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bivalirudin

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Description

bivalirudin: designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

bivalirudin : A synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant. [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 CID16129704
CHEMBL ID2103749
CHEBI ID59173
SCHEMBL ID25739
MeSH IDM0201405

Synonyms (46)

Synonym
CHEBI:59173 ,
bivalirudinum
bivalirudina
bivalirudine
128270-60-0
bivalirudin
DB00006
d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-l-leucine
bg-8967
hirulog
angiomax
l-leucine, d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-alpha-aspartyl-l-phenylalanyl-l-alpha-glutamyl-l-alpha-glutamyl-l-isoleucyl-l-prolyl-l-alpha-glutamyl-l-alpha-glutamyl-l-tyrosyl-
phe-pro-arg-pro-(gly)4-asn-gly-asp-phe-glu-glu-ile-pro-glu-glu-tyr-leu
phe-pro-arg-pro-(gly)4-desulfohirudin-(53-64)
hirulog-1
phe-pro-arg-pro-(gly)4 desulfato-tyr63'-hirugen
bg8967
bdbm50248103
bg 8967
bivalirudin trifluoroacetate
angiomax rtu
CHEMBL2103749
AKOS015994644
bivalirudin;0.9% sodium chloride
bivalirudin [usan:inn:ban]
angiox
tn9bex005g ,
unii-tn9bex005g
gtpl6470
SCHEMBL25739
HS-2004 ,
1191386-55-6
J-005587
Q4919218
EX-A5843
mfcd08692016
bivalirudin trifluoroacetate (h-dl-phe-dl-pro-dl-arg-dl-pro-gly-gly-gly-gly-dl-asn-gly-dl-asp-dl-phe-dl-glu-dl-glu-xiile-dl-pro-dl-glu-dl-glu-dl-tyr-dl-leu-oh.tfa)
DTXSID00155847 ,
bivalirudin tfa
dtxcid4078338
b01ae06
bivalirudin in 0.9% sodium chloride
bivalirudin (mart.)
bivalirudinrtu
bivalirudin (usp-rs)
AC-8916

Research Excerpts

Overview

Bivalirudin is an alternative to heparin anticoagulation in infants and children in the setting of extracorporeal life support (ECLS) It is a direct thrombin inhibitor and is inherently not dependent on AT III. BivalirUDin is a well-tolerant antICOagulant in Chinese STEMI patients undergoing PCI procedure.

ExcerptReferenceRelevance
"Bivalirudin is a safe and efficacious alternative to UFH in patients requiring VA ECMO for cardiogenic shock."( Bivalirudin Versus Unfractionated Heparin in Patients With Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation.
D'Aloiso, B; Esper, SA; Gomez, H; Kaczorowski, DJ; Murray, H; Ramanan, R; Rivosecchi, RM; Sanchez, PG; Sappington, PL; Sciortino, C; Uricchio, MN, 2023
)
3.07
"Bivalirudin is a promising alternative anticoagulant for pediatric ECMO patients who have failed UFH. "( Bivalirudin in pediatric extracorporeal membrane oxygenation.
McMichael, ABV; Ryerson, LM, 2022
)
3.61
"Bivalirudin is a direct thrombin inhibitor that is being increasingly used for anticoagulation in children after ventricular assist device (VAD) implantation. "( Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective Cohort Study.
Adachi, I; Choudhry, S; Denfield, SW; Dreyer, WJ; Hensch, LA; Hui, SK; Humlicek, TJ; Loh, J; Price, JF; Puri, K; Razavi, A; Spinner, JA; Teruya, J; Tume, SC; Tunuguntla, HP, 2022
)
3.61
"Bivalirudin is a well-tolerant anticoagulant in Chinese STEMI patients undergoing PCI procedure."( Comprehensive safety profile evaluation of bivalirudin in Chinese ST-segment elevation myocardial infarction patients receiving percutaneous coronary intervention: a prospective, multicenter, intensive monitoring study.
Chen, A; Deng, J; Li, Q; Liu, Y; Su, G; Wang, Z; Zhao, Y; Zheng, H, 2022
)
2.43
"Bivalirudin is a synthetic analogue of hirudin found in the saliva of the medicinal leech and has a relatively short half-life of ~25 min."( Assays to Monitor Bivalirudin.
Davidson, S, 2023
)
1.97
"Bivalirudin is a reversible direct thrombin inhibitor that can be used instead of heparin."( Bivalirudin for cardiopulmonary bypass in a patient with heparin allergy.
Beyazal, OF; Boysan, E; Circi, R; Şener, E, 2023
)
3.07
"Bivalirudin is an alternative to heparin anticoagulation in infants and children in the setting of extracorporeal life support (ECLS). "( Monitoring bivalirudin therapy in children on extracorporeal circulatory support devices: Thromboelastometry versus routine coagulation testing.
Adachi, I; Bruzdoski, K; Hensch, L; Hui, SR; Kostousov, V; Teruya, J, 2020
)
2.39
"Bivalirudin is a direct thrombin inhibitor and is inherently not dependent on AT III."( Heparin vs bivalirudin anticoagulation for extracorporeal membrane oxygenation.
Guru, P; Kaseer, H; Moss, J; Pham, S; Ratzlaff, R; Sanghavi, D; Soto-Arenall, M, 2020
)
1.67
"Bivalirudin is a reversible direct thrombin inhibitor that inhibits both bound and free thrombin and binds to the active (catalytic) and fibrinogen-binding sites of thrombin, with high affinity and specificity. "( Age-specific differences in the in vitro anticoagulant effect of Bivalirudin in healthy neonates and children compared to adults.
Busuttil-Crellin, X; Cowley, J; Ignjatovic, V; Letunica, N; Monagle, P, 2020
)
2.24
"Bivalirudin appears to be a viable option for systemic anticoagulation in pediatric extracorporeal membrane oxygenation patients who have failed unfractionated heparin, but questions remain namely its optimal monitoring strategy. "( Prospective Exploratory Experience With Bivalirudin Anticoagulation in Pediatric Extracorporeal Membrane Oxygenation.
Balutis, KR; Bauman, ME; Granoski, DA; Lequier, LL; Massicotte, MP; Nelson, LR; Ryerson, LM, 2020
)
2.27
"Bivalirudin is a reasonable choice during transradial PCI for acute MI when bleeding risk is high and clopidogrel or cangrelor is used Heparin is reasonable during transradial PCI when bleeding risk is low and high-intensity antiplatelet therapy is used Future studies are required to define the utility of post-PCI bivalirudin infusions."( Bivalirudin or heparin for radial access?
Bittl, JA, 2017
)
3.34
"Bivalirudin is a specific and reversible direct thrombin inhibitor (DTI)."( A Case of Diffuse Alveolar Hemorrhage as a Possible Complication of Bivalirudin Therapy.
Aung, S; Aung, TT; Kyaw, K; Latt, H; Roongsritong, C, 2017
)
1.41
"Bivalirudin is a safe and feasible adjunct therapy for treatment of flap congestion. "( Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps.
Boahene, K; Byrne, PJ; Harun, A; Kruer, RM; Lee, A; Richmon, JD, 2018
)
2.18
"Bivalirudin appears to be a potential option for adult patients on ECLS who are unable to receive or fail heparin therapy; however, the wide variation in dosing suggests the need for careful management."( Bivalirudin Dosing Requirements in Adult Patients on Extracorporeal Life Support With or Without Continuous Renal Replacement Therapy.
Dager, WE; Louie, EL; Roberts, AJ; Walker, EA, 2019
)
2.68
"Bivalirudin is a safe and effective anticoagulant for pediatric OHS. "( Randomized Controlled Trial of Heparin Versus Bivalirudin Anticoagulation in Acyanotic Children Undergoing Open Heart Surgery.
Chauhan, S; Chowdhury, UK; Hasija, S; Krishna, NS; Makhija, N; Malhotra, P; Sharma, G; Talwar, S, 2018
)
2.18
"Bivalirudin is a direct thrombin inhibitor that is used as a procedural anticoagulant during percutaneous coronary interventions and cardiac surgery for patients with heparin-resistant thrombosis or heparin-induced thrombocytopenia. "( Titration of Bivalirudin Infusion in the Pediatric Cardiac Catheterization Laboratory: A Case Report.
DiNardo, J; Streiff, A; Zaleski, K, 2019
)
2.33
"Bivalirudin is a direct thrombin inhibitor that can be used as an alternative anticoagulant in neonates and infants demonstrating inaccurate heparin monitoring."( Bivalirudin Anticoagulation for an Infant with Hyperbilirubinemia and Elevated Plasma-Free Hemoglobin on ECMO.
Ezetendu, C; Hamzah, M; Jarden, A; Stewart, R, 2019
)
2.68
"Bivalirudin is a synthetic anticoagulant drug sometimes employed as a substitute for heparin, a commonly used anticoagulant that can cause a condition called heparin-induced thrombocytopenia (HIT)."( Selection of an aptamer antidote to the anticoagulant drug bivalirudin.
Dennis, DM; Gravenstein, N; Kim, Y; Martin, JA; Morey, TE; Parekh, P; Sefah, K; Tan, W, 2013
)
1.35
"Bivalirudin is an ultrashort acting direct thrombin inhibitor, which has been used in place of heparin in selected settings. "( Bivalirudin as a bridge for anticoagulation in high risk neurosurgical patients with active DVT or high risk of thrombosis.
Babbini, V; Janjua, T; Lowary, J; Nussbaum, E, 2013
)
3.28
"Bivalirudin is a direct thrombin inhibitor that is increasingly used in patients undergoing mechanical circulatory support as it presents many advantages compared with unfractionated heparin. "( Primary anticoagulation with bivalirudin for patients with implantable ventricular assist devices.
Agracheva, N; De Bonis, M; Di Prima, AL; Isella, F; Nisi, T; Pappalardo, F; Pieri, M; Zangrillo, A, 2014
)
2.14
"Bivalirudin (BVR) is a direct thrombin inhibitor used as an adjunctive antithrombotic agent in combination with aspirin and an ADP-receptor blocker in patients with acute coronary syndrome undergoing percutaneous coronary intervention. "( The clinical and economic impact of bivalirudin for percutaneous coronary intervention.
Gershlick, AH; Malik, N, 2013
)
2.11
"Bivalirudin is a direct thrombin inhibitor that also inhibits platelet adhesion."( Bivalirudin for treatment of LVAD thrombosis: a case series.
DeNofrio, D; Kiernan, M; Ordway, L; Pham, DT; Sylvia, LM,
)
2.3
"Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention (PCI). "( Bivalirudin versus heparin in patients planned for percutaneous coronary intervention: a meta-analysis of randomised controlled trials.
Cavender, MA; Sabatine, MS, 2014
)
3.29
"Bivalirudin is a direct thrombin inhibitor used in the cardiac intensive care unit when heparin is contraindicated due to heparin-induced thrombocytopenia. "( Adaptive control of bivalirudin in the cardiac intensive care unit.
Edrich, T; Paschalidis, IC; Zhao, Q, 2015
)
2.18
"Bivalirudin is an accepted alternative to heparin for anticoagulation during select cardiac procedures. "( Bivalirudin and transcatheter aortic valve replacement: a cautionary tale.
Greason, KL; Mathew, V; Sangani, NK; Suri, RM; Torres, NE, 2014
)
3.29
"Bivalirudin is a valuable anticoagulant option in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention. "( Bivalirudin for acute coronary syndromes: premises, promises and doubts.
Capodanno, D; De Caterina, R, 2015
)
3.3
"Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. "( Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention.
Barria Perez, AE; Bertrand, OF; Costerousse, O; Jolly, SJ; Pancholy, SB; Plourde, G; Poirier, Y; Rao, SV; Rimac, G, 2016
)
2.17
"Bivalirudin proved to be a safe and effective anticoagulant during percutaneous coronary intervention."( Effectiveness and Safety of Bivalirudin During Percutaneous Coronary Intervention in Acute Coronary Syndrome in the Real World: CARTAGOMAX Study.
Abellán-Huerta, J; Bonilla-Pacheco, YI; Cascón-Pérez, JD; Castillo-Moreno, JA; Dau-Villareal, DF; Giner-Caro, JA; Jaulent-Huertas, L; Mármol-Lozano, R; Picó-Aracil, F; Ruiz-Abellón, Mdel C, 2016
)
1.45
"Bivalirudin is a 20-amino acid synthetic polypeptide that directly inhibits both fibrin-bound and soluble thrombin. "( Bivalirudin: in patients with acute coronary syndromes : planned for urgent or early intervention.
Curran, MP; Deeks, ED, 2008
)
3.23
"Bivalirudin is a safe and feasible alternative to unfractionated heparin in patients undergoing EVAR."( Clinical experience with the use of bivalirudin in a large population undergoing endovascular abdominal aortic aneurysm repair.
Baum, SZ; Diehm, N; Katzen, BT; Stamler, S; Tsoukas, AI, 2009
)
2.07
"Bivalirudin seems to be an attractive antithrombotic agent in patients with acute coronary syndrome undergoing early invasive management."( Pharmacotherapy of acute coronary syndrome: the ACUITY trial.
Eagle, KA; Mukherjee, D, 2009
)
1.07
"Bivalirudin is an attractive antithrombotic choice in patients undergoing primary PCI."( HORIZONS trial: a step forward for primary percutaneous coronary intervention.
White, HD, 2009
)
1.07
"Bivalirudin is a direct thrombin inhibitor with several pharmacological advantages over heparin. "( Pharmacological and clinical profile of bivalirudin in the treatment of patients with acute coronary syndrome.
White, HD, 2009
)
2.06
