity Index (PRI)
NCT03437044 (2) [back to overview]P2Y12 Reaction Units (PRU)
NCT03649711 (2) [back to overview]ADP Induced Platelet Aggregation
NCT03649711 (2) [back to overview]Platelet Surface P-selectin Expression
NCT03766581 (23) [back to overview]Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
NCT03766581 (23) [back to overview]Number of Participants With Bleeding Based on BARC Types 1-5
NCT03766581 (23) [back to overview]Number of Participants With Bleeding Based on ISTH-Defined Criteria
NCT03766581 (23) [back to overview]Number of Participants With Bleeding Based on PLATO-Defined Criteria
NCT03766581 (23) [back to overview]Number of Participants With Clinically Significant Laboratory Abnormalities - Liver
NCT03766581 (23) [back to overview]Percent of Participants With Ischemic Stroke Events
NCT03766581 (23) [back to overview]Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death
NCT03766581 (23) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
NCT03766581 (23) [back to overview]Pharmacokinetic Parameter - Estimated Clearance (CL)
NCT03766581 (23) [back to overview]Pharmacokinetic Parameter - Volume of the Central Compartment (VC)
NCT03766581 (23) [back to overview]Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
NCT03766581 (23) [back to overview]Digit Symbol Substitution Test (DSST)
NCT03766581 (23) [back to overview]Modified Rankin Scale (mRS)
NCT03766581 (23) [back to overview]Number of Participants With Adverse Events (AEs)
NCT03766581 (23) [back to overview]Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
NCT03766581 (23) [back to overview]Percent of Participants With Major Bleeding According to BARC Type 3 and 5
NCT03766581 (23) [back to overview]National Institutes of Health Stroke Scale (NIHSS)
NCT03766581 (23) [back to overview]Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
NCT03766581 (23) [back to overview]Percent Change From Baseline in Factor XI Clotting Activity
NCT03766581 (23) [back to overview]Percent Change From Baseline in aPTT Activity
NCT03766581 (23) [back to overview]Number of Participants With Clinically Significant Vital Sign Abnormalities
NCT03766581 (23) [back to overview]Number of Participants With Clinically Significant Physical Examination Abnormalities
NCT03766581 (23) [back to overview]Montreal Cognitive Assessment (MoCA)
NCT03774394 (4) [back to overview]Clopidogrel Active Metabolite Concentration
NCT03774394 (4) [back to overview]P2Y12 Reaction Units (PRU) Assessed by VerifyNow. The Cutoff for High Platelet Reactivity is >208.
NCT03774394 (4) [back to overview]Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%
NCT03774394 (4) [back to overview]Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%
NCT04006288 (1) [back to overview]Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

Number of Participants With Major Adverse Cardiovascular Events (MACE)

Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization. (NCT00059215)
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)

Interventionparticipants (Number)
Prasugrel (CS-747) 40-mg LD/7.5-mg MD15
Prasugrel (CS-747) 60-mg LD/10-mg MD15
Prasugrel (CS-747) 60-mg LD/15-mg MD17
Clopidogrel24
Prasugrel (CS-747) Combined47

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Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE

"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE.~Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL.~MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization" (NCT00059215)
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)

Interventionparticipants (Number)
Prasugrel (CS-747) 40-mg LD/7.5-mg MD17
Prasugrel (CS-747) 60-mg LD/10-mg MD19
Prasugrel (CS-747) 60-mg LD/15-mg MD20
Clopidogrel27
Prasugrel (CS-747) Combined56

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Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin." (NCT00059215)
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)

Interventionparticipants (Number)
Prasugrel (CS-747) 40-mg LD/7.5-mg MD1
Prasugrel (CS-747) 60-mg LD/10-mg MD1
Prasugrel (CS-747) 60-mg LD/15-mg MD1
Clopidogrel2
Prasugrel (CS-747) Combined3

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Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events

"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL." (NCT00059215)
Timeframe: randomization though 30 days after percutaneous coronary intervention (PCI)

Interventionparticipants (Number)
Prasugrel (CS-747) 40-mg LD/7.5-mg MD3
Prasugrel (CS-747) 60-mg LD/10-mg MD4
Prasugrel (CS-747) 60-mg LD/15-mg MD4
Clopidogrel3
Prasugrel (CS-747) Combined11

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Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke

The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI). (NCT00097591)
Timeframe: Randomization up to 15 months

,
InterventionParticipants (Number)
UA/NSTEMI (n=5044, n=5030)STEMI (n=1769, n=1765)All ACS (n=6813, n=6795)
Clopidogrel565216781
Prasugrel469174643

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Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke

The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population. (NCT00097591)
Timeframe: Randomization up to 15 months

InterventionParticipants (Number)
Prasugrel692
Clopidogrel822

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Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events

The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population. (NCT00097591)
Timeframe: Randomization up to 15 months

InterventionParticipants (Number)
Prasugrel797
Clopidogrel938

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Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke

The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods. (NCT00097591)
Timeframe: Randomization to 30 days; randomization to 90 days

,
InterventionParticipants (Number)
All ACS (Through 30 days)All ACS (Through 90 days)
Clopidogrel502573
Prasugrel389462

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Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)

The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods. (NCT00097591)
Timeframe: Randomization to 30 days; randomization to 90 days

,
InterventionParticipants (Number)
All ACS (Through 30 days)All ACS (Through 90 days)
Clopidogrel504588
Prasugrel399472

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Number of Patients With Ipsilateral Ischemic Stroke Rate

ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis (NCT00130039)
Timeframe: upto 7 months after randomization

Interventionparticipants (Number)
Cilostazol9
Clopidogrel5

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Numbers of Fatal or Major Bleeding Complications

life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood (NCT00130039)
Timeframe: upto 7 months after randomization

Interventionevents (Number)
Cilostazol2
Clopidogrel6

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Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI

number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI. (NCT00130039)
Timeframe: 7 months after treatment

Interventionpariticipants (Number)
Cilostazol34
Clopidogrel23

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Number of Participants With Stroke Events

including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke (NCT00130039)
Timeframe: upto 7 months after randomization

Interventionparticipants (Number)
Cilostazol11
Clopidogrel7

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Number of Participants With Progression of Symptomatic Intracranial Stenosis

"Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA.~The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA." (NCT00130039)
Timeframe: 7 months after treatment

Interventionparticipants (Number)
Cilostazol20
Clopidogrel32

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Number of Participants With Overall Cardiovascular Events

including nonfatal stroke, nonfatal myocardial infarction and vascular death. (NCT00130039)
Timeframe: upto 7 months after randomization

Interventionparticipants (Number)
Cilostazol15
Clopidogrel10

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Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)

Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure (NCT00153062)
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 years

InterventionParticipants (Number)
Telmisartan1367
Placebo1463

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Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)

(NCT00153062)
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 years

InterventionParticipants (Number)
Aspirin + Extended Release Dipyridamole916
Clopidogrel898

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Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)

(NCT00153062)
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 years

InterventionParticipants (Number)
Telmisartan880
Placebo934

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Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)

(NCT00153062)
Timeframe: Randomization to final patient contact

InterventionParticipants (Number)
Telmisartan125
Placebo151

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Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)

Number of patients with any of stroke, myocardial infarction, vascular death (NCT00153062)
Timeframe: time since randomization; follow-up period is 1.5 to 4.4 years

InterventionParticipants (Number)
Aspirin + Extended Release Dipyridamole1333
Clopidogrel1333

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Vein Graft Intimal Area

IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed (NCT00228423)
Timeframe: One year following surgery

Interventionmm (Mean)
75mg Clopidogrel4.1
Placebo4.5

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Vein Graft Angiographic Patency

Postoperative angiogram 12 months post-CABG (NCT00228423)
Timeframe: One year following surgery

Interventionpercentage (Number)
75mg Clopidogrel94.3
Placebo93.2

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Incidence of Major Bleeding Events Within One Year Following Surgery

(NCT00228423)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
75mg Clopidogrel1
Placebo0

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Incidence of Major Adverse Coronary Events Within One Year Following Surgery

(NCT00228423)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
75mg Clopidogrel4
Placebo5

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Death From Any Cause (Cardiovascular and Noncardiovascular)

The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group. (NCT00249873)
Timeframe: expected median follow-up of approximately 3 years

Interventionparticipants (Number)
Clopidogrel + ASA825
Placebo + ASA841

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Adjudicated Major Bleedings

The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug). (NCT00249873)
Timeframe: expected median follow-up of approximately 3 years

Interventionparticipants (Number)
Clopidogrel + ASA251
Placebo + ASA162

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First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication

"The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :~stroke (nonfatal or fatal)~myocardial infarction (nonfatal or fatal)~non-CNS systemic embolism~vascular death~The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group." (NCT00249873)
Timeframe: expected median follow-up of approximately 3 years

,
Interventionparticipants (Number)
All components- Myocardial Infarction (fatal or not)- Stroke (fatal or not)- Non-CNS systemic embolism- Vascular death
Clopidogrel + ASA8328428550413
Placebo + ASA92410539148380

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Occurrence of Stroke

The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group. (NCT00249873)
Timeframe: expected median follow-up of approximately 3 years

Interventionparticipants (Number)
Clopidogrel + ASA296
Placebo + ASA408

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Death/Reinfarction/Disabling Stroke at 30 Days

Incidence of Death or Reinfarction or Disabling Stroke at 30 days (NCT00257309)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Thrombolysis34
Primary Angioplasty25

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Incidence of Death or Reinfarction or Disabling Stroke

Incidence of all-cause death or myocardial reinfarction or disabling stroke (NCT00257309)
Timeframe: 30 days

Interventionparticipants (Number)
Thrombolysis34
Primary Angioplasty25

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Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups

Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU). (NCT00263211)
Timeframe: Baseline, 2 weeks and 1 month

,
InterventionAspirin Reaction Units (Mean)
Baseline Aspirin Reaction UnitsARU2 weeks ARU1 month ARU
Observation Only579.81578.35593.58
Plavix and Aspirin610.39435.33455.44

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Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug

Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type. (NCT00263211)
Timeframe: Maximum of 6 months

,
Interventionparticipants (Number)
Bleeding (possibly related)Back pain (unlikely related)
Observation Only00
Plavix and Aspirin11

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Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time

Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only (NCT00263211)
Timeframe: Baseline, 2 weeks and 1 month

,
Interventionpercentage of participants (Number)
Baseline 0 CTCs2 week 0 CTCs1 month 0 CTCsBaseline 1-5 CTCs2 weeks 1-5 CTCs1 month 1-5 CTCsBaseline >=5 CTS2 weeks >=5 CTCs1 month >=5 CTCs
Observation Only22.7340.0035.0063.6445.0055.0013.6415.0010.00
Plavix and Aspirin40.0045.0041.1845.0031.5852.9415.0021.055.88

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Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs

Measured by number of patients who have detectable circulating tumor cells (NCT00263211)
Timeframe: Week 4

Interventionparticipants (Number)
Plavix and Aspirin11
Observation Only15

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Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups

Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups (NCT00263211)
Timeframe: Baseline, 2 weeks and 1 month

,
Interventionpercentage of platelet inhibition (Mean)
Baseline2 weeks1 month
Observation Only13.009.057.05
Plavix and Aspirin9.8537.3535.56

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Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)

excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm78
Clopidogrel Arm65

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Incidence of All Cause Mortality

(excluding STEMI) (NCT00305162)
Timeframe: randomization through 1 year after randomization

Interventionparticipants (Number)
Cangrelor Arm116
Clopidogrel Arm120

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Incidence of All-cause Mortality

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm34
Clopidogrel Arm29

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Incidence of All-cause Mortality and MI

(composite incidence) (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm285
Clopidogrel Arm261

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Incidence of All-cause Mortality or MI

(composite incidence) (NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm321
Clopidogrel Arm298

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Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

(composite incidence) (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm290
Clopidogrel Arm276

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Incidence of GUSTO Severe / Life-threatening Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm10
Clopidogrel Arm11

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Incidence of IDR

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm44
Clopidogrel Arm52

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Incidence of MI

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm297
Clopidogrel Arm276

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Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm19
Clopidogrel Arm14

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Incidence of All-cause Mortality, MI or IDR

(composite incidence) (NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm343
Clopidogrel Arm327

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Individual Incidence of All-cause Mortality

(NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm8
Clopidogrel Arm5

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Incidence of ACUITY Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm151
Clopidogrel Arm120

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Incidence of Stroke

(NCT00305162)
Timeframe: randomization through 30 days after randomization

Interventionparticipants (Number)
Cangrelor Arm5
Clopidogrel Arm7

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Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI

(a patient could have multiple procedural events) (NCT00305162)
Timeframe: during index PCI

Interventionparticipants (Number)
Cangrelor Arm127
Clopidogrel Arm141

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Incidence of Stroke

"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:~primary hemorrhagic - stroke with focal collections of intracranial blood~ischemic cerebral infarction - stroke without focal collections of intracranial blood~infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding~uncertain - no imaging or autopsy data are available." (NCT00305162)
Timeframe: randomization through 48 hours after randomization

,
Interventionparticipants (Number)
primary hemorrhagicinfarction with hemorrhagic conversioncerebral infarctionuncertain type
Cangrelor Arm1050
Clopidogrel Arm0070

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Individual Incidence of IDR

(NCT00305162)
Timeframe: randomization through 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Arm13
Clopidogrel Arm23

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First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level

(NCT00335452)
Timeframe: 30 days

Interventionparticipants (Number)
Clopidogrel 300/75/75 mg + ASA Low Dose267
Clopidogrel 300/75/75 mg + ASA High Dose290
Clopidogrel 600/150/75 mg + ASA Low Dose282
Clopidogrel 600/150/75 mg + ASA High Dose240

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First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup

(NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
CV death/MI/Stroke- CV death- MI (fatal or not)- Stroke (fatal or not)
Clopidogrel 300/75/75 mg + ASA39213222535
Clopidogrel 600/150/75 mg + ASA33013017228

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Occurrence of Major Bleeding - ASA Dose Level Comparison

(NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
Major bleeding- Severe bleeding- Major but not severe bleeding
Clopidogrel + ASA High Dose28221673
Clopidogrel + ASA Low Dose28521574

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Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison

This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC. (NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
Stent trombosis- Definite- Probable
Clopidogrel 300/75/75 mg + ASA20011189
Clopidogrel 600/150/75 mg + ASA1355877

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Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison

Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC. (NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
Major bleeding- Severe bleeding- Major but not severe bleeding
Clopidogrel 300/75/75 mg + ASA25519565
Clopidogrel 600/150/75 mg + ASA31323683

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First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison

"The primary endpoint is the first occurrence of any of the following events:~Cardiovascular death (any death with a clear cardiovascular or unknown cause),~Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)~Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)~reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC)." (NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
CV death/MI/Stroke- CV death- MI (fatal or not)- Stroke (fatal or not)
Clopidogrel 300/75/75 mg + ASA55722227461
Clopidogrel 600/150/75 mg + ASA52222623759

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First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison

(NCT00335452)
Timeframe: 30 days

,
Interventionparticipants (Number)
CV death/MI/Stroke- CV death- MI (fatal or not)- Stroke (fatal or not)
Clopidogrel + ASA High Dose52721125165
Clopidogrel + ASA Low Dose54623126055

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Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week

Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation. (NCT00356135)
Timeframe: 1 week after randomized study drug

,,
Interventioncorrelation coefficient (Number)
MPA (20 uM ADP) at 1 weekRPA (20 uM ADP) at 1 week
Clopidogrel 75/75 mg0.4260.425
Prasugrel 10/10 mg0.5640.640
Prasugrel 60/10 mg0.4390.547

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Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks

Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA). (NCT00356135)
Timeframe: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug

,,
Interventionpercent maximum platelet aggregation (%) (Mean)
2 Hour (20 uM ADP)24 Hour (20 uM ADP)1 Week (20 uM ADP)2 Week (20 uM ADP)2 Hour (5 uM ADP)24 Hour (5 uM ADP)1 Week (5 uM ADP)2 Week (5 uM ADP)
Clopidogrel 75/75 mg48.0753.8053.8052.2537.2540.8841.9441.05
Prasugrel 10/10 mg49.4652.2942.9540.8437.8738.8432.4430.18
Prasugrel 60/10 mg26.6527.3640.6438.6119.9720.9431.4528.64

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Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria

Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed. (NCT00356135)
Timeframe: End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug

,,
InterventionParticipants (Number)
Any Bleeding at Any Time During Randomized PeriodBaseline: Any BleedingBaseline: Insignificant BleedingBaseline: Minor BleedingBaseline: Major BleedingHour 24: Any BleedingHour 24: Insignificant BleedingHour 24: Minor BleedingHour 24: Major BleedingDay 7: Any BleedingDay 7: Insignificant BleedingDay 7: Minor BleedingDay 7: Major BleedingDay 14: Any BleedingDay 14: Insignificant BleedingDay 14: Minor BleedingDay 14: Major Bleeding
Clopidogrel 75/75 mg63300000022004400
Prasugrel 10/10 mg40000000022002200
Prasugrel 60/10 mg61100110033002200

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Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks

Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA). (NCT00356135)
Timeframe: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug

,,
Interventionpercent residual platelet aggregation (Mean)
2 Hour (20 uM ADP)24 Hour (20 uM ADP)1 Week (20 uM ADP)2 Week (20 uM ADP)2 Hour (5 uM ADP)24 Hour (5 uM ADP)1 Week (5 uM ADP)2 Week (5 uM ADP)
Clopidogrel 75/75 mg28.2135.1634.4534.5614.8419.6621.5719.28
Prasugrel 10/10 mg32.0632.9722.9218.8918.8319.1811.1110.03
Prasugrel 60/10 mg5.104.7017.9415.174.174.459.949.43

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Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)

Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA). (NCT00356135)
Timeframe: 1 week after first dose of randomized study drug

Interventionpercent maximum platelet aggregation (%) (Least Squares Mean)
Prasugrel 10/10 mg41.1
Clopidogrel 75/75 mg55.0
Prasugrel 60/10 mg41.0

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Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event

Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event. (NCT00356135)
Timeframe: End of 14 day open label

Interventionpercent maximum platelet aggregation (%) (Mean)
Clopidogrel Use60.73
No Clopidogrel Use55.53

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Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase

Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% (NCT00357968)
Timeframe: 14 days after cross-over

Interventionparticipants (Number)
Clopidogrel4
Prasugrel1

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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose

Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis. (NCT00357968)
Timeframe: 18 to 24 hours after loading dose

InterventionIU/L (Median)
Prasugrel11.64
Clopidogrel11.16

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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose

Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis (NCT00357968)
Timeframe: 6 hours after loading dose

InterventionIU/L (Mean)
Prasugrel9.16
Clopidogrel8.13

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Number of Hyporesponsive Participants at 6 Hours After the Loading Dose

Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% (NCT00357968)
Timeframe: 6 hours after loading dose

Interventionparticipants (Number)
Prasugrel0
Clopidogrel21

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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment

"Measures IPA during maintenance dosing before and after cross-over for each therapy.~IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100." (NCT00357968)
Timeframe: after 14 days of maintenance dosing

Interventionpercent inhibition (Mean)
Prasugrel61.34
Clopidogrel46.06

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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase

"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL." (NCT00357968)
Timeframe: after 14 days of treatment (before cross-over)

Interventionparticipants (Number)
Prasugrel2
Clopidogrel0

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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose

IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100. (NCT00357968)
Timeframe: 2 hours after loading dose

Interventionpercent inhibition (Mean)
Prasugrel64.54
Clopidogrel20.32

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Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose

Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis. (NCT00357968)
Timeframe: 18 to 24 hours after loading dose

Interventionng/ml (Mean)
Prasugrel0.12
Clopidogrel0.13

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Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose

Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis. (NCT00357968)
Timeframe: 6 hours after loading dose

Interventionng/ml (Mean)
Prasugrel0.06
Clopidogrel0.05

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Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase

Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20% (NCT00357968)
Timeframe: From loading dose to day 15

Interventionparticipants (Number)
Prasugrel1
Clopidogrel7

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Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase

Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization (NCT00357968)
Timeframe: after 14 days of treatment (before cross-over)

Interventionparticipants (Number)
Prasugrel2
Clopidogrel1

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Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase

Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization (NCT00357968)
Timeframe: 14 days after cross-over

Interventionparticipants (Number)
Clopidogrel1
Prasugrel0

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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase

"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL." (NCT00357968)
Timeframe: 14 days after cross-over

Interventionparticipants (Number)
Clopidogrel0
Prasugrel0

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Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose

IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100. (NCT00357968)
Timeframe: 6 hours after loading dose

Interventionpercent inhibition (Mean)
Prasugrel74.81
Clopidogrel31.77

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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose

VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect. (NCT00357968)
Timeframe: 18 to 24 hours after loading dose

Interventionpercent (%) platelet reactivity index (Mean)
Prasugrel10.3
Clopidogrel64.3

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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment

VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect. (NCT00357968)
Timeframe: after 14 days of maintenance dosing

Interventionpercent (%) platelet reactivity index (Mean)
Prasugrel23.4
Clopidogrel43.8

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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose

VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect. (NCT00357968)
Timeframe: 2 hours after loading dose

Interventionpercent (%) platelet reactivity index (Mean)
Prasugrel21.5
Clopidogrel75.0

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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose

VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect. (NCT00357968)
Timeframe: 6 hours after loading dose

Interventionpercent (%) platelet reactivity index (Mean)
Prasugrel7.4
Clopidogrel68.4

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Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]

mITT population A patient could have multiple procedural events. (NCT00385138)
Timeframe: During index PCI

Interventionparticipants (Number)
Cangrelor122
Clopidogrel142

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Incidence of Stent Thrombosis

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor15
Clopidogrel28

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Incidence of Stent Thrombosis

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor5
Clopidogrel16

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Incidence of Stroke

mITT (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor7
Clopidogrel5

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Incidence of Stroke

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor6
Clopidogrel5

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Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor4
Clopidogrel9

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Incidence of All-cause Mortality or MI

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor180
Clopidogrel204

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Incidence of All-cause Mortality, MI, or IDR

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor227
Clopidogrel249

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Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

mITT population; (composite incidence) (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor185
Clopidogrel210

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Incidence of GUSTO Severe / Life-threatening

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor9
Clopidogrel6

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Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor6
Clopidogrel18

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Incidence of IDR

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor19
Clopidogrel24

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Incidence of MI

mITT population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor177
Clopidogrel191

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Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor35
Clopidogrel45

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Incidence of All-cause Mortality

mITT population (NCT00385138)
Timeframe: randomization through 1 year post randomization

Interventionparticipants (Number)
Cangrelor94
Clopidogrel113

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Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm

Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm. (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor43
Clopidogrel29

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Incidence of ACUITY Major Bleeding

Major bleeding (non-CABG-related) - Safety population (NCT00385138)
Timeframe: randomization through 48 hours post randomization

Interventionparticipants (Number)
Cangrelor145
Clopidogrel91

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Incidence of IDR

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor37
Clopidogrel46

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Incidence of All-cause Mortality or MI

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor213
Clopidogrel233

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Incidence of MI

mITT population (NCT00385138)
Timeframe: randomization through 30 days post randomization

Interventionparticipants (Number)
Cangrelor189
Clopidogrel201

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Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA. (NCT00385944)
Timeframe: Baseline to 6-18 hrs post loading dose (LD)

InterventionPercentage aggregation (Mean)
Clopidogrel 900 mg-35.5

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Correlation of MPA to 20 μM ADP and PRU

Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU (NCT00385944)
Timeframe: Baseline through 29 days of treatment

InterventionCorrelation coefficient (Number)
Intent-to-treat Population0.8

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Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP

"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%" (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage inhibition (Mean)
Prasugrel87.1
Clopidogrel75.9

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Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP

"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%" (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage inhibition (Mean)
Prasugrel95.6
Clopidogrel91.4

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Inhibition Platelet Aggregation (IPA) to 20 μM ADP

"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%" (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage inhibition (Mean)
Prasugrel64.2
Clopidogrel48.5

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Inhibition Platelet Aggregation (IPA) to 5 μM ADP

"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%" (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage inhibition (Mean)
Prasugrel72.4
Clopidogrel58.8

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Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)

Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA). (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel27.1
Clopidogrel40.3

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Mean Residual Platelet Aggregation (RPA) to 20 µM ADP

Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel9.4
Clopidogrel21.6

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Mean Residual Platelet Aggregation (RPA) to 5 µM ADP

Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel2.7
Clopidogrel7.1

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MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA. (NCT00385944)
Timeframe: 14 days after the first maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel/Clopidogrel28.9
Clopidogrel/Prasugrel38.2

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MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA. (NCT00385944)
Timeframe: 14 days after the second maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel/Clopidogrel42.5
Clopidogrel/Prasugrel25

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MPA to 5 μM ADP

Maximum platelet aggregation to 5 μM ADP was assessed by LTA. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel16.9
Clopidogrel25.0

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P2Y12 Reaction Units (PRU)

P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPRU (Mean)
Prasugrel44
Clopidogrel98.7

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Platelet Reactivity Index (PRI)

"Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:~PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100~Lower PRI% values indicate greater P2Y12 receptor blockade." (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

InterventionPercentage PRI (Mean)
Prasugrel22.1
Clopidogrel39.4

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Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)

Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

,
InterventionParticipants (Number)
Severe or life-threateningModerateMinor
Clopidogrel002
Prasugrel003

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Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria

Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

,
InterventionParticipants (Number)
MajorMinorInsignificant
Clopidogrel011
Prasugrel003

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Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)

Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD. (NCT00385944)
Timeframe: 14 days after maintenance dose (MD)

,
InterventionParticipants (Number)
ResponderPoor Responder
Clopidogrel3512
Prasugrel481

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Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA. (NCT00385944)
Timeframe: 6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)

InterventionPercentage aggregation (Mean)
Prasugrel/Clopidgrel-9
Clopidogrel/Prasugrel-0.6

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Participants With Major or Minor Bleeding

Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

InterventionParticipants (Number)
TICAGRELOR1339
CLOPIDOGREL1215

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Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke

Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR901
CLOPIDOGREL1065

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Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.

Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR1290
CLOPIDOGREL1456

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Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR569
CLOPIDOGREL668

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Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR864
CLOPIDOGREL1014

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Participants With Any Major Bleeding Event

Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

InterventionParticipants (Number)
TICAGRELOR961
CLOPIDOGREL929

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Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding

Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months

InterventionParticipants (Number)
TICAGRELOR619
CLOPIDOGREL654

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Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding

Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months

InterventionParticipants (Number)
TICAGRELOR329
CLOPIDOGREL341

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Participants With Death From Any Cause

Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR399
CLOPIDOGREL506

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Participants With Death From Vascular Causes

Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR353
CLOPIDOGREL442

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Participants With MI Event

Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR504
CLOPIDOGREL593

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Participants With Non-procedural Major Bleeding

Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

InterventionParticipants (Number)
TICAGRELOR235
CLOPIDOGREL180

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Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization

InterventionParticipants (Number)
TICAGRELOR21
CLOPIDOGREL16

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Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization

InterventionParticipants (Number)
TICAGRELOR84
CLOPIDOGREL51

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Participants With Stroke

Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

InterventionParticipants (Number)
TICAGRELOR125
CLOPIDOGREL106

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Number of Participants With Bleeding Events

"Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted." (NCT00396877)
Timeframe: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first

,
Interventionparticipants (Number)
Any bleeding event- Serious- Serious with an outcome of death- Leading to permanent treatment discontinuation
Clopidogrel 0.2 mg/kg/Day873019
Placebo883219

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Number of Participants According to Bleeding Type/Etiology

For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times. (NCT00396877)
Timeframe: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first

,
Interventionparticipants (Number)
SpontaneousPost-traumaticPuncture (vascular access site)Surgical
Clopidogrel 0.2 mg/kg/Day5611917
Placebo6061910

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Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)

"The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.~Only the first event was counted." (NCT00396877)
Timeframe: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)

,
Interventionparticipants (Number)
Death / Shunt Thrombosis / Cardiac Procedure- Death- Shunt thrombosis- Cardiac procedure <120 days of thrombotic nature
Clopidogrel 0.2 mg/kg/Day89512612
Placebo9060219

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Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 72 hours after last dose

InterventionPercentage (Median)
Ticagrelor11.76
Clopidogrel21.09

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Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 48 hours after last dose

InterventionPercentage (Median)
Ticagrelor30.94
Clopidogrel45.79

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Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 8 hours after first dose

InterventionPercentage (Median)
Ticagrelor96.99
Clopidogrel46.90

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Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 8 hours after last dose

InterventionPercentage (Median)
Ticagrelor88.31
Clopidogrel61.31

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Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug

IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour. (NCT00528411)
Timeframe: 4 to 72 Hours after last dose of study drug

InterventionPercentage/Hour (Least Squares Mean)
Ticagrelor-1.037
Clopidogrel-0.482

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Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 120 hours - Day 5 after last dose

InterventionPercentage (Median)
Ticagrelor0.0
Clopidogrel21.15

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Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 240 hours - Day 10 after last dose

InterventionPercentage (Median)
Ticagrelor1.64
Clopidogrel0.98

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Cardiopulmonary Parameters at Post 6-week Treatment: FVC

FVC is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter (Mean)
Ticagrelor3.70
Clopidogrel3.78
Placebo3.98

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Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 4 hours after first dose

InterventionPercentage (Median)
Ticagrelor98.39
Clopidogrel40.87

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Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 1 hour after first dose

InterventionPercentage (Median)
Ticagrelor86.71
Clopidogrel15.83

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Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 0.5 hours after first dose

InterventionPercentage (Median)
Ticagrelor45.39
Clopidogrel4.71

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Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 0 hour before last dose

InterventionPercentage (Median)
Ticagrelor74.53
Clopidogrel51.75

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Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose

IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: At 2 hours after first dose of study drug

InterventionPercentage (Median)
Ticagrelor93.15
Clopidogrel31.05

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Cardiopulmonary Parameters Post 6-week Treatment: VT

VT is measured by Body Box Plethysmography, the unit is Liter/Minute. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiters/minute (Mean)
Ticagrelor0.92
Clopidogrel0.93
Placebo0.83

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Cardiopulmonary Parameters Post 6-week Treatment: VE

VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter/minute (Mean)
Ticagrelor13.69
Clopidogrel13.14
Placebo11.45

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Cardiopulmonary Parameters Post 6-week Treatment: TLC

TLC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter (Mean)
Ticagrelor5.70
Clopidogrel5.85
Placebo5.96

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Cardiopulmonary Parameters Post 6-week Treatment: SpO2

SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. (NCT00528411)
Timeframe: 6-week post treatment

InterventionPercentage (Mean)
Ticagrelor97.73
Clopidogrel97.35
Placebo98.56

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Cardiopulmonary Parameters Post 6-week Treatment: RV

RV is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter (Mean)
Ticagrelor1.88
Clopidogrel1.97
Placebo1.90

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Cardiopulmonary Parameters Post 6-week Treatment: RR

RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. (NCT00528411)
Timeframe: 6-week post treatment

InterventionBreaths/minute (Mean)
Ticagrelor15.21
Clopidogrel15.10
Placebo14.91

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Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP

NT-proBNP is measured by clinical lab, the unit is pg/mL. (NCT00528411)
Timeframe: 6-week post treatment

Interventionpg/ml (Mean)
Ticagrelor139.88
Clopidogrel214.43
Placebo140.68

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Cardiopulmonary Parameters Post 6-week Treatment: FRC

FRC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter (Mean)
Ticagrelor2.73
Clopidogrel2.79
Placebo2.75

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Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75

FEF25-75 is measured by Spirometry, the unit is Liter/Second. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter/second (Mean)
Ticagrelor2.77
Clopidogrel2.67
Placebo2.91

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Cardiopulmonary Parameters Post 6-week Treatment: EF

EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. (NCT00528411)
Timeframe: 6-week post treatment

InterventionPercent (Mean)
Ticagrelor60.70
Clopidogrel62.38
Placebo60.73

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Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB

DLCOSB is measured by Body Box Plethysmography, the unit is Percent. (NCT00528411)
Timeframe: 6-week post treatment

InterventionPercent (Mean)
Ticagrelor16.38
Clopidogrel16.53
Placebo16.09

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Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio

FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. (NCT00528411)
Timeframe: 6-week post treatment

InterventionRatio (Mean)
Ticagrelor74.71
Clopidogrel72.84
Placebo74.27

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Cardiopulmonary Parameters at Post 6-week Treatment: FEV1

FEV1 is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment

InterventionLiter (Mean)
Ticagrelor2.77
Clopidogrel2.74
Placebo2.95

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Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)

TLC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline

InterventionLiter (Mean)
Ticagrelor5.78
Clopidogrel5.83
Placebo6.10

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Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)

VT is measured by Body Box Plethysmography, the unit is Liter/Minute. (NCT00528411)
Timeframe: Baseline

InterventionLiters/minute (Mean)
Ticagrelor0.96
Clopidogrel0.89
Placebo0.89

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Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)

DLCOSB is measured by Body Box Plethysmography, the unit is Percent. (NCT00528411)
Timeframe: Baseline

InterventionPercent (Mean)
Ticagrelor17.00
Clopidogrel17.29
Placebo15.83

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Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)

RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. (NCT00528411)
Timeframe: Baseline

InterventionBreaths/minute (Mean)
Ticagrelor14.79
Clopidogrel14.15
Placebo15.5

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Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)

FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. (NCT00528411)
Timeframe: Baseline

InterventionRatio (Mean)
Ticagrelor75.01
Clopidogrel73.04
Placebo73.13

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Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

NT-proBNP is measured by clinical lab, the unit is pg/mL. (NCT00528411)
Timeframe: Baseline

Interventionpg/ml (Mean)
Ticagrelor163.34
Clopidogrel185.98
Placebo145.41

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Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)

VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute (NCT00528411)
Timeframe: Baseline

InterventionLiter/minute (Mean)
Ticagrelor12.92
Clopidogrel12.17
Placebo12.06

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Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)

FEF25-75 is measured by Spirometry, the unit is Liter/Second. (NCT00528411)
Timeframe: Baseline

InterventionLiter/second (Mean)
Ticagrelor2.88
Clopidogrel2.70
Placebo2.50

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Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)

FRC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline

InterventionLiter (Mean)
Ticagrelor2.79
Clopidogrel2.89
Placebo2.91

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Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)

FVC is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: Baseline

InterventionLiter (Mean)
Ticagrelor3.72
Clopidogrel3.73
Placebo4.03

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Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: Baseline

InterventionLiter (Mean)
Ticagrelor2.79
Clopidogrel2.71
Placebo2.94

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Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)

EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. (NCT00528411)
Timeframe: Baseline

InterventionPercent (Mean)
Ticagrelor57.96
Clopidogrel61.91
Placebo59.92

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Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)

SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. (NCT00528411)
Timeframe: Baseline

InterventionPercent (Mean)
Ticagrelor96.59
Clopidogrel96.78
Placebo97.58

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Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 4 hours after last dose

InterventionPercentage (Median)
Ticagrelor96.10
Clopidogrel61.80

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Cardiopulmonary Parameters at Baseline: Residual Volume (RV)

RV is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline

InterventionLiter (Mean)
Ticagrelor1.94
Clopidogrel2.01
Placebo1.91

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Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 168 hours - Day 7 after last dose

InterventionPercentage (Median)
Ticagrelor0.0
Clopidogrel6.32

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Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 2 hours after last dose

InterventionPercentage (Median)
Ticagrelor91.49
Clopidogrel62.96

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Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 24 hours after first dose

InterventionPercentage (Median)
Ticagrelor87.29
Clopidogrel49.64

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Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose

IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 24 hours after last dose

InterventionPercentage (Median)
Ticagrelor55.18
Clopidogrel53.91

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Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.

Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units. (NCT00619073)
Timeframe: Baseline and 45 days after intervention

Interventionmean fluorescence intensity (MFI) (Mean)
Clopidogrel + Aspirin123.2
Placebo + Aspirin126.7

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Number of Patients With All Cause Death and Non-fatal Stroke

This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)50
Primary PCI (Group B)43

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Number of Patients With Total Non-disabling Stroke

This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)8
Primary PCI (Group B)1

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Number of Patients With Cardiac Mortality

This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)31
Primary PCI (Group B)32

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Number of Patients With Cardiogenic Shock

This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)41
Primary PCI (Group B)56

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Number of Patients With Congestive Heart Failure (CHF)

This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)57
Primary PCI (Group B)72

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Number of Patients With Intracranial Haemorrhage

This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)9
Primary PCI (Group B)2

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Number of Patients With Ischaemic Stroke

This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)6
Primary PCI (Group B)3

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Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions

This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)61
Primary PCI (Group B)45

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Number of Patients With Rehospitalisation for Cardiac Reasons

This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)45
Primary PCI (Group B)41

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Number of Patients With Rehospitalisation for Non-cardiac Reasons

This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)19
Primary PCI (Group B)11

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Number of Patients With Serious Repeat Target Vessel Revascularization

This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)1
Primary PCI (Group B)2

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Number of Patients With Serious Resuscitated Ventricular Fibrillation

This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)32
Primary PCI (Group B)38

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Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures

This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)10
Primary PCI (Group B)29

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Number of Patients With Minor Non-intracranial Bleeds

This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)206
Primary PCI (Group B)191

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Number of Patients With Recurrent Myocardial Infarction (Reinfarction)

This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)23
Primary PCI (Group B)21

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Number of Patients With Total Disabling Stroke

This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)2
Primary PCI (Group B)0

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Number of Patients With Total Stroke (All Types)

This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)15
Primary PCI (Group B)5

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Number of Patients With Total Non-intracranial Bleeds

This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)267
Primary PCI (Group B)236

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Number of Patients With Total Fatal Stroke

This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)7
Primary PCI (Group B)4

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Number of Patients With All Cause Death and Shock

This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)59
Primary PCI (Group B)73

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Number of Patients With All Cause Death and Shock and CHF

This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)100
Primary PCI (Group B)123

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Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke

This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)117
Primary PCI (Group B)135

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Number of Patients With All Cause Death and Shock and Reinfarction

This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)77
Primary PCI (Group B)85

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Number of Patients With All Cause Mortality

This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)43
Primary PCI (Group B)42

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Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.

The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS). (NCT00623623)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Tenecteplase (Group A)116
Primary PCI (Group B)135

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Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate

Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) - Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing. (NCT00642174)
Timeframe: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

,
Interventionmillimeters (mm) (Least Squares Mean)
Baseline1 Hour After Loading Dose4 Hours After Loading Dose24 Hours After Loading Dose24 Hours After Last Maintenance Dose
Clopidogrel58.154.848.149.246.8
Prasugrel56.838.524.229.344.2

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Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)

Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists. (NCT00642174)
Timeframe: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

,
Interventionpercent platelet aggregation (Least Squares Mean)
Baseline (5 μM ADP)1 Hour After Loading Dose (5 μM ADP)4 Hours After Loading Dose (5 μM ADP)24 Hours After Loading Dose (5 μM ADP)24 Hours After Last Maintenance Dose (5 μM ADP)Baseline (20 μM ADP)1 Hour After Loading Dose (20 μM ADP)4 Hours After Loading Dose (20 μM ADP)24 Hours After Loading Dose (20 μM ADP)24 Hours After Last Maintenance Dose (20 μM ADP)
Clopidogrel65.756.744.645.638.376.969.857.558.450.7
Prasugrel64.933.718.022.329.677.144.722.427.438.3

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Platelet Reactivity Index (PRI)

Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition. (NCT00642174)
Timeframe: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose

,
Interventionpercent inhibition (Least Squares Mean)
Baseline1 Hour After Loading Dose4 Hours After Loading Dose24 Hours After Loading Dose24 Hours After Last Maintenance Dose
Clopidogrel80.676.267.558.542.3
Prasugrel83.540.014.515.727.4

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Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay

Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. (NCT00642174)
Timeframe: 1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)

,
Interventionpercent inhibition (Least Squares Mean)
1 Hour After Loading Dose24 Hours After Loading Dose24 Hours After Last Maintenance Dose
Clopidogrel13.429.344.2
Prasugrel49.987.161.8

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Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay

The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100. (NCT00642174)
Timeframe: 4 hours after loading dose

,
Interventionpercent inhibition (Least Squares Mean)
Baseline4 Hours After Loading Dose
Clopidogrel9.327.7
Prasugrel9.489.3

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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28

IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: 4 hrs post first dose on day 28

InterventionPercent (Least Squares Mean)
Responder: Ticagrelor77.4
Responder: Clopidogrel60.8

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Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.

The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00642811)
Timeframe: Day 14, and day 28, 4 hours post dose

InterventionPercent of participants (Number)
Non-responder: Ticagrelor81.3
Non-responder: Clopidogrel25.0

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Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)

The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00642811)
Timeframe: Day 14 and Day 28, 4 Hrs Post Dose.

InterventionPercent of Participants (Number)
Non-responder: Ticagrelor100
Non-responder: Clopidogrel93.8

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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15

IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: Day 15, 4 hrs post switching

InterventionPercent (Least Squares Mean)
Responder: Ticagrelor95.0
Responder: Clopidogrel48.5

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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15

IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: Day 15, 4 hrs post switching

InterventionPercent (Least Squares Mean)
Responder: Ticagrelor66.7
Responder: Clopidogrel65.3

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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28

IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: 4 hrs post first dose on day 28

InterventionPercent (Least Squares Mean)
Responder: Ticagrelor91.0
Responder: Clopidogrel61.2

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The Percentage of Coated Platelets After Coronary Angiography and/or PCI

The percentage of coated platelets 24 hours after coronary angiography and/or PCI (NCT00644657)
Timeframe: 6 hrs after procedure

InterventionPercentage of platelets that are coated (Mean)
Clopidogrel Loading Dose33.9

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The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty

The percentage of platelets that are collagen coated after the administration of clopidogrel. (NCT00644657)
Timeframe: 24 hours after the administration of clopidotrel

InterventionPercent of platelets that are coated. (Mean)
Clopidogrel Loading Dose32.8

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Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI

Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Baseline Up To Day 60

,,
Interventionng/mL (Mean)
BaselineTime of Hospital Discharge
Placebo/Placebo Non-PCI11.112.9
Vorapaxar 20 mg Loading Dose Non-PCI8.410.1
Vorapaxar 40 mg Loading Dose Non-PCI4.67.1

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Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI

Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Up to Day 60

,,
InterventionParticipants (Number)
Major TIMI EventsMinor TIMI EventsNon-TIMI Bleeding Events
Placebo/Placebo Non-PCI001
Vorapaxar 20 mg Loading Dose Non-PCI101
Vorapaxar 40 mg Loading Dose Non-PCI208

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Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge

Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group. (NCT00684203)
Timeframe: Up to Day 121

,,,,
InterventionParticipants (Number)
Treatment PhasePost-Hospital Discharge
Placebo/Placebo PCI00
Vorapaxar 20 mg/1 mg PCI31
Vorapaxar 20 mg/2.5 mg PCI00
Vorapaxar 40 mg/1 mg PCI22
Vorapaxar 40 mg/2.5 mg PCI00

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Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion

Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Up to Day 60

InterventionParticipants (Number)
Vorapaxar 20 mg Loading Dose Non-PCI1
Vorapaxar 40 mg Loading Dose Non-PCI2
Placebo/Placebo Non-PCI0

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Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization

Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Up to Day 30

InterventionParticipants (Number)
Vorapaxar 20 mg Loading Dose Non-PCI0
Vorapaxar 40 mg Loading Dose Non-PCI1
Placebo/Placebo Non-PCI0

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Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group. (NCT00684203)
Timeframe: Up to Day 121

InterventionParticipants (Number)
Vorapaxar 20 mg/1 mg PCI21
Vorapaxar 20 mg/2.5 mg PCI19
Vorapaxar 40 mg/1 mg PCI16
Vorapaxar 40 mg/2.5 mg PCI14
Placebo/Placebo PCI21

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Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI

Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Baseline Up To Day 60

,,
Interventionmg/L (Median)
BaselineTime of Hospital Discharge
Placebo/Placebo Non-PCI6.943.96
Vorapaxar 20 mg Loading Dose Non-PCI2.573.56
Vorapaxar 40 mg Loading Dose Non-PCI1.052.65

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Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit

Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group. (NCT00684203)
Timeframe: Baseline, Day 30, Day 60

,,
Interventionmg/L (Median)
Baseline (n=37, 34, 21)Day 30 (n=35, 34, 21)Day 60 (n=30, 25, 13)
Placebo/Placebo PCI1.782.991.27
Vorapaxar 1 mg Maintenance Dose PCI1.301.281.20
Vorapaxar 2.5 mg Maintenance Dose PCI2.001.010.79

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Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI

Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group. (NCT00684203)
Timeframe: Baseline, Day 30, Day 60

,,
InterventionArbitrary Units (Mean)
Baseline (n=4, 4, 3)Day 30 (n=3, 4, 3)Day 60 (n=2, 3, 1)
Placebo/Placebo PCI15.918.819.4
Vorapaxar 1 mg Maintenance Dose PCI24.820.625.0
Vorapaxar 2.5 mg Maintenance Dose PCI16.516.414.9

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Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Up to Day 121

InterventionParticipants (Number)
Vorapaxar 20 mg Loading Dose Non-PCI6
Vorapaxar 40 mg Loading Dose Non-PCI15
Placebo/Placebo Non-PCI1

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Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. (NCT00684203)
Timeframe: Up to Day 60

InterventionParticipants (Number)
Vorapaxar 20 mg Loading Dose PCI40
Vorapaxar 40 mg Loading Dose PCI30
Placebo/Placebo PCI21

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Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit

Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group. (NCT00684203)
Timeframe: Baseline, Day 30, Day 60, Day 74, Day 90, Day 121

,,
InterventionParticipants (Number)
BaselineDay 30Day 60Day 74 (follow-up period)Day 90 (follow-up period)Day 121 (follow-up period)
Placebo/Placebo PCI331333
Vorapaxar 1 mg Maintenance Dose PCI553555
Vorapaxar 2.5 mg Maintenance Dose PCI443444

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Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI

Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group. (NCT00684203)
Timeframe: Up to Day 60

,,
InterventionParticipants (Number)
Major TIMI Bleeding EventsMinor TIMI Bleeding EventsNon-TIMI Bleeding Events
Placebo/Placebo PCI0211
Vorapaxar 1 mg Maintenance Dose PCI2522
Vorapaxar 2.5 mg Maintenance Dose PCI0317

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Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events

Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group. (NCT00684203)
Timeframe: Baseline Up To Day 60

,,
InterventionParticipants (Number)
Intracranial hemorrhageBleeding requiring transfusionBleeding requiring hospitalizationMajor TIMI bleeding
Placebo/Placebo Non-PCI0000
Vorapaxar 20 mg Loading Dose Non-PCI0101
Vorapaxar 40 mg Loading Dose Non-PCI1212

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Mean CD40 Ligand Levels Among Participants Who Underwent PCI

Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group. (NCT00684203)
Timeframe: Baseline, Day 30, Day 60

,,
Interventionng/mL (Mean)
Baseline (n=37, 34, 21)Day 30 (n=35, 34, 31)Day 60 (n=30, 25, 13)
Placebo/Placebo PCI4.86.25.7
Vorapaxar 1 mg Maintenance Dose PCI5.65.95.6
Vorapaxar 2.5 mg Maintenance Dose PCI6.95.95.4

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Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis

"The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.~Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4)." (NCT00687076)
Timeframe: Measured at baseline and 24 Months

Interventionmm^3, at 24-months (Mean)
Triple Therapy58.1
Mono Therapy60.5

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Change in Total Cholesterol (mg/dl) From Baseline to Month 12

Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl]. (NCT00687076)
Timeframe: Measured at baseline and 12 months

Interventionmg/dl (Median)
Triple Therapy-30.0
Mono Therapy-7.5

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Platelet Aggregation Measures

Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and 12 Months

,,,
InterventionP2Y12 Reaction Units (PRU) (Least Squares Mean)
Day 30Month 12 (n=386, 76, 400, 103)
Clopidogrel: <75 Years of Age193.489199.003
Clopidogrel: 75 Years of Age or Older200.285181.360
Prasugrel: <75 Years of Age93.28094.529
Prasugrel: 75 Years of Age or Older151.872135.096

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Summary of All Deaths

All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

,,,
Interventionparticipants (Number)
Congestive Heart FailureCardiogenic ShockCardiac RuptureMyocardial InfarctionDysrhythmiaStent ThrombosisDirectly Related to Revascularization-CABG or PCIIntracranial HemorrhageNon-Hemorrhagic StrokeSudden death due to cardiovascular eventPulmonary EmbolismStroke, unknown typeOther Cardiovascular EventCardiovascular event, unknown typeAccidentalTraumaHemorrhage, not intracranialInfectionMalignancySuicideOther Non-Cardiovascular eventCause unknown (nonadjudicated event)
Clopidogrel: <75 Years of Age13100246014470200451001614080
Clopidogrel: 75 Years of Age or Older2390213011343101451141711060
Prasugrel: <75 Years of Age1080165012475006401211414180
Prasugrel: 75 Years of Age or Older214124201143911141031217041

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Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age10.06
Prasugrel: 75 Years of Age or Older24.64
Clopidogrel: <75 Years of Age10.96
Clopidogrel: 75 Years of Age or Older24.13

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Percentage of Participants With a Composite Endpoint of CV Death and MI