"Bivalirudin is a direct thrombin inhibitor that seems to be a promising anticoagulation treatment in patient with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). "( Bivalirudin during percutaneous coronary interventions in patients with ST segment elevation myocardial infarction.
Albertsson, P; Koutouzis, M, 2010
)
3.25
"Bivalirudin is a synthetic 20 amino acid polypeptide that directly inhibits both fibrin-bound and soluble thrombin. "( Bivalirudin: in patients with ST-segment elevation myocardial infarction.
Curran, MP, 2010
)
3.25
"Bivalirudin is a safe and effective anticoagulant for lower extremity bypass operations. "( A pilot, prospective evaluation of a direct thrombin inhibitor, bivalirudin (Angiomax), in patients undergoing lower extremity bypass.
Bena, JF; Bishop, PD; Kashyap, VS; Ouriel, K; Rosa, K; Sarac, TP, 2010
)
2.04
"Bivalirudin (Angiomax) is a direct thrombin inhibitor used in interventional cardiology due to its several distinct advantages over heparin, most notably a shorter half-life and a potentially superior safety profile. "( Safety and tolerability of high-intensity anticoagulation with bivalirudin during neuroendovascular procedures.
Georgiadis, AL; Hassan, AE; Memon, MZ; Qureshi, AI; Suri, MF; Vazquez, G, 2011
)
2.05
"Bivalirudin is a therapeutic option for anticoagulation during left-sided catheter RFA procedures in patients with a history of HIT."( Bivalirudin use during radiofrequency catheter ablation procedures in two patients with a history of heparin-induced thrombocytopenia.
Baetz, BE; Gerstenfeld, EP; Kolansky, DM; Spinler, SA, 2010
)
2.52
"Bivalirudin is a reasonable choice of treatment in the prehospital setting for patients with STEMI."( Prehospital treatment of patients with acute myocardial infarction with bivalirudin.
Brunner, W; Erhart, F; Gattermeier, M; Hirschl, MM; Mayr, H; Pfeffel, F; Steger, F, 2012
)
1.33
"Bivalirudin is a DTI indicated for use in PCI."( Looking back into the future: desirudin in acute coronary syndromes and coronary stenting.
Serruys, P; Valgimigli, M; Vranckx, P, 2011
)
1.09
"Bivalirudin is a direct thrombin inhibitor with several pharmacological advantages over UFH and is currently endorsed by practice guidelines, particularly in patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI)."( Safety of bivalirudin in patients with coronary artery disease.
Abdel-Wahab, M; Richardt, G, 2012
)
1.49
"Bivalirudin is a direct thrombin inhibitor with a short half-life and linear pharmacokinetics, which results in predictable serum concentrations and anticoagulant effect."( Outcome of the HORIZONS-AMI trial: bivalirudin enhances long-term survival in patients with ST-elevation myocardial infarction undergoing angioplasty.
Feldman, DN; Shah, A, 2012
)
1.38
"Bivalirudin is a direct thrombin inhibitor that is increasingly used in percutaneous coronary intervention (PCI) and has been previously shown to lack inherent platelet activation. "( Dichotomous effects of exposure to bivalirudin in patients undergoing percutaneous coronary intervention on protease-activated receptor-mediated platelet activation.
Blakemore, D; Chen, Q; Cleator, JH; Colowick, NE; Hamm, HE; Holinstat, M; Hudson, WJ, 2013
)
2.11
"Bivalirudin is a direct thrombin inhibitor that has been approved for use in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention. "( [Optimal dose of bivalirudin in dialysis patients at high risk of heparin-induced thrombocytopenia undergoing percutaneous coronary intervention: case report].
Ardissino, D; Boffetti, F; Bontardelli, F; Coppini, L; Notarangelo, MF; Vignali, L, 2013
)
2.17
"Bivalirudin is a direct thrombin inhibitor that recently was approved as an alternative to heparin in patients undergoing PTCA."( Bivalirudin: a direct thrombin inhibitor for percutaneous transluminal coronary angioplasty.
Spinler, S; Stringer, KA; Wiggins, BS; Wittkowsky, AK, 2002
)
2.48
"Bivalirudin is a small peptide consisting of 20 amino acid residues that binds thrombin in a direct, reversible, and bivalent fashion."( Bivalirudin, a bivalent, thrombin specific anticoagulant as an alternative to heparin in interventional procedures as an alternative to heparin in interventional procedures.
Chew, DP, 2002
)
2.48
"Bivalirudin is a practical alternative to heparin during cardiac surgical procedures."( Favorable outcome with bivalirudin anticoagulation during cardiopulmonary bypass.
Anderson, R; Davis, Z; Garber, D; Short, D; Valgiusti, A, 2003
)
1.35
"Bivalirudin is a new, direct thrombin inhibitor. "( An assessment of different filter systems for extracorporeal elimination of bivalirudin: an in vitro study.
Chew, D; Grauhan, O; Gründel, M; Hausmann, H; Koster, A; Kuppe, H; Spiess, BD, 2003
)
1.99
"Bivalirudin is a safe and feasible alternative anticoagulant in renal and iliac PPI and may offer decreased sheath removal time, time to ambulation and LOS. "( Bivalirudin as a foundation anticoagulant in peripheral vascular disease: a safe and feasible alternative for renal and iliac interventions.
Allie, AA; Allie, DE; Chaisson, G; Ellis, SD; Fail, PS; Hebert, CJ; Keller, VA; Khan, MA; Khan, MH; Lirtzman, MD; Mitran, E; Stagg, S; Walker, CM; Wyatt, CH, 2003
)
3.2
"Bivalirudin is a synthetic antithrombin sharing a sequence of 11 amino acids with the recombinant hirudin lepirudin. "( Antibodies against lepirudin are polyspecific and recognize epitopes on bivalirudin.
Eichler, P; Greinacher, A; Lubenow, N; Strobel, U, 2004
)
2
"Bivalirudin is a direct thrombin inhibitor approved for use in PCI."( Bivalirudin in percutaneous coronary intervention.
Caron, MF; McKendall, GR, 2003
)
2.48
"Bivalirudin is a direct thrombin inhibitor that has been demonstrated in the cardiology literature to have a more favorable efficacy and bleeding profile than other antithrombotic medications."( Bivalirudin for endovascular intervention in acute ischemic stroke: case report.
Bendok, BR; Harrigan, MR; Hopkins, LN; Levy, EI, 2004
)
2.49
"Bivalirudin is a short-acting direct thrombin inhibitor, with advantages over unfractionated heparin for anticoagulation in cardiac surgery. "( Bivalirudin versus heparin and protamine in off-pump coronary artery bypass surgery.
Frampton, CM; McDougall, JM; Merry, AF; Middleton, NG; Mills, BP; Nand, P; Raudkivi, PJ; Webber, BJ; White, HD, 2004
)
3.21
"Bivalirudin (Angiomax) is a thrombin-inhibiting oligopeptide that was developed via rational drug design as a hirudin analogue ('hirulog'). "( Bivalirudin: a review.
Koster, A; Warkentin, TE, 2005
)
3.21
"Bivalirudin is a safe alternative to unfractionated heparin as the anticoagulation agent in peripheral interventions. "( Bivalirudin as an anticoagulation agent: safety and efficacy in peripheral interventions.
Ardid, MI; Benenati, JF; Katzen, BT; Kovacs, MF; MacLean, AA; Powell, A; Samuels, S; Zemel, G, 2005
)
3.21
"Bivalirudin is shown to be a competent substitute for heparin in percutaneous coronary intervention (PCI). "( Brachytherapy and bivalirudin evaluation study.
Canos, D; Cheneau, E; Kent, KM; Kuchulakanti, P; Pichard, AD; Pinnow, EE; Rha, SW; Satler, LF; Torguson, R; Waksman, R; Wolfram, R, 2005
)
2.1
"Bivalirudin is a DTI, which can be used as an alternative anticoagulant for CPB in HIT positive patients. "( Bivalirudin anticoagulation for cardiopulmonary bypass in a patient with heparin-induced thrombocytopenia.
Borger, MA; Harwood, S; Vegas, A; Wasowicz, M, 2005
)
3.21
"Bivalirudin is a direct thrombin inhibitor proven to decrease post-PCI ischemic complication rate compared with UFH and have a lower vascular complication rate compared with glycoprotein IIb/IIIa receptor antagonists."( Intracoronary macrothrombus formation during percutaneous coronary intervention despite optimal activated clotting time using bivalirudin--a case report.
Bachour, F; Broder, K; Tadros, GM,
)
1.06
"Bivalirudin is a short-acting direct thrombin inhibitor that has been used in cardiac surgical patients with heparin-induced thrombocytopenia (HIT) or suspected HIT. "( Use of bivalirudin as an anticoagulant during cardiopulmonary bypass.
Dyke, CM; McCarthy, HM; Palmer, G; Veale, JJ, 2005
)
2.23
"Bivalirudin is a safe and effective anticoagulant for patients undergoing a wide range of cardiac surgical procedures with cardiopulmonary bypass. "( A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: the EVOLUTION-ON study.
Aronson, S; Dyke, CM; Kirshner, R; Koster, A; Lincoff, AM; McCarthy, HL; Smedira, NG; Spiess, BD, 2006
)
2.12
"Bivalirudin is a short-acting direct thrombin inhibitor that has been used successfully in routine cardiac surgical cases."( Cardiopulmonary bypass for complex cardiac surgery using bivalirudin anticoagulation in a patient with heparin antibodies.
Boettcher, W; Buz, S; Dyke, CM; Hetzer, R; Huebler, M; Koster, A; Kuppe, H,
)
1.1
"Bivalirudin is a direct thrombin inhibitor that has biological and pharmacokinetic advantages over heparin, e.g., by inhibiting both fibrin-bound and -unbound thrombin. "( [Bivalirudin: a direct thrombin inhibitor in percutaneous coronary interventions].
Hansen, PR, 2006
)
2.69
"Bivalirudin is a member of the direct thrombin inhibitor group of anticoagulants. "( Bivalirudin in percutaneous coronary intervention.
Chew, DP; Lehman, SJ, 2006
)
3.22
"Bivalirudin is a bivalent reversible direct thrombin inhibitor, with a half-life of 25 min, eliminated mostly by proteolytic cleavage."( Successful use of bivalirudin for cardiopulmonary bypass in a patient with heparin allergy.
Crescenzi, G; Franco, A; Koster, A; Pappalardo, F; Poli, A; Zangrillo, A, 2007
)
1.39
"Bivalirudin is a safe and effective anticoagulant that may be routinely used as an alternative to heparin and protamine in patients undergoing OPCAB."( Routine use of the direct thrombin inhibitor bivalirudin for off-pump coronary artery bypass grafting is safe and effective.
Dyke, CM; Ebra, G; Koster, A; Palmer, GJ; Sankaran, IS; Sparkman, GM, 2008
)
1.33
"Bivalirudin is a direct thrombin inhibitor which has been found to have similar efficacy with less bleeding compared with heparin plus glycoprotein IIb/IIIa inhibitors when used with elective PCI and with PCI for unstable angina and non-ST elevation myocardial infarction."( What anti-thrombotic therapy is best with primary PCI for acute ST elevation myocardial infarction: how should the HORIZONS trial change current practice?
Brodie, BR, 2008
)
1.07
"Bivalirudin is a direct thrombin inhibitor with an efficacy comparable to that of heparin, a short half-life, and reduced bleeding complications in adults."( Successful use of bivalirudin for superior vena cava recanalization and stent placement in a child with heparin-induced thrombocytopenia.
Breinholt, JP; Ing, FF; Moffett, BS; Texter, KM, 2008
)
1.4
"Bivalirudin is a direct thrombin inhibitor (DTI) frequently used for anticoagulation in the setting of invasive cardiology, particularly percutaneous coronary intervention (PCI). "( Bivalirudin.
Greinacher, A; Koster, A; Warkentin, TE, 2008
)
3.23
"Bivalirudin (Hirulog) is a direct thrombin inhibitor that can be safely substituted for heparin during angioplasty."( Bivalirudin compared with heparin during coronary angioplasty for thrombus-containing lesions.
Ahmed, WH; Bittl, JA; Ganz, P; Shah, PB, 1997
)
2.46
"Bivalirudin is a new anticoagulant treatment option in patients with acute myocardial infarction treated with streptokinase."( Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial.
White, H, 2001
)
1.3
"Bivalirudin is a synthetic polypeptide that directly inhibits thrombin by binding simultaneously to its active catalytic site and its substrate recognition site. "( Bivalirudin: a direct thrombin inhibitor.
Gladwell, TD, 2002
)
3.2
"Bivalirudin is an effective alternative to heparin in the prevention of ischaemic complications in patients with unstable angina undergoing PTCA. "( Bivalirudin: a review of its potential place in the management of acute coronary syndromes.
Carswell, CI; Plosker, GL, 2002
)
3.2
"Bivalirudin is a semisynthetic derivative of hirudin, a modified component of leech saliva."( Bivalirudin: a new approach to anticoagulation.
Anderson, JR; Nawarskas, JJ,
)
2.3
"Bivalirudin is a direct thrombin inhibitor that inactivates both unbound and fibrin-bound thrombin. "( Pharmacology and clinical use of bivalirudin.
Mauro, VF; Sciulli, TM, 2002
)
2.04

Effects

Bivalirudin has a short elimination half-life of approximately 25 to 30 minutes, but no antidote is available. Unlike other marketed DTIs, it undergoes predominant non-organ elimination (proteolysis), and has the shortest half- life (approximately 25 min) BivalirUDin has an impressive safety profile in CAD patients treated with PCI.

Bivalirudin has been shown to reduce bleeding events in a multitude of diverse clinical settings and bleeding definitions. It has become the preferred antithrombotic agent in the setting of acute coronary syndromes.

ExcerptReferenceRelevance
"Bivalirudin has a safety and efficacy profile similar to weight-adjusted UFH during the TAVI procedure."( Bivalirudin vs Heparin in Patients Who Undergo Transcatheter Aortic Valve Implantation.
Becker, C; Bischoff, B; Boekstegers, P; Bongiovanni, D; D'Anastasi, M; Greif, M; Helbig, S; Kupatt, C; Lange, P; Massberg, S; Mehilli, J; Näbauer, M; Schmitz, C; Thaumann, A, 2015
)
3.3
"Bivalirudin has a short elimination half-life of approximately 25 to 30 minutes, but no antidote is available. "( Effect of modified ultrafiltration on bivalirudin elimination and postoperative blood loss after on-pump coronary artery bypass grafting: assessment of different filtration strategies.
Aronson, S; Buz, S; Dehmel, F; Dyke, CM; Hetzer, R; Koster, A; Krabatsch, T; Kuppe, H,
)
1.85
"Bivalirudin has an impressive safety profile in CAD patients treated with PCI. "( Safety of bivalirudin in patients with coronary artery disease.
Abdel-Wahab, M; Richardt, G, 2012
)
2.21
"Bivalirudin has a different mechanism of anticoagulant action than heparin."( Can bivalirudin and provisional GP IIb/IIIa blockade REPLACE heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention?
Doggrell, S, 2003
)
1.6
"Bivalirudin has a relatively short half-life and a predictable response, which makes it attractive as an anticoagulant in patients requiring invasive or surgical procedures, those who are acutely ill, or patients with both renal and hepatic insufficiency."( Treatment of heparin-induced thrombocytopenia: is there a role for bivalirudin?
Coons, JC; Seybert, AL; Zerumsky, K, 2006
)
1.29
"Bivalirudin has a unique pharmacologic profile: unlike other marketed DTIs, it undergoes predominant non-organ elimination (proteolysis), and has the shortest half-life (approximately 25 min)."( Bivalirudin.
Greinacher, A; Koster, A; Warkentin, TE, 2008
)
2.51
"Bivalirudin has been associated with fewer hemorrhagic complications than unfractionated heparin (UFH) in patients undergoing PCI."( Evaluation of Bivalirudin-Associated Major Adverse Cardiac and Hemorrhagic Events in Acute Coronary Syndrome Patients on Chronic Dialysis Following Percutaneous Coronary Intervention.
Fu, D; Gao, T; Jiang, H; Li, C; Li, X; Liao, J; Liu, M; Shao, M; Xiao, X; Yang, P, 2021
)
1.7
"Bivalirudin has been recently proposed for ECMO patients, and there is no evidence regarding its effectiveness and safety."( Is bivalirudin an alternative anticoagulant for extracorporeal membrane oxygenation (ECMO) patients? A systematic review and meta-analysis.
Deng, L; Jiang, H; Li, DH; Sun, MW; Zhang, C; Zhang, JC, 2022
)
2.06
"Bivalirudin has been suggested as an alternative to heparin for anticoagulation in patients receiving extracorporeal membrane oxygenation (ECMO). "( Bivalirudin versus heparin anticoagulation in patients receiving extracorporeal membrane oxygenation.
Guan, Q; Huang, D; Qin, J; Shan, R; Wu, J; Zhang, C, 2023
)
3.8
"Bivalirudin has been used in increasing frequency as an alternative to unfractionated heparin (UFH) in pediatric recipients of Berlin Heart EXCOR ventricular assist devices (VAD). "( Bivalirudin Compared to Heparin as the Primary Anticoagulant in Pediatric Berlin Heart Recipients.
Chen, JK; Corbo, H; Freniere, V; Law, S; McAllister, J; Neunert, C; Salerno, DM, 2023
)
3.8
"Bivalirudin has been shown to decrease major bleeding when compared to heparin ± glycoprotein IIb/IIIa inhibitors (GPI) in patients undergoing PCI. "( Gender-based outcomes of bivalirudin versus heparin in patients undergoing percutaneous coronary interventions: Meta-analysis of randomized controlled trials.
Dominic, P; Firouzbakht, T; Mina, GS; Modi, K, 2017
)
2.2
"Bivalirudin has been reported to be an alternative to unfractionated heparin (UFH) for anticoagulation during percutaneous coronary intervention (PCI) and associated with less bleeding risk. "( Bivalirudin in percutaneous coronary intervention for chronic total occlusion: A single-center pilot study.
Dai, Y; Ge, J; Ge, L; Li, C; Ma, J; Qian, J; Shen, Y; Xu, R; Zhang, F, 2018
)
3.37
"Bivalirudin has been reported as an alternative therapy whenever an intervention that requires systemic anticoagulation and cardiopulmonary by-pass pump is needed."( [Fulminant coagulopathy after bivalirudin use in a patient diagnosed with heparin-induced thrombocytopenia and subject to cardiac bypass surgery].
de Prada Martín, B; Gualis Cardona, J; Martínez Comendador, JM; Pérez Blanco, I, 2014
)
1.41
"Bivalirudin has been shown to be an effective and safe anticoagulant during angioplasty. "( Safety and feasibility of intra-arterial bivalirudin bolus administration during primary angioplasty.
Chorzempa, A; Coven, D; Hong, MK; Leber, R; Palazzo, A; Simon, C; Tamis, J, 2013
)
2.1
"Bivalirudin has been shown to reduce bleeding complications in patients who underwent PCI; however, the impact of anemia on bleeding complications and long-term mortality has not been studied."( Impact of major bleeding on long-term mortality in anemic versus nonanemic patients undergoing percutaneous coronary intervention using bivalirudin.
Ali, AA; Ali, ZA; Baber, U; Dangas, G; Downey, P; George, I; Kini, AS; Krishnan, P; Mandava, A; Mehran, R; Nazif, T; Poludasu, S; Qureshi, YH; Sharma, SK; Tatonetti, N; Zalewski, A, 2014
)
1.33
"Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. "( Comprehensive meta-analysis of safety and efficacy of bivalirudin versus heparin with or without routine glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndrome.
Andreotti, F; Berti, S; Brockmeyer, M; Gorny, B; Kandzari, DE; Kelm, M; Kowalewski, M; Kołodziejczak, M; Kubica, J; Meyer, C; Navarese, EP; Rassaf, T; Schulze, V; Valgimigli, M, 2015
)
2.11
"Bivalirudin, has been shown to have comparable efficacy and better safety profile when compared to unfractionated heparin (UFH) in percutaneous coronary interventions. "( Hemorrhagic and ischemic outcomes of Heparin vs. Bivalirudin in carotid artery stenting: A meta-analysis of studies.
Abdullah, O; Abu-Fadel, M; Al-Dadah, AS; Aronow, HD; Drachman, DE; Firwana, B; Gray, WA; Mahmud, E; Omran, J; White, CJ, 2017
)
2.15
"Bivalirudin has been shown to be safe and efficacious compared with heparin plus glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI). "( Bivalirudin versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in Women Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.
Ma, S; Wang, B; Xie, X; Xu, H; Yang, J, 2017
)
3.34
"Bivalirudin has been associated with reduced bleeding and mortality during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). "( Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI: A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial.
Dangas, GD; Deliargyris, EN; Gibson, CM; Kirtane, AJ; Litherland, C; Mehran, R; Ortiz, G; Pinto, DS; Stone, GW; Tamez, H; Yeh, RW, 2017
)
2.16
"Bivalirudin has been associated with decreased bleeding, with similar rates of ischemia in patients with stable angina, unstable angina, non-ST elevation myocardial infarction and elective percutaneous coronary intervention (PCI). "( HORIZONS trial: a step forward for primary percutaneous coronary intervention.
White, HD, 2009
)
1.8
"Bivalirudin has been studied as an alternative to heparin plus glycoprotein IIb/IIIa inhibitor (GPI) during percutaneous coronary intervention (PCI)."( Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention.
Alan Brookhart, M; Glynn, RJ; Mittleman, MA; Rassen, JA; Schneeweiss, S, 2010
)
1.38
"Bivalirudin has been associated with fewer bleeding complications than unfractionated heparin (UFH) in patients undergoing PCI in various clinical settings."( Safety and in-hospital outcomes of bivalirudin use in dialysis patients undergoing percutaneous coronary intervention.
Ben-Dor, I; Collins, SD; Delhaye, C; Gaglia, MA; Gonzalez, MA; Kent, KM; Lindsay, J; Maluenda, G; Pichard, AD; Satler, LF; Suddath, WO; Syed, AI; Torguson, R; Wakabayashi, K; Waksman, R; Xue, Z, 2010
)
1.36
"Bivalirudin has been further investigated and used as the anticoagulation strategy in the setting of cardiac and endovascular surgical procedures and is frequently utilized in the management of patients with heparin-induced thrombocytopenia."( Bivalirudin: a review of the pharmacology and clinical application.
Ohman, EM; Rao, SV; Van De Car, DA, 2010
)
2.52
"Bivalirudin has been shown to reduce bleeding complication and improve outcomes."( Use of low-dose heparin with bivalirudin for ad-hoc transradial coronary interventions: experience from a single center.
Bhasin, N; Edasery, D; Jauhar, R; Kaplan, B; Noor, A; Singh, A, 2011
)
1.38
"Bivalirudin has been evaluated in elective procedures and across the spectrum of acute coronary syndromes and is associated with decreased bleeding events compared to unfractionated heparin (UFH) in combination with glycoprotein IIb/IIIa inhibitors (GPI) when used for the duration of PCI."( Use of prolonged bivalirudin infusions following percutaneous coronary intervention.
Good, KL; Moser, LR; Nemerovski, CW, 2011
)
1.43
"Bivalirudin has been used as an alternative to heparin for adults undergoing cardiac surgery and cardiopulmonary bypass, but has only been used minimally in children for this purpose."( Novel techniques in the use of bivalirudin for cardiopulmonary bypass anticoagulation in a child with heparin-induced thrombocytopenia.
Biniwale, R; Chalfant, A; Dragomer, D; Federman, M; Reemtsen, B, 2011
)
1.38
"Bivalirudin has been shown to reduce bleeding events in a multitude of diverse clinical settings and bleeding definitions, and has become the preferred antithrombotic agent in the setting of acute coronary syndromes."( What is the optimal antithrombotic strategy in primary percutaneous coronary intervention?
Mehran, R; Sergie, Z; Stone, GW, 2012
)
1.1
"Bivalirudin has been proposed as the sole anticoagulant in patients under extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass. "( Bivalirudin and post-cardiotomy ECMO: a word of caution.
Ranucci, M, 2012
)
3.26
"Bivalirudin has been studied in patients undergoing percutaneous coronary revascularization, with very promising efficacy and safety profile compared with unfractionated heparin."( Direct thrombin inhibitors for non-ST-segment elevation acute coronary syndromes: what, when, and where?
Lincoff, AM, 2003
)
1.04
"Bivalirudin has been successfully used as a replacement for heparin during on-pump coronary artery bypass grafting. "( Assessment of hemostatic activation during cardiopulmonary bypass for coronary artery bypass grafting with bivalirudin: results of a pilot study.
Buz, S; Dyke, CM; Hetzer, R; Koster, A; Kuppe, H; Lincoff, AM; Smedira, NG; Spiess, B; Yeter, R, 2005
)
1.98
"Bivalirudin has been successfully used in off- and on-pump cardiac surgery."( Direct antithrombins: mechanisms, trials, and role in contemporary interventional medicine.
White, HD; Wong, CK, 2007
)
1.06
"Bivalirudin has been shown to be a very effective anticoagulant in laboratory models, though its clinical efficacy remains to be fully proven."( Bivalirudin: a new approach to anticoagulation.
Anderson, JR; Nawarskas, JJ,
)
2.3
"Bivalirudin has been used in patients with immunologically mediated, heparin-induced thrombocytopenia (HIT) without complications."( Pharmacology and clinical use of bivalirudin.
Mauro, VF; Sciulli, TM, 2002
)
1.32
"Bivalirudin has been shown to significantly reduce the risk of reinfarction in patients with acute myocardial infarction (MI) treated with streptokinase, but its use for this indication is not approved in the US."( Bivalirudin: an anticoagulant for acute coronary syndromes and coronary interventions.
Chew, DP; White, HD, 2002
)
2.48

Actions

Bivalirudin had lower hospital mortality (26% vs 32%; adjusted SHR 0.57, 95% CI 0.40-0.83) driven by lower VAD mortality. The compound has lower thrombin affinity than hirUDin and therefore is believed to be a much safer compound.

ExcerptReferenceRelevance
"Bivalirudin had lower hospital mortality (26% vs 32%; adjusted SHR 0.57, 95% CI 0.40-0.83) driven by lower VAD mortality (20% vs 27%; adjusted SHR 0.46, 95% CI 0.32-0.77) after adjusting for year, age, diagnosis, and center VAD volume."( Cost-effectiveness of bivalirudin in pediatric ventricular assist devices.
Ankola, A; Buchholz, H; Burstein, D; Conway, J; Edelson, J; Kimmel, S; Lin, K; Lorts, A; Maeda, K; O'Connor, M; Putt, M; Rossano, J; VanderPluym, C, 2023
)
1.95
"Bivalirudin did not increase postoperative bleeding and transfusion requirement."( Randomized Controlled Trial of Heparin Versus Bivalirudin Anticoagulation in Acyanotic Children Undergoing Open Heart Surgery.
Chauhan, S; Chowdhury, UK; Hasija, S; Krishna, NS; Makhija, N; Malhotra, P; Sharma, G; Talwar, S, 2018
)
1.46
"Bivalirudin may cause a falsely prolonged international normalized ratio (INR) that complicates the discontinuation of bivalirudin when used as a bridge to warfarin. "( Prospective evaluation of a bivalirudin to warfarin transition nomogram.
Connors, JM; DeiCicchi, D; Hohlfelder, B; Rimsans, J; Sylvester, KW, 2017
)
2.19
"Bivalirudin has lower thrombin affinity than hirudin and therefore is believed to be a much safer compound."( Bivalirudin: a new approach to anticoagulation.
Anderson, JR; Nawarskas, JJ,
)
2.3
"Bivalirudin displays linear kinetics and is primarily eliminated renally."( Pharmacology and clinical use of bivalirudin.
Mauro, VF; Sciulli, TM, 2002
)
1.32

Treatment

Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit. Treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89)

ExcerptReferenceRelevance
"Bivalirudin treatment was associated with a reduction of major bleeding (p=0.05) compared with the control group. "( Anticoagulation for critically ill cardiac surgery patients: is primary bivalirudin the next step?
Agracheva, N; Calabrò, MG; Covello, RD; De Bonis, M; Koster, A; Pappalardo, F; Pieri, M; Zangrillo, A, 2014
)
2.08
"A bivalirudin treatment protocol was developed with the initial dosage and dosage adjustments based on the value of activated partial thromboplastin time (aPTT), the risk of bleeding, and the recurrence of ECT."( Successful use of a bivalirudin treatment protocol to prevent extracorporeal thrombosis in ambulatory hemodialysis patients with heparin-induced thrombocytopenia.
Abdulla, AE; Al-Ali, FS; Bouanane, H; Elsayed, M; Hamad, A; Ibrahim, R; Khalifa, S; Tolba, H, 2016
)
1.32
"Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit."( Prediction of 1-year mortality and impact of bivalirudin therapy according to level of baseline risk: A patient-level pooled analysis from three randomized trials.
Brodie, BR; Clayton, T; Dangas, GD; Deliargyris, EN; Gersh, BJ; Gibson, CM; Lincoff, AM; Mehran, R; Pocock, SJ; Stone, GW; Witzenbichler, B; Yu, J, 2016
)
1.42
"Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15)."( Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials.
Bansilal, S; Bernstein, D; Brener, SJ; Dangas, GD; Deliargyris, EN; Feit, F; Francese, DP; Généreux, P; Giustino, G; Kirtane, AJ; Lansky, AJ; Lincoff, M; Mehran, R; Prats, J; Redfors, B; Skerjanec, S; Stone, GW, 2016
)
1.47
"Bivalirudin treatment started at a dosage of 0.005 or 0.01 mg/kg/hour with titration to maintain normocoagulability, which occurred (without concomitant warfarin therapy) within the dosage range of 0.01-0.02 mg/kg/hour."( Successful use and dosing of bivalirudin after temporary total artificial heart implantation: a case series.
Cahoon, W; Crouch, MA; Gunnerson, KJ; Kasirajan, V; Katlaps, GJ, 2008
)
1.36
"The bivalirudin treated patients were matched for age, gender, and type of procedure with a random sample of patients who underwent neuroendovascular procedures with the standardized heparin protocol."( Safety and tolerability of high-intensity anticoagulation with bivalirudin during neuroendovascular procedures.
Georgiadis, AL; Hassan, AE; Memon, MZ; Qureshi, AI; Suri, MF; Vazquez, G, 2011
)
1.09
"Bivalirudin treatment was associated with improved event-free survival at 30 days and reduced rates of major bleeding."( Outcome of the HORIZONS-AMI trial: bivalirudin enhances long-term survival in patients with ST-elevation myocardial infarction undergoing angioplasty.
Feldman, DN; Shah, A, 2012
)
1.38
"The treatment of bivalirudin showed better efficacy and safety as compared to UFH among patients with ACS undergoing PCI at high risk of bleeding in contemporary practice."( Bivalirudin versus unfractionated heparin during percutaneous coronary intervention in high-bleeding-risk patients with acute coronary syndrome in contemporary practice.
Chen, K; Liu, G; Liu, Z; Zhang, B; Zhang, Y, 2020
)
2.34
"Treatment with bivalirudin monotherapy reduces major hemorrhagic complications irrespective of lesion complexity with comparable suppression of adverse ischemic events as heparin plus glycoprotein IIb/IIIa inhibitor."( Prognostic value of angiographic lesion complexity in patients with acute coronary syndromes undergoing percutaneous coronary intervention (from the acute catheterization and urgent intervention triage strategy trial).
Bertrand, ME; Desmet, W; Feit, F; Goto, K; Hamon, M; Lansky, AJ; Mehran, R; Nargileci, E; Ng, VG; Ohman, EM; Parise, H; Pietras, C; Stone, GW; White, HD, 2014
)
0.74
"Treatment with bivalirudin was safe and effective. "( Evaluation of procedure-related bleeding risk in patients receiving bivalirudin during percutaneous coronary intervention.
Baek, VS; Edwin, SB; Hurren, J, 2015
)
1.01
"Treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor was associated with a nonsignificant 8% increase in MI and a highly significant 50% decrease in major bleeding."( Prognostic modeling of individual patient risk and mortality impact of ischemic and hemorrhagic complications: assessment from the Acute Catheterization and Urgent Intervention Triage Strategy trial.
Bertrand, ME; Clayton, TC; Fahy, M; Lansky, AJ; Lincoff, AM; Mehran, R; Moses, JW; Nikolsky, E; Ohman, EM; Parise, H; Pocock, SJ; Stone, GW; White, HD, 2010
)
0.7
"Treatment with bivalirudin glycoprotein IIb/IIIa inhibitors significantly reduced major bleeding at 30 days (2.5% bivalirudin monotherapy; P=0.005, 2.0% bivalirudin plus glycoprotein IIb/IIIa inhibitors; P=0.0002 versus 4.4% heparin with glycoprotein IIb/IIIa inhibitors)."( Predictors of outcomes in medically treated patients with acute coronary syndromes after angiographic triage: an Acute Catheterization And Urgent Intervention Triage Strategy (ACUITY) substudy.
Alexander, KP; Bertrand, ME; Cristea, E; Desmet, W; Fahy, M; Feit, F; Goto, K; Hamon, M; Lansky, AJ; Mehran, R; Ohman, EM; Stone, GW; White, HD, 2010
)
0.7
"Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs."( Bivalirudin during primary PCI in acute myocardial infarction.
Brodie, BR; Dangas, G; Dudek, D; Gersh, BJ; Guagliumi, G; Hartmann, F; Kirtane, AJ; Kornowski, R; Mehran, R; Parise, H; Peruga, JZ; Pocock, SJ; Stone, GW; Witzenbichler, B; Wong, SC, 2008
)
2.13

Toxicity

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.