The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age9.61
Prasugrel: 75 Years of Age or Older22.53
Clopidogrel: <75 Years of Age10.21
Clopidogrel: 75 Years of Age or Older22.69

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Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age12.13
Prasugrel: 75 Years of Age or Older26.27
Clopidogrel: <75 Years of Age12.83
Clopidogrel: 75 Years of Age or Older25.67

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Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke

The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age10.61
Prasugrel: 75 Years of Age or Older27.04
Clopidogrel: <75 Years of Age11.12
Clopidogrel: 75 Years of Age or Older26.83

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Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)

C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and Month 6

,,,
Interventionmilligrams per liter (mg/L) (Geometric Mean)
Day 306 Months (n=755, 143, 745, 178)
Clopidogrel: <75 Years of Age2.2872.149
Clopidogrel: 75 Years of Age or Older2.2261.543
Prasugrel: <75 Years of Age2.3302.272
Prasugrel: 75 Years of Age or Older2.4411.593

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Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)

Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and 6 Months

,,,
Interventionpicograms per milliliter (pg/mL) (Geometric Mean)
Day 306 Months (n=725, 125, 701, 174)
Clopidogrel: <75 Years of Age319.345250.982
Clopidogrel: 75 Years of Age or Older951.359722.750
Prasugrel: <75 Years of Age313.494253.434
Prasugrel: 75 Years of Age or Older1082.396770.132

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Economic and Quality of Life Outcomes

Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life. (NCT00699998)
Timeframe: Baseline and follow-up (24 months)

,
Interventionunits on a scale (Mean)
Baseline, physical limitationsBaseline, angina frequency24 Months, physical limitations (n=420, 412)24 Months, angina frequency (n=420, 412)
Clopidogrel67.073.174.589.5
Prasugrel67.873.675.189.7

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Number of Subjects With Effective Closure in Test (Device) Arm

"Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up.~Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles)." (NCT00738894)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Device Closure312

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Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)

A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction. (NCT00738894)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Device Closure6
Medical Management12

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Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)

"Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days.~An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm." (NCT00738894)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Device Closure22
Medical Management20

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Changes in Platelet Function in Response to Clopidogrel Plus Aspirin

Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation (NCT00799396)
Timeframe: Measured at baseline, and after clopidogrel plus aspirin treatment

Interventionpercentage of max aggregation change (Mean)
PRP ADP 20PRP Collagen 5
Overall Study41.2156.64

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Changes in Platelet Function in Response to Clopidogrel

Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation. (NCT00799396)
Timeframe: Measured at baseline, and after clopidogrel treatment

Interventionpercentage of maximum aggregation change (Mean)
PRP ADP 20PRP Collagen 5
Overall Study38.5114.06

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Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months

"The primary effectiveness endpoint was a composite of the two following outcomes:~Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization~Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization~A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.~The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months)." (NCT00816166)
Timeframe: One Year

Interventionpercent probability (Number)
Stent Group62.24
Medical Therapy Group83.68

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% Platelet Inhibition

% platelet inhibition measured by Verify Now (NCT00817999)
Timeframe: 6 hours

Interventionpercentage of platelet inhibition (Mean)
Loading Dose With Grapefruit Juice23.4
Maintenance Dose With Grapefruit Juice24.6
Loading Dose Without Grapefruit Juice41.2
Maintenance Dose Without Grapefruit Juice59

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT00823212)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
PROMUS0.1
PROMUS Element0.1

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT00823212)
Timeframe: >30 days-1 year

Interventionpercentage of participants (Number)
PROMUS0.0
PROMUS Element0.3

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT00823212)
Timeframe: >24 hr-30 days

Interventionpercentage of participants (Number)
PROMUS0.3
PROMUS Element0.0

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Target Lesion Failure (TLF)

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT00823212)
Timeframe: 30 days

InterventionPercentage of participants (Number)
PROMUS1.4
PROMUS Element0.9

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Target Lesion Failure (TLF)

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS1.9
PROMUS Element1.7

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Target Lesion Revascularization (TLR)

Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS0.8
PROMUS Element0.1

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Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)

See above for definitions of MI and TVR. (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS2.4
PROMUS Element2.4

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS1.1
PROMUS Element0.5

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS4.0
PROMUS Element4.2

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS1.4
PROMUS Element0.9

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS2.0
PROMUS Element1.8

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Target Vessel Revascularization (TVR)

Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS0.8
PROMUS Element0.1

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS2.9
PROMUS Element2.7

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Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)

See above for definitions of MI and TVR. (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS4.9
PROMUS Element5.0

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Non-cardiac Death

Defined as a death not due to cardiac causes (see definition of cardiac death above) (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS0.5
PROMUS Element0.4

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS1.9
PROMUS Element1.9

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Acute Technical Success

Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent (NCT00823212)
Timeframe: Acute-At time of index procedure

Interventionpercentage of stents (Number)
PROMUS98.8
PROMUS Element99.4

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All Cause Mortality

(NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS1.2
PROMUS Element1.3

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All Cause Mortality

(NCT00823212)
Timeframe: 30 days

Interventionpercentage of patients (Number)
PROMUS0.1
PROMUS Element0.1

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS1.2
PROMUS Element0.7

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All Cause Mortality

(NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS0.5
PROMUS Element0.8

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All Death or Myocardial Infarction (MI)

Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS3.0
PROMUS Element2.4

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All Death or Myocardial Infarction (MI)

Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS1.4
PROMUS Element0.8

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All Death or Myocardial Infarction (MI)

Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS2.0
PROMUS Element1.7

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Cardiac Death or Myocardial Infarction (MI)

Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS2.5
PROMUS Element2.0

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Cardiac Death or Myocardial Infarction (MI)

Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS1.4
PROMUS Element0.8

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Cardiac Death or Myocardial Infarction (MI)

Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above (NCT00823212)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS1.8
PROMUS Element1.4

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Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)

See above for definitions of MI and TVR (NCT00823212)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS1.6
PROMUS Element0.9

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Clinical Procedural Success

Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death (NCT00823212)
Timeframe: In hospital

Interventionpercentage of participants (Number)
PROMUS98.2
PROMUS Element98.3

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Non-cardiac Death

Defined as a death not due to cardiac causes (see definition of cardiac death above) (NCT00823212)
Timeframe: 30 Days

Interventionpercentage of participants (Number)
PROMUS0.0
PROMUS Element0.0

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Non-cardiac Death

Defined as a death not due to cardiac causes (see definition of cardiac death above) (NCT00823212)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
PROMUS0.1
PROMUS Element0.3

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Target Lesion Failure (TLF)

Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT00823212)
Timeframe: 12-month post index procedure

Interventionpercentage of participants (Number)
PROMUS2.9
PROMUS Element3.4

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Target Lesion Failure (TLF)

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT00823212)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS3.2
PROMUS Element3.5

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Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort

Risk was defined as the number of participants with events of all-cause death. (NCT00830960)
Timeframe: Randomization through end of study (90 days)

InterventionParticipants (Number)
Prasugrel 60/10 Primary5
Prasugrel 30/7.5 Primary4
Prasugrel 30/5 Primary3
Clopidogrel 300/75 Primary2
Prasugrel 30/5 Low Weight/Elderly7
Clopidogrel 300/75 Low Weight/Elderly1

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Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.

"Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.~Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel." (NCT00830960)
Timeframe: At 30 minutes, 2 hours, and 4 hours following LD administration

,,,,
InterventionPRU (Mean)
30 min (n=40, n=79, n=48, n=33, n=34)2 hours (n=37, n=80, n=49, n=33, n=33)4 hours (n=35, n=79, n=44, n=33, n=33)
Clopidogrel 300-mg LD Low Weight/Elderly379.5339.0337.8
Clopidogrel 300-mg LD Primary312.1289.5261.8
Prasugrel 30-mg LD Low Weight/Elderly311.2171.8127.3
Prasugrel 30-mg LD Primary280.4178.8124.2
Prasugrel 60-mg LD Primary250.5116.988.5

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Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort

"Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.~Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel." (NCT00830960)
Timeframe: At 30 Days and 90 days during MD therapy

,,,,,
InterventionPRU (Mean)
30 days (n=69, n=63, n=69, n=78, n=47, n=48)90 Days (n=60, n=57, n=64, n=72, n=43, n=42)
Clopidogrel 300/75 Low Weight/Elderly237.5219.6
Clopidogrel 300/75 Primary206.5188.3
Prasugrel 30/5 Low Weight/Elderly134.2128.5
Prasugrel 30/5 Primary150.8138.5
Prasugrel 30/7.5 Primary99.389.4
Prasugrel 60/10 Primary71.664.8

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Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort

A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition. (NCT00830960)
Timeframe: 30 minutes, 2 hours, and 4 hours following LD administration

,,,,
InterventionPercent inhibition (Number)
30 minutes (n=40, n=79, n=47, n=32, n=31)2 hours (n=37, n=80, n=48, n=33, n=33)4 hours (n=34, n=79, n=43, n=33, n=33)
Clopidogrel 300-mg LD Low Weight/Elderly027
Clopidogrel 300-mg LD Primary-5-24
Prasugrel 30-mg LD Low Weight/Elderly115163
Prasugrel 30-mg LD Primary43451
Prasugrel 60-mg LD Primary104965

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Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort

A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition. (NCT00830960)
Timeframe: 30 days and at 90 days during MD therapy

,,,,,
InterventionPercent inhibition (Number)
30 Days (n=69, n=63, n=68, n=78, n=47, n=48)90 Days (n=60, n=57, n=64, n=72, n=43, n=42)
Clopidogrel 300/75 Low Weight/Elderly3238
Clopidogrel 300/75 Primary2938
Prasugrel 30/5 Low Weight/Elderly6869
Prasugrel 30/5 Primary4548
Prasugrel 30/7.5 Primary6066
Prasugrel 60/10 Primary6773

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Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort

"Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure" (NCT00830960)
Timeframe: Randomization through end of study (90 days)

,,,,,
InterventionParticipants (Number)
Fatal MINonfatal MIFatal StrokeNonfatal StrokeDefinite Stent ThrombosisUTVR
Clopidogrel 300/75 Low Weight/Elderly020001
Clopidogrel 300/75 Primary010011
Prasugrel 30/5 Low Weight/Elderly100211
Prasugrel 30/5 Primary010000
Prasugrel 30/7.5 Primary001111
Prasugrel 60/10 Primary110001

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Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort

"Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel." (NCT00830960)
Timeframe: At 30 days during MD therapy

InterventionPRU (Mean)
Prasugrel 60/10 Primary71.6
Prasugrel 30/7.5 Primary99.3
Prasugrel 30/5 Primary150.8
Clopidogrel 300/75 Primary206.5

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Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)

"ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.~Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase." (NCT00830960)
Timeframe: At 4 hours following LD administration

InterventionPRU (Mean)
Prasugrel 60-mg LD Primary88.5
Prasugrel 30-mg LD Primary124.2
Clopidogrel 300-mg LD Primary261.8

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Number of Participants According to Bleeding Type/Etiology

For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. (NCT00833703)
Timeframe: Up to a maximum of 6 months

,
Interventionparticipants (Number)
SpontaneousPuncture (vascular access site)
Clopidogrel 0.2 mg/kg/Day11
Placebo00

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Number of Participants With Bleeding Events

"All bleeding events experienced during the study period were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted." (NCT00833703)
Timeframe: Up to a maximum of 6 months

,
Interventionparticipants (Number)
Any bleeding event- Serious- Serious with an outcome of death- Leading to permanent treatment discontinuation
Clopidogrel 0.2 mg/kg/Day2000
Placebo0000

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Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths

"Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.~Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first)." (NCT00833703)
Timeframe: Up to a maximum of 6 months

,
Interventionparticipants (Number)
shunt thrombosis requiring interventiondeath
Clopidogrel 0.2 mg/kg/Day00
Placebo01

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Number of Participants With Stent Thrombosis (ST)

Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. (NCT00910299)
Timeframe: Baseline through 6 months

Interventionparticipants (Number)
Prasugrel0
Clopidogrel0

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Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)

The endpoint in this measure is a combination of cardiovascular death or MI. (NCT00910299)
Timeframe: Baseline through 6 months

Interventionparticipants (Number)
Prasugrel0
Clopidogrel1

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Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)

The endpoint in this measure is a combination of all-cause death or MI. (NCT00910299)
Timeframe: Baseline through 6 months

Interventionparticipants (Number)
Prasugrel0
Clopidogrel2

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Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).

PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry). (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercent inhibition (Mean)
PPI Group 1: Regimen A42.3
PPI Group 1: Regimen B46.4
PPI Group 2: Regimen A41.3
PPI Group 2: Regimen C43.0
PPI Group 3: Regimen A47.9
PPI Group 3: Regimen D59.1
PPI Group 4: Regimen A46.5
PPI Group 4: Regimen E58.0

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Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.

Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]). (NCT00942175)
Timeframe: Day 9 of each period

Interventionng*hr/ML (Mean)
PPI Group 1: Regimen A41.69
PPI Group 1: Regimen B36.42
PPI Group 2: Regimen A41.25
PPI Group 2: Regimen C37.75
PPI Group 3: Regimen A37.78
PPI Group 3: Regimen D26.28
PPI Group 4: Regimen A42.35
PPI Group 4: Regimen E31.23

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Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.

MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate. (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercentage of MPA (Mean)
PPI Group 1: Regimen A36.7
PPI Group 1: Regimen B41.6
PPI Group 2: Regimen A43.1
PPI Group 2: Regimen C46.3
PPI Group 3: Regimen A43.5
PPI Group 3: Regimen D53.5
PPI Group 4: Regimen A39.3
PPI Group 4: Regimen E47.9

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Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.

Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate. (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercentage of MPA (Mean)
PPI Group 1: Regimen A28.1
PPI Group 1: Regimen B30.8
PPI Group 2: Regimen A34.6
PPI Group 2: Regimen C36.2
PPI Group 3: Regimen A34.2
PPI Group 3: Regimen D42.5
PPI Group 4: Regimen A29.3
PPI Group 4: Regimen E38.2

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Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT00942175)
Timeframe: Day 9 of each period

Interventionng/mL (Mean)
PPI Group 1: Regimen A39.14
PPI Group 1: Regimen B30.01
PPI Group 2: Regimen A38.85
PPI Group 2: Regimen C29.33
PPI Group 3: Regimen A38.25
PPI Group 3: Regimen D22.55
PPI Group 4: Regimen A40.98
PPI Group 4: Regimen E24.69

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Rate of Major Adverse Cardiac Events (MACE)

MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent172

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Rate of Non-cardiac Death

Include all deaths due to non-cardiac causes. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent16

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Rate of Procedure Success

Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay. (NCT00954707)
Timeframe: From post- procedure to hospital discharge, up to 39 days

Interventionparticipants (Number)
CYPHER® Stent2444

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Rate of Protocol Defined Major Bleeding Complications

Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent71

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Rate of Protocol Defined Stent Thrombosis (ST)

Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent21

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Rate of Target Vessel Failure (TVF)

Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent184

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Phase I: the Rate of Target Lesion Failure (TLF)

Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months. (NCT00954707)
Timeframe: 12 months

Interventionparticipants (Number)
CYPHER® Stent149

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Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)

ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent26

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Rate of Cardiac Death

Include all deaths due to cardiac causes. (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent18

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Rate of Clinically Driven Target Vessel Revascularization (TVR)

Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA. (NCT00954707)
Timeframe: 12 months

Interventionparticipants (Number)
CYPHER® Stent124

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Rate of Clinically-driven Target Lesion Revascularization (TVR)

"Defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA." (NCT00954707)
Timeframe: 12 Months

Interventionparticipants (Number)
CYPHER® Stent98

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Rate of Device Success

A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. (NCT00954707)
Timeframe: From post- procedure to hospital discharge, up to 39 days

InterventionDevices (Number)
CYPHER® Stent3205

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Rate of Lesion Success

Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method. (NCT00954707)
Timeframe: From post- procedure to hospital discharge, up to 39 days

InterventionLesions (Number)
CYPHER® Stent3264

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Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
DES 30-month DAPT0.69
DES 12-month DAPT1.45

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Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
BMS 30-month DAPT0.50
BMS 12-month DAPT1.11

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Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
BMS 30-month DAPT0.50
BMS 12-month DAPT1.11

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Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS

Secondary powered endpoint (NCT00977938)
Timeframe: 33 months (0-33 months post-index procedure)

Interventionpercentage of patients (Number)
Propensity-matched DES1.70
Propensity-matched BMS2.61

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Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
DES 30-month DAPT0.40
DES 12-month DAPT1.35

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GUSTO Severe or Moderate Bleeding - Randomized DES ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (Number)
DES 30-month DAPT2.74
DES 12-month DAPT1.88

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MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

(NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
BMS 30-month DAPT4.04
BMS 12-month DAPT4.69

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GUSTO Severe or Moderate Bleeding - Randomized DES ITT

The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (Number)
DES 30-month DAPT2.53
DES 12-month DAPT1.57

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MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS

Secondary powered endpoint (NCT00977938)
Timeframe: 33 months (0-33 months post-index procedure)

Interventionpercentage of patients (Number)
Propensity-matched DES11.37
Propensity-matched BMS13.24

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MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
DES 30-month DAPT4.34
DES 12-month DAPT5.92

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MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

(NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
DES 30-month DAPT5.62
DES 12-month DAPT6.49

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MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

(NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (KM estimate) (Number)
BMS 30-month DAPT4.68
BMS 12-month DAPT5.48

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GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Interventionpercentage of patients (Number)
BMS 30-month DAPT2.09
BMS 12-month DAPT1.05

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GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Interventionpercentage of patients (Number)
BMS 30-month DAPT2.03
BMS 12-month DAPT0.90

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Minor Hemorrhage

Other safety outcome:Number of Participants with Minor hemorrhage (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel40
Placebo13

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Ischemic Stroke

Secondary efficacy outcome:Number of participants with Ischemic stroke (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel112
Placebo155

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Hemorrhagic Stroke

Other safety outcome: Number of participants with Hemorrhagic stroke (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel5
Placebo3

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Major Hemorrhage Other Than Intracranial Hemorrhage

Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel17
Placebo7

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Death From Any Cause

Other safety outcome: Number of Participants with Death from any cause (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel18
Placebo12

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Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel121
Placebo160

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Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage

Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel141
Placebo167

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Major Hemorrhage

Primary safety outcome: Number of Participants with major hemorrhage (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel23
Placebo10

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Symptomatic Intracerebral Hemorrhage

Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel2
Placebo2

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Ischemic or Hemorrhagic Stroke

Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel116
Placebo156

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Myocardial Infarction

Secondary efficacy outcome: Number of participants with Myocardial infarction (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel10
Placebo7

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Other Symptomatic Intracranial Hemorrhage

Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage (NCT00991029)
Timeframe: up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel2
Placebo0

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Death From Ischemic Vascular Causes

Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes (NCT00991029)
Timeframe: Up to 90 days

InterventionParticipants (Count of Participants)
Clopidogrel6
Placebo4

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Cutaneous Bleeding Time (BT)

"Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.~The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.~Period 3 was not analyzed as bleeding time was not an objective for this part of the study." (NCT01012219)
Timeframe: Day 8

InterventionSeconds (Least Squares Mean)
Clopidogrel + Aspirin +Laropiprant478
Clopidogrel + Aspirin389

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Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population

On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participants met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. (NCT01014624)
Timeframe: up to 12 days after last dose

,
Interventiondays (Number)
Washout day 50% returned to baseline PRUWashout day 75% returned to baseline PRUWashout day 90% returned to baseline PRU
Clopidogrel356
Prasugrel679

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Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population

On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. (NCT01014624)
Timeframe: up to 12 days after last dose

,
Interventiondays (Number)
Washout day 50% returned to baseline PRUWashout day 75% returned to baseline PRUWashout day 90% returned to baseline PRU
Clopidogrel357
Prasugrel679

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Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population

On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%. (NCT01014624)
Timeframe: up to 12 days after the last dose

,
Interventiondays (Number)
Washout day 50% returned to baseline PRUWashout day 75% returned to baseline PRUWashout day 90% returned to baseline PRU
Clopidogrel567
Prasugrel679

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The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline

On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants. (NCT01014624)
Timeframe: up to 12 days after last dose

,
Interventioncumulative percentage of participants (Number)
return to baseline PRU by washout day 1return to baseline PRU by washout day 3return to baseline PRU by washout day 5return to baseline PRU by washout day 6return to baseline PRU by washout day 7return to baseline PRU by washout day 9
Clopidogrel30.853.984.696.296.2100.0
Prasugrel03.637.062.977.8100.0

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The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline

On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. (NCT01014624)
Timeframe: up to 12 days after last dose

,
Interventioncumulative percentage of participants (Number)
returned to baseline PRU by washout day 1returned to baseline PRU by washout day 3returned to baseline PRU by washout day 5returned to baseline PRU by washout day 6returned to baseline PRU by washout day 7returned to baseline PRU by washout day 9
Clopidogrel30.853.980.888.596.2100.0
Prasugrel0.00.037.055.677.8100.0

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Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population

On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%. (NCT01014624)
Timeframe: up to 12 days after last dose

,
Interventiondays (Number)
Washout day 50% returned to baseline PRUWashout day 75% returned to baseline PRUWashout day 90% returned to baseline PRU
Clopidogrel556
Prasugrel679

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Percentage of Inhibition of Platelet Aggregation on Washout Day 1

Inhibition of platelet aggregation was assessed by Accumetrics VerifyNow® P2Y12 reaction units (PRU). On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. (NCT01014624)
Timeframe: Washout Day 1

Interventionpercentage (Mean)
Prasugrel72.3
Clopidogrel35.4

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Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose

Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to return to baseline PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to return to baseline PRU derived from: Number days to return to baseline PRU=-3.350+0.079*PI(1)+0.014*baseline PRU. The predicted number of days to return to baseline based on device-derived platelet percentage inhibition is reported for each treatment group. (NCT01014624)
Timeframe: up to 12 days after the last dose

Interventiondays (Number)
Prasugrel6.2
Clopidogrel3.7

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Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230

P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy. (NCT01097343)
Timeframe: Approximately 90 days

InterventionNumber of Patients with PRU>230 (Number)
Cross-over Study- 75 mg Dose30
Cross-over Study - 150 mg Dose18

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Number of Participants With Elevation of Cardiac Enzyme

Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure. (NCT01103440)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Conventional Strategy4
Aggressive Strategy2

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Number of Participants With Major Adverse Cardiac Event (MACE)

Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product. (NCT01103440)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Conventional Strategy5
Aggressive Strategy1

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Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU

To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at 24 hours post LD]/PRU at baseline) x 100%. (NCT01107899)
Timeframe: Up through 11 days

Interventiondays (Number)
20% Initial Inhibition40% Initial Inhibition60% Initial Inhibition80% Initial Inhibition
All Treatments3.24.66.07.4

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Platelet Function by LTA at 5 and 20 μM ADP

MPA to 5 and 20 μM ADP were assessed by LTA. (NCT01107899)
Timeframe: 24 hours post-loading dose

,,
Interventionpercent aggregation (Mean)
Maximum Aggregation (20 µM ADP)Maximum Aggregation (5 µM ADP)
Clopidogrel 600 mg52.6039.40
Prasugrel 30 mg31.6725.50
Prasugrel 60 mg27.3022.00

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Platelet Function by Multiplate® ADP Test and ADP Test HS

The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated. (NCT01107899)
Timeframe: 24 hours post-loading dose

,,
Interventionaggregation units*minute (Mean)
ADP Test AUCADP Test HS AUC
Clopidogrel 600 mg248.80166.80
Prasugrel 30 mg118.1770.17
Prasugrel 60 mg90.0034.50

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Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD

Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230. (NCT01107899)
Timeframe: 24 hours post-loading dose

Interventionpercentage of participants (Number)
Clopidogrel 600 mg40.0
Prasugrel 60 mg0
Prasugrel 30 mg0

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Platelet Function 24 Hours Post Loading Dose

PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation. (NCT01107899)
Timeframe: 24 hours post-loading dose

InterventionP2Y12 Reaction Units (PRU) (Mean)
Clopidogrel 600 mg193.0
Prasugrel 60 mg32.5
Prasugrel 30 mg70.0

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Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)

Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day. (NCT01107899)
Timeframe: Up through 11 days