ExcerptReferenceRelevance
" Adverse events were recorded prospectively by study personnel and confirmed independently by clinical monitors blinded to treatment assignment."( Comparative safety profiles of hirulog and heparin in patients undergoing coronary angioplasty. The Hirulog Angioplasty Study Investigators.
Bittl, JA, 1995
)
0.29
"Bivalirudin is a safe and feasible alternative anticoagulant in renal and iliac PPI and may offer decreased sheath removal time, time to ambulation and LOS."( Bivalirudin as a foundation anticoagulant in peripheral vascular disease: a safe and feasible alternative for renal and iliac interventions.
Allie, AA; Allie, DE; Chaisson, G; Ellis, SD; Fail, PS; Hebert, CJ; Keller, VA; Khan, MA; Khan, MH; Lirtzman, MD; Mitran, E; Stagg, S; Walker, CM; Wyatt, CH, 2003
)
3.2
"The combination of DTI with bivalirudin and GP IIb-IIIa inhibition with tirofiban is a safe and feasible alternative anticoagulation and antiplatelet strategy in PPI, and may offer improved clinical and hemostasis outcomes in treating CLI."( A safety and feasibility report of combined direct thrombin and GP IIb/IIIa inhibition with bivalirudin and tirofiban in peripheral vascular disease intervention: treating critical limb ischemia like acute coronary syndrome.
Allie, AA; Allie, DE; Allie, SE; Barker, EA; Chaisson, G; Fail, PS; Hebert, CJ; Keller, VA; Khan, MA; Khan, MH; Lirtzman, MD; McElderry, MW; Mitran, EV; Stagg, SJ; Vivekananthan, K; Walker, CM; Wyatt, CH, 2005
)
0.84
" Bivalirudin, a direct thrombin inhibitor, has been shown to reduce adverse bleeding events compared to unfractionated heparin in patients undergoing PCI."( Safety of bivalirudin during percutaneous coronary interventions in patients with abnormal renal function.
Resar, JR; Roguin, A; Steinberg, BA; Watkins, SP, 2005
)
1.64
"Bivalirudin is a safe alternative to unfractionated heparin as the anticoagulation agent in peripheral interventions."( Bivalirudin as an anticoagulation agent: safety and efficacy in peripheral interventions.
Ardid, MI; Benenati, JF; Katzen, BT; Kovacs, MF; MacLean, AA; Powell, A; Samuels, S; Zemel, G, 2005
)
3.21
" While bivalirudin-based therapy has emerged as an attractive alternative to heparin in patients undergoing contemporary percutaneous coronary intervention, it is unclear if such a strategy is safe in patients undergoing rotational atherectomy."( The safety of a bivalirudin-based approach in patients undergoing rotational atherectomy.
Bhatt, DL; Ellis, SG; Gurm, HS; Lincoff, AM; Rajagopal, V, 2007
)
1.14
" The primary endpoints were transfusion and in-hospital major adverse cardiovascular events (MACE) defined as the composite of death, MI, stroke, and any coronary artery bypass grafting (CABG) or target lesion revascularization."( Temporal trends, safety, and efficacy of bivalirudin in elective percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.
Carter, AJ; Chetcuti, SJ; Gurm, HS; Khanal, S; Kline-Rogers, E; Lalonde, T; Moscucci, M; O'Donnell, M; O'Neill, W; Riba, A; Safian, R; Share, D; Smith, DE, 2007
)
0.61
" The risk of heparin-induced adverse reactions dictates the need for a safe and effective alternative, particularly in off-pump coronary artery bypass (OPCAB) surgery, an approach associated with a perioperative prothrombotic condition that may negatively influence graft patency."( Routine use of the direct thrombin inhibitor bivalirudin for off-pump coronary artery bypass grafting is safe and effective.
Dyke, CM; Ebra, G; Koster, A; Palmer, GJ; Sankaran, IS; Sparkman, GM, 2008
)
0.61
" However, despite the integration of newer therapies including stents, glycoprotein IIb/IIIa inhibitors (GPI), and thienopyridines, the rate of adverse ischemic events still remains unacceptably high."( Safety and efficacy of bivalirudin in acute coronary syndromes.
Hartmann, F, 2008
)
0.66
" At day 7/hospital discharge, there were no incidences of major adverse cardiac events or major bleeding."( Safety and efficacy of indigenously developed and manufactured bivalirudin in moderate/high-risk Indian patients undergoing percutaneous coronary intervention: the Bivaflo Registry.
Chandra, P; Hiremath, MS; Mehta, AB; Parikh, K; Patel, T; Pinto, B; Sengottuvelu, S; Seth, A; Sethi, KK; Sinha, N,
)
0.37
"Bivaflo is safe and effective sole anticoagulation strategy during PCI of moderate-high risk patients."( Safety and efficacy of indigenously developed and manufactured bivalirudin in moderate/high-risk Indian patients undergoing percutaneous coronary intervention: the Bivaflo Registry.
Chandra, P; Hiremath, MS; Mehta, AB; Parikh, K; Patel, T; Pinto, B; Sengottuvelu, S; Seth, A; Sethi, KK; Sinha, N,
)
0.37
" In conclusion, the results suggest that prehospital bivalirudin administration is as safe and effective as heparin in the treatment of patients with STEMI."( Feasibility and safety of prehospital administration of bivalirudin in patients with ST-elevation myocardial infarction.
Clemmensen, P; Engstrøm, T; Jørgensen, E; Nielsen, SL; Sejersten, M, 2009
)
0.85
" Endpoints included periprocedural myocardial infarction (MI), 30-day major adverse cardiac events, and in-hospital major and minor bleeding."( Safety and efficacy of a prolonged bivalirudin infusion after urgent and complex percutaneous coronary interventions: a descriptive study.
Bandinelli, L; Brizi, MG; Cortese, B; Limbruno, U; Micheli, A; Picchi, A; Severi, S, 2009
)
0.63
"0%, P = NS) or 30-day major adverse cardiac events (8."( Safety and efficacy of a prolonged bivalirudin infusion after urgent and complex percutaneous coronary interventions: a descriptive study.
Bandinelli, L; Brizi, MG; Cortese, B; Limbruno, U; Micheli, A; Picchi, A; Severi, S, 2009
)
0.63
"Low-dose UFH is as effective and safe as bivalirudin when used as an anticoagulation strategy in patients undergoing PPI, and low-dose UFH is less costly than bivalirudin."( Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in percutaneous peripheral intervention: a single-center experience.
Ahmed, SH; Allaqaband, S; Bajwa, T; Gupta, A; Mewissen, M; Mori, N; Sheikh, IR, 2009
)
0.89
" In conclusion, a dose-adjusted bivalirudin anticoagulation regimen for patients requiring chronic dialysis undergoing PCI seems to be as safe and as effective as UFH use alone."( Safety and in-hospital outcomes of bivalirudin use in dialysis patients undergoing percutaneous coronary intervention.
Ben-Dor, I; Collins, SD; Delhaye, C; Gaglia, MA; Gonzalez, MA; Kent, KM; Lindsay, J; Maluenda, G; Pichard, AD; Satler, LF; Suddath, WO; Syed, AI; Torguson, R; Wakabayashi, K; Waksman, R; Xue, Z, 2010
)
0.92
"169), and major adverse cardiovascular events (MACE) (death, MI, stroke or urgent revascularization) (4."( Efficacy and safety of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention in current clinical practice.
Bergman, G; Feldman, DN; Kim, LK; Minutello, RM; Wong, SC, 2010
)
0.67
" All in-hospital adverse events were independently adjudicated."( In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.
Dippel, EJ; Jerin, M; Shammas, AN; Shammas, GA; Shammas, NW, 2010
)
0.63
" In-hospital major bleeding and other adverse events were infrequent."( In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.
Dippel, EJ; Jerin, M; Shammas, AN; Shammas, GA; Shammas, NW, 2010
)
0.63
"Bivalirudin use seems to be as safe and effective as UFH in patients undergoing RA."( Safety and efficacy of bivalirudin for percutaneous coronary intervention with rotational atherectomy.
Ben-Dor, I; Delhaye, C; Kent, KM; Lindsay, J; Maluenda, G; Pichard, AD; Satler, LF; Suddath, WO; Torguson, R; Wakabayashi, K; Waksman, R; Xue, Z, 2010
)
2.11
" Bivalirudin is also safe to use in patients with active or remote heparin-induced thrombocytopenia."( Safety and tolerability of high-intensity anticoagulation with bivalirudin during neuroendovascular procedures.
Georgiadis, AL; Hassan, AE; Memon, MZ; Qureshi, AI; Suri, MF; Vazquez, G, 2011
)
1.52
"Our data supports that bivalirudin usage is likely a safe alternative to heparin for high-intensity anticoagulation in neuroendovascular procedures."( Safety and tolerability of high-intensity anticoagulation with bivalirudin during neuroendovascular procedures.
Georgiadis, AL; Hassan, AE; Memon, MZ; Qureshi, AI; Suri, MF; Vazquez, G, 2011
)
0.92
" 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
)
0.89
"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
)
0.87
" There were no significant differences among diabetic patients randomized to bivalirudin versus heparin plus GPI in the 1-year rates of major adverse cardiac events (14."( Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty: analysis from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocard
Dudek, D; Fahy, M; Guagliumi, G; Huber, K; Kornowski, R; Mehran, R; Parise, H; Stone, GW; Stuckey, TD; Witzenbichler, B, 2011
)
0.84
"In patients with diabetes mellitus presenting with STEMI undergoing primary PCI, anticoagulant therapy with bivalirudin compared with heparin plus GPI is safe and effective and might reduce cardiac mortality at 30 days and 1 year."( Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty: analysis from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocard
Dudek, D; Fahy, M; Guagliumi, G; Huber, K; Kornowski, R; Mehran, R; Parise, H; Stone, GW; Stuckey, TD; Witzenbichler, B, 2011
)
0.82
" The safety observations showed that bivalirudin was well tolerated in the studied dose range, all adverse events were mild in severity."( Pharmacokinetics, pharmacodynamics, tolerability and safety of single doses of bivalirudin in healthy chinese subjects.
Cui, Y; Gu, J; Lu, W; Wang, Z; Zhang, D; Zhao, X, 2011
)
0.87
" Hence, we conclude that bivalirudin may be safe for use in CAS procedures with a safety profile similar to that validated in percutaneous coronary interventions."( Clinical safety of bivalirudin in patients undergoing carotid stenting.
Abu-Fadel, M; Chrysant, GS; Cogar, BD; Ghani, MK; Hennebry, TA; Kipperman, RM; Wayangankar, SA, 2012
)
1.01
" The primary end points were the rate of major bleeding and the rate of net adverse clinical events as defined in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial."( Safety of bivalirudin in percutaneous coronary intervention following thrombolytic therapy.
Lindsay, J; Sardi, GL; Waksman, R, 2013
)
0.79
" The net adverse clinical events rate was lower in the intraprocedural BIV group (3 [6."( Safety of bivalirudin in percutaneous coronary intervention following thrombolytic therapy.
Lindsay, J; Sardi, GL; Waksman, R, 2013
)
0.79
"The use of BIV in patients presenting with STEMI who were pretreated with thrombolytic therapy and who subsequently underwent PCI is safe and is associated with less ischemic and bleeding events when compared with UFH, and should be considered as the first line anticoagulant for these patients during PCI."( Safety of bivalirudin in percutaneous coronary intervention following thrombolytic therapy.
Lindsay, J; Sardi, GL; Waksman, R, 2013
)
0.79
" The primary efficacy end point was the 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization)."( Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in high-risk patients undergoing percutaneous coronary intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Hepa
Colonna, G; D'Ambrosio, A; D'Antonio, L; Di Sciascio, G; Dicuonzo, G; Macrì, M; Montinaro, A; Pasceri, V; Patti, G, 2012
)
0.65
" The primary end point was time to sheath removal and ambulation where as peri-procedure myocardial damage, access site bleeding and major adverse cardiac events (MACE) rates were secondary end points."( Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention.
Admane, P; Deshpande, NV; Mardikar, HM; Mukherjee, D; Pratiti, R,
)
0.44
"The combination of bivalirudin + tirofiban was safe and effective as compared to UFH + tirofiban in high risk patients undergoing elective PCI."( Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention.
Admane, P; Deshpande, NV; Mardikar, HM; Mukherjee, D; Pratiti, R,
)
0.77
"Bivalirudin has been shown to be an effective and safe anticoagulant during angioplasty."( Safety and feasibility of intra-arterial bivalirudin bolus administration during primary angioplasty.
Chorzempa, A; Coven, D; Hong, MK; Leber, R; Palazzo, A; Simon, C; Tamis, J, 2013
)
2.1
"We conclude that intra-arterial bivalirudin bolus during primary angioplasty is safe and could ensure effective systemic delivery of bivalirudin."( Safety and feasibility of intra-arterial bivalirudin bolus administration during primary angioplasty.
Chorzempa, A; Coven, D; Hong, MK; Leber, R; Palazzo, A; Simon, C; Tamis, J, 2013
)
0.94
" The efficacy was evaluated by comparing the activated coagulation time (ACT), the procedural success rate (residual stenosis < 20% in target lesions without any coronary artery related adverse events within 24 hours after PCI), and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups."( Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention.
Fan, WM; Geng, SH; Gu, XL; Hu, R; Huang, WJ; Liu, ZZ; Pan, CM; Song, YM; Tang, LQ; Wan, HB; Xiang, DC; Xiao, FY; Yin, YH; Zhang, Y; Zhou, H, 2013
)
0.64
" Survival rates without major adverse cardiac events at 30 days after PCI were 100."( Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention.
Fan, WM; Geng, SH; Gu, XL; Hu, R; Huang, WJ; Liu, ZZ; Pan, CM; Song, YM; Tang, LQ; Wan, HB; Xiang, DC; Xiao, FY; Yin, YH; Zhang, Y; Zhou, H, 2013
)
0.64
"Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures."( Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention.
Fan, WM; Geng, SH; Gu, XL; Hu, R; Huang, WJ; Liu, ZZ; Pan, CM; Song, YM; Tang, LQ; Wan, HB; Xiang, DC; Xiao, FY; Yin, YH; Zhang, Y; Zhou, H, 2013
)
1.06
"Patients presenting with ST-segment elevation myocardial infarction (STEMI) represent a high-risk group for in-hospital adverse events and bleeding."( Safety of eptifibatide when added to bivalirudin during ST-segment elevation myocardial infarction.
Baker, NC; Escarcega, RO; Lipinski, MJ; Magalhaes, MA; Torguson, R; Waksman, R,
)
0.4
"Being female is an independent predictor of adverse events during percutaneous coronary interventions (PCI)."( The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial.
Han, Y; Li, Y; Liang, Z; Liu, H; Ma, L; Stone, GW; Wang, D; Wang, J; Wang, S; Yang, L, 2016
)
0.72
" The primary efficiency endpoint was 30-day net adverse clinical events (NACEs)."( The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial.
Han, Y; Li, Y; Liang, Z; Liu, H; Ma, L; Stone, GW; Wang, D; Wang, J; Wang, S; Yang, L, 2016
)
0.72
" Secondary efficacy endpoints were incidence of major adverse cardiovascular events (MACE),(3) myocardial infarction (MI),(4) target vessel revascularization (TVR)(5) and stent thrombosis up to 30days and 1year."( Efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.
Ba, Y; Cheng, G; Gao, W; Li, H; Liu, Y; Sun, S; Zhang, S; Zou, M, 2016
)
0.74
" The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days."( Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials.
Bansilal, S; Bernstein, D; Brener, SJ; Dangas, GD; Deliargyris, EN; Feit, F; Francese, DP; Généreux, P; Giustino, G; Kirtane, AJ; Lansky, AJ; Lincoff, M; Mehran, R; Prats, J; Redfors, B; Skerjanec, S; Stone, GW, 2016
)
0.74
" Bivalirudin proved to be a safe and effective anticoagulant during percutaneous coronary intervention."( Effectiveness and Safety of Bivalirudin During Percutaneous Coronary Intervention in Acute Coronary Syndrome in the Real World: CARTAGOMAX Study.
Abellán-Huerta, J; Bonilla-Pacheco, YI; Cascón-Pérez, JD; Castillo-Moreno, JA; Dau-Villareal, DF; Giner-Caro, JA; Jaulent-Huertas, L; Mármol-Lozano, R; Picó-Aracil, F; Ruiz-Abellón, Mdel C, 2016
)
1.64
" The secondary endpoints were a composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, a new target vessel revascularisation and all-cause mortality at 30 days."( Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction.
Laine, M; Nieminen, T; Tierala, I; Viikilä, J, 2016
)
0.64
" The primary outcome was 30-day net adverse clinical event (NACE), defined as a composite of major cardiac and cerebral events or any bleeding."( Efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access: A subgroup analysis from the bivalirudin in acute myocardial infarction versus heparin and GPI plus heparin trial.
Bao, D; Chen, Y; Cong, H; Ding, S; Han, Y; Jia, S; Jing, Q; Li, J; Li, L; Li, Y; Liang, Z; Liu, B; Liu, H; Wang, H; Zhao, X, 2017
)
0.76
" The primary efficacy endpoint was the incidence of major adverse cardiovascular events (MACE), and the primary safety endpoint was the incidence of major bleeding."( Efficacy and safety of bivalirudin versus heparin in patients with diabetes mellitus undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.
Yang, X; Zhang, J, 2017
)
0.77
" Among the trials retrieved, efficacy endpoints were defined as mortality, myocardial infarction (MI), repeat revascularization, stent thrombosis, and major adverse cardiac events (MACEs)."( Efficacy and safety of bivalirudin in coronary artery disease patients with mild to moderate chronic kidney disease: Meta-analysis.
Elbez, Y; Huang, W; Jing, Z; Lei, H; Lin, J; Lincoff, AM; McAndrew, T; Mehran, R; Schulz-Schüpke, S; Shi, W; Steg, PG; Stone, GW; Zeng, X; Zhang, X, 2018
)
0.79
" In mixed-comparison models, switching to bivalirudin during primary PCI was associated with lower rates for all-cause mortality and major adverse cardiovascular events (MACEs) compared to the other strategies."( Safety and efficacy of switching from unfractionated heparin to bivalirudin during primary percutaneous coronary intervention.
Askari, R; Berzingi, C; Chaudhry, A; Dennis, MM; Haji, SA; Jovin, IS; Rao, SV; Shah, R, 2019
)
1.02
" The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up."( Efficacy and safety of bivalirudin during percutaneous coronary intervention in high-bleeding-risk elderly patients with chronic total occlusion: A prospective randomized controlled trial.
Fan, CY; Hou, AJ; Luan, B; Luo, DF; Wang, CF; Wang, Y; Yu, GN; Zhang, XJ; Zhao, HW; Zhu, Y, 2019
)
0.82
" Patients with successful PCI and no cardiogenic shock who were anticoagulated with either of the above regimens were followed for 30-day major bleeding and major adverse cardiovascular events (death, nonfatal myocardial infarction, and urgent target vessel revascularization) at 30 days, 1 year, and long term."( Safety and Efficacy of Periprocedural Heparin Plus a Short-Term Infusion of Tirofiban Versus Bivalirudin Monotherapy in Patients Who Underwent Percutaneous Coronary Intervention (from the Intermountain Heart Institute STAIR Observational Registry).
Anderson, JL; Bair, TL; Hackett, IS; Knowlton, KU; Lappé, DL; Le, VT; May, HT; Muhlestein, JB; Whisenant, B, 2019
)
0.73
"We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy."( Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triag
Bansilal, S; Ben-Yehuda, O; Brener, SJ; Chen, S; Dangas, GD; Feite, F; Huang, X; Kirtane, AJ; Mehran, R; Redfors, B; Souza, CF; Stone, GW; Zhang, Y, 2020
)
0.87
" Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14."( Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triag
Bansilal, S; Ben-Yehuda, O; Brener, SJ; Chen, S; Dangas, GD; Feite, F; Huang, X; Kirtane, AJ; Mehran, R; Redfors, B; Souza, CF; Stone, GW; Zhang, Y, 2020
)
0.87
" The primary efficacy endpoint was the incidence of major adverse cardiovascular events (MACE) and the primary safety endpoint was the incidence of major bleeding."( Efficacy and safety of bivalirudin vs heparin in patients with coronary heart disease undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.
Liu, XQ; Luo, XD; Wu, YQ, 2020
)
0.87
" The primary endpoints were 30-day net adverse clinical events (NACEs) post-emergency percutaneous coronary intervention, including major adverse cardiac and cerebrovascular events (MACCEs) and Bleeding Academic Research Consortium grades 2 to 5 (BARC 2-5) bleeding events."( Efficacy and safety of bivalirudin application during primary percutaneous coronary intervention in older patients with acute ST-segment elevation myocardial infarction.
Chen, H; Kong, X; Li, L; Ma, L; Wu, J; Yu, X, 2020
)
0.87
" Our study aimed to investigate these information and analyze the independent predictors of postoperative adverse events."( Bivalirudin in patients undergoing percutaneous coronary intervention and independent predictors of postoperative adverse events in these patients: A real world retrospective study.
Cong, HL; Hu, YC; Jin, DX; Wang, L; Xu, JH; Yao, WJ; Zhang, JX; Zhang, R, 2021
)
2.06
" The primary end point was the 30-day incidence of net adverse clinical events (NACEs), and the secondary end point was the major adverse cardiovascular events (MACEs), which were related to safety and efficacy, respectively."( Efficacy and Safety of Bivalirudin During Percutaneous Coronary Intervention in Chronic Total Occlusion: A Retrospective Study.
Chang, C; Chen, K; Chen, Z; Liu, G; Yan, S; Zhang, L; Zhang, Y, 2021
)
0.93
" However, its safe and efficacious use in elderly patients, a typical high bleeding risk cohort, in real world practice is yet to be reported."( Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real-world study.
Han, Y; Li, J; Li, Y; Liu, X; Ma, S; Na, K; Qi, Z; Qiu, M; Xu, Y, 2022
)
1.02
" The primary outcome was 12-month net adverse clinical events (NACE) defined as a composite of cardiac death, myocardial infarction, stroke, revascularization, or any bleeding."( Effectiveness and safety of bivalirudin in elderly patients with coronary artery disease undergoing percutaneous coronary intervention: A real-world study.
Han, Y; Li, J; Li, Y; Liu, X; Ma, S; Na, K; Qi, Z; Qiu, M; Xu, Y, 2022
)
1.02
"The present study aimed to comprehensively investigate the occurrence and risk factors of adverse events (AEs) or adverse drug reactions (ADRs) (especially for thrombocytopenia and bleeding) in Chinese female patients receiving bivalirudin during percutaneous coronary intervention (PCI)."( Safety profile of bivalirudin in Chinese female patients undergoing percutaneous coronary intervention: a multi-center study.
Liu, X; Ran, H; Tang, Q; Wu, F; Wu, Y; Xiao, J; Zhong, C, 2022
)
1.24
"This prospective, multi-center, intensive monitoring study aimed to systematically assess the occurrence of adverse events (AEs) and adverse drug reactions (ADRs), especially thrombocytopenia and bleeding, as well as their risk factors in Chinese ST-segment elevation myocardial infraction (STEMI) patients receiving bivalirudin as anticoagulant for percutaneous coronary intervention (PCI)."( Comprehensive safety profile evaluation of bivalirudin in Chinese ST-segment elevation myocardial infarction patients receiving percutaneous coronary intervention: a prospective, multicenter, intensive monitoring study.
Chen, A; Deng, J; Li, Q; Liu, Y; Su, G; Wang, Z; Zhao, Y; Zheng, H, 2022
)
1.16
" The adverse events and the hemorrhage events 30 days after the operation were observed and recorded."( Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction.
Chen, YX; Li, P; Liang, XW; Liao, W; Liu, M; Wang, ZD; Xie, WC; Zhu, XZ,
)
0.53

Pharmacokinetics

The developed assay method was successfully applied to a pharmacokinetic (PK) study in healthy volunteers. The half-life of bivalirudin was approximately 0.

ExcerptReferenceRelevance
" The developed assay method was successfully applied to a pharmacokinetic (PK) study in healthy volunteers after intravenous administration of bivalirudin."( Development and validation of a LC-MS/MS method for determination of bivalirudin in human plasma: Application to a clinical pharmacokinetic study.
Gao, X; Huang, Y; Pan, G; Wang, X; Wang, Y, 2010
)
0.8
"This article reviews the potential use of argatroban for the treatment of ACS and presents the pharmacokinetic data currently available."( Pharmacokinetic evaluation of argatroban for the treatment of acute coronary syndrome.
Cruz-González, I; López-Jiménez, R; Perez-Rivera, A; Yan, BP, 2012
)
0.38

Compound-Compound Interactions

Atorvastatin combined with bivalirudin can improve the efficiency of clinical treatment in elderly AMI patients who undergo PCI. It can simultaneously improve blood coagulation function and reduce the occurrence of bleeding, compared to bivalrudin alone.

ExcerptReferenceRelevance
"8) in combination with tPA or tPA alone (1."( Effective use of BCH-2763, a new potent injectable direct thrombin inhibitor, in combination with tissue plasminogen activator (tPA) in a rat arterial thrombolysis model.
Deschênes, I; Finkle, CD; Winocour, PD, 1998
)
0.3
" Here, we aim to explore the effects of atorvastatin combined with bivalirudin on coagulation function, cardiac function, and inflammatory factors in elderly patients with AMI who underwent PCI."( Effects of atorvastatin combined with bivalirudin on coagulation function, cardiac function, and inflammatory factors of percutaneous coronary intervention in elderly patients with acute myocardial infarction.
Chen, X; Ding, S; Wu, S; Xu, S, 2020
)
1.07
"Atorvastatin combined with bivalirudin can improve the efficiency of clinical treatment in elderly AMI patients who undergo PCI, while simultaneously improving blood coagulation function and reducing the occurrence of bleeding, compared with bivalrudin alone."( Effects of atorvastatin combined with bivalirudin on coagulation function, cardiac function, and inflammatory factors of percutaneous coronary intervention in elderly patients with acute myocardial infarction.
Chen, X; Ding, S; Wu, S; Xu, S, 2020
)
1.13
"The present study aimed to investigate the application safety of bivalirudin combined with ticagrelor in the emergency percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI)."( Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction.
Chen, YX; Li, P; Liang, XW; Liao, W; Liu, M; Wang, ZD; Xie, WC; Zhu, XZ,
)
0.77
"Compared with unfractionated heparin combined with ticagrelor in patients with STEMI undergoing emergency PCI treatment, bivalirudin combined with ticagrelor could significantly reduce the occurrence of mild hemorrhage events, and it would not increase the incidence of MACE during the 30 days of follow-up."( Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction.
Chen, YX; Li, P; Liang, XW; Liao, W; Liu, M; Wang, ZD; Xie, WC; Zhu, XZ,
)
0.74

Bioavailability

ExcerptReferenceRelevance
" For some of them oral bioavailability is claimed and they are effective in in vitro coagulation assays."( Advances in the development of thrombin inhibitors.
Hauptmann, J; Steinmetzer, T; Sturzebecher, J, 2001
)
0.31
" Fondaparinux has excellent bioavailability when administered subcutaneously, has a longer half-life than LMWHs, and is given once daily by subcutaneous injection in fixed doses, without anticoagulant monitoring."( Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).
Bauer, KA; Donati, MB; Gould, M; Hirsh, J; Samama, MM; Weitz, JI, 2008
)
0.35
" Fondaparinux exhibits complete bioavailability when administered subcutaneously, has a longer half-life than LMWHs, and is given once daily by subcutaneous injection in fixed doses, without coagulation monitoring."( Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Baglin, TP; Garcia, DA; Samama, MM; Weitz, JI, 2012
)
0.38
"The use of direct thrombin inhibitors (DTIs) for prophylactic or therapeutic anticoagulation is increasing because of the predictable bioavailability and short half-life of these DTIs."( Measuring direct thrombin inhibitors with routine and dedicated coagulation assays: which assay is helpful?
Curvers, J; Scharnhorst, V; Stroobants, AK; van de Kerkhof, D; van den Dool, EJ, 2012
)
0.38
" Moreover, the micellar formulation significantly prolonged the half-life and thereby increased the bioavailability of bivalirudin."( Clot-targeted micellar formulation improves anticoagulation efficacy of bivalirudin.
Kotamraju, VR; Liu, X; Ruoslahti, E; She, ZG, 2014
)
0.84

Dosage Studied

Bivalirudin dosing in ECMO and VAD patients is consistent with dosing seen in previous reports but may be higher in Vad patients.