,,
Interventionpercent platelet aggregation (Mean)
Baseline (20 μM ADP) (n=5, n=10, n=6)Day 1 (20 μM ADP) (n=5, n=10, n=6)Day 3 (20 μM ADP) (n=5, n=10, n=6)Day 5 (20 μM ADP) (n=5, n=10, n=4)Day 7 (20 μM ADP) (n=5, n=10, n=5)Day 9 (20 μM ADP) (n=5, n=10, n=5)Day 11 (20 μM ADP) (n=5, n=10, n=5)Baseline (5 μM ADP) (n=5, n=10, n=6)Day 1 (5 μM ADP) (n=5, n=10, n=6)Day 3 (5 μM ADP) (n=5, n=10, n=6)Day 5 (5 μM ADP) (n=5, n=10, n=4)Day 7 (5 μM ADP) (n=5, n=10, n=5)Day 9 (5 μM ADP) (n=5, n=10, n=5)Day 11 (5 μM ADP) (n=5, n=10, n=5)
Clopidogrel 600 mg68.0052.6056.0070.4071.0062.4072.0064.4039.4050.2064.2060.4058.4061.80
Prasugrel 30 mg76.3331.6746.3358.2573.2068.6063.8070.6725.5048.6753.2565.4060.0056.00
Prasugrel 60 mg72.7027.3042.5047.0058.3062.0065.2062.6022.0032.8039.5052.4056.0058.90

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Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)

Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU*min) of aggregation units (AU). (NCT01107899)
Timeframe: Up through 11 days

,,
InterventionAggregation Units * minutes (Mean)
Baseline (ADP) (n=5, n=10, n=6)Day 1 (ADP) (n=5, n=10, n=6)Day 3 (ADP) (n=5, n=10, n=6)Day 5 (ADP) (n=5, n=10, n=4)Day 7 (ADP) (n=5, n=10, n=5)Day 9 (ADP) (n=5, n=10, n=5)Day 11 (ADP) (n=5, n=10, n=5)Baseline (ADP HS) (n=5, n=10, n=6)Day 1 (ADP HS) (n=5, n=10, n=6)Day 3 (ADP HS) (n=5, n=10, n=6)Day 5 (ADP HS) (n=5, n=10, n=4)Day 7 (ADP HS) (n=5, n=10, n=5)Day 9 (ADP HS) (n=5, n=10, n=5)Day 11 (ADP HS) (n=5, n=10, n=5)
Clopidogrel 600 mg536.60248.80347.60428.40478.80529.40555.00361.00166.80257.60256.80263.60388.20373.20
Prasugrel 30 mg459.33118.17134.67296.00295.40484.40564.00344.0070.1790.50145.00170.60343.60404.00
Prasugrel 60 mg601.6090.00140.90231.30316.20549.00500.20411.7034.5079.30114.10189.50344.60365.40

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Percentage of Participants Returning to Baseline Platelet Function

Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. (NCT01107899)
Timeframe: Days 3, 5, 7, 9, and 11

,,
Interventionpercentage of participants (Number)
Day 3Day 5Day 7Day 9Day 11
Clopidogrel 600 mg60.080.0100.0100.0100.0
Prasugrel 30 mg00100.0100.0100.0
Prasugrel 60 mg010.060.0100.0100.0

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Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy

Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. (NCT01107912)
Timeframe: Baseline, Day 12

,,,,,
Interventionpercentage of aggregation (Mean)
BaselineDay 12 (n=71, 70, 70, 78, 79, 79)
10 mg Prasugrel (Elderly)78.7545.54
10 mg Prasugrel (Non-Elderly)76.6145.83
5 mg Prasugrel (Elderly)79.1057.05
5 mg Prasugrel (Non-Elderly)76.6156.83
75 mg Clopidogrel (Elderly)79.1163.08
75 mg Clopidogrel (Non-Elderly)76.6159.09

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Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period

Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition. (NCT01107912)
Timeframe: Baseline, 12 days

,
Interventionpercentage of aggregation (Median)
BaselinePeriod 1 (12 days) (n=71, 79)
10 mg Prasugrel (Non-Elderly)75.0046.00
5 mg Prasugrel (Elderly)78.0058.00

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Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy

Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12. (NCT01107912)
Timeframe: Baseline, Day 12

,,,,,
Interventionpercentage platelet reactive index (PRI) (Mean)
Baseline (n=68, 66, 67, 71, 72, 72)Day 12 (n=67, 65, 67, 73, 74, 73)
10 mg Prasugrel (Elderly)85.6622.66
10 mg Prasugrel (Non-Elderly)86.1827.74
5 mg Prasugrel (Elderly)85.6244.30
5 mg Prasugrel (Non-Elderly)86.1054.72
75 mg Clopidogrel (Elderly)85.6054.95
75 mg Clopidogrel (Non-Elderly)86.1854.53

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Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy

The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12. (NCT01107912)
Timeframe: Baseline, Day 12

,,,,,
InterventionP2Y12 reaction units (PRU) (Mean)
BaselineDay 12 (n=71, 67, 69, 77, 79, 79)
10 mg Prasugrel (Elderly)314.1184.13
10 mg Prasugrel (Non-Elderly)291.6285.46
5 mg Prasugrel (Elderly)315.63175.52
5 mg Prasugrel (Non-Elderly)291.81177.01
75 mg Clopidogrel (Elderly)314.14212.33
75 mg Clopidogrel (Non-Elderly)291.62181.22

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Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing

A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances. (NCT01107912)
Timeframe: Baseline up to 4 hours post-dose

Interventionnanogram*hour/milliliter (ng*hr/mL) (Geometric Mean)
5 mg Prasugrel (Elderly)18.9
10 mg Prasugrel (Elderly)41.2
75 mg Clopidogrel (Elderly)13.0
5 mg Prasugrel (Non-Elderly)16.1
10 mg Prasugrel (Non-Elderly)36.7
75 mg Clopidogrel (Non-Elderly)11.8

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Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)

A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances. (NCT01107925)
Timeframe: baseline (pre-dose) up to 4 hours post-dose

Interventionnanogram•hour/milliliter (ng•hr/mL) (Geometric Mean)
Prasugrel 5 mg (LBW)28.9
Prasugrel 10 mg (LBW)59.3
Clopidogrel 75 mg (LBW)18.4
Prasugrel 5 mg (HBW)19.4
Prasugrel 10 mg (HBW)46.7
Clopidogrel 75 mg (HBW)12.7

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Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy

MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. (NCT01107925)
Timeframe: Baseline , Day 12

,,,,,
Interventionpercent aggregation (Mean)
BaselineDay 12 ( n= 32,32,31,35,37,35)
10 mg Prasugrel (HBW)77.9347.92
10 mg Prasugrel (LBW)76.2038.11
5 mg Prasugrel (HBW)77.6361.90
5 mg Prasugrel (LBW)76.2748.10
75 mg Clopidogrel (HBW)77.6365.28
75 mg Clopidogrel (LBW)76.2051.41

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Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)

MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. (NCT01107925)
Timeframe: Baseline, Day 12

,
Interventionpercent aggregation (Median)
BaselineDay 12 (n=32, 37)
Prasugrel 10 mg (HBW)76.4047.00
Prasugrel 5 mg (LBW)75.0047.00

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Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy

VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition. (NCT01107925)
Timeframe: Baseline, Day 12

,,,,,
Interventionpercentage PRI (Mean)
BaselineDay 12 (n=32,31,30,32,36,34)
10 mg Prasugrel (HBW)86.7627.79
10 mg Prasugrel (LBW)86.4415.09
5 mg Prasugrel (HBW)86.7756.87
5 mg Prasugrel (LBW)86.5733.54
75 mg Clopidogrel (HBW)86.7756.35
75 mg Clopidogrel (LBW)86.4439.01

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Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy

The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation. (NCT01107925)
Timeframe: Baseline, Day 12

,,,,,
InterventionP2Y12 reaction units (PRU) (Mean)
BaselineDay 12 (n=32,31,32,35,34,34)
10 mg Prasugrel (HBW)311.0102.1
10 mg Prasugrel (LBW)315.355.9
5 mg Prasugrel (HBW)312.8193.9
5 mg Prasugrel (LBW)317.9129.5
75 mg Clopidogrel (HBW)312.8207.0
75 mg Clopidogrel (LBW)315.3151.7

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Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin

(NCT01115738)
Timeframe: Baseline, 72 hours

Interventiongram per deciliter (g/dL) (Mean)
Placebo and 60-mg Prasugrel-0.9
600-mg Clopidogrel and 60-mg Prasugrel-0.6
600-mg Clopidogrel and 30-mg Prasugrel-0.6

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Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit

(NCT01115738)
Timeframe: Baseline, 72 hours

Interventionproportion of 1.0 (Mean)
Placebo and 60-mg Prasugrel0.0
600-mg Clopidogrel and 60-mg Prasugrel0.0
600-mg Clopidogrel and 30-mg Prasugrel0.0

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Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)

ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. (NCT01115738)
Timeframe: Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose

,,
InterventionPRU (Least Squares Mean)
Baseline2 Hours after Prasugrel LD24 Hours after Prasugrel LD72 Hours after Prasugrel LD
600-mg Clopidogrel and 30-mg Prasugrel229.62117.1051.4360.29
600-mg Clopidogrel and 60-mg Prasugrel248.58113.1034.0548.08
Placebo and 60-mg Prasugrel265.51122.5562.7356.95

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Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)

ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. (NCT01115738)
Timeframe: 6 hours after prasugrel loading dose

InterventionPRU (Least Squares Mean)
Placebo and 60-mg Prasugrel57.86
600-mg Clopidogrel and 60-mg Prasugrel35.61
600-mg Clopidogrel and 30-mg Prasugrel53.92

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Percentage of Poor Responders

Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240. (NCT01115738)
Timeframe: Baseline and 2 and 6 and 24 and 72 hours after loading dose

,,
Interventionpercentage of participants (Number)
Baseline2 Hours after Prasugrel LD6 Hours after Prasugrel LD24 Hours after Prasugrel LD72 Hours after Prasugrel LD
600-mg Clopidogrel and 30-mg Prasugrel51.221.44.48.80
600-mg Clopidogrel and 60-mg Prasugrel66.712.85.32.90
Placebo and 60-mg Prasugrel68.123.311.69.50

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Percentage of Inhibition of Platelet Aggregation

Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country. (NCT01115738)
Timeframe: Baseline and 2 and 6 and 24 and 72 hours after loading dose

,,
Interventionpercentage of inhibition (Least Squares Mean)
Baseline2 Hours after Prasugrel LD6 Hours after Prasugrel LD24 Hours after Prasugrel LD72 Hours after Prasugrel LD
600-mg Clopidogrel and 30-mg Prasugrel14.9454.8978.5578.5678.17
600-mg Clopidogrel and 60-mg Prasugrel13.0258.7586.7787.6483.51
Placebo and 60-mg Prasugrel9.7156.0479.8777.5778.48

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section. (NCT01115738)
Timeframe: Baseline through 72 hours after prasugrel loading dose

,,
Interventionparticipants (Number)
Serious Adverse EventsNonserious Adverse Events
600-mg Clopidogrel and 30-mg Prasugrel131
600-mg Clopidogrel and 60-mg Prasugrel831
Placebo and 60-mg Prasugrel237

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P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. (NCT01115738)
Timeframe: Baseline

InterventionPRU (Least Squares Mean)
Clopidogrel at Baseline -CYP2C19 EM243.549
Clopidogrel at Baseline - CYP2C19 RM240.100

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P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group. (NCT01115738)
Timeframe: 6 hours after prasugrel loading dose

InterventionPRU (Least Squares Mean)
Placebo and 60 mg Prasugrel-CYP2C19 EM39.036
Placebo and 60 mg Prasugrel -CYP2C19 RM47.750
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM20.190
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM23.625
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM36.478
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM24.778

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AZD6140 (Cmax) at Week 4

Maximum plasma AZD6140 concentration (NCT01118325)
Timeframe: Week 4

Interventionng/mL (Geometric Mean)
AZD6140 45 mg bd in Japanese Patients422
AZD6140 45 mg bd in Non-Japanese Patients341
AZD6140 90 mg bd in Japanese Patients931
AZD6140 90 mg bd in Non-Japanese Patients1380

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AZD6140 (Tmax) at Week 4

Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration (NCT01118325)
Timeframe: Week 4

Interventionhour (Median)
AZD6140 45 mg bd in Japanese Patients2.0
AZD6140 45 mg bd in Non-Japanese Patients4.0
AZD6140 90 mg bd in Japanese Patients2.0
AZD6140 90 mg bd in Non-Japanese Patients4.0

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Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients

"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4

Interventionpercentage inhibition (Mean)
AZD6140 45 mg bd64.5
AZD6140 90 mg bd73.0
Clopidogrel 75 mg od38.9

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IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients

"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4

Interventionpercentage inhibition (Mean)
Arm 1 - AZD6140 45 mg bd56.9
AZD6140 90 mg bd66.8
Clopidogrel 75 mg od41.8

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IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients

"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4

Interventionpercentage inhibition (Mean)
AZD6140 45 mg bd46.2
AZD6140 90 mg bd59.1
Clopidogrel 75 mg od38.0

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IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients

"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4

Interventionpercentage inhibition (Mean)
AZD6140 45 mg bd67.3
AZD6140 90 mg bd73.2
Clopidogrel 75 mg od43.7

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IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients

"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4

Interventionpercentage inhibition (Mean)
AZD6140 45 mg bd62.7
AZD6140 90 mg bd68.6
Clopidogrel 75 mg od42.5

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AR-C124910XX (Tmax) at Week 4

Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration (NCT01118325)
Timeframe: Week 4

Interventionhour (Median)
AZD6140 45 mg bd in Japanese Patients4.0
AZD6140 45 mg bd in Non-Japanese Patients4.0
AZD6140 90 mg bd in Japanese Patients2.1
AZD6140 90 mg bd in Non-Japanese Patients2.0

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AR-C124910XX (AUC0-tau) at Week 4

Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval (NCT01118325)
Timeframe: Week 4

Interventionng.h/mL (Geometric Mean)
AZD6140 45 mg bd in Japanese Patients1180
AZD6140 45 mg bd in Non-Japanese Patients954
AZD6140 90 mg bd in Japanese Patients2720
AZD6140 90 mg bd in Non-Japanese Patients3380

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AR-C124910XX (Cmax) at Week 4

Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX (NCT01118325)
Timeframe: Week 4

Interventionng/mL (Geometric Mean)
AZD6140 45 mg bd in Japanese Patients135
AZD6140 45mg bd in Non-Jpanese Patients101
AZD6140 90 mg bd in Japanese Patients326
AZD6140 90 mg bd in Non-Jpanese Patients381

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AZD6140 (AUC0-tau) at Week 4

Area under the plasma concentration curve of AZD6140 from time zero to dosing interval (NCT01118325)
Timeframe: Week 4

Interventionng.h/mL (Geometric Mean)
AZD6140 45 mg bd in Japanese Patients3050
AZD6140 45 mg bd in Non-Japanese Patients2930
AZD6140 90 mg bd in Japanese Patients6080
AZD6140 90 mg bd in Non-Japanese Patients10900

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In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.

This outcome is for the in-segment binary restenosis. (NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group57
Drug Eluting Stent Group56

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Number of Participants With Target Lesion Revascularization (TLR)

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group40
DES Group47

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Procedural Success

The procedural success rate and the incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses. (NCT01121224)
Timeframe: Discharge from Index Hospitalization (an average of 36 hours)

InterventionParticipants (Count of Participants)
Bare Metal Stent Group291
Drug Eluting Stent Group274

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Patient-Oriented Composite Endpoint Will be Used as Secondary Outcome

"The patient-oriented composite endpoint is defined as the composite of all-cause death, any myocardial infarction and target vessel revascularization.~Target vessel (SVG) revascularization (TVR) will be defined as any repeat percutaneous intervention or surgical bypass of any segment of the target SVG and the native coronary vessel distal to the SVG anastomosis. Non-target vessel revascularization will be defined as any repeat percutaneous intervention or surgical bypass of any SVG or any native coronary vessel apart from the target SVG and the native coronary artery supplied by the target SVG." (NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group68
Drug Eluting Stent Group62

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Number of Participants With Target Vessel Revascularization (TVR)

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group105
DES Group108

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Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.

(NCT01121224)
Timeframe: 12 months

InterventionU.S. Dollars (Mean)
Diabetes-2578.71
Number of Lesions (1 Lesion)-2971.90
Number of Lesions (2 or More Lesions)-17998.43
Stent Diameter (2.25 to Less Than 3)-11768.06
Stent Diameter (3 to Less Than 3.5)-5069.18
Stent Diameter (3.5 to Less Than 4)-14152
Recipient Target Vessel (Laddiag)-771.50
Recipient Target Vessel (Cxom)-4,487.11
Lesion Location (Aortic/Ostial)8433.33
Lesion Location (Body)4780.21
Antiplatelet-1483.97
Baseline ACS Score-3733.04

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Device-oriented Composite Endpoint of Target Lesion Failure Will be Used as a Secondary Outcome

"The Device-oriented composite endpoint of Target lesion failure is defined as the composite of cardiac or unknown death, target vessel myocardial infarction, and target lesion revascularization.~Target lesion revascularization (TLR) will be defined as any repeat percutaneous intervention of the target SVG lesion or bypass surgery of the target SVG lesion performed for restenosis or other complication of the target lesion. The target lesion will be defined as the treated SVG segment from 5 mm proximal to the stent to 5 mm distal to the stent." (NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group51
Drug Eluting Stent Group45

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Number of Participants With Target Vessel Myocardial Infarction

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group40
DES Group35

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Number of Participants With Stroke

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group3
Drug Eluting Stent Group2

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Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group34
Drug Eluting Stent Group34

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Incremental Cost-effectiveness of DES Relative to BMS

(NCT01121224)
Timeframe: 12 months

InterventionU.S. Dollars (Mean)
Bare Metal Stent Group20939
Drug Eluting Stent Group21051

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Procedural Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding)

Incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses. (NCT01121224)
Timeframe: Discharge from Index Hospitalization (an average of 36 hours)

InterventionParticipants (Count of Participants)
Bare Metal Stent Group22
Drug Eluting Stent Group15

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Quality Adjusted Life Years of DES Relative to BMS

(NCT01121224)
Timeframe: 12 months

Interventionyears (Mean)
Bare Metal Stent Group0.467
Drug Eluting Stent Group0.503

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Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group20
Drug Eluting Stent Group16

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Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
BMS Group16
DES Group17

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Number of Participants With Stroke

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
Bare Metal Stent Group12
Drug Eluting Stent Group10

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Number of Participants With Any Revascularization

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
BMS Group53
DES Group56

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Number of Participants With Non-Target Revascularization

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Bare Metal Stent Group26
Drug Eluting Stent Group33

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Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition

"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes suggestive of acute ischemia~Rise and fall of cardiac biomarkers~Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream~Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy." (NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
BMS Group7
DES Group6

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Number of Participants With Myocardial Infarction (MI)

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group62
DES Group53

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Number of Participants With Non-Target Revascularization

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
Bare Metal Stent Group60
Drug Eluting Stent Group69

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Number of Participants With Target Lesion Revascularization (TLR)

(NCT01121224)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
BMS Group25
DES Group26

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Number of Participants With Definite or Probable Stent Thrombosis

"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause." (NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group30
DES Group26

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In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.

This outcome is for the angiographic late in-segment luminal loss. (NCT01121224)
Timeframe: 12 months

Interventionlesions (Mean)
Bare Metal Stent Group1.05
Drug Eluting Stent Group0.96

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Quality Adjusted Life Years for Subgroups of Patients

(NCT01121224)
Timeframe: 12 months

Interventionyears (Mean)
Diabetes-0.03
Number of Lesions (1 Lesion)-0.04
Number of Lesions (2 or More Lesions)-0.03
Stent Diameter (2.25 to Less Than 3)0.03
Stent Diameter (3 to Less Than 3.5)0.02
Stent Diameter (3.5 to Less Than 4)0.04
Recipient Target Vessel (Laddiag)-0.04
Recipient Target Vessel (Cxom)-0.13
Lesion Location (Aortic/Ostial)-0.15
Lesion Location (Body)0.02
Antiplatelet-0.04
Baseline ACS Score-0.01

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Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.

(NCT01121224)
Timeframe: Entire Duration of Follow-up (median 2.7 years)

InterventionParticipants (Count of Participants)
BMS Group51
DES Group55

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Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)

CEC-adjudicated results (mITT population) (NCT01156571)
Timeframe: 48 hours after randomization

,
Interventionparticipants (Number)
Stent ThrombosisDeathMI (myocardial infarction)IDR (ischemia-driven revascularization)
Cangrelor Treatment Arm461820728
Clopidogrel Treatment Arm741825538

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The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)

Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population) (NCT01156571)
Timeframe: 48 hours after randomization

Interventionparticipants (Number)
Cangrelor Treatment Arm257
Clopidogrel Treatment Arm322

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Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone

Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo (NCT01158703)
Timeframe: 52 weeks

Interventionoccluded grafts (Number)
Clopidogrel10
Sugar Pill9

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Incidence of Bleeding Between the Two Treatment Arms

(NCT01158703)
Timeframe: 52 weeks

InterventionBLEEDING EVENTS (Number)
Clopidogrel0
Sugar Pill0

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Number of Angina Events

Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone (NCT01158703)
Timeframe: 52 weeks

InterventionAngina Events over 52Wks (Number)
Clopidogrel7
Sugar Pill5

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Number of Major Adverse Cardiovascular Events With Combination Therapy

Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone (NCT01158703)
Timeframe: 52 weeks

InterventionMACE Events over 52Wks (Number)
Clopidogrel10
Sugar Pill6

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Number of Myocardial Infarction Events

Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone (NCT01158703)
Timeframe: 52 weeks

InterventionMI Events over 52Wks (Number)
Clopidogrel2
Sugar Pill1

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Number of Thrombotic Events

Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone (NCT01158703)
Timeframe: 52 weeks

Interventionthrombotic Events over 52Wks (Number)
Clopidogrel1
Sugar Pill0

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Number of Participants With Occlusion and Restenosis at One Year

Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100% (NCT01163604)
Timeframe: at one year

Interventionparticipants (Number)
Argatroban Group58
Non-argatroban Treated Group56

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Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)

"In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.~The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section)." (NCT01212302)
Timeframe: 2 years

Interventionparticipants (Number)
Clopidogrel Low Response155

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Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)

The outcome measurement was on-treatment PRI determined through flow cytometric assessment of phosphorylation status of VASP. (NCT01235351)
Timeframe: Approximately every 2 weeks for 8 weeks

Intervention% of PRI (Mean)
Clopidogrel 75 mgClopidogrel 150 mgClopidogrel 225 mgClopidogrel 300 mg
CYP2C19*2 Carriers71.062.454.050.1

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Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)

The outcome measurement was on-treatment PRI determined through flow cytometric assessment of phosphorylation status of VASP. (NCT01235351)
Timeframe: Approximately every 2 weeks for 8 weeks

Intervention% of PRI (Mean)
Clopidogrel 75 mgClopidogrel 150 mg
CYP2C19*2 Non-Carriers57.546.9

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Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status

"Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders~Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose." (NCT01260584)
Timeframe: Day 10 for Active Treatment Periods 1 and 2

InterventionP2Y12 reaction unit (Least Squares Mean)
Prasugrel Smokers85.1
Prasugrel Non-Smokers106.3
Clopidogrel Smokers178.9
Clopidogrel Non-Smokers215.1

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Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status

"Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose." (NCT01260584)
Timeframe: Day 10 for Active Treatment Periods 1 and 2

Intervention% vasodilator stimulated phosphoprotein (Least Squares Mean)
Prasugrel Smokers25.4
Prasugrel Non-Smokers31.2
Clopidogrel Smokers48.1
Clopidogrel Non-Smokers55.7

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Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers

Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose. (NCT01260584)
Timeframe: After dose on Day 10 of Active Treatment Periods 1 and 2

Interventionhr*ng/mL (Geometric Mean)
Prasugrel Smokers53.7
Prasugrel Non-Smokers48.1
Clopidogrel Smokers19.9
Clopidogrel Non-Smokers16.2

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Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers

(NCT01260584)
Timeframe: After dose on Day 10 of Active Treatment Periods 1 and 2

Interventionng/mL (Geometric Mean)
Prasugrel Smokers42.9
Prasugrel Non-Smokers35.9
Clopidogrel Smokers14.1
Clopidogrel Non-Smokers10.8

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Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235

(NCT01260584)
Timeframe: Day 10 for Active Treatment Periods 1 and 2

Intervention% participants with PRU <=235 (Number)
Prasugrel Smokers98.0
Prasugrel Non-Smokers96.2
Clopidogrel Smokers76.6
Clopidogrel Non-Smokers61.1

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Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.

IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay). (NCT01260584)
Timeframe: Baseline to day 10 for Active Treatment Periods 1 and 2

Interventionpercentage of device derived inhibition (Least Squares Mean)
Prasugrel Smokers70.3
Prasugrel Non-Smokers65.6
Clopidogrel Smokers38.6
Clopidogrel Non-Smokers30.9

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Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%

"Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose." (NCT01260584)
Timeframe: Day 10 for Active Treatment Periods 1 and 2

Intervention% participants with PRI <=50% (Number)
Prasugrel Smokers96.0
Prasugrel Non-Smokers82.7
Clopidogrel Smokers51.1
Clopidogrel Non-Smokers44.4

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Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)

R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. (NCT01263093)
Timeframe: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose

Interventionhours (Median)
Clopidogrel1.50
LY2216684 + Clopidogrel1.50

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Percentage Inhibition of Platelet Aggregation

Blood samples for the measurement of platelet aggregation using a point-of-care device, Accumetrics VerifyNow™ P2Y12 (VN-P2Y12), were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Device-reported percent inhibition of VN-P2Y12 (IPRU) is presented. (NCT01263093)
Timeframe: predose and 2, 4, and 24 hours postdose

,
InterventionIPRU (Mean)
Predose2 Hours Postdose4 Hours Postdose24 Hours Postdose
Clopidogrel1.716.030.425.1
LY2216684 + Clopidogrel1.47.614.014.3

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Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. (NCT01263093)
Timeframe: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose

Interventionhours*nanograms/milliliters (h*ng/mL) (Geometric Mean)
Clopidogrel61.8
LY2216684 + Clopidogrel55.3

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Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)

R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed AUC0-tlast was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect. (NCT01263093)
Timeframe: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose

Interventionhours*nanograms/milliliters (h*ng/mL) (Geometric Mean)
Clopidogrel60.5
LY2216684 + Clopidogrel46.9

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Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)

R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed Cmax was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect. (NCT01263093)
Timeframe: predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose

Interventionnanograms/milliliter (ng/mL) (Geometric Mean)
Clopidogrel37.6
LY2216684 + Clopidogrel22.7

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Endothelial Progenitor Cells (EPCs)

The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+ (NCT01283282)
Timeframe: Week 12

,
Interventioncells/µL (Mean)
CD34+CD34+/133+CD34+/VEGF2R+CD34+/CD133+/VEGF2R+
Clopidogrel1.460.680.080.03
Placebo1.540.750.090.03

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Oxidative Stress Markers

Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels. (NCT01283282)
Timeframe: Week 12

,
InterventionµM (Mean)
CystineCysteineGlutathioneOxidized glutathione
Clopridogrel105.2513.711.520.08
Placebo102.3914.751.710.19

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Inflammatory Marker CD40 Ligand

CD40 ligand levels were measured. The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B. (NCT01283282)
Timeframe: Week 12

Interventionpg/mL (Mean)
Clopridogrel1202.21
Placebo2169.32

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Flow-mediated Dilation (FMD)

Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks. (NCT01283282)
Timeframe: Baseline, Week 12

Interventionpercent change in diameter (Mean)
Clopridogrel4.89
Placebo4.81

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Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)

High-sensitivity C-reactive protein (hsCRP) was measured. The hsCRP levels were measured by Dade Behring nephelometry. (NCT01283282)
Timeframe: Week 12

Interventionmg/L (Mean)
Clopridogrel5.98
Placebo4.31

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Pulse Wave Velocity (PWV)

PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually. (NCT01283282)
Timeframe: Week 12

Interventionm/s (Mean)
Clopridogrel8.77
Placebo9.044

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Nitroglycerin-mediated Vasodilation

Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually. Brachial artery images were obtained via ultrasound after three minutes of NTG administration. Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks. (NCT01283282)
Timeframe: Baseline, Week 12

Interventionpercent change in diameter (Mean)
Clopridogrel19.31
Placebo17.10

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Major Bleeding

Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to12 months

InterventionPercent probability (Number)
Ticagrelor (AZD6140)11.2
Clopidogrel8.4

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Major and Minor Bleeding

Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to12 months

InterventionPercent probability (Number)
Ticagrelor (AZD6140)26.8
Clopidogrel16.2

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Major Adverse Cardiac Events (MACE)

Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to 12 months

InterventionPercent probability (Number)
Ticagrelor (AZD6140)10.2
Clopidogrel8.1

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Composite of All-cause Mortality, MI or Stroke

Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to 12 months

InterventionPercent probability (Number)
Ticagrelor (AZD6140)10.5
Clopidogrel8.1

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Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole

The change in maximum platelet aggregation in response to ADP 4-hours post dose on day 8 of therapy with clopidogrel and omeprazole will be compared to the baseline measure of platelet aggregation at day 1 prior to drug therapy (NCT01341600)
Timeframe: Baseline, Day 8

Interventionpercentage of aggregation (Mean)
Poor Metabolizers11.6
Intermediate Metabolizers27.9
Extensive Metabolizers37.5

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Level of Active Clopidogrel Metabolite

The level of the active clopidogrel metabolite will be measured at at 0.25, 0.5, 1, 2, and 4 hours after the Day One dose is administered for pharmacokinetic analysis. The analysis will measure the Area Under the Curve. (NCT01341600)
Timeframe: Baseline, 0.25, 0.5, 1, 2, and 4 hours

,,
Interventionng h/mL (Mean)
Clopidogrel 75mgClopidogrel 150mgClopidogrel 300mg
Extensive Metabolizers32.753.680.4
Intermediate Metabolizers33.343.873.7
Poor Metabolizers17.424.236

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Change in Platelet Aggregation Following Therapy With Clopidogrel

ADP mediated platelet aggregation measured 4 hours post Day 8 clopidogrel dose (NCT01341600)
Timeframe: 4 hours post Day 8 dose

,,
Interventionpercentage of aggregation (Mean)
Clopidogrel 75mgClopidogrel 150mgClopidogrel 300mg
Extensive Metabolizers31.325.119.5
Intermediate Metabolizers37.833.225.7
Poor Metabolizers55.044.232.6

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Change in Platelet Aggregation Following Therapy With Clopidogrel

Adenosine diphosphate (ADP) mediated platelet aggregation measured 4 hours post-dose of clopidogrel on Day 1. (NCT01341600)
Timeframe: Day 1, 4 hours post clopidogrel dose

,,
Interventionpercentage of aggregation (Mean)
Clopidogrel 75mgClopidogrel 150mgClopidogrel 300mg
Extensive Metabolizers62.553.938.6
Intermediate Metabolizers68.157.847.8
Poor Metabolizers62.963.253.3

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Blood Concentration of the Active Metabolite of Clopidogrel

Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods. (NCT01341964)
Timeframe: 1 hour after loading dose of study medications

Interventionng/ml (Median)
Clopidogrel Concentration of Higher Dose Aspirin Group14.45
Clopidogrel Concentration of Low Dose Aspirin Group13.80

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Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization

(NCT01452152)
Timeframe: One year

Interventionparticipants (Number)
Genotype-directed, Clopidogrel0
Standard of Care0

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Post-treatment Platelet Aggregation

Platelet aggregation will be performed on a subset of subjects using VerifyNow P2Y12 which measures platelet reactivity due to the effect of a P2Y12. Values less than 180 P2Y12 Reaction Units (PRU) suggest evidence of a P2Y12 inhibitor effect. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy. (NCT01452152)
Timeframe: 10 days

Interventionpercentage of inhibition (Mean)
Genotype-directed, Clopidogrel33.7

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Occurrence of Post-randomization Cardiovascular Events

Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause. (NCT01452152)
Timeframe: One year

Interventionparticipants (Number)
Genotype-directed, Clopidogrel0
Standard of Care0

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Occurrence of Bleeding Events

Bleeding events will classified by the Bleeding Academic Research Consortium definition. The number of bleeding events will be tabulated. (NCT01452152)
Timeframe: One year

Interventionevents (Number)
Genotype-directed, Clopidogrel0
Standard of Care0

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Occurrence of Adverse Events

The number of subjects reporting any AEs will be tabulated. (NCT01452152)
Timeframe: One year

Interventionparticipants (Number)
Genotype-directed, Clopidogrel1
Standard of Care3

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) (NCT01500434)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT01500434)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element2.0

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All Cause Death

(NCT01500434)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS Element1.0

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT01500434)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element2.0

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT01500434)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT01500434)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS Element4.1

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Acute Technical Success

Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent (NCT01500434)
Timeframe: Index Procedure

Interventionpercentage of stents (Number)
PROMUS Element98.2

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT01500434)
Timeframe: 30 Days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Vessel Failure (TVF)

TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. (NCT01500434)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS Element4.2

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT01500434)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element1.0

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT01500434)
Timeframe: 30 days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Lesion Failure (TLF)

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT01500434)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
PROMUS Element1.0

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Target Lesion Failure (TLF)

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT01500434)
Timeframe: 30 Days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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All Cause Death

(NCT01500434)
Timeframe: 30 Days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Lesion Failure (TLF)

Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. (NCT01500434)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS Element3.2

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) (NCT01500434)
Timeframe: 31-365 days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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All Cause Death

(NCT01500434)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element1.0

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT01500434)
Timeframe: 12 months

Interventionpercentage of participants (Number)
PROMUS Element3.1

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Clinical Procedural Success

Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death (NCT01500434)
Timeframe: In hospital (average of 1-2 days post index procedure)

Interventionpercentage of participants (Number)
PROMUS Element100.0

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) (NCT01500434)
Timeframe: >24 hours-30 days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Interventionng*hr/mL (Mean)
Everolimus Dose of 95.4 µg6.83
Everolimus Dose of 102.4 µg6.14
Everolimus Dose of 138.6 µg9.51

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All Death

Number of participants no longer alive (NCT01510327)
Timeframe: 6 months

Interventionpercentage of participants who died (Number)
PROMUS Element0.0

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Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Interventionng*hr/mL (Mean)
Everolimus Dose of 95.4 µg7.27
Everolimus Dose of 102.4 µg6.45
Everolimus Dose of 138.6 µg10.87

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Terminal Phase Half-life (t1/2) Everolimus

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent. (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

InterventionHours (Mean)
Everolimus Dose of 95.4 µg34.19
Everolimus Dose of 102.4 µg22.83
Everolimus Dose of 138.6 µg136.06

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Target Vessel Revascularization (TVR)

TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. (NCT01510327)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Target Lesion Revascularization (TLR)

TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. (NCT01510327)
Timeframe: 6 months

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Maximum Observed Everolimus Blood Concentration (Cmax)

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Interventionng/mL (Mean)
Everolimus Dose of 95.4 µg0.71
Everolimus Dose of 102.4 µg0.67
Everolimus Dose of 138.6 µg0.91

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Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT01510327)
Timeframe: >30 days-1 year

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT01510327)
Timeframe: >24 hours-30 days

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). (NCT01510327)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
PROMUS Element0.0

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Total Blood Clearance - Everolimus (CL)

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent. (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

InterventionL/h (Mean)
Everolimus Dose of 95.4 µg6445
Everolimus Dose of 102.4 µg8044
Everolimus Dose of 138.6 µg2511

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Time of Occurrence of Maximum Everolimus Concentration (Tmax)

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Interventionhours (Mean)
Everolimus Dose of 95.4 µg0.47
Everolimus Dose of 102.4 µg0.62
Everolimus Dose of 138.6 µg0.52

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Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent. (NCT01510327)
Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Interventionng*hr/mL (Mean)
Everolimus Dose of 95.4 µg19.26
Everolimus Dose of 102.4 µg12.95
Everolimus Dose of 138.6 µg60.74

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Any Bleeding Event

"Bleeding classified by the TIMI hemorrhage classification scheme:~Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL~Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL" (NCT01515345)
Timeframe: 30days

Interventionparticipants (Number)
Standard Therapy17
Individualized Therapy9

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Definite Stent Thrombosis

"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis" (NCT01515345)
Timeframe: 30 days

Interventionparticipants (Number)
Standard Therapy1
Individualized Therapy0

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Probable Stent Thrombosis

"Probable stent thrombosis is considered to have occurred in case of~any unexplained death within the first 30 days.~any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure" (NCT01515345)
Timeframe: 30days

Interventionparticipants (Number)
Standard Therapy2
Individualized Therapy0

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Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD. (NCT01523366)
Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

,
Interventionng/mL (Geometric Mean)
Baseline (0 hours - pre-dose)0,.5 hours after the loading dose2 hours after the loading dose - Period 2 N=188 hours after the loading dose0 hours after multiple doses2 hours after multiple doses8 hours after multiple dosesEnd of dosing interval on Day 8 - Period 1 N=17
Ticagrelor (Treatment Period 1)1.2206.7665.4376.9248.8609.3340.4283.3
Ticagrelor (Treatment Period 2)1.1118.6758.5479.6220.1466.5305.2200.7

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Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose

Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 2 hours after the loading dose

InterventionPRU (Least Squares Mean)
Ticagrelor Arm34.2
Clopidogrel Arm201.4

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AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses

The SD is a statistic using the log-transformed data and is not the geometric SD. (NCT01523366)
Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

,
Interventionng/mL (Geometric Mean)
Baseline (0 hours - pre-dose)0,.5 hours after the loading dose2 hours after the loading dose - Period 2 N=188 hours after the loading dose0 hours after multiple doses2 hours after multiple doses8 hours after multiple dosesEnd of dosing interval on Day 8 - Period 1 N=17
Ticagrelor (Treatment Period 1)1.113.6153.2113.8113.3183.4132.8124.8
Ticagrelor (Treatment Period 2)1.09.3170.897.762.797.483.557.7

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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose

Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 0.5 and 8 hours after the loading dose

,
InterventionPRU (Least Squares Mean)
0.5 hours8 hours
Clopidogrel Arm269.8202.8
Ticagrelor Arm134.634.0

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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8

The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8

,
InterventionPRU (Least Squares Mean)
2 hours on day 78 hours on Day 7 -ticagrelor N=36 clopidogrel N=33End of Dosing Interval on Day 8 - N's per 8 hours
Clopidogrel Arm179.0178.9182.1
Ticagrelor Arm28.538.751.5

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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose

(NCT01523392)
Timeframe: At 0.5 hour and 8 hours after the loading dose

,
InterventionPRU (Least Squares Mean)
0.5 hours8 hours (N=28 ticagrelor, N=27 clopidogrel)
Clopidogrel270.1192.6
Ticagrelor166.327.2

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Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose

(NCT01523392)
Timeframe: At 2 hours after the loading dose

InterventionPRU (Least Squares Mean)
Ticagrelor27.6
Clopidogrel211.2

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Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is the geometric SD (NCT01523392)
Timeframe: Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose

,
Interventionng/mL (Geometric Mean)
Baseline (0 pre-dose hours)0.5 hours after the loading dose2 hours after the loading dose8 hours after the loading dose - Period 1 N=190 hours after multiple doses - Period 1 N=182 hours after multiple doses - Period 1 N=188 hours after multiple doses - Period 1 N=18End of dosing interval on Day 8 - Period 1 N=18
Ticagrelor (Treatment Period 1)1.0206.61167.3395.9168.4324.6179.2284.9
Ticagrelor (Treatment Period 2)1.233.7756.9141.9187.4608.8311.3295.7

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AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses

The standard deviation (SD) is the geometric SD (NCT01523392)
Timeframe: Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose

,
Interventionng/mL (Geometric Mean)
Baseline (0 pre-dose hours)0.5 hours after the loading dose2 hours after the loading dose8 hours after the loading dose - Period 1 N=190 hours after multiple doses - Period 1 N=182 hours after multiple doses - Period 1 N=188 hours after multiple doses - Period 1 N=18End of dosing interval on Day 8 - Period 1 N=18
Ticagrelor (Treatment Period 1)1.09.8222.6119.093.2136.789.8140.8
Ticagrelor (Treatment Period 2)1.02.3150.954.874.5172.3112.6110.3

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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8

(NCT01523392)
Timeframe: At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8

,
InterventionPRU (Least Squares Mean)
2 hours on Day 7 (N=27 for clopidogrel)8 hours on Day 7End of dosing interval on Day 8
Clopidogrel157.8146.5172.7
Ticagrelor22.928.539.3

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PFA1

"Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds." (NCT01586975)
Timeframe: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)

Interventionseconds (Mean)
Clopidogrel 75 mg202.0
Aspirin 81 mg271.1
Aspirin > 300 mg234.7

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Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients

Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%) (NCT01589978)
Timeframe: 12 months

Interventionpercentage of patients (Number)
PROMUS Element1.78

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Cardiac Death or Myocardial Infarction (MI) Rate

See individual descriptions of events. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element2.3

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ARC ST Rate in PLATINUM-like Population.

Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%). (NCT01589978)
Timeframe: Annually through 5 years

Interventionpercentage of participants (Number)
PROMUS Element Overall Population0.0023

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All Death Rate

All death includes cardiac death and non-cardiac death. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element2.3

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All Death or Myocardial Infarction Rate

See description of individual events. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element3.2

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element0.7

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Myocardial Infarction (MI) Rate

New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element1.1

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Cardiac Death Rate

Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element1.4

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Target Vessel Revascularization (TVR) Rate

Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element5.6

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Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients

Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%) (NCT01589978)
Timeframe: 12 Months

Interventionpercentage of patients (Number)
PROMUS Element3.26

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Target Vessel Failure (TVF) Rate

"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF." (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element6.7

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Rate of Longitudinal Stent Deformation

Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent. (NCT01589978)
Timeframe: Index Procedure

Interventionstents (Number)
PROMUS Element2

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Non-cardiac Death Rate

"Non-cardiac death is defined as death not due to cardiac causes.~Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded." (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element0.9

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Major Adverse Cardiac Event Rate (MACE)

Composite of cardiac death, myocardial infarction, and target vessel revascularization (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Interventionpercentage of patients (Number)
PROMUS Element6.9

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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients

ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%) (NCT01589978)
Timeframe: 12 months

Interventionpercentage of patients (Number)
PROMUS Element0.3

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Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™

Participants with low (<150) baseline PRU values were excluded. (NCT01603082)
Timeframe: 0.5 hours, end of PCI, and 8 hours after the loading dose

,
InterventionPRU (Mean)
0.5 hours8 hoursEnd of PCI (n=41 for ticagrelor)
Clopidogrel297.7202.3307.8
Ticagrelor277.343.8264.2

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Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™

Participants with low (<150) baseline PRU values were excluded. (NCT01603082)
Timeframe: 2 hours after the loading dose

InterventionPRU (Mean)
Ticagrelor98.4
Clopidogrel257.5

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Number of Participants With Ischemic Events

Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention (NCT01612884)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Death72248361Death72248362Myocardial Infarction72248361Myocardial Infarction72248362Recurrent coronary intervention72248361Recurrent coronary intervention72248362Unstable Angina72248362Unstable Angina72248361
No EventEvent
Thrombelastography (TEG) Guided0
Thrombelastography (TEG) Guided19
Thrombelastography (TEG) Guided1
Light Transmittance Aggregometry Guided0
Thrombelastography (TEG) Guided18
Light Transmittance Aggregometry Guided18
Thrombelastography (TEG) Guided3
Light Transmittance Aggregometry Guided2
Thrombelastography (TEG) Guided16
Light Transmittance Aggregometry Guided16
Thrombelastography (TEG) Guided2
Thrombelastography (TEG) Guided17

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Thrombelastography (TEG) MA

Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel (NCT01612884)
Timeframe: 1 day

Interventionmm (Mean)
Thrombelastography (TEG) Guided66.4
Light Transmittance Aggregometry Guided65.8

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Platelet Reactivity

Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: Pre-treatment baseline

Interventionpercent inhibition (Number)
Ticagrelor + ASA + Bivalirudin2.9
Clopidogrel + ASA + Bivalirudin3.7

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Platelet-thrombus Formation in an ex Vivo Model of Thrombosis

Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size. (NCT01642238)
Timeframe: Pre-treatment baseline and 1 hour

Interventionpercent change (Mean)
Ticagrelor + ASA + Bivalirudin56.3
Clopidogrel + ASA + Bivalirudin35.2

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Platelet-thrombus Formation in an ex Vivo Model of Thrombosis

Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size. (NCT01642238)
Timeframe: Pre-treatment baseline and 24 hrs post treatment

Interventionpercent change (Mean)
Ticagrelor + ASA + Bivalirudin34.1
Clopidogrel + ASA + Bivalirudin18.5

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Blood Thrombogenicity

Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: 1 hr post-treatment

Interventionseconds (Mean)
Ticagrelor + ASA + Bivalirudin163.1
Clopidogrel + ASA + Bivalirudin174.0

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Blood Thrombogenicity

Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: 24-hours post-treatment

Interventionseconds (Mean)
Ticagrelor + ASA + Bivalirudin56.1
Clopidogrel + ASA + Bivalirudin54.3

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Blood Thrombogenicity

Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: Pre-treatment baseline

Interventionseconds (Mean)
Ticagrelor + ASA + Bivalirudin53.1
Clopidogrel + ASA + Bivalirudin51.1

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Platelet Reactivity

Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: 1 hr post-treatment

Interventionpercent inhibition (Mean)
Ticagrelor + ASA + Bivalirudin69.4
Clopidogrel + ASA + Bivalirudin20.1

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Platelet Reactivity

Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: 24-hours post-treatment

Interventionpercent inhibition (Mean)
Ticagrelor + ASA + Bivalirudin67.4
Clopidogrel + ASA + Bivalirudin53.4

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Changes in Fontaine Stage

"Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.~Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

,,,,,,,,,
InterventionParticipant (Number)
Stage I - End of treatmentStage IIa - End of treatmentStage IIb - End of treatmentStage III - End of treatmentStage IV - End of treatmentMissing - End of treatment
Clopidogrel - Stage I7432305694250
Clopidogrel - Stage IIa7231956311157724
Clopidogrel - Stage IIb1985574502310370
Clopidogrel - Stage III33333823560
Clopidogrel - Stage IV192115121345
Ticagrelor - Stage I7752274577248
Ticagrelor - Stage IIa6831948269247743
Ticagrelor - Stage IIb171560469125403
Ticagrelor - Stage III15413931159
Ticagrelor - Stage IV26281971347

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Any Amputation Caused by PAD

Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd179
Clopidogrel 75 mg od208

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All-cause Mortality

Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd628
Clopidogrel 75 mg od635

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ALI

Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd117
Clopidogrel 75 mg od115

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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)

Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd983
Clopidogrel 75 mg od992

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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd1119
Clopidogrel 75 mg od1140

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MI

Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd349
Clopidogrel 75 mg od334

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Major Amputation Caused by PAD

Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd100
Clopidogrel 75 mg od116

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Lower Extremity Revascularization

Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd846
Clopidogrel 75 mg od892

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Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke

Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipants (Number)
Ticagrelor 90 mg bd751
Clopidogrel 75 mg od740

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CV Death

Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd363
Clopidogrel 75 mg od343

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Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])

Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd1211
Clopidogrel 75 mg od1250

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Composite of CV Death, MI, Ischemic Stroke, and ALI

Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd839
Clopidogrel 75 mg od833

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Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)

Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd766
Clopidogrel 75 mg od759

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Change in ABI/TBI From Baseline

"Change in ankle brachial index (ABI) / toe brachial index (TBI).~Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):~Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4~Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:~Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

,
InterventionChange in ABI/TBI (Mean)
ABI - 6 months N = 6184(Tica), 6319(Clopi)ABI - End of treatment N = 4951(Tica), 5073(Clopi)TBI - 6 months N = 55(Tica), 48(Clopi)TBI - End of treatment N = 36(Tica), 21(Clopi)
Clopidogrel 75 mg od0.0110.0160.036-0.065
Ticagrelor 90 mg bd0.0160.0220.0500.059

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TIMI Major or Minor Bleeding Events

Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

InterventionParticipant (Number)
Ticagrelor 90 mg bd193
Clopidogrel 75 mg od175

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Changes in Rutherford Classification

"Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.~Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

,,,,,,,,,,,
InterventionParticipant (Number)
Category 0 - End of treatmentCategory 1/2 - End of treatmentCategory 3 - End of treatmentCategory 4 - End of treatmentCategory 5 - End of treatmentCategory 6 - End of treatmentMissing - End of treatment
Clopidogrel - Cat 074323056922250
Clopidogrel - Cat 1/272319563111561724
Clopidogrel - Cat 31985574502364370
Clopidogrel - Cat 4333338234160
Clopidogrel - Cat 51318121112034
Clopidogrel - Cat 663311011
Ticagrelor - Cat 077522745752248
Ticagrelor - Cat 31715604691232403
Ticagrelor - Cat 4154139311059
Ticagrelor - Cat 5232313411033
Ticagrelor - Cat 635630214
Ticagrelor - Stage II68319482692443743

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TIMI Major Bleeding Events

Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

InterventionParticipant (Number)
Ticagrelor 90 mg bd113
Clopidogrel 75 mg od109

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Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event

Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

InterventionParticipant (Number)
Ticagrelor 90 mg bd168
Clopidogrel 75 mg od112

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PLATO Major Bleeding Events

Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug

InterventionParticipant (Number)
Ticagrelor 90 mg bd206
Clopidogrel 75 mg od188

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Non-CV Death

Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd250
Clopidogrel 75 mg od272

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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd1183
Clopidogrel 75 mg od1199

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Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)

Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years

InterventionParticipant (Number)
Ticagrelor 90 mg bd789
Clopidogrel 75 mg od786

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Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.

Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding in subjects identified as CYP2C19 LOF carriers by TaqMan (NCT01742117)
Timeframe: 1 year after percutaneous coronary intervention (PCI)

InterventionParticipants (Count of Participants)
Genotype-Guided Therapy16
Conventional Therapy14

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Thrombolysis in Myocardial Infarction Major or Minor Bleeding

Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding (NCT01742117)
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)

InterventionParticipants (Count of Participants)
Genotype-Guided Therapy54
Conventional Therapy53

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Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.

Number of subjects who experienced major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis in subjects identified as CPY2C19 LOF carriers by TaqMan. (NCT01742117)
Timeframe: 1 year after percutaneous coronary intervention (PCI)

InterventionParticipants (Count of Participants)
Genotype-Guided Therapy35
Conventional Therapy54

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Occurrence of the a Major Adverse Cardiovascular Event

Number of subjects to experience a major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis. (NCT01742117)
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)

InterventionParticipants (Count of Participants)
Genotype-Guided Therapy262
Conventional Therapy269

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The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication

(NCT01765400)
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel

,
Interventionpercentage of platelt inhibition (Mean)
5 umol/L ADP20 umol/L ADP
Clopidogrel4754
Prasugrel3238

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The Change in Platelet Activation Assay (VASP)Between Baseline and Each Antiplatelet Medication

(NCT01765400)
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel

InterventionPRI (platelt reactivity index) (Mean)
Prasugrel25
Clopidogrel49

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The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication

(NCT01765400)
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel, Change From Baseline at Week 2 Reported

InterventionPRU (P2Y12 reactivity units) (Mean)
Prasugrel66.4
Clopidogrel156.2

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Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate

Citrated whole blood was used to measure platelet aggregation induced by agonist (adenosine diphosphate at 20mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) and on aspirin (visit 2) was compared between groups with post treatment values (visit 3) after 2 weeks of aspirin and clopidogrel treatment (NCT01768637)
Timeframe: 4 weeks

,
Interventionohms (Mean)
Baselinevisit 2visit 3
Chronic Kidney Disease13.511.08.0
Normal Controls9.010.03.0

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Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid

Citrated whole blood was used to measure platelet aggregation induced by agonist (arachidonic acid at 5 mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment (NCT01768637)
Timeframe: 2 weeks

,
Interventionohms (Median)
Baselinevisit 2
Chronic Kidney Disease21.00
Normal Controls18.00

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Whole Blood Platelet Aggregation to 2 µg/mL Collagen

Citrated whole blood was used to measure platelet aggregation induced by agonist (collagen at 2mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment (NCT01768637)
Timeframe: 2 weeks

,
Interventionohms (Median)
Baselinevisit 2
Chronic Kidney Disease28.519.5
Normal Controls25.019.0

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Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.

"To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel.~The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point." (NCT01789814)
Timeframe: Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion

,
Intervention% inhibitn of platelet aggregation (Number)
ADP 20 uM-1 hour %ADP 20 uM-2 hour %ADP 20 uM-4 hour %ADP 20 uM-16 hour %SFFLRN 5 uM-1 hourSFFLRN 5 uM-2 hourSFFLRN 5 uM-4 hourSFFLRN 5 uM-16 hourAYP 160 uM-1 hourAYP 160 uM-2 hourAYP 160 uM-4 hourAYP 160 uM-16 hour
Clopidogrel38538585291715791311
Prasugrel849498986264755839445341

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Percentage of Participants With Clinically Relevant Bleeding During Treatment

Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH) (NCT01802775)
Timeframe: at 3 months

,
Interventionpercentage of participants (Number)
Including Access Site Bleeding (IASB)Excluding Access Site Bleed (EASB)
Clopidogrel86
Edoxaban116

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Safety Assessments

"Number of participants with serious adverse events (SAEs) within 6 months~Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality." (NCT01802775)
Timeframe: within 6 months

InterventionParticipants (Count of Participants)
Clopidogrel30
Edoxaban31

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Percentage of Participants With First Re-stenosis / Re-occlusion

Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant (NCT01802775)
Timeframe: within 6 months

Interventionpercentage of participants (Number)
Clopidogrel34.7
Edoxaban30.9

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Number of Participants With Amputations

Number of participants with amputations within 6 months (NCT01802775)
Timeframe: within 6 months

InterventionParticipants (Count of Participants)
Clopidogrel3
Edoxaban1

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Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period

Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death (NCT01802775)
Timeframe: within 6 months

InterventionParticipants (Count of Participants)
Clopidogrel1
Edoxaban3

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Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment

The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months (NCT01802775)
Timeframe: within 3 months

,
Interventionpercentage of participants (Number)
IASB : Major BleedingIASB: CRNM BleedingIASB: Minor BleedingEASB : Major BleedingEASB : CRNM BleedingEASB : Minor Bleeding
Clopidogrel5420.84317.8
Edoxaban110201519

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Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction

shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded (NCT01813435)
Timeframe: 2-year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy362
Reference Treatment Strategy416

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Number of Participants With All-cause Mortality

(NCT01813435)
Timeframe: 2-year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy224
Reference Treatment Strategy253

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Number of Participants With Myocardial Infarction

(NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy248
Reference Treatment Strategy250

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Number of Participants With New Q-wave Myocardial Infarction

(NCT01813435)
Timeframe: 2-year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy83
Reference Treatment Strategy103

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Number of Participants With a Stroke

(NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy80
Reference Treatment Strategy82

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Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding

"BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.~Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:~Type 3a:~Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed)~Any transfusion with overt bleeding~Type 3b:~Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)~Cardiac tamponade~Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)~Bleeding requiring intravenous vasoactive agents~Type 3c:~Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision. Type 5: Fatal bleeding~Type 5a:~• Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious~Type 5b:~Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation" (NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy163
Reference Treatment Strategy169

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Number of Participants With a Definite Stent Thrombosis

(NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy64
Reference Treatment Strategy64

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Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)

Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation. (NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy304
Reference Treatment Strategy349

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Number of Participants With a Myocardial Revascularisation

(NCT01813435)
Timeframe: 2 year

InterventionParticipants (Count of Participants)
Experimental Treatment Strategy739
Reference Treatment Strategy793

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Difference in Arachidonic Acid-induced Platelet Aggregation

Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined (NCT01815008)
Timeframe: At baseline and after 1-week

InterventionDifference in ohms (Post-Pre) (Mean)
Clopidogrel-5.2

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Difference in ADP-induced Platelet Aggregation

ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation. (NCT01815008)
Timeframe: at baseline and at 1 week

InterventionDifference in ohms (Post-Pre) (Mean)
Clopidogrel-5.2

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Changes in Platelet Transcriptome With Clopidogrel

Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined (NCT01815008)
Timeframe: At baseline and at 1 week

InterventionFPKM (Mean)
Clopidogrel13.7

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Difference in Collagen-induced Platelet Aggregation

Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined (NCT01815008)
Timeframe: At Baseline and at 1 week

InterventionDifference in ohms (Post-Pre) (Mean)
Clopidogrel-1.13

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Thrombus Formation

Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis). (NCT01823510)
Timeframe: up to 7 days

,
Interventionpercentage of baseline size (Mean)
2 hour post loading dose6 hours post loading dose5-7 days of maintenance dose
Clopidogrel + Aspirin84.479.882.6
Ticagrelor + Aspirin66.959.968.9

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P2Y12 Reaction Unit (PRU)

Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow (NCT01823510)
Timeframe: up to 7 days

,
Interventionpercentage of baseline PRU (Mean)
2 hour post-loading dose6 hour post-loading dose5-7 days of maintenance dosing
Clopidogrel + Aspirin77.866.862.7
Ticagrelor + Aspirin14.88.214.5

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Platelet Reactivity Index (PRI)

Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay. (NCT01823510)
Timeframe: up to 7 days

,
Interventionpercentage of baseline PRI (Mean)
2 hour post-loading dose6 hour post-loading dose5-7 days of maintenance dosing
Clopidogrel + Aspirin85.882.568.4
Ticagrelor + Aspirin21.817.817.2

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Platelet Reactivity

Platelet reactivity by Multiplate Analyzer (NCT01823510)
Timeframe: up to 7 days

,
Interventionpercentage of baseline Unit (Mean)
2 hour post-loading dose6 hour post-loading dose5-7 days of maintenance dosing
Clopidogrel + Aspirin54.543.645.5
Ticagrelor + Aspirin20.520.624.2

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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108,113)End of DAPT-6 Month (n= 0, 248,243)End of DAPT-12 Month (n= 0, 350,341)
Rivaroxaban 15 mg2.0NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.70.92.81.1
Vitamin K Antagonist (VKA)2.94.43.71.8

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Percentage of Participants With Stroke

The percentage of participants with the first occurrence of Stroke were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg1.2NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.41.92.40.6
Vitamin K Antagonist (VKA)12.701.2

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Percentage of Participants With Stent Thrombosis

The percentage of participants with the first occurrence of stent thrombosis were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg0.7NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)0.91.91.60
Vitamin K Antagonist (VKA)0.60.90.40.6

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Percentage of Participants With Myocardial Infarction

The percentage of participants with the first occurrence of Myocardial Infarction were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg2.7NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)2.42.82.82
Vitamin K Antagonist (VKA)30.92.54.1

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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding

TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108, 113)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 350, 341)
Rivaroxaban 15 mg1.0NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.00.90.41.4
Vitamin K Antagonist (VKA)1.91.82.51.5

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Percentage of Participants With Clinically Significant Bleeding

Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12

Interventionpercentage of participants (Number)
Rivaroxaban 15 mg15.7
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)16.6
Vitamin K Antagonist (VKA)24.0

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Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)

A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108, 113)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 350, 341)
Rivaroxaban 15 mg13.4NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)14.416.712.914.9
Vitamin K Antagonist (VKA)19.918.62318.2

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Percentage of Participants With Cardiovascular Death

The percentage of participants with the first occurrence of cardiovascular death were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg2.2NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)21.92.41.7
Vitamin K Antagonist (VKA)1.61.81.61.5

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Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)

Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg5.9NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)5.15.66.54
Vitamin K Antagonist (VKA)5.24.53.76.5

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the Percentage Inhibition of the P2Y12 Receptor

(NCT01864005)
Timeframe: at 0.5 hour after first dose of study drug

InterventionPercentage Inhibition (Mean)
Ticagrelor8.23
Clopidogrel-3.91

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the Percentage Inhibition of the P2Y12 Receptor

(NCT01864005)
Timeframe: at 24 hours after first dose of study drug

InterventionPercentage Inhibition (Mean)
Ticagrelor79.25
Clopidogrel28.76

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the Percentage Inhibition of the P2Y12 Receptor

(NCT01864005)
Timeframe: at 6 weeks after first dose of study drug

InterventionPercentage Inhibition (Mean)
Ticagrelor83.78
Clopidogrel24.22

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the Percentage Inhibition of the P2Y12 Receptor

(NCT01864005)
Timeframe: at 8 hours after first dose of study drug

InterventionPercentage Inhibition (Mean)
Ticagrelor67.91
Clopidogrel25.38

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the Percentage Inhibition of the P2Y12 Receptor

Note: the primary endpoint was changed per the statistical analysis plan prior database lock. (NCT01864005)
Timeframe: at 2 hours after first dose of study drug

InterventionPercentage Inhibition (Mean)
Ticagrelor48.20
Clopidogrel9.78

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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment

One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units. (NCT01896557)
Timeframe: One week after randomized treatment exposure (omeprazole or ranitidine)

InterventionP2Y12 Reactivity Units (Mean)
Omeprazole173.54
Ranitidine153.61

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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.

One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative. (NCT01896557)
Timeframe: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline

InterventionPercentage (Mean)
Omeprazole17.4
Ranitidine30.1

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Comparison of the Primary Outcome With Bioimpedance Aggregometry

After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: bioimpedance aggregometry with ADP 10 mcM as reagent (NCT01896557)
Timeframe: 1 week after drug exposure

InterventionOhms (Mean)
Omeprazole2
Ranitidine2.77

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Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)

After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: PFA-100(Collagen/ADP cartridge). (NCT01896557)
Timeframe: 1 week after drug exposure

Interventionseconds (Mean)
Omeprazole95.1
Ranitidine97.2

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Average Change in Hematocrit

hematocrit levels change from preoperative to postoperative (NCT01960296)
Timeframe: baseline and Day 1

Interventionpercent change (Mean)
Clopidogrel-3
Discontinue-1

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Average Length of Hospital Stay

(NCT01960296)
Timeframe: up to 90 days

Interventiondays (Mean)
Clopidogrel2.2
Discontinue2.4

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Development of Myocardial Infarction or Thrombosis

(NCT01960296)
Timeframe: up to 90 days

Interventionparticipants (Number)
Clopidogrel0
Discontinue0

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Perioperative Bleeding Complications

Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation. (NCT01960296)
Timeframe: up to 90 days postop

Interventionparticipants (Number)
Clopidogrel0
Discontinue0

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Procedure Estimated Blood Loss

(NCT01960296)
Timeframe: up to 90 days postop

InterventionmL (Mean)
Clopidogrel73.6
Discontinue52.1

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Procedure Time

(NCT01960296)
Timeframe: Day 1

Interventionminutes (Mean)
Clopidogrel114.3
Discontinue100.4

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Same Day Discharged

Number of patients discharged on the day of surgery (NCT01960296)
Timeframe: up to 90 days

,
Interventionparticipants (Number)
same day dischargedhospital admission
Clopidogrel813
Discontinue1210

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Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay

A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU. (NCT01979445)
Timeframe: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion

,,,
InterventionPRU (Mean)
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)1.75 hrs2 hrs
Clopidogrel 1 Hr During Cangrelor7.06.35.7
Clopidogrel 1.5 Hrs During Cangrelor17.725.028.8
Clopidogrel Within 5 Min After Cangrelor7.33.7NA
Prasugrel 30 Min After Cangrelor208.03.35.3

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Bleeding Events In Accordance With GUSTO Scale

"Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale.~The severity of bleeding events by GUSTO Criteria is defined as the following:~Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results~Moderate: transfusion required~Mild: no transfusion or hemodynamic compromise~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module." (NCT01979445)
Timeframe: Screening through the follow-up period (5 to 7 days after Day 1)

,,,
Interventionbleeding events (Number)
MildModerateLife-threatening/Severe
Clopidogrel 1 Hr During Cangrelor000
Clopidogrel 1.5 Hrs During Cangrelor000
Clopidogrel Within 5 Min After Cangrelor000
Prasugrel 30 Min After Cangrelor000

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Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone

A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response). (NCT01979445)
Timeframe: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion

,,,
Intervention% aggregation (Mean)
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)2.25 hrs2.5 hrs2.75 hrs3 hrs4 hrs5.5 hrs
Clopidogrel 1 Hr During Cangrelor50.333.362.067.765.062.7NA
Clopidogrel 1.5 Hrs During Cangrelor50.022.254.356.856.251.2NA
Clopidogrel Within 5 Min After Cangrelor21.726.049.758.356.038.026.7
Prasugrel 30 Min After Cangrelor1.316.360.063.365.016.31.3

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Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay

A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU. (NCT01979445)
Timeframe: Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion

,,,
InterventionPRU (Mean)
Prasugrel/Clopidogrel Reference (6 or 5.5 hrs)2.25 hrs2.5 hrs2.75 hrs3 hrs4 hrs5.5 hrs
Clopidogrel 1 Hr During Cangrelor197.398.7206.3214.3212.7203.7NA
Clopidogrel 1.5 Hrs During Cangrelor211.390.3229.8255.8234.5215.5NA
Clopidogrel Within 5 Min Post Cangrelor159.099.0220.7233.0215.7182.0155.0
Prasugrel 30 Min After Cangrelor8.076.7208.0225.7226.077.024.5

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Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone

A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response). (NCT01979445)
Timeframe: Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion

,,,
Intervention% aggregation (Mean)
Cangrelor Reference (2.5, 2, 1.5, or 1 hrs)1.75 hrs2 hrs
Clopidogrel 1 Hr During Cangrelor3.01.32.3
Clopidogrel 1.5 Hrs During Cangrelor2.01.81.5
Clopidogrel Within 5 Min After Cangrelor01.0NA
Prasugrel 30 Min After Cangrelor60.00.30.3

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Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)

(NCT02010632)
Timeframe: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Interventionpercent inhibition*hour (Mean)
Generic Clopidogrel Product1853.58
Original Clopidogrel Product1892.84

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P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose

PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus (NCT02052635)
Timeframe: 0.5 hours post loading dose

InterventionPRUs (Mean)
Ticagrelor289.2
Clopidogrel292.8

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P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose

PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus (NCT02052635)
Timeframe: 1 hour post loading dose

InterventionPRUs (Mean)
Ticagrelor174.4
Clopidogrel249.8

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Time to First Adjudicated ST

Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg15
Dabigatran Etexilate 150mg7
Warfarin8
Warfarin (Excluding Elder Patients Outside USA)7

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Time to First Adjudicated SE

"Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.~SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg3
Dabigatran Etexilate 150mg1
Warfarin3
Warfarin (Excluding Elder Patients Outside USA)3

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Time to First Adjudicated ISTH MBE or CRNMBE

"Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.~Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.~Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.~Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg151
Dabigatran Etexilate 150mg154
Warfarin264
Warfarin (Excluding Elder Patients Outside USA)196

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Time to Adjudicated All Cause Death

Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg55
Dabigatran Etexilate 150mg30
Warfarin48
Warfarin (Excluding Elder Patients Outside USA)35

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Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg149
Dabigatran Etexilate 150mg90
Warfarin131
Warfarin (Excluding Elder Patients Outside USA)98
All Dabigatran Etexilate239

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Time to Composite Endpoint of Death or First Thrombotic Event

Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE). (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg108
Dabigatran Etexilate 150mg60
Warfarin83
Warfarin (Excluding Elder Patients Outside USA60
All Dabigatran Etexilate168

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Time to First Adjudicated MI

Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg44
Dabigatran Etexilate 150mg26
Warfarin29
Warfarin (Excluding Elder Patients Outside USA)22

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Time to Composite Endpoint of Death + MI + Stroke

Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg107
Dabigatran Etexilate 150mg60
Warfarin80
Warfarin (Excluding Elder Patients Outside USA)57

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Time to Adjudicated Undetermined Cause of Death

"Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.~This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg4
Dabigatran Etexilate 150mg5
Warfarin4
Warfarin (Excluding Elder Patients Outside USA)3

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Time to Adjudicated CV

"Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.~CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes." (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg37
Dabigatran Etexilate 150mg21
Warfarin31
Warfarin (Excluding Elder Patients Outside USA)24

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Time to Adjudicated Non-CV

"Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.~Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV" (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg14
Dabigatran Etexilate 150mg4
Warfarin13
Warfarin (Excluding Elder Patients Outside USA)8

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Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg76
Dabigatran Etexilate 150mg51
Warfarin69
Warfarin (Excluding Elder Patients Outside USA)52

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Time to First Adjudicated Stroke

"Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction" (NCT02164864)
Timeframe: up to 30 months

InterventionParticipants (Count of Participants)
Dabigatran Etexilate 110mg17
Dabigatran Etexilate 150mg9
Warfarin13
Warfarin (Excluding Elder Patients Outside USA)8

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Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))

Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US. (NCT02185534)
Timeframe: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose

Interventionh*ng/mL (Geometric Mean)
European Clopidogrel Tablets, 75 mg0.705
Japanese Clopidogrel Tablets, 75 mg0.751
US Clopidogrel Tablets, 75 mg0.767

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Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)

Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US. (NCT02185534)
Timeframe: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose

Interventionng/mL (Geometric Mean)
European Clopidogrel Tablets, 75 mg0.551
Japanese Clopidogrel Tablets, 75 mg0.511
US Clopidogrel Tablets, 75 mg0.521

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Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))

Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan. (NCT02185534)
Timeframe: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose

Interventionng*h/mL (Geometric Mean)
European Clopidogrel Tablets, 75 mg1.05
Japanese Clopidogrel Tablets, 75 mg0.992
US Clopidogrel Tablets, 75 mg1.09

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Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death

Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer. (NCT02217501)
Timeframe: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years

InterventionParticipants (Count of Participants)
DAPT - Clinically Indicated Duration+12m13
DAPT - Clinically Indicated Duration16

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Number of Participants With First Occurrence of Bleeding

"Any mild, moderate, severe, or life-threatening bleeding.~Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria~Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification." (NCT02217501)
Timeframe: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years

InterventionParticipants (Count of Participants)
DAPT - Clinically Indicated Duration+12m5
DAPT - Clinically Indicated Duration4

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VerifyNow P2Y12Test - Platelet Reactivity

Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU. (NCT02224274)
Timeframe: 12 h after P2Y12 inhibitor loading

InterventionPRU (Mean)
Clopidogrel238
Ticagrelor101

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Multiplate ADP Test

"Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets.~High on-treatment platelet reactivity was defined as >46 U." (NCT02224274)
Timeframe: 12 hours after P2Y12 inhibitor loading

InterventionU (Mean)
Clopidogrel28
Ticagrelor15

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VerifyNow P2Y12Test - % Inhibition

% inhibition reflects P2Y12 inhibitor effect regarding basal platelet reactivity (defined as: (1- (platelet reactivity/basal platelet reactivity)) x 100). Higher values mean better P2Y12 inhibition response. High on-treatment platelet reactivity was defined as <11% inhibition. (NCT02224274)
Timeframe: 12 hours after P2Y12 inhibitor loading

Intervention% inhibition (Mean)
Clopidogrel4
Ticagrelor55

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Absolute Change in TcPO2 From Baseline to Month 6

The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups. (NCT02230527)
Timeframe: 6 months

InterventionmmHG (Mean)
Clopidogrel14.9
Ticagrelor4.2

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TVR

Target vessel revascularization (TVR between day 1 and final visit) (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin2
Rivaroxaban Plus Aspirin1

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The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)

Target lesion revascularization (TLR) between day 1 and final visit (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin2
Rivaroxaban Plus Aspirin1

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Reintervention, Above Ankle Amputation and Restenosis (RAS)

The primary outcome is a combined endpoint consisting of any Reintervention (surgical procedures to revascularize), Above ankle amputation and restenosis(recurrence of blockage in the vein) (RAS) at one year (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin7
Rivaroxaban Plus Aspirin4

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Peri-procedure Death

The number of patients that die within 30 days of the revascularization procedure. (NCT02260622)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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Number of Participants With 2 Class Improvement on the Rutherford Scale

"Clinical improvement defined as cumulative improvement of 2 classes of the Rutherford scale without the need for repeated TLR in surviving patients.~There are seven stages to consider. the lower the score the less severe the disease or condition.~Rutherford Scale:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene" (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin5
Rivaroxaban Plus Aspirin8

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Minor Bleeding

Cumulative clinically relevant or minor bleeding between day 1 and day 90 (NCT02260622)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin1

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Major Bleeding

Cumulative rate of major bleeding between day 1 and day 90 (NCT02260622)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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MACE

Cumulative rate of major adverse cardiovascular events between day 1 and final visit (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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Event-free Survival

Event-free survival How long a patient is alive without the need for any further intervention or vascular events. (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin4
Rivaroxaban Plus Aspirin4

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Overall Survival

Overall survival. How long a patient is alive following the intervention. (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin11
Rivaroxaban Plus Aspirin9

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Platelet Reactivity Unit

PRU assessed by VerifyNow at 48 hours after switching of clopidogrel 600 mg LD administered 24 hours after the last ticagrelor MD vs. clopidogrel 75 mg MD given 24 hours after the last ticagrelor MD (NCT02287909)
Timeframe: 48 hours after switch

InterventionPRU (Least Squares Mean)
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor177
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor164
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor174
D) Continue Ticagrelor MD 90mg Twice Daily26

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Number of Patients With Central Vascular Accidents Proved by CT Scan

the number of patients with major vascular brain accidents ( CVA) proved by CT scan (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term0
Plavix Long Term1

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Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues

the number of patients who are able to take plavix concerning compliance and economic issues (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term500
Plavix Long Term506

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Number of Patients With Minor Bleeding

the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term13
Plavix Long Term4

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Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty

need for redo bypass surgery and redo angioplasty (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term15
Plavix Long Term14

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Number of Patients With Major Bleeding Need Transfusion

number of patients with major bleeding need transfusion (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term7
Plavix Long Term10

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Number of Patients With Death Due to Cardiac Causes

the number patients with death due to cardiac causes (NCT02327741)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Plavix Short Term0
Plavix Long Term0

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Number of Patients With Myocardial Infarction Need Hospital Admission

The number of patients with myocardial infarction need hospital admission (NCT02327741)
Timeframe: 12 month

InterventionParticipants (Count of Participants)
Plavix Short Term5
Plavix Long Term7

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Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml

The parent compound of Ticagrelor was also analysed within the same patient group of Ticagrelor as it is a directly acting agent that does not require metabolic conversion to its active form. (NCT02376283)
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutes

,,,
Interventionng/ml (Mean)
STEMI at 20 minsSTEMI at balloon inflationSTEMI at 60 minsSTEMI at 240 minsNSTEMI at 20 minsNSTEMI at 60 minsNSTEMI at 240 mins
Clopidogrel39.12107.8371.0232.4141.9993.3527.71
Prasugrel14.2724.2036.8638.44515.80194.5936.80
Ticagrelor0.161.6414.4353.387.7258.40113.59
Ticagrelor Parent Compound9.0428.5647.1384.9222.7884.13140.61

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Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)

(NCT02376283)
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutes

,,
Intervention%PRI (Mean)
STEMI at 20 minsSTEMI at balloon inflationSTEMI at 60 minsSTEMI at 240 minsNSTEMI at 20 minsNSTEMI at 60 minsNSTEMI at 240 mins
Clopidogrel76.2974.8671.5763.1475.1776.7561.83
Prasugrel46.2541.1350.5057.0033.2721.9115.18
Ticagrelor79.7574.6376.2551.3862.0033.1720.17

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Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)

(NCT02376283)
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutes

,,
InterventionP2Y12 reaction units (PRU) (Mean)
STEMI at 20 minsSTEMI at balloon inflationSTEMI at 60 minsSTEMI at 240 minsNSTEMI at 20 minsNSTEMI at 60 minsNSTEMI at 240 mins
Clopidogrel270.23286.46293.46226.42213.21227.36214.00
Prasugrel247.73253.73262.87128.64125.8076.9331.87
Ticagrelor256.73257.93225.20176.27172.80114.2023.00

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Thrombotic Complications

(NCT02384070)
Timeframe: Hospital Stay and after 30 days post PCI

InterventionNumber of Patients (Number)
Group 10
Group 20
Group 30

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TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores

"Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.~Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention" (NCT02384070)
Timeframe: Hospital Stay and after 30 days post PCI

InterventionPatients (Number)
Group 11
Group 23
Group 31

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Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure

(NCT02384070)
Timeframe: 48 hours post procedure

Interventionparticipants (Number)
Group 10
Group 20
Group 30

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Change in D-Dimer Levels as Measured by Blood Test

(NCT02486367)
Timeframe: Day 0,1,7,&30

,
Interventionng/mL (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel1564.6682851.9122653.551869.85
Ticagrelor1377.072961.4752635.9581554.43

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Change in Mono-CD62P as Measured by Blood Test

(NCT02486367)
Timeframe: Day 0,1,7,&30

,
Interventionpercentage of monocytes (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel1.6750.750.690.695
Ticagrelor1.5250.7150.730.765

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Change in Mono-2b3a as Measured by Blood Test

(NCT02486367)
Timeframe: Day 0,1,7,&30

,
Interventionpercentage of monocytes (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel2.271.450.6150.765
Ticagrelor1.450.931.230.86

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Change in IL-6 as Measured by Blood Test.