ExcerptRelevanceReference
" A dose-response curve of both ACTs and aPTTs was noted; no coronary thrombotic closures occurred in the small number of patients with ACT > 300 seconds."( Use of a direct antithrombin, hirulog, in place of heparin during coronary angioplasty.
Bonan, R; de Bono, D; Ferguson, J; Jewitt, D; Kakkar, VV; Rothman, M; Sigwart, U; Strony, J; Topol, EJ; Willerson, JT, 1993
)
0.29
"Heparin, the most widely used antithrombin, suffers several limitations, including high inter-individual variability of anticoagulant response, a nonlinear dose-response curve, inability to inactivate clot-bound thrombin, a requirement for endogenous cofactors and inactivation by platelet factor 4 and heparinase."( Direct thrombin inhibitors in cardiovascular disease.
Catella-Lawson, F, 1997
)
0.3
" The thrombin inhibitors were given intravenously, and complete concentration- and/or dose-response curves were constructed."( The importance of enzyme inhibition kinetics for the effect of thrombin inhibitors in a rat model of arterial thrombosis.
Deinum, J; Elg, M; Gustafsson, D, 1997
)
0.3
" On a molar dosing basis, the approximate order of potency of the thrombin and factor Xa inhibitors was similar in artery and vein: hirudin>tick anticoagulant peptide>hirulog> or =L-370,518."( Assessment of thrombin inhibitor efficacy in a novel rabbit model of simultaneous arterial and venous thrombosis.
Gardell, SJ; Lehman, ED; Lewis, SD; Lynch, JJ; Marsh Lyle, E; Motzel, SL, 1998
)
0.3
"The dosing of anticoagulants during coronary angioplasty is commonly guided by measurements of activated clotting time (ACT), but the usefulness of these measurements remains uncertain."( Relation between abrupt vessel closure and the anticoagulant response to heparin or bivalirudin during coronary angioplasty.
Ahmed, WH; Bittl, JA, 1998
)
0.52
"5-fold prolongation of quantitative thrombin time one hour after an injection, but with a reduction to almost baseline levels at the end of the dosing interval."( Systemic thrombin inhibition by Hirulog does not alter medial smooth muscle cell proliferation and inflammatory activation after vascular injury in the rabbit.
Baciu, R; Kranzhöfer, R; Libby, P; Maraganore, JM, 1999
)
0.3
" These results have been achieved with an acceptable risk of bleeding, when administered in appropriate dosing regimens."( Direct thrombin inhibitors as adjuncts to thrombolytic therapy.
French, JK; White, HD, 1999
)
0.3
" However, for use in prophylaxis of thrombotic diseases such inhibitors should be orally available, must be safe to avoid bleeding complications and should have an appropriate half-life, allowing once or twice daily dosing to maintain adequate antithrombotically effective blood levels."( Advances in the development of thrombin inhibitors.
Hauptmann, J; Steinmetzer, T; Sturzebecher, J, 2001
)
0.31
" Alternate agents such as the direct thrombin inhibitors (hirudin and argatroban) are available, but careful dosing and monitoring of the anticoagulant effect are required."( Alternative methods of anticoagulation for dialysis-dependent patients with heparin-induced thrombocytopenia.
Kovalik, EC; O'Shea, SI; Ortel, TL,
)
0.13
"The chemistry and pharmacology, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, dosing and administration, and pharmacoeconomics of bivalirudin are reviewed; clinical trials of bivalirudin's application in percutaneous coronary intervention (PCI) are also discussed."( Bivalirudin in percutaneous coronary intervention.
Caron, MF; McKendall, GR, 2003
)
1.96
" Optimal dosing regimens for argatroban, lepirudin, and bivalirudin should be further established in PCI patients."( Percutaneous interventions in patients with immune-mediated heparin-induced thrombocytopenia.
Dangas, GD; Nikolsky, E, 2004
)
0.57
" Herein we describe the dosing and intraoperative management of bivalrudin anti-coagulation in a patient undergoing urgent cardiac transplantation in the context of recently diagnosed HIT."( Use of bivalirudin, a direct thrombin inhibitor, and its reversal with modified ultrafiltration during heart transplantation in a patient with heparin-induced thrombocytopenia.
Achorn, N; De Silva, A; Demarco, T; Hoopes, C; Mann, MJ; Moskalik, W; Ratcliffe, M; Strattman, G; Tseng, E, 2005
)
0.78
" Bivalirudin dosing was adjusted based on renal function."( Safety of bivalirudin during percutaneous coronary interventions in patients with abnormal renal function.
Resar, JR; Roguin, A; Steinberg, BA; Watkins, SP, 2005
)
1.64
" Low-molecular-weight heparins, available in the last 20 years, are manufactured from unfractionated heparin and have superior dose-response relationships because of fewer nonspecific reactions with plasma proteins and cells."( Heparin and other rapidly acting anticoagulants.
Hyers, TM, 2005
)
0.33
" Reports of anticoagulation with bivalirudin are sporadic, however, with variable dosing and management strategies."( Use of bivalirudin as an anticoagulant during cardiopulmonary bypass.
Dyke, CM; McCarthy, HM; Palmer, G; Veale, JJ, 2005
)
1.06
" The dosage was adjusted for the patient's renal dysfunction."( Bivalirudin use in carotid endarterectomy in a patient with heparin-induced thrombocytopenia.
Finks, SW, 2006
)
1.78
" Lepirudin requires dosage adjustments in patients with renal insufficiency and has potential for antibody formation."( Treatment of heparin-induced thrombocytopenia: is there a role for bivalirudin?
Coons, JC; Seybert, AL; Zerumsky, K, 2006
)
0.57
" After Ethics Committee approval, a pilot study was performed to evaluate the feasibility of using bivalirudin for on-pump cardiac surgery and to evaluate dosing of bivalirudin in terms of the pharmacokinetic and safety profile in patients undergoing coronary artery bypass graft (CABG) surgery."( Sensitivity of a modified ACT test to levels of bivalirudin used during cardiac surgery.
Koster, A; Laduca, FM; Prats, J; Zucker, ML, 2005
)
0.8
" Thirty diabetic patients were randomized to receive during PCI either bivalirudin (bivalirudin group, n=15) or eptifibatide plus heparin (eptifibatide group, n=15) at standard dosing regimens."( Anti-thrombotic effect of bivalirudin compared with eptifibatide and unfractionated heparin in diabetic patients: an ex vivo human study.
Badimon, JJ; Karim, A; Kleiman, A; Kleiman, NS; Lev, EI; Patel, R, 2006
)
0.87
"To evaluate the safety, effectiveness, and dosing of bivalirudin for treatment of heparin-induced thrombocytopenia (HIT) in critically ill patients with hepatic and/or renal dysfunction."( Evaluation of bivalirudin treatment for heparin-induced thrombocytopenia in critically ill patients with hepatic and/or renal dysfunction.
Fish, DN; Kiser, TH, 2006
)
0.94
"Patient records were reviewed for dosage and duration of bivalirudin therapy, occurrence of thrombosis, and clinically significant adverse effects."( Evaluation of bivalirudin treatment for heparin-induced thrombocytopenia in critically ill patients with hepatic and/or renal dysfunction.
Fish, DN; Kiser, TH, 2006
)
0.94
"This analysis indicates that bivalirudin with provisional GP IIb-IIIa inhibitor therapy is the most cost-effective antithrombotic treatment strategy in nonurgent PCI when its use and dosing are consistent with the REPLACE-2 trial."( Cost-effectiveness analysis of antithrombotic therapy in nonurgent percutaneous coronary intervention.
Crouch, MA; Holdford, DA; Summers, KM, 2006
)
0.63
" However, with this dosing regimen, the combination of heparin and bivalirudin does not seem to confer any measurable advantages over full-dose bivalirudin anticoagulation."( Effect of combined anticoagulation using heparin and bivalirudin on the hemostatic and inflammatory responses to cardiopulmonary bypass in the rat.
Arepally, G; Becker, R; De Lange, F; Grocott, HP; Jones, WL; Mackensen, GB; Phillips-Bute, B; Welsby, IJ; Yoshitani, K, 2007
)
0.83
" 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
" Careful attention to dosing and excellent vascular access site management after cardiac catheterization are required to decrease the risk of bleeding and blood transfusion, which have been associated with increased mortality risk."( New anticoagulant options for ST-elevation myocardial infarction and unstable angina pectoris/non-ST-elevation myocardial infarction.
Bates, ER, 2007
)
0.34
" Patients received one of three bolus doses and one of two initial infusion doses with subsequent dosing adjusted utilizing the activated partial thromboplastin time."( Pilot dose-finding and safety study of bivalirudin in infants <6 months of age with thrombosis.
Belvedere, M; Nugent, DJ; Tarantino, MD; Weber, LC; Wohrley, J; Young, G, 2007
)
0.61
" A dose-response effect was noted for the continuous infusion but not the bolus dosing."( Pilot dose-finding and safety study of bivalirudin in infants <6 months of age with thrombosis.
Belvedere, M; Nugent, DJ; Tarantino, MD; Weber, LC; Wohrley, J; Young, G, 2007
)
0.61
" DTIs have antiplatelet effects, anticoagulant action, and most do not bind to plasma proteins, thereby providing a more consistent dose-response effect than UFH."( Anticoagulation for acute coronary syndromes: from heparin to direct thrombin inhibitors.
Lepor, NE, 2007
)
0.34
" Important drug-specific limitations and dosing and monitoring guidelines must be respected for patient safety."( The laboratory diagnosis and clinical management of patients with heparin-induced thrombocytopenia: an update.
Prechel, M; Walenga, JM, 2008
)
0.35
" However, bivalirudin dosing and goal-activated clotting times varied between the studies and case reports."( Bivalirudin for patients with heparin-induced thrombocytopenia undergoing cardiovascular surgery.
Czosnowski, QA; Finks, SW; Rogers, KC, 2008
)
2.19
"To evaluate the safety, efficacy, and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia (HIT)."( Safety, efficacy, and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia.
Burch, JC; Hassell, KL; Kiser, TH; Klem, PM, 2008
)
0.85
" Patients were divided into three renal function groups for assessment of bivalirudin dosing requirements: creatinine clearance (Cl(cr)) greater than 60 ml/minute (12 patients, group 1); Cl(cr) 30-60 ml/minute (11 patients, group 2); and Cl(cr) lower than 30 ml/minute or receiving continuous renal replacement therapy ([RRT] 14 patients, group 3)."( Safety, efficacy, and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia.
Burch, JC; Hassell, KL; Kiser, TH; Klem, PM, 2008
)
0.84
"Bivalirudin dosing requirements correlated with renal function; therefore, dosage reduction is required in patients with moderate or severe renal dysfunction."( Safety, efficacy, and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia.
Burch, JC; Hassell, KL; Kiser, TH; Klem, PM, 2008
)
2.05
" All patients had inadequate ACT measurements, despite conventional heparin dosage and ongoing clopidogrel treatment."( 'Bail-out' bivalirudin use in patients with thrombotic complications unresponsive to conventional treatment during percutaneous coronary intervention.
Cabianca, E; Fontanelli, A; La Vecchia, L; Varotto, L; Vincenzi, P, 2008
)
0.74
" At concentrations higher than the "therapeutic" levels, the dose-response curve in the Ks assay became very steep for lepirudin while those were shallow for the others."( The direct thrombin inhibitors (argatroban, bivalirudin and lepirudin) and the indirect Xa-inhibitor (danaparoid) increase fibrin network porosity and thus facilitate fibrinolysis.
Bark, N; Blombäck, M; He, S; Johnsson, H; Wallén, NH, 2010
)
0.62
" Reliable anticoagulation was achieved with weight-based dosing with activated clotting time values at baseline (systemic) of 131 +/- 92 seconds, during infusion (systemic) of 347 +/- 36 seconds, and from the distal vasculature (limb) of 345 +/- 66 seconds."( A pilot, prospective evaluation of a direct thrombin inhibitor, bivalirudin (Angiomax), in patients undergoing lower extremity bypass.
Bena, JF; Bishop, PD; Kashyap, VS; Ouriel, K; Rosa, K; Sarac, TP, 2010
)
0.6
"The bivalirudin dosing regimens reported in the cardiac literature were modified empirically for two different activated clotting time (ACT) target ranges."( Safety and tolerability of high-intensity anticoagulation with bivalirudin during neuroendovascular procedures.
Georgiadis, AL; Hassan, AE; Memon, MZ; Qureshi, AI; Suri, MF; Vazquez, G, 2011
)
1.17
" However, no dosage adjustment was made based on the ACT, and the infusion rate of bivalirudin remained fixed during the procedures."( Bivalirudin use during radiofrequency catheter ablation procedures in two patients with a history of heparin-induced thrombocytopenia.
Baetz, BE; Gerstenfeld, EP; Kolansky, DM; Spinler, SA, 2010
)
2.03
" Data regarding demographics, direct thrombin inhibitor (DTI) dosing and monitoring, and related clinical outcomes were collected; statistical analysis was performed to compare results for patients receiving bivalirudin versus those receiving argatroban."( Comparison of bivalirudin and argatroban for the management of heparin-induced thrombocytopenia.
Arnold, H; Deal, EN; Hollands, JM; Martinez, EJ; Micek, ST; Skrupky, LP; Smith, JR, 2010
)
0.91
" Additionally, further studies with bivalirudin are needed to determine the best monitoring modality and dosing regimen."( Bivalirudin utilization in cardiac surgery: shifting anticoagulation from indirect to direct thrombin inhibition.
Anand, SX; Heerdt, PM; Mahboobi, SK; Viles-Gonzalez, JF, 2011
)
2.09
" Patients with clinically active HIT who require cardiac surgery before the resolution of the HIT preferably should be anticoagulated with bivalirudin, dosed according to body weight and the goal-activated coagulation time."( Update in hematology: heparin-induced thrombocytopenia and bivalirudin.
Augoustides, JG, 2011
)
0.81
" Protocol patients had DTI initial doses based on organ function and fixed dosage adjustments of 10, 25, or 50%."( Evaluation of empiric versus nomogram-based direct thrombin inhibitor management in patients with suspected heparin-induced thrombocytopenia.
Hassell, KL; Kiser, TH; Mann, AM; Trujillo, TC, 2011
)
0.37
" We sought to evaluate the safety, plasma concentration (pharmacokinetics, PK), pharmacodynamics (PD), and dosing guidelines of bivalirudin when used as a procedural anticoagulant in pediatric percutaneous intravascular procedures."( Pediatric catheterization laboratory anticoagulation with bivalirudin.
Aquino, PM; Forbes, TJ; Hijazi, ZM; Holzer, RJ; Jones, TK; Moskowitz, WB; Qureshi, AM; Rhodes, JF; Ringewald, JM; Rome, JJ; Vincent, RN; Young, G; Zamora, R, 2011
)
0.82
" Initial dosing in patients with renal dysfunction, including those on hemodialysis, is unclear."( Bivalirudin dosing adjustments for reduced renal function with or without hemodialysis in the management of heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2011
)
1.81
"To evaluate initial bivalirudin dosing requirements in patients with and without renal dysfunction, including patients on different forms of dialysis."( Bivalirudin dosing adjustments for reduced renal function with or without hemodialysis in the management of heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2011
)
2.14
"07 mg/kg/h) compared with patients with normal renal function, but higher dosing requirements than patients not receiving dialysis with CrCl <30 mL/min."( Bivalirudin dosing adjustments for reduced renal function with or without hemodialysis in the management of heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2011
)
1.81
"To evaluate steady-state bivalirudin dosing requirements in patients with a wide range of kidney function who were being treated for heparin-induced thrombocytopenia (HIT)-related disorders."( Correlation of bivalirudin dose with creatinine clearance during treatment of heparin-induced thrombocytopenia.
Abramson, S; Cabral, KP; Fraser, GL; Hedlund, J; May, T; Redding, D; Riker, RR; Runyan, CL; Savic, M; Seder, DB, 2011
)
1.03
"Bivalirudin dosing requirements increased with increasing Clcr values."( Correlation of bivalirudin dose with creatinine clearance during treatment of heparin-induced thrombocytopenia.
Abramson, S; Cabral, KP; Fraser, GL; Hedlund, J; May, T; Redding, D; Riker, RR; Runyan, CL; Savic, M; Seder, DB, 2011
)
2.16
" The findings of this study suggest that the same dosing regimens of bivalirudin may be administered to Chinese and Caucasian patients."( Pharmacokinetics, pharmacodynamics, tolerability and safety of single doses of bivalirudin in healthy chinese subjects.
Cui, Y; Gu, J; Lu, W; Wang, Z; Zhang, D; Zhao, X, 2011
)
0.83
"Limited data are available regarding adverse bleeding events associated with antithrombotic agents incorrectly dosed based on renal function in patients receiving percutaneous coronary intervention (PCI)."( Incidence of bleeding in renally impaired patients receiving incorrectly dosed eptifibatide or bivalirudin while undergoing percutaneous coronary intervention.
Mauro, VF; Taylor, LA, 2012
)
0.6
"To compare the incidence of bleeding during their hospital stay in patients with reduced renal function receiving incorrect doses of bivalirudin or eptifibatide to the incidence of correct doses, based on manufacturer recommendations; secondary objectives were to determine the incidence of correct dosing based on manufacturer recommendations and the incidence of TIMI (Thrombolysis in Myocardial Infarction) major bleeding."( Incidence of bleeding in renally impaired patients receiving incorrectly dosed eptifibatide or bivalirudin while undergoing percutaneous coronary intervention.
Mauro, VF; Taylor, LA, 2012
)
0.8
"A chart review over a 32-month period showed that patients with reduced renal function who received either eptifibatide or bivalirudin during PCI were evaluated for correct dosing based on manufacturer recommendations, bleeding incidence according to the TIMI criteria, and extent of bleeding according to the TIMI and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) criteria."( Incidence of bleeding in renally impaired patients receiving incorrectly dosed eptifibatide or bivalirudin while undergoing percutaneous coronary intervention.
Mauro, VF; Taylor, LA, 2012
)
0.8
" Eptifibatide was dosed incorrectly in 64% of the patients."( Incidence of bleeding in renally impaired patients receiving incorrectly dosed eptifibatide or bivalirudin while undergoing percutaneous coronary intervention.
Mauro, VF; Taylor, LA, 2012
)
0.6
"Patients receiving incorrectly dosed eptifibatide and bivalirudin are susceptible to adverse bleeding events."( Incidence of bleeding in renally impaired patients receiving incorrectly dosed eptifibatide or bivalirudin while undergoing percutaneous coronary intervention.
Mauro, VF; Taylor, LA, 2012
)
0.85
" We reviewed individual pharmacy and medical records for laboratory and bivalirudin dosing information, medical comorbidities, and adverse clinical outcomes during administration."( Evaluation of dose requirements for prolonged bivalirudin administration in patients with renal insufficiency and suspected heparin-induced thrombocytopenia.
Becker, RC; Washam, JB; Wisler, JW, 2012
)
0.87
"To compare dosing strategies using total body weight (actual measured body weight), adjusted body weight, and ideal body weight when starting bivalirudin for the treatment for heparin-induced thrombocytopenia (HIT) in obese patients, and to compare differences in dosing requirements and clinical outcomes between obese and nonobese patients."( Comparison of bivalirudin dosing strategies using total, adjusted, and ideal body weights in obese patients with heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2012
)
0.94
" Of the three weight-based dosing approaches, total body weight followed by adjusted body weight provided the closest correlation to rates observed at the target aPTT goal."( Comparison of bivalirudin dosing strategies using total, adjusted, and ideal body weights in obese patients with heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2012
)
0.74
"This study provides evidence that the dosing strategy for bivalirudin based on total body weight is the most accurate predictor of achieving aPTT goal in obese patients with HIT."( Comparison of bivalirudin dosing strategies using total, adjusted, and ideal body weights in obese patients with heparin-induced thrombocytopenia.
Dager, WE; Tsu, LV, 2012
)
0.98
" To further explore the direct effect of anticoagulation on circulating angiogenic peptides, adult, male wild-type mice received venous injections of clinically dosed UFH or bivalirudin."( Distinct effects of unfractionated heparin versus bivalirudin on circulating angiogenic peptides.
Esposito, ML; Jaffe, IZ; Kapur, NK; Karas, RH; Mackey, EE; Mohammad, NN; Paruchuri, V; Qiao, X; Shah, A; Shenoy, C; Wilson, S; Yunis, AA, 2012
)
0.83
"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
)
0.89
" There have been few experiences published involving the pediatric population and controversy exists regarding the properties and optimal dosing of these drugs."( Alternative anticoagulation during cardiovascular procedures in pediatric patients with heparin-induced thrombocytopenia.
Argueta-Morales, IR; DeCampli, WM; Felix, DE; Munro, HM; Olsen, MC, 2012
)
0.38
" Dosing at LIC levels also induced more disaggregation than IV levels when aggregates were aged for 30 min prior to exposure."( Elevating local concentrations of GPIIb-IIIa antagonists counteracts platelet thrombus stability.
Furman, RR; Jennings, LK; Lands, LT; Moodie, GD; Speich, HE, 2013
)
0.39
"A retrospective chart review was conducted to compare selected outcome measures between cohorts of adults who received argatroban or bivalirudin therapy for suspected heparin-induced thrombocytopenia (HIT) before (n = 25) and after (n = 25) the implementation of an institutional DTI protocol under which properly trained and credentialed pharmacists have a primary role in dosing and monitoring DTI infusions."( Safety and effectiveness outcomes of an inpatient collaborative drug therapy management service for direct thrombin inhibitors.
Cooper, T; Kokko, H; Mazur, J; Taber, D; Uber, WE; White, CL, 2012
)
0.58
" Therefore, dosage adjustments may be necessary in patients with renal impairment."( [Optimal dose of bivalirudin in dialysis patients at high risk of heparin-induced thrombocytopenia undergoing percutaneous coronary intervention: case report].
Ardissino, D; Boffetti, F; Bontardelli, F; Coppini, L; Notarangelo, MF; Vignali, L, 2013
)
0.73
" In clinical trials, bivalirudin dosing was standardized, and activated clotting time (ACT) did not influence dosing adjustments."( Evaluation of bivalirudin hyper- and hypo-ACT responses in the setting of percutaneous coronary intervention.
Alkhateeb, HM; Diez, JG; Michaud, SE; Weeks, PA, 2013
)
1.07
"To facilitate the availability of bivalirudin [corrected] as an alternative direct thrombin inhibitor (DTI) for patients with HIT at The Ohio State University Wexner Medical Center (OSUWMC), a team of clinical pharmacists developed a nomogram designed to simplify infusion dosage adjustments by nurses."( Development and implementation of a nurse-driven, sliding-scale nomogram for bivalirudin in the management of heparin-induced thrombocytopenia.
Abel, EE; Belcher, M; Blais, DM; Burcham, PK; Gerlach, AT; Murphy, CV, 2013
)
0.9
"A nurse-driven, sliding-scale nomogram for bivalirudin therapy in patients with HIT provided a simple dosing protocol and resulted in a high rate of adherence by nurses."( Development and implementation of a nurse-driven, sliding-scale nomogram for bivalirudin in the management of heparin-induced thrombocytopenia.
Abel, EE; Belcher, M; Blais, DM; Burcham, PK; Gerlach, AT; Murphy, CV, 2013
)
0.88
" Except for two patients needing additional dosing in the heparin group, the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus."( Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention.
Fan, WM; Geng, SH; Gu, XL; Hu, R; Huang, WJ; Liu, ZZ; Pan, CM; Song, YM; Tang, LQ; Wan, HB; Xiang, DC; Xiao, FY; Yin, YH; Zhang, Y; Zhou, H, 2013
)
0.64
" Since it is a rarely used drug, clinical experience with its dosing is sparse."( Predicting and evaluating the effect of bivalirudin in cardiac surgical patients.
Edrich, T; Paschalidis, ICh; Zhao, Q, 2014
)
0.67
" Dosing variations representing possible under- or over-dosing of BIV were frequent at 35%."( Bivalirudin in percutaneous coronary intervention: the EUROpean BiValIrudin UtiliSatION in Practice (EUROVISION) Registry.
Amabile, N; Bernstein, D; Deliargyris, E; Galli, S; Hamon, M; Hill, JM; Huber, K; Lafont, A; Lipiecki, J; Nienaber, CA; Steg, PG, 2014
)
1.85
" 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
" Since it is not a commonly used drug, clinical experience with its dosing is sparse."( Adaptive control of bivalirudin in the cardiac intensive care unit.
Edrich, T; Paschalidis, IC; Zhao, Q, 2015
)
0.74
"Excess dosing of anticoagulant agents has been linked to increased risk of bleeding after percutaneous coronary intervention (PCI) for women compared with men, but these studies have largely included older patients."( Frequency and Effects of Excess Dosing of Anticoagulants in Patients ≤55 Years With Acute Myocardial Infarction Who Underwent Percutaneous Coronary Intervention (from the VIRGO Study).
Alexander, KP; Chui, P; Curtis, JP; D' Onofrio, G; Geda, M; Gupta, A; Krumholz, HM; Lee, I; Lichtman, JH; Lorenze, N; Spertus, JA; Zhou, S, 2015
)
0.42
"To determine appropriate dosing of bivalirudin in children and adolescents and the relationship between activated partial thromboplastin time (APTT) and plasma bivalirudin concentration."( UNBLOCK: an open-label, dose-finding, pharmacokinetic and safety study of bivalirudin in children with deep vein thrombosis.
Goldenberg, NA; Lira, J; O'Brien, SH; Yee, DL; Young, G, 2015
)
0.92
"To evaluate the safety, effectiveness, and dosing of off-label bivalirudin to argatroban and lepirudin in patients with heparin-induced thrombocytopenia (HIT) using a new pharmacist driven protocol."( Comparison of bivalirudin to lepirudin and argatroban in patients with heparin-induced thrombocytopenia.
Bain, J; Meyer, A, 2015
)
1.02
" A bivalirudin treatment protocol was developed with the initial dosage and dosage adjustments based on the value of activated partial thromboplastin time (aPTT), the risk of bleeding, and the recurrence of ECT."( Successful use of a bivalirudin treatment protocol to prevent extracorporeal thrombosis in ambulatory hemodialysis patients with heparin-induced thrombocytopenia.
Abdulla, AE; Al-Ali, FS; Bouanane, H; Elsayed, M; Hamad, A; Ibrahim, R; Khalifa, S; Tolba, H, 2016
)
1.38
" The evidence available is complicated by variances in use of glycoprotein IIb/IIIa inhibitors (GPIs), P2Y12 inhibitors, access sites, and anticoagulant dosing strategies."( Heparin Versus Bivalirudin Monotherapy in the Setting of Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction.
Beavers, JC; Faulkenberg, KD; Finks, SW, 2016
)
0.79
" We aimed at evaluating its safety and its optimal dosing for ECMO."( Bivalirudin for Alternative Anticoagulation in Extracorporeal Membrane Oxygenation: A Systematic Review.
Asmussen, S; Erdoes, G; Fraser, JF; Maybauer, DM; Maybauer, MO; Sanfilippo, F; Santonocito, C, 2017
)
1.9
" Excess dosing of UFH (75."( Trends in use of anti-thrombotic agents and outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) managed with an invasive strategy.
Alexander, KP; Chen, AY; de Lemos, JA; Giugliano, RP; Gupta, RS; Newby, LK; Roe, MT; Sanborn, TA; Saucedo, JF; Wayangankar, SA,
)
0.13
" There were sizeable reductions in the rates of excess dosing of UFH (though still occurred in 67% of patients), GPI and LMWH."( Trends in use of anti-thrombotic agents and outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) managed with an invasive strategy.
Alexander, KP; Chen, AY; de Lemos, JA; Giugliano, RP; Gupta, RS; Newby, LK; Roe, MT; Sanborn, TA; Saucedo, JF; Wayangankar, SA,
)
0.13
" This retrospective analysis evaluated the dosing and outcomes associated with bivalirudin use in 14 adult ECLS patients."( Bivalirudin Dosing Requirements in Adult Patients on Extracorporeal Life Support With or Without Continuous Renal Replacement Therapy.
Dager, WE; Louie, EL; Roberts, AJ; Walker, EA, 2019
)
2.18
" For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants."( STS/SCA/AmSECT Clinical Practice Guidelines: Anticoagulation during Cardiopulmonary Bypass.
Baker, RA; Ferraris, V; Fitzgerald, D; Greilich, PE; Hammon, J; Roman, P; Shore-Lesserson, L, 2018
)
0.48
" The objective of this analysis was to assess if a comprehensive bivalirudin dosing and monitoring protocol effectively guides dose adjustments and monitoring of bivalirudin in patients during ECMO."( Bivalirudin Anticoagulation Dosing Protocol for Extracorporeal Membrane Oxygenation: A Retrospective Review.
Greenlee, J; Hart, S; Netley, J; Roy, J; Statz, B; Todt, M, 2018
)
2.16
"To determine the safety and efficacy of bivalirudin as an anticoagulant for pediatric open heart surgery (OHS) and to determine its appropriate dosage for this purpose."( Randomized Controlled Trial of Heparin Versus Bivalirudin Anticoagulation in Acyanotic Children Undergoing Open Heart Surgery.
Chauhan, S; Chowdhury, UK; Hasija, S; Krishna, NS; Makhija, N; Malhotra, P; Sharma, G; Talwar, S, 2018
)
1.01
" We reviewed case reports and case series of IVIG for treating HIT, focusing on various IVIG dosing regimens used."( Autoimmune heparin-induced thrombocytopenia and venous limb gangrene after aortic dissection repair: in vitro and in vivo effects of intravenous immunoglobulin.
Arcinas, LA; Dao, V; Hrymak, C; Manji, RA; Sheppard, JI; Warkentin, TE, 2019
)
0.51
" Our literature review indicated 1 g/kg × 2 IVIG dosing as most common for treating HIT, usually associated with rapid PLT count recovery."( Autoimmune heparin-induced thrombocytopenia and venous limb gangrene after aortic dissection repair: in vitro and in vivo effects of intravenous immunoglobulin.
Arcinas, LA; Dao, V; Hrymak, C; Manji, RA; Sheppard, JI; Warkentin, TE, 2019
)
0.51
" Our case experience and literature review suggests dosing of 1 g/kg IVIG × 2 for patients with severe aHIT."( Autoimmune heparin-induced thrombocytopenia and venous limb gangrene after aortic dissection repair: in vitro and in vivo effects of intravenous immunoglobulin.
Arcinas, LA; Dao, V; Hrymak, C; Manji, RA; Sheppard, JI; Warkentin, TE, 2019
)
0.51
" There is a robust literature describing its safety and efficacy in adults; however, its use in the pediatric population is relatively rare, with dosing extrapolated from adult data."( Titration of Bivalirudin Infusion in the Pediatric Cardiac Catheterization Laboratory: A Case Report.
DiNardo, J; Streiff, A; Zaleski, K, 2019
)
0.88
" Further studies are warranted for head to head comparison of bivalirudin to heparin monotherapy to establish an optimal heparin dosing regimen and post-PCI bivalirudin infusion to affirm its beneficial effect in reducing acute stent thrombosis."( Bivalirudin Versus Heparin During Intervention in Acute Coronary Syndrome: A Systematic Review of Randomized Trials.
Bagai, J; Bhogal, S; Mukherjee, D; Murtaza, G; Panchal, HB; Paul, TK; Sachdeva, R; Truong, HT; Zaman, M, 2020
)
2.24
" All PD endpoints showed dose-response relationship, and their changes over time paralleled those of CTB-101 concentrations."( Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of CTB-001, a Recently Developed Generic of Bivalirudin.
Bae, KS; Choi, HY; Han, S; Kim, MJ; Kim, WJ; Kim, YH; Lim, HS; Park, H, 2019
)
0.72
"The modeling and simulation analysis well-characterized the PK and PD of CTB-001 in healthy Koreans, which will be valuable for identifying optimal dosing regimens of CBT-001."( Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of CTB-001, a Recently Developed Generic of Bivalirudin.
Bae, KS; Choi, HY; Han, S; Kim, MJ; Kim, WJ; Kim, YH; Lim, HS; Park, H, 2019
)
0.72
"Younger age, normal renal function, and nonadherence to the dosing protocol when targeting therapeutic anticoagulation is associated with increased risk of failure to achieve ETA."( Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study.
Abel, EE; Blais, DM; Burcham, PK; Orzel, LA; Porter, KA; Wang, TF, 2019
)
0.74
" Our findings support the concept of age-specific pharmaco-dynamic responses to Bivalirudin and support the need for further ex vivo studies in hospitalised children to determine accurate clinical dosing recommendations."( Age-specific differences in the in vitro anticoagulant effect of Bivalirudin in healthy neonates and children compared to adults.
Busuttil-Crellin, X; Cowley, J; Ignjatovic, V; Letunica, N; Monagle, P, 2020
)
1.02
"Although heparin has previously been the anticoagulant of choice during mechanical circulatory support (MCS), there is a lack of consistency in dose-response in pediatric patients."( Description of Bivalirudin Use for Anticoagulation in Pediatric Patients on Mechanical Circulatory Support.
Campbell, CT; Diaz, L; Kelly, B, 2021
)
0.97
"Bivalirudin dosing in ECMO and VAD patients is consistent with dosing seen in previous reports but may be higher in VAD patients."( Description of Bivalirudin Use for Anticoagulation in Pediatric Patients on Mechanical Circulatory Support.
Campbell, CT; Diaz, L; Kelly, B, 2021
)
2.42
" Consistent dose-response relationships between bivalirudin and aPTT or TEG-R were not seen, but gradually increasing doses were needed to maintain therapeutic anticoagulation."( A perioperative bivalirudin anticoagulation protocol for neonates with congenital diaphragmatic hernia on extracorporeal membrane oxygenation.
Goldenberg, NA; Kays, DW; Nguyen, ATH; Smithers, CJ; Snyder, CW, 2020
)
1.16
" Nine patients were included in the evaluation which analyzed Impella device purge flow and purge pressure along with bivalirudin dosing requirements, incidence of thrombosis, and incidence of pump failure."( Anticoagulation with temporary Impella device in patients with heparin-induced thrombocytopenia: A case series.
Hohlfelder, B; Militello, MA; Soltesz, EG; Tong, MZ; Wanek, MR, 2021
)
0.83
"The purpose of this study was to evaluate the utilization of a pharmacist-driven bivalirudin dosing protocol for anticoagulation in the setting of ECMO for COVID-19-associated respiratory failure."( Evaluation of Bivalirudin as the Primary Anticoagulant in Patients Receiving Extracorporeal Membrane Oxygenation for SARS-CoV-2-Associated Acute Respiratory Failure.
Ather, A; Baz, MA; Bissell, BD; Davis, GA; Gabbard, T; Sheridan, EA, 2022
)
1.31
" The authors set out to compare the pharmacologic characteristics and dosing requirements of bivalirudin in patients requiring ECMO support for ARDS due to COVID-19 versus ARDS from other etiologies."( Efficacy of Bivalirudin for Therapeutic Anticoagulation in COVID-19 Patients Requiring ECMO Support.
Anderson, E; Garcia, J; Hage, C; Jennings, M; Kapoor, R; Moiz, S; Porter, S; Rahman, O; Smith, N; Trigonis, R, 2022
)
1.32
" However, dosing is not well described in those requiring continuous renal replacement therapy (CRRT)."( Impact of Continuous Renal Replacement Therapy on Bivalirudin Dosing in Pediatric Extracorporeal Membrane Oxygenation.
Abarbanell, AM; Burns, EL; Gu, H; Lahart, MA; Neumayr, TM; Said, AS; Streb, MM, 2022
)
0.97
"To determine the dosage of bivalirudin as the anticoagulant for cardiac surgery in neonates and infants."( Bivalirudin anticoagulation in neonates and infants undergoing cardiac surgery.
Chauhan, S; Hasija, S; Hote, MP; Khan, MA; Makhija, N; Malhotra, P; Sharma, G, 2022
)
2.46
" This multicenter retrospective analysis evaluated the bivalirudin dosing in pediatric ECMO and correlated these doses with the severity of renal dysfunction."( Evaluation of Bivalirudin Dosing in Pediatric Extracorporeal Membrane Oxygenation with Renal Insufficiency or Renal Replacement Therapy.
Beshish, AG; Byrnes, JW; Hall, J; Hamzah, M; Niebler, RA; Seelhammer, TG; Wang, L; Yabrodi, M, 2022
)
1.33
" Further research is warranted to address the optimal test to guide clinical decision-making for anticoagulation dosing in ECMO patients."( Correlation between partial thromboplastin time and thromboelastography in adult critically ill patients requiring bivalirudin for extracorporeal membrane oxygenation.
Benanti, GE; Buckley, MS; Gilbert, B; Korkames, G; MacLaren, R; McNierney, DA; Meckel, J; O'Hea, JA; Park, A; Puebla Neira, D; Tekle, LA; Yerondopoulos, M, 2023
)
1.12
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
anticoagulantAn agent that prevents blood clotting.
EC 3.4.21.5 (thrombin) inhibitorAn EC 3.4.21.* (serine endopeptidase) inhibitor that interferes with the action of thrombin (EC 3.4.21.5).
[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 (1)