(NCT02486367)
Timeframe: Day 0,1,7,&30

,
Interventionpg/mL (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel4.76143.1277.6035.0825
Ticagrelor4.452.1257.185024.511

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Change in IL-8 as Measured by Blood Test

(NCT02486367)
Timeframe: Day0,1,7,&30

,
Interventionpg/mL (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel6.8410638.584.984.81
Ticagrelor4.8373717.5589234.5844263.783523

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Platelet Reactivity

Platelet reactivity will be measured and reported as platelet reactivity units (PRU) using the VerifyNow system. (NCT02486367)
Timeframe: Day 0,1,7,&30

,
InterventionPlatelet Reactivity Units (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel275.5234208183
Ticagrelor251128.580134.5

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Inflammatory Monocyte Proportion

The percentage of inflammatory (CD14+CD16+) monocytes as a proportion of total monocytes will be measured using flow cytometry on whole blood. (NCT02486367)
Timeframe: Day 0,1,7&30

,
Interventionpercentage of inflammatory monocyte (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel21.5510322.2335617.9834217.93496
Ticagrelor21.5003325.1227521.62621.06446

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Change in sCD14 as Measured by Blood Test.

(NCT02486367)
Timeframe: Day 0,1,7,&30

,
Interventionpg/mL (Median)
Day 0Day 1Day 7Day 30
Standard Care/Clopidogrel1638.7211713.161765.9341525.929
Ticagrelor1712.9431896.4891958.0132077.568

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Maximal Platelet Aggregation in Non-DM

Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in non-diabetic patients (NCT02548650)
Timeframe: 30 days

Interventionpercentage of aggregation (Mean)
Triple Therapy60
Dual Therapy70

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Maximal Platelet Aggregation in DM

Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in diabetic patients (NCT02548650)
Timeframe: 30 days

Interventionpercentage of aggregation (Mean)
Triple Therapy65
Dual Therapy78

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Effects On Skin Bleeding Time (BT)

The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on skin BT (minutes) was determined with the Ivy method, utilizing standardized bleeding with the Surgicutt device. Results include the 95% confidence intervals for the reported GMRs ([cilostazol+reference]/reference) for skin BT. (NCT02554721)
Timeframe: Visit 5 (Day 22-29)

Interventionratio (Geometric Mean)
Acetylsalicylic Acid - Cilostazol1.31
Clopidogrel - Cilostazol1.27

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Ex-vivo Inhibition Of Platelet Aggregation (IPA)

The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on IPA was determined ex vivo in citrated platelet rich plasma (PRP) after stimulation of aggregation by low-level adenosine diphosphate (ADP) (5 micromolar [uM]) and arachidonic acid (AA) (500 milligrams/liter [mg/L]). Light transmission aggregometry (LTA) was used to measure residual aggregation (the percentage of aggregation 5 minutes after the addition of ADP or AA). Results are reported as the 95% confidence intervals for the reported geometric mean ratios (GMRs) ([cilostazol+reference (ASA or clopidogrel)]/reference) for IPA. (NCT02554721)
Timeframe: Baseline, Visit 5 (Day 22-29)

,
Interventionratio (Geometric Mean)
5 µM ADP500 mg/L AA
Acetylsalicylic Acid - Cilostazol0.821.03
Clopidogrel - Cilostazol1.214.42

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Number of Participants With Primary Bleeding Event (PBE)

PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding. (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)46
Antiplatelet31

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Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds

Composite of TIMI major and minor bleedings (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)42
Antiplatelet24

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Number of Participants With Death or First Thromboembolic Event (DTE)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. (NCT02556203)
Timeframe: Through study completion, on average 14 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)68
Antiplatelet63

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Number of Participants With Cardiovascular Death or Thromboembolic Event

Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication). (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)83
Antiplatelet68

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Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds

Composite of BARC 2,3 or 5 bleedings (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)148
Antiplatelet85

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Number of Participants With Death or First Thromboembolic Event (DTE)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)105
Antiplatelet78

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Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds

ISTH major bleeds (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)49
Antiplatelet30

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Number of Participants With Net-clinical Benefit

The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety). (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)137
Antiplatelet100

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Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min

(NCT02559414)
Timeframe: Baseline, 14 Days

Intervention%aggregation (Mean)
Placebo Baseline69.45
Placebo Follow up80.33
Aspirin Baseline82.04
Aspirin Randomization62.00
Clopidogrel Baseline78.86
Clopidogrel Randomization39.88

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Percentage Monocyte-Platelet Aggregates

Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation (NCT02559414)
Timeframe: 14 Days

Intervention%aggregation (Mean)
Placebo Baseline69.45
Placebo Follow up80.33
Aspirin Baseline82.04
Aspirin Randomization62.00
Clopidogrel Baseline78.86
Clopidogrel Randomization39.88

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Percentage Monocyte-Platelet Aggregates

Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity (NCT02559414)
Timeframe: 14 Days

Intervention%aggregation (Mean)
Placebo Baseline15.53
Placebo Follow up15.43
Aspirin Baseline13.15
Aspirin Follow up14.96
Clopidogrel Baseline16.03
Clopidogrel Follow up14.85

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Percentage Leukocyte-Platelet Aggregate

Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function. (NCT02559414)
Timeframe: 14 Days

Intervention%aggregation (Mean)
Placebo Baseline14.06
Placebo Follow up13.84
Aspirin Baseline11.18
Aspirin Randomization12.11
Clopidogrel Baseline13.06
Clopidogrel Randomization12.29

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Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min

The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control. (NCT02559414)
Timeframe: Baseline, 14 Days

Intervention%aggregation (Mean)
Placebo Baseline72.35
Placebo Follow up79.11
Aspirin Baseline72.79
Aspirin Randomization26.77
Clopidogrel Baseline71.07
Clopidogrel Randomization65.00

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Change in Spontaneous Platelet Aggregometry From Baseline to Week 24

Change in spontaneous % platelet from baseline to week 24. Spontaneous platelet aggregation? (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet (Mean)
Aspirin and Placebo-0.75
Clopidogrel and Placebo-0.60
Placebo Only-0.88

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Change in sCD14 From Baseline to Week 24

Soluble CD14 (sCD14) levels in blood. sCD14 is a nonspecific maker of monocyte activation. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionpg/mL (Mean)
Aspirin and Placebo35.75
Clopidogrel and Placebo-251.40
Placebo Only-101.75

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Change in sCD40L From Baseline to Week 24

Soluble CD40-ligand levels (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionpg/mL (Mean)
Aspirin and Placebo-28.05
Clopidogrel and Placebo-25.68
Placebo Only13.65

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Change in Platelet Aggregometry in Response to ADP 20µM From Baseline to Week 24

Change in % platelet aggregation in response to stimulation by Adenosine Diphosphate (ADP) from baseline to week 24 (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet aggregation (Mean)
Aspirin and Placebo-7.25
Clopidogrel and Placebo-32.40
Placebo Only-6.50

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Change in Maximum Clot Firmness (MCF) From Baseline to 24 Weeks

Maximum Clot Firmness (MCF) is measured using thromboelastography. maximum ampliture in mm (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionmm (Mean)
Aspirin and Placebo1.38
Clopidogrel and Placebo1.20
Placebo Only0.38

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Change in Intermediate Monocyte Subsets From Baseline to Week 24.

The intermediate monocyte with high level expression of CD14 and low level expression of CD16 (CD14++CD16+ monocytes). (NCT02578706)
Timeframe: Baseline and 24 weeks

Intervention10^3 cells/µl (Mean)
Aspirin and Placebo0.02
Clopidogrel and Placebo0.06
Placebo Only0.04

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Change in IL-6 From Baseline to Week 24

Interleukin 6 gene encodes a cytokine that functions in inflammation and implicated in a variety of inflammatory-associated disease states. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionpg/mL (Mean)
Aspirin and Placebo-0.36
Clopidogrel and Placebo0.02
Placebo Only0.85

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Change in D-dimer From Baseline to Week 24

D-Dimer level looks at coagulation of blood. D-dimers are not normally present in blood except when coagulation has occurred. (NCT02578706)
Timeframe: Baseline and 24 weeks

Interventionmcg/L (Mean)
Aspirin and Placebo-295.99
Clopidogrel and Placebo151.96
Placebo Only1109.38

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Change in Coagulation Time (CT) From Baseline to 24 Weeks

Clot formation kinetics, or coagulation time, is measured using thromboelastography. time to 2mm amplitude in seconds. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionseconds (Mean)
Aspirin and Placebo3.00
Clopidogrel and Placebo1.00
Placebo Only-13.13

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Change in Clot Formation Time (CFT) From Baseline to 24 Weeks

Clot formation time is measured using thromboelastography. time from 2 to 20 mm amplitude in seconds. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionseconds (Mean)
Aspirin and Placebo-1.00
Clopidogrel and Placebo2.00
Placebo Only1.63

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Change in sTNFR I From Baseline to Week 24

Soluble tumor necrosis factor receptor (sTNFR) serum concentration (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionpg/ml (Mean)
Aspirin and Placebo137.77
Clopidogrel and Placebo59.46
Placebo Only19.78

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Change in sTNFR II From Baseline to Week 24

Soluble tumor necrosis factor receptor (sTNFR) serum concentration (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionpg/ml (Mean)
Aspirin and Placebo283.13
Clopidogrel and Placebo347.00
Placebo Only4.25

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Change in Classical Monocyte Subsets From Baseline to Week 24

The classical monocyte is characterized by high level expression of the CD14 cell surface receptor (CD14++ CD16- monocyte) (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention10^3 cells/µl (Mean)
Aspirin and Placebo-0.09
Clopidogrel and Placebo-0.12
Placebo Only-0.04

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Change in Alpha Angle From Baseline to 24 Weeks

Alpha angle is measured using thromboelastography, measured by a tangent to the clotting curve through the 2mm point (NCT02578706)
Timeframe: baseline and 24 weeks

Interventiondegree (Mean)
Aspirin and Placebo0.00
Clopidogrel and Placebo-0.60
Placebo Only-0.50

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Change in Thrombus Formation (High Shear) From Baseline to 24 Weeks

substudy - Change in thrombus formation by Badimon chamber (high shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. The high shear chambers (inner lumen diameter 0.1 mm, Reynolds number 60, shear rate 1690 s- 1) mimic the rheologic conditions of a moderately stenosed coronary artery. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionμ(2)/mm (Mean)
Aspirin and Placebo-3052.20
Clopidogrel and Placebo-2798.80
Placebo Only-753.00

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Change in Thrombus Formation (Low Shear) From Baseline to 24 Weeks

substudy - Change in thrombus formation by Badimon chamber (low shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. μ(2)/mm is the area of thrombus. The low shear chamber (inner lumen diameter 0.2 mm, Reynolds number 30, shear rate 500 s- 1) simulates flow conditions of a normal coronary artery. (NCT02578706)
Timeframe: baseline and 24 weeks

Interventionμ(2)/mm (Mean)
Aspirin and Placebo-1036
Clopidogrel and Placebo-899.20
Placebo Only-203.75

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Number of Subjects With at Least One Grade 3 or Higher Sign/Symptom or Laboratory Abnormality

Safety as measured by a Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. A grade 3 sign/symptom was defined as medically significant but not immediately life threatening. (NCT02578706)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Aspirin and Placebo0
Clopidogrel and Placebo1
Placebo Only0

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Change in Monocyte Activation sCD163 From Baseline to Week 24

Soluble CD163 is a specific macrophage activation marker, associated with morphological disease grade. A high sCD163 indicates more disease. (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention10^3 cells/µl (Mean)
Aspirin and Placebo26.88
Clopidogrel and Placebo15.8
Placebo Only-63.38

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Change in Monocyte Platelet Aggregates From Baseline to 24 Weeks

Change in % platelet monocyte aggregates from baseline to week 24 (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet monocyte aggregates (Mean)
Aspirin and Placebo10.55
Clopidogrel and Placebo3.88
Placebo Only8.96

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Change in Non-classical Monocyte Subsets From Baseline to Week 24

The non-classical monocyte shows low level expression of CD14 and additional co-expression of the CD16 receptor (CD14+CD16++ monocyte).[ (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention10^3 cells/µl (Mean)
Aspirin and Placebo0.002
Clopidogrel and Placebo0.03
Placebo Only-0.03

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Change in Platelet Aggregometry in Response to Arachidonic Acid 1500µM From Baseline to Week 24

Change in % platelet aggregation in response to stimulation by arachidonic acid 1500µM from baseline to week 24 (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet aggregation (Mean)
Aspirin and Placebo-53.33
Clopidogrel and Placebo-31.00
Placebo Only-13.25

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Change in Platelet Aggregometry in Response to Collagen 2µg/mL From Baseline to Week 24

Change in % platelet aggregation in response to stimulation by Collagen 2µg/mL from baseline to week 24 (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet aggregation (Mean)
Aspirin and Placebo-40.37
Clopidogrel and Placebo-9.60
Placebo Only8.62

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Change in Platelet Aggregometry in Response to Epi 5µM From Baseline to Week 24

Change in % platelet aggregation in response to stimulation by light transmission aggregometry as measured by epinephrine 5µM from baseline to week 24 (NCT02578706)
Timeframe: baseline and 24 weeks

Intervention% platelet aggregation (Mean)
Aspirin and Placebo-35.25
Clopidogrel and Placebo-21.40
Placebo Only-10.63

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Flow-mediated Dilation of the Brachial Artery

Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion (NCT02742987)
Timeframe: 4 weeks

InterventionFMD (%) (Mean)
Ticagrelor Group16.6
Clopidogrel Group11.6

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Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.

"Effective orifice area (cm2) as determined by transthoracic echocardiography at three months after randomization.~scale [0.1-4.0]" (NCT02833948)
Timeframe: 3 months

Interventioncm2 (Mean)
ASA + Clopidogrel1.8
Rivaroxaban + ASA1.8

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Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.

Thromboembolic event, Dichotomization by RLM (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
RLM>2 (-)2
RLM(+)0

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The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan

The rate of prosthetic leaflet with HALT as assessed by cardiac 4DCT-scan (NCT02833948)
Timeframe: 3 months

InterventionLeaflets (Number)
ASA + Clopidogrel53
Rivaroxaban + ASA16

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Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.

Death, Dichotomization by RLM (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
RLM>2 (-)0
RLM(+)0

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Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.

"Transprosthetic mean pressure gradiënt as determined by transthoracic echocardiography at three months after randomization.~scale [0-100]" (NCT02833948)
Timeframe: 3 months

Interventionmm Hg (Mean)
ASA + Clopidogrel10
Rivaroxaban + ASA10

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Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan

Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (<50%), (III) moderate to severely reduced (>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is > 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets. (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
ASA + Clopidogrel11
Rivaroxaban + ASA2

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Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.

Thromboembolic event, Dichotomization by HALT (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
HALT (-)2
HALT (+)0

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Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.

Death, Dichotomization by HALT (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
HALT (-)0
HALT (+)0

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The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan

The rate of prosthetic leaflets with RLM> grade 3 as assessed by cardiac 4DCT (NCT02833948)
Timeframe: 3 months

Interventionleaflets (Number)
ASA + Clopidogrel14
Rivaroxaban + ASA3

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The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan

The rate of patients with at least one prosthetic leaflet with hypoattenuated leaflet thickening (HALT) as assessed by cardiac 4DCT. (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
ASA + Clopidogrel33
Rivaroxaban + ASA12

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Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen

The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis. (NCT02866175)
Timeframe: Day 1 to 12 months postdose

,
InterventionParticipants (Count of Participants)
Composite MEE eventCardiovascular death (ARC)Stroke (Protocol definition)Systemic Embolic EventMyocardial infarctionDefinite stent thrombosis
Edoxaban Regimen4910100227
Vitamin K Antagonist Regimen4612110185

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Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen

All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. (NCT02866175)
Timeframe: Day 1 to 12 months postdose

,
InterventionParticipants (Count of Participants)
Major bleedingClinically relevant non-major bleedingMinor bleedingSymptomatic intracranial hemorrhageFatal major bleedingFatal intracranial hemorrhageLife-threatening bleedingSpontaneous bleeding
Edoxaban Regimen45971164105184
Vitamin K Antagonist Regimen481141259748210

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Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen

Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding) (NCT02866175)
Timeframe: Day 1 to 12 months postdose

,
InterventionParticipants (Count of Participants)
Major bleedingFatal bleedingMajor or minor bleedingMinor bleedingMinimal bleeding
Edoxaban Regimen151124113117
Vitamin K Antagonist Regimen244144126131

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Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen

"Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome.~Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding" (NCT02866175)
Timeframe: Day 1 to 12 months postdose

,
InterventionParticipants (Count of Participants)
Bleeding (BARC Type 3 or 5)Bleeding (BARC Type 2, 3, or 5)Bleeding (BARC Type 1, 2, 3, or 5)
Edoxaban Regimen36124207
Vitamin K Antagonist Regimen42144242

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Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen

Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. (NCT02866175)
Timeframe: Day 1 to 12 months postdose

,
InterventionParticipants (Count of Participants)
Composite MCRBMajor bleedingClinically relevant non-major bleeding
Edoxaban Regimen1283989
Vitamin K Antagonist Regimen15244108

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen

Treatment-emergent adverse events (TEAEs) in >1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug. (NCT02866175)
Timeframe: Day 1 to 30 days after the last dose

,
InterventionParticipants (Count of Participants)
Any TEAEInfections and InfestationsNasopharyngitisPneumoniaBronchitisUrinary tract infectionRespiratory tract infectionInfluenzaCardiac DisordersCardiac failureAtrial fibrillationBradycardiaCardiac failure congestiveVentricular extrasystolesTachycardiaGeneral Disorders & Administration Site ConditionNon-cardiac chest painOedema peripheralAstheniaChest painFatigueGastrointestinal DisordersDiarrhoeaConstipationAbdominal pain upperGastritisNauseaDyspepsiaRespiratory,Thoracic, and Mediastinal DisordersDyspnoeaCoughDyspnoea exertionalChronic obstructive pulmonary diseaseMusculoskeletal and Connective Tissue DisordersBack painArthralgiaPain in extremityMyalgiaOsteoarthritisInvestigationsBlood creatinine increasedAlanine aminotransferase increasedBlood pressure increasedCreatinine renal clearance decreasedAspartate aminotransferase increasedInternational normalised ratio increasedNervous System DisordersDizzinessHeadacheSyncopeVascular DisordersHypertensionHypotensionHypertensive crisisRenal and Urinary DisordersRenal failureAcute kidney injuryRenal impairmentInjury, Poisoning, and Procedural ComplicationsFallSkin and Subcutaneous Tissue DisordersPruritusRashMetabolism and Nutrition DisordersGoutBlood and Lymphatic System DisordersAnaemiaPsychiatric DisorderInsomniaEar and Labyrinth DisordersVertigo
Edoxaban Regimen4571452520191412101364039108711113303121711110231169888722211866914115897015812127083301985523141149118744855121042114119238128
Vitamin K Antagonist Regimen44714022222019157134474178839824221411683197105537226115108314121385791313871112652212662231485512138441233794243520208165

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Number of Patients With Minor Bleeding Complications

We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. (NCT02925923)
Timeframe: At 1 year post-PCI

InterventionParticipants (Count of Participants)
Ticagrelor0
Eptifibatide Bolus+Clopidogrel0

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A Change in Hematocrit Levels

Hematocrit levels (%) will be measured at baseline and on the next day after PCI. (NCT02925923)
Timeframe: At baseline and at 24 hours post-PCI

,
Interventionhematocrit (%) (Mean)
Baseline (hematocrit, %)Post-PCI (hematocrit, %)
Eptifibatide Bolus+Clopidogrel40.0237.5
Ticagrelor40.1137.68

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Heparin Dose, Unit/Kg

For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight. (NCT02925923)
Timeframe: 24 hours after the PCI

Interventionunits per kilogram (Mean)
Ticagrelor8854
Eptifibatide Bolus+Clopidogrel6021

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Activated Clotting Time (ACT), Seconds

The Level of the highest ACT during PCI will be compared between the groups (NCT02925923)
Timeframe: At the end of PCI

Interventions (Mean)
Ticagrelor332
Eptifibatide Bolus+Clopidogrel278

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Platelet Aggregation Levels

The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel (NCT02925923)
Timeframe: At baseline and at 0.5, 2, 4, and 24 hours after loading dose

,
Interventionμmol/L (Mean)
Baseline (ADP 20)0.5 h (ADP 20)2 h (ADP 20)4 h (ADP 20)24 h (ADP 20)Baseline (ADP 5)0.5 h (ADP 5)2 h (ADP 5)4 h (ADP 5)24 h (ADP 5)Baseline (TRAP 20)0.5 h (TRAP 20)2 h (TRAP 20)4 h (TRAP 20)24 h (TRAP 20)Baseline (TRAP 10)0.5 h (TRAP 10)2 h (TRAP 10)
Eptifibatide Bolus+Clopidogrel621.3.343.538541.18.31.627673.961451541.181.57
Ticagrelor655335232556442415186860514854564837

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Number of Patients With Negative Clinical Outcomes

The rates of death, myocardial infarction, and revascularization at 1-year post-PCI. (NCT02925923)
Timeframe: At 1-year post-PCI

,
InterventionParticipants (Count of Participants)
DeathMyocardial infarctionRevascularization
Eptifibatide Bolus+Clopidogrel000
Ticagrelor201

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Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)

We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM. (NCT02925923)
Timeframe: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)

,
Interventioncount of participants (Number)
Baseline (n-50, n-48)0.5 h (n-50, n-48)2 h (n-50, n-48)4 h (n-50, n-48)24 h (n-50, n-48)
Eptifibatide Bolus+Clopidogrel330005
Ticagrelor3724602

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Change in Hemoglobin Levels (g/dL)

Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI. (NCT02925923)
Timeframe: At baseline and at 24 hours post-PCI

,
Interventiong/dL (Mean)
Baseline (hemoglobin, g/dL)Post-PCI (hemoglobin, g/dL)
Eptifibatide Bolus+Clopidogrel13.3412.71
Ticagrelor13.5212.73

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Number of Patients With Minor Bleeding Complications

We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. (NCT02925923)
Timeframe: At 24 hours post-PCI

InterventionParticipants (Count of Participants)
Ticagrelor0
Eptifibatide Bolus+Clopidogrel0

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Number of Patients With Major Bleeding Complications

We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. (NCT02925923)
Timeframe: At 24 hours post-PCI

InterventionParticipants (Count of Participants)
Ticagrelor0
Eptifibatide Bolus+Clopidogrel0

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Number of Patients With Major Bleeding Complications

We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. (NCT02925923)
Timeframe: At 1 year post-PCI

InterventionParticipants (Count of Participants)
Ticagrelor0
Eptifibatide Bolus+Clopidogrel0

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Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)

The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel (NCT02925923)
Timeframe: At baseline and every 8 hours post- PCI

InterventionParticipants (Count of Participants)
Ticagrelor24
Eptifibatide Bolus+Clopidogrel14

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Concentration of Platelet Extracellular Vesicles/ml

Concentration of platelet extracellular vesicles/ml measured with flow cytometry (NCT02931045)
Timeframe: 6 months following the beginning of antiplatelet therapy

InterventionPlatelet Extracellular Vesicles/mL (Median)
Ticagrelor2690000
Clopidogrel4310000

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Changes in Platelet Function in Response to Clopidogrel Plus Aspirin

Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation in response to ADP (20 ug/ml) or collagen (5 ug/ml). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline (recorded as a percentage) minus the maximum platelet aggregation value obtained after clopidogrel and aspirin administration (also recorded as percentage). Thus, values recorded below represent a percentage change. (NCT03188705)
Timeframe: Measured at baseline and after 8 days clopidogrel administration plus 1 day of aspirin treatment

Interventionpercentage of max aggregation change (Mean)
Change in the percentage of maximal platelet aggregation in response to 20 ug/ml ADPChange in the percentage of maximal platelet aggregation in response to 5 ug/ml collagen
Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment38.055.8

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Changes in Platelet Function in Response to Clopidogrel

Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation in response to ADP (20 ug/ml) or collagen (5 ug/ml). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline (recorded as a percentage) minus the maximum platelet aggregation value obtained after clopidogrel administration but before aspirin administration (also recorded as percentage). Thus, values recorded below represent a percentage change. (NCT03188705)
Timeframe: Measured at baseline and after 8 days of clopidogrel treatment

Interventionpercentage of maximum aggregation change (Mean)
Change in the percentage of maximal platelet aggregation in response to 20 ug/ml ADPChange in the percentage of maximal platelet aggregation in response to 5 ug/ml collagen
Clopidogrel Alone Followed by Clopidogrel and Aspirin Treatment37.420.4

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PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication

PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication (NCT03190005)
Timeframe: 24 hours

InterventionPRU(Platelet Rreactivity Unit) (Mean)
Group 1148
Group 2289
Group 379
Group 4132
Group 581
Group 662
Group 7114

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Effects of Vorapaxar on Von Willebrand Factor (vWF).

Effects of plasma von Willebrand factor (vWF) at 30 days after treatment with Vorapaxar (NCT03207451)
Timeframe: 30 Days after treatment with Vorapaxar

Interventionactivity % (Mean)
Vorapaxar130
Vorapaxar and Clopidogrel137
Vorapaxar and Aspirin132
Vorapaxar, Aspirin, and Clopidogrel137

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Effects of Vorapaxar on Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS)

Thrombin induced platelet-fibrin clot strength (TIP-FCS) at 30 days after treatment with Vorapaxar as measured by thromboelastography. (NCT03207451)
Timeframe: 30 days after treatment with Vorapaxar

Interventionmm (Mean)
Vorapaxar62.8
Vorapaxar and Clopidogrel61.0
Vorapaxar and Aspirin61.6
Vorapaxar, Aspirin, and Clopidogrel62.2

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Effects of Vorapaxar on 15 μmol/L SFLLRN (PAR-1 Activating Peptide) Induced Platelet Aggregation

15 μmol/L SFLLRN (PAR-1 activating peptide) induced maximum platelet aggregation at 30 days after treatment with Vorapaxar (NCT03207451)
Timeframe: 30 days after treatment with Vorapaxar

InterventionMaximum aggregation (%) (Mean)
Vorapaxar8
Vorapaxar and Clopidogrel5
Vorapaxar and Aspirin5
Vorapaxar, Aspirin, and Clopidogrel4

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ADP-induced Platelet-fibrin Clot Strength (MA)

The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.). (NCT03381742)
Timeframe: up to 5 days

Interventionmm (Median)
Clopidogrel 75mg Qdpo.40.3
Ticagrelor 90mg Bidpo.28.4
Ticagrelor 45mg Bidpo.32.3
Ticagrelor 90mg Qdpo.34.05

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ADP-induced Inhibition of Platelet Aggregation

The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition. (NCT03381742)
Timeframe: up to 5 days

Interventionpercentage of inhibition of platelet agg (Median)
Clopidogrel 75mg Qdpo.54.9
Ticagrelor 90mg Bidpo.80.6
Ticagrelor 45mg Bidpo.73.6
Ticagrelor 90mg Qdpo.66

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Platelet Reactivity Index (PRI)

Platelet reactivity measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP), of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRI% is a marker of platelet reactivity. Higher PRI values correspond to higher aggregation and lower response to antiplatelet therapy. (NCT03437044)
Timeframe: 30 days

InterventionPRI % (Mean)
Ticagrelor25
Clopidogrel65

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P2Y12 Reaction Units (PRU)

The primary endpoint of our study will be platelet reactivity, measured as PRU level using VerifyNow PRU, of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRU is a marker of platelet reactivity. Higher PRU values correspond to higher aggregation and lower response to antiplatelet therapy. (NCT03437044)
Timeframe: 30 days

InterventionPRU (Mean)
Ticagrelor60
Clopidogrel146

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ADP Induced Platelet Aggregation

We will use summary statistics to describe the distribution of the data. Post-treatment ADP-induced WBPA value in ohms (Ω) will be the primary outcome variable. We will use an analysis of covariance (ANCOVA) model to compare the treatment effects of ticagrelor vs. clopidogrel in CKD patients because this approach has higher statistical power than other methods to analyze drug effects. T (NCT03649711)
Timeframe: 2 weeks

Interventionohms (Median)
CKD-Ticagrelor0
CKD-Clopidogrel6
Control-ticagrelor1

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Platelet Surface P-selectin Expression

Platelet surface P-selectin expression was measured using flow cytometry before and after treatment. (NCT03649711)
Timeframe: 2 weeks

InterventionFluorescence intensity (Median)
CKD-Ticagrelor1002.5
CKD-Clopidogrel1037.5
Control-ticagrelor1052

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Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI

Number of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI. (NCT03766581)
Timeframe: At day 90

,,,,,,,
InterventionParticipants (Count of Participants)
>012345>5
Milvexian 100 mg BID352432213
Milvexian 100 mg QD3200100
Milvexian 200 mg BID352362220
Milvexian 25 mg BID493654202
Milvexian 25 mg QD402685100
Milvexian 50 mg BID362651301
Milvexian 50 mg QD3120000
Placebo8257118114

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Number of Participants With Bleeding Based on BARC Types 1-5

Number of participants with bleeding based on Bleeding Academic Research Consortium (BARC) Type 1 to 5. BARC bleeding types: 0=No bleeding. 1=Not actionable bleeding. 2=Overt, actionable sign of hemorrhage requiring nonsurgical, medical intervention by a health-care professional, leading to hospitalization or increased level of care, or prompting evaluation. 3a=Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL. 3b=Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring IV vasoactive agents. 3c=Intracranial hemorrhage; intraocular bleed compromising vision. 4=CABG-related bleeding, perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy to control bleeding, transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period, chest tube output more than or equal to 2L within a 24-hour period. 5a=Probable fatal bleeding. 5b=Definite fatal bleeding. (NCT03766581)
Timeframe: From first dose to up to 107 days after first dose

,,,,,,,
InterventionParticipants (Count of Participants)
Type 1Type 2Type 3AType 3BType 3CType 4Type 5AType 5B
Milvexian 100 mg BID2510230000
Milvexian 100 mg QD21000000
Milvexian 200 mg BID228311000
Milvexian 25 mg BID169110000
Milvexian 25 mg QD267110000
Milvexian 50 mg BID287113000
Milvexian 50 mg QD51000000
Placebo419202000

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Number of Participants With Bleeding Based on ISTH-Defined Criteria

Number of participants with bleeding based on International Society on Thrombosis and Hemostasis (ISTH). ISTH Bleeding Types: 1) Fatal bleeding and/or 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome and/or 3) Bleeding causing a fall in hemoglobin level of ≥2 g/dL, or leading to transfusion of ≥2 units of whole blood or red cells. (NCT03766581)
Timeframe: From first dose to up to 107 days after first dose

,,,,,,,
InterventionParticipants (Count of Participants)
MajorClinically Relevant Non-Major (CRNM)Major or CRNMMinor Bleed
Milvexian 100 mg BID681426
Milvexian 100 mg QD0112
Milvexian 200 mg BID581322
Milvexian 25 mg BID291116
Milvexian 25 mg QD281025
Milvexian 50 mg BID571228
Milvexian 50 mg QD0115
Placebo471143

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Number of Participants With Bleeding Based on PLATO-Defined Criteria

"Number of participants with bleeding based on Platelet Inhibition and Patient Outcomes (PLATO) defined criteria. PLATO bleeding definitions:~Major Life-threatening: Fatal, Intracranial, Intrapericardial with cardiac tamponade, Resulting in hypovolemic shock or severe hypotension that requires pressors or surgery, Clinically overt or apparent bleeding associated with decrease in hemoglobin >5 g/dL, Requiring transfusion of ≥4 U whole blood or packed red blood cells (PRBCs)~Other Major: Significantly disabling (eg, intraocular with permanent vision loss), Associated drop in hemoglobin of 3 to 5 g/dL, Requiring transfusion of 2 to 3 U whole blood or PRBCs~Any Major: Any one of the above criteria~Minor: Bleeding that does not meet criteria for PLATO Major bleeding, and requiring medical intervention" (NCT03766581)
Timeframe: From first dose to up to 107 days after first dose

,,,,,,,
InterventionParticipants (Count of Participants)
MAJOR LIFE-THREATENINGOTHER MAJOR BLEEDINGANY MAJORMINORMINIMAL
Milvexian 100 mg BID325926
Milvexian 100 mg QD00012
Milvexian 200 mg BID235921
Milvexian 25 mg BID112718
Milvexian 25 mg QD112627
Milvexian 50 mg BID415728
Milvexian 50 mg QD00006
Placebo224743

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Number of Participants With Clinically Significant Laboratory Abnormalities - Liver

"The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.~Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)" (NCT03766581)
Timeframe: From first dose to up to approximately 38 months

,,,,,,,
InterventionParticipants (Count of Participants)
ALT > 3x ULNALT > 5x ULNALT > 10x ULNALT > 20x ULNAST > 3x ULNAST > 5x ULNAST > 10x ULNAST > 20x ULNALP > 2x ULNTotal Bilirubin > 1.5x ULNTotal Bilirubin > 2x ULNConcurrent ALT/AST Elevation > 3x ULN with total bilirubin >2x ULN
Milvexian 100 mg BID321132114521
Milvexian 100 mg QD000000000000
Milvexian 200 mg BID321031002210
Milvexian 25 mg BID000011001210
Milvexian 25 mg QD200052005610
Milvexian 50 mg BID200040006720
Milvexian 50 mg QD000011000000
Placebo4110631041030

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Percent of Participants With Ischemic Stroke Events

Secondary analysis of symptomatic ischemic stroke events. Clinical events are included up to day 90. Wald 95% CI within group. Undetermined stroke is included. (NCT03766581)
Timeframe: From randomization to up to 90 days after randomization

,,,,,,,
InterventionPercentage of participants (Number)
Ischemic strokeUndetermined stroke
Milvexian 100 mg BID3.50
Milvexian 100 mg QD5.60
Milvexian 200 mg BID7.70
Milvexian 25 mg BID3.80
Milvexian 25 mg QD4.60
Milvexian 50 mg BID4.00
Milvexian 50 mg QD13.60
Placebo5.50

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Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death

Composite of percent of participants of new ischemic stroke, (Myocardial Infarction) MI and all cause death. (NCT03766581)
Timeframe: From randomization to up to 90 days after randomization

InterventionPercentage of participants (Number)
Placebo6.1
Milvexian 25 mg QD5.2
Milvexian 25 mg BID4.7
Milvexian 50 mg BID4.9
Milvexian 100 mg BID5.2
Milvexian 200 mg BID9.4
Milvexian 50 mg QD18.2
Milvexian 100 mg QD5.6

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Number of participants with clinically significant ECG abnormalities. (NCT03766581)
Timeframe: From first dose to up to 90 days after first dose

InterventionParticipants (Count of Participants)
Placebo0
Milvexian 25 mg QD0
Milvexian 25 mg BID0
Milvexian 50 mg BID0
Milvexian 100 mg BID0
Milvexian 200 mg BID0
Milvexian 50 mg QD0
Milvexian 100 mg QD0

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Pharmacokinetic Parameter - Estimated Clearance (CL)

Pharmacokinetic Parameter - Estimated Clearance (CL). CL is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90. (NCT03766581)
Timeframe: From first dose to up to 90 days after first dose

InterventionL/h (Geometric Mean)
Milvexian 25 mg QD8.15
Milvexian 25 mg BID8.01
Milvexian 50 mg BID7.54
Milvexian 100 mg BID7.08
Milvexian 200 mg BID7.43

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Pharmacokinetic Parameter - Volume of the Central Compartment (VC)

Pharmacokinetic Parameter - Volume of the Central Compartment (VC). VC is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90. (NCT03766581)
Timeframe: From first dose to up to 90 days after first dose

InterventionL (Geometric Mean)
Milvexian 25 mg QD34.9
Milvexian 25 mg BID31.4
Milvexian 50 mg BID30.9
Milvexian 100 mg BID28.9
Milvexian 200 mg BID31.6

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Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI

Total volume of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI. (NCT03766581)
Timeframe: At day 90

InterventionmL (Mean)
Placebo2.3492
Milvexian 25 mg QD0.8976
Milvexian 25 mg BID2.9902
Milvexian 50 mg BID1.2682
Milvexian 100 mg BID1.4727
Milvexian 200 mg BID1.2711
Milvexian 50 mg QD8.8960
Milvexian 100 mg QD1.4503

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Digit Symbol Substitution Test (DSST)

The Descriptive Summary of the Digit Symbol Substitution Test (DSST) is a scale item, with a lowest score of 0 and highest total score of 135. Higher score indicates better cognitive functioning. (NCT03766581)
Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

,,,,,,,
InterventionScore on a scale (Mean)
BaselineDay 21Day 90First recurrent stroke
Milvexian 100 mg BID33.741.245.523.0
Milvexian 100 mg QD29.237.140.747.0
Milvexian 200 mg BID31.739.141.427.5
Milvexian 25 mg BID32.940.241.342.0
Milvexian 25 mg QD31.238.941.728.0
Milvexian 50 mg BID37.245.145.240.5
Milvexian 50 mg QD47.154.647.59.0
Placebo34.941.242.836.3

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Modified Rankin Scale (mRS)

"The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 6.~0 = No symptoms at all~= No significant disability despite symptoms; able to carry out all usual duties and activities~= Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~= Moderate disability; requiring some help, but able to walk without assistance~= Moderately severe disability; unable to walk and attend to bodily needs without assistance~= Severe disability; bedridden, incontinent and requiring constant nursing care and attention~= Dead" (NCT03766581)
Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

,,,,,,,
InterventionScore on a scale (Mean)
BaselineDay 21Day 90First recurrent stroke
Milvexian 100 mg BID0.51.00.72.9
Milvexian 100 mg QD0.71.31.01.0
Milvexian 200 mg BID0.60.90.81.8
Milvexian 25 mg BID0.60.90.82.6
Milvexian 25 mg QD0.61.00.82.7
Milvexian 50 mg BID0.50.90.72.3
Milvexian 50 mg QD0.20.90.62.0
Placebo0.51.00.73.0

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Number of Participants With Adverse Events (AEs)

AE: include all non-serious adverse events with onset on or after first dose date and within 2 days after the last dose of study treatment. (NCT03766581)
Timeframe: From first dose to 2 days after last dose of study therapy (up to approximately 107 days)

InterventionParticipants (Count of Participants)
Placebo399
Milvexian 25 mg QD190
Milvexian 25 mg BID186
Milvexian 50 mg BID192
Milvexian 100 mg BID193
Milvexian 200 mg BID211
Milvexian 50 mg QD11
Milvexian 100 mg QD13

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Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90

Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples). (NCT03766581)
Timeframe: From randomization to up to 90 days after randomization

InterventionPercentage of participants (Number)
Placebo16.8
Milvexian 25 mg QD16.7
Milvexian 25 mg BID16.6
Milvexian 50 mg BID15.6
Milvexian 100 mg BID15.4
Milvexian 200 mg BID15.3

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Percent of Participants With Major Bleeding According to BARC Type 3 and 5

"Percent of participants with major bleeding based on the Bleeding Academic Research Consortium (BARC) Types 3 and 5 definitions. BARC bleeding types:~3a = Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL transfusion with overt bleeding 3b = Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3c = Intracranial hemorrhage, 5a = Probable fatal bleeding 5b = Definite fatal bleeding" (NCT03766581)
Timeframe: From first dose to up to 107 days after first dose

InterventionPercentage of participants (Number)
Placebo0.6
Milvexian 25 mg QD0.6
Milvexian 25 mg BID0.6
Milvexian 50 mg BID1.5
Milvexian 100 mg BID1.6
Milvexian 200 mg BID1.5
Milvexian 50 mg QD0
Milvexian 100 mg QD0

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National Institutes of Health Stroke Scale (NIHSS)

The NIHSS is an 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke participant is. (NCT03766581)
Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

,,,,,,,
InterventionScore on a scale (Mean)
BaselineDay 21Day 90First recurrent stroke
Milvexian 100 mg BID1.80.80.67.1
Milvexian 100 mg QD2.00.90.61.0
Milvexian 200 mg BID1.60.90.64.4
Milvexian 25 mg BID1.60.80.65.4
Milvexian 25 mg QD1.70.80.64.6
Milvexian 50 mg BID1.60.80.64.6
Milvexian 50 mg QD1.10.80.35.3
Placebo1.60.90.56.2

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Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90

Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90. (NCT03766581)
Timeframe: From randomization to up to 90 days after randomization

InterventionPercentage of participants (Number)
Placebo16.6
Milvexian 25 mg QD16.2
Milvexian 25 mg BID18.5
Milvexian 50 mg BID14.1
Milvexian 100 mg BID14.8
Milvexian 200 mg BID16.4
Milvexian 50 mg QD19.0
Milvexian 100 mg QD18.8

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Percent Change From Baseline in Factor XI Clotting Activity

Percent change from baseline in factor XI clotting activity via exposure response. (NCT03766581)
Timeframe: Baseline and day 90

InterventionPercent change (Mean)
Placebo4.48
Milvexian 25 mg QD-8.88
Milvexian 25 mg BID-17.67
Milvexian 50 mg BID-37.20
Milvexian 100 mg BID-61.52
Milvexian 200 mg BID-70.25
Milvexian 50 mg QD3.86
Milvexian 100 mg QD-44.27

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Percent Change From Baseline in aPTT Activity

Percent change from baseline in activated partial thromboplastin time (aPTT) activity via exposure response. (NCT03766581)
Timeframe: Baseline and day 90

InterventionPercent change (Mean)
Placebo2.47
Milvexian 25 mg QD38.72
Milvexian 25 mg BID58.30
Milvexian 50 mg BID97.32
Milvexian 100 mg BID140.76
Milvexian 200 mg BID193.64
Milvexian 50 mg QD48.48
Milvexian 100 mg QD118.06

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Number of Participants With Clinically Significant Vital Sign Abnormalities

Number of participants with clinically significant vital sign abnormalities. Vital signs included heart rate and diastolic and systolic blood pressure. (NCT03766581)
Timeframe: From first dose to up to 90 days after first dose

InterventionParticipants (Count of Participants)
Placebo0
Milvexian 25 mg QD0
Milvexian 25 mg BID0
Milvexian 50 mg BID0
Milvexian 100 mg BID0
Milvexian 200 mg BID0
Milvexian 50 mg QD0
Milvexian 100 mg QD0

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Number of Participants With Clinically Significant Physical Examination Abnormalities

Number of participants with clinically significant physical examination abnormalities. (NCT03766581)
Timeframe: From first dose to up to 90 days after first dose

InterventionParticipants (Count of Participants)
Placebo0
Milvexian 25 mg QD0
Milvexian 25 mg BID0
Milvexian 50 mg BID0
Milvexian 100 mg BID0
Milvexian 200 mg BID0
Milvexian 50 mg QD0
Milvexian 100 mg QD0

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Montreal Cognitive Assessment (MoCA)

"The Montreal Cognitive Assessment (MoCA) is a survey with a summed score. MoCA score ranges between a lowest score of 0 to a highest score of 30. A score of:~≥26 points: indicates normal cognitive function~18-25 points: Mild cognitive impairment~10-17 points: Moderate cognitive impairment~fewer than 10 points: Severe cognitive impairment" (NCT03766581)
Timeframe: At baseline, on Days 21 and 90, and at the time of a new stroke event

,,,,,,,
InterventionScore on a scale (Mean)
BaselineDay 21Day 90First recurrent stroke
Milvexian 100 mg BID22.423.624.53.0
Milvexian 100 mg QD22.024.126.422.0
Milvexian 200 mg BID22.124.024.223.1
Milvexian 25 mg BID22.024.024.225.3
Milvexian 25 mg QD21.623.924.017.3
Milvexian 50 mg BID22.524.324.419.0
Milvexian 50 mg QD24.426.425.011.0
Placebo22.324.024.623.2

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Clopidogrel Active Metabolite Concentration

Comparison of clopidogrel active metabolite plasma concentrations by means of AUC (NCT03774394)
Timeframe: 6 hours

Interventionng*h/mL (Median)
Diabetes Mellitus Patients With Chronic Kidney Disease47.1
Diabetes Mellitus Patients Without Chronic Kidney Disease39.6

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P2Y12 Reaction Units (PRU) Assessed by VerifyNow. The Cutoff for High Platelet Reactivity is >208.

Comparison of platelet reactivity measured as PRU assessed by VerifyNow after a 600 mg clopidogrel LD between DM patients with and without CKD (NCT03774394)
Timeframe: 6 hours

InterventionPRU (Mean)
Diabetes Mellitus Patients With Chronic Kidney Disease164
Diabetes Mellitus Patients Without Chronic Kidney Disease156

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Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%

Comparison of of platelet reactivity measured as PRI assessed by VASP after incubation with clopidogrel active metabolite between DM patients with and without CKD (NCT03774394)
Timeframe: Baseline

InterventionPRI% (Mean)
Diabetes Mellitus Patients With Chronic Kidney Disease92.7
Diabetes Mellitus Patients Without Chronic Kidney Disease94.4

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Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%

Comparison of platelet reactivity measured as PRI assessed by VASP after a 600 mg clopidogrel LD between DM patients with and without CKD (NCT03774394)
Timeframe: 6 hours

InterventionPRI% (Mean)
Diabetes Mellitus Patients With Chronic Kidney Disease67.5
Diabetes Mellitus Patients Without Chronic Kidney Disease67.2

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Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen (NCT04006288)
Timeframe: 30 days

Interventionpercentage of MPA (Median)
Aspirin and Clopidogrel27
Aspirin and Rivaroxaban From Aspirin and Clopidogrel53
Aspirin and Prasugrel20
Aspirin and Rivaroxaban From Aspirin and Prasugrel4
Aspirin and Ticagrelor15
Aspirin and Rivaroxaban From Aspirin and Ticagrelor20

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