ClassDescription
polypeptideA peptide containing ten or more amino acid residues.
[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]

Protein Targets (4)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (41)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (24)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (17)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (7)

Assay IDTitleYearJournalArticle
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID1345816Human coagulation factor II, thrombin (S1: Chymotrypsin)1992The Biochemical journal, May-01, Volume: 283 ( Pt 3)Thrombin-specific inhibition by and slow cleavage of hirulog-1.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,263)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's92 (7.28)18.2507
2000's390 (30.88)29.6817
2010's633 (50.12)24.3611
2020's148 (11.72)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 64.54

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index64.54 (24.57)
Research Supply Index7.37 (2.92)
Research Growth Index5.05 (4.65)
Search Engine Demand Index111.70 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (64.54)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials263 (19.88%)5.53%
Reviews301 (22.75%)6.00%
Case Studies133 (10.05%)4.05%
Observational47 (3.55%)0.25%
Other579 (43.76%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (67)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention (PCI) [NCT03567408]Phase 2200 participants (Anticipated)Interventional2018-09-15Not yet recruiting
Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction [NCT01160900]Phase 3180 participants (Anticipated)Interventional2010-07-31Active, not recruiting
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 Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction [NCT02448550]Phase 3250 participants (Actual)Interventional2015-05-31Terminated
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial [NCT03822975]6,016 participants (Actual)Interventional2019-02-14Active, not recruiting
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation [NCT03318393]Phase 430 participants (Actual)Interventional2018-03-25Completed
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2) [NCT03965208]Phase 434 participants (Anticipated)Interventional2019-05-23Recruiting
BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO) [NCT05959252]Phase 280 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Clinical Trial Program of a Medical Instrument Product [NCT01157455]Phase 41,900 participants (Anticipated)Interventional2010-05-31Recruiting
Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention [NCT03882775]Phase 4240 participants (Anticipated)Interventional2019-01-16Recruiting
A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support [NCT03707418]Phase 10 participants (Actual)Interventional2021-04-30Withdrawn(stopped due to unable to secure funding)
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty [NCT02592694]Phase 41,000 participants (Anticipated)Interventional2015-10-31Recruiting
Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention [NCT04046029]Phase 4240 participants (Anticipated)Interventional2019-07-08Recruiting
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3) [NCT01651780]Phase 3803 participants (Actual)Interventional2012-10-31Completed
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction [NCT03537586]135 participants (Anticipated)Interventional2018-06-29Recruiting
Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary An [NCT00433966]Phase 33,602 participants (Actual)Interventional2005-03-31Completed
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study [NCT01084993]Phase 42,000 participants (Anticipated)Interventional2010-03-31Recruiting
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
Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention [NCT04475835]100 participants (Anticipated)Interventional2021-01-12Recruiting
Bivalirudin PCI Registry in HIT/HITTS Patients [NCT00759083]Phase 40 participants (Actual)Interventional2008-09-30Withdrawn(stopped due to The study was discontinued early due to inadequate patient enrollment. No patients were enrolled.)
[NCT00616460]Phase 3100 participants (Actual)Interventional2008-02-29Completed
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI [NCT02787317]Phase 41,770 participants (Anticipated)Interventional2016-05-31Not yet recruiting
The Efficiency and Safety of Bivalirudin in latE percuTaneous Coronary inTervention for Patients With ST-Elevation Myocardial InfaRction (BETTER Trial) [NCT04185077]Phase 41,200 participants (Anticipated)Interventional2019-11-30Not yet recruiting
Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients [NCT00669149]Phase 499 participants (Actual)Interventional2008-06-30Terminated(stopped due to recruitment difficulties)
Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS) [NCT02592720]Phase 4500 participants (Anticipated)Interventional2015-10-31Recruiting
An Open-label, Dose-finding, Pharmacokinetic, Safety and Efficacy Study of Bivalirudin in Children Between 6 Months and 18 Years of Age [NCT00812370]Phase 118 participants (Actual)Interventional2008-09-30Completed
A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study To Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention [NCT01848106]Phase 33,232 participants (Actual)Interventional2013-09-30Terminated(stopped due to Clinical Hold)
Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III [NCT00464087]Phase 3100 participants (Actual)Interventional2007-06-30Completed
Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms: an Open-label, Multicenter, Randomized Pilot Study(BUILD) [NCT04532333]Phase 3236 participants (Anticipated)Interventional2020-08-31Not yet recruiting
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects [NCT01647893]Phase 133 participants (Anticipated)Interventional2012-07-31Recruiting
A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients With ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI) [NCT00093184]Phase 3300 participants Interventional2004-04-30Completed
Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial [NCT01555658]Phase 3204 participants (Anticipated)Interventional2012-04-30Not yet recruiting
Comparison of Bivalirudin and Unfractioned Heparin in Elective Percutaneous Coronary Interventions [NCT00448461]Phase 4850 participants (Actual)Interventional2007-03-31Completed
Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease [NCT00503126]Phase 2110 participants (Actual)Interventional2007-08-31Completed
Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial [NCT02897037]Phase 3380 participants (Anticipated)Interventional2016-11-30Recruiting
Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion [NCT04195997]Phase 4100 participants (Anticipated)Interventional2020-02-01Not yet recruiting
The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function [NCT03588611]Phase 4204 participants (Actual)Interventional2019-10-01Completed
Prospective, Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Bivalirudin and Un-fractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions. ISAR-REACT-3 [NCT00262054]Phase 44,570 participants (Actual)Interventional2005-11-30Completed
Angiomax in Patients With HIT/HITTS Type II Undergoing Off-PUMP CABG [NCT00073580]Phase 388 participants (Actual)Interventional2003-10-31Completed
A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB) [NCT00079508]Phase 3125 participants (Actual)Interventional2004-04-30Completed
A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB) [NCT00079586]Phase 3150 participants (Actual)Interventional2004-04-30Completed
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation [NCT03532399]30 participants (Anticipated)Observational2018-07-12Recruiting
The ACUITY Trial: A Randomized Comparison of Angiomax (Bivalirudin) Versus Heparin (Unfractionated Heparin or Enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation [NCT00093158]Phase 313,800 participants Interventional2003-08-31Completed
Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin) [NCT01087723]Phase 32,198 participants (Actual)Interventional2010-03-31Completed
Bivalirudin in Patient at High Risk of Bleeding Undergoing Percutaneous Coronary Interventions. [NCT01465503]Phase 3837 participants (Actual)Interventional2008-01-31Completed
STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention [NCT01464671]Phase 4260 participants (Actual)Interventional2009-07-31Terminated(stopped due to DSMB halted the study early due to futility. There were no safety concerns.)
A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery [NCT00073593]Phase 3150 participants (Actual)Interventional2003-08-31Completed
Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis [NCT00043277]Phase 225 participants Interventional2002-08-31Completed
Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia [NCT00043940]Phase 350 participants (Actual)Interventional1999-04-30Completed
Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve [NCT02384070]300 participants (Actual)Interventional2009-01-31Completed
RIAPRE - A Non-interventional Registry on the Anticoagulation Treatment in High Risk Elective Percutaneous Coronary Interventions [NCT00317343]0 participants (Actual)Observational2006-03-31Withdrawn
European Registry of Consecutive Patients Undergoing PCI Evaluating the Use of the Thrombin-specific Anticoagulant Bivalirudin With Focus on Patient Selection, Convenience and Safety Aspects. [NCT00290849]4,000 participants Observational2005-03-31Completed
Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial [NCT01696110]Phase 42,194 participants (Actual)Interventional2012-08-31Completed
The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial [NCT01848899]Phase 4100 participants (Actual)Interventional2013-02-28Completed
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
A Randomised Controlled Trial to Compare Unfractionated Heparin Versus Bivalirudin in the Treatment of Patients With a Clinical Diagnosis of ST-Segment Elevation Myocardial Infarction Events - For Planned Management With Primary PCI [NCT01519518]Phase 41,829 participants (Actual)Interventional2012-02-29Completed
Phase IIIb Study Minimizing Adverse Haemmhorragic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) [NCT01433627]Phase 37,200 participants (Anticipated)Interventional2011-10-31Active, not recruiting
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform [NCT02311231]Phase 46,012 participants (Actual)Interventional2014-06-30Completed
Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome [NCT03664180]Phase 42,989 participants (Actual)Interventional2019-01-11Completed
Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial [NCT05334654]58 participants (Actual)Interventional2022-04-20Completed
Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions (ISAR-REACT-4) [NCT00373451]Phase 41,721 participants (Actual)Interventional2006-07-31Completed
Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin -The CLEAR PLATELETS-2 Study [NCT00370045]Phase 4200 participants Interventional2006-03-31Recruiting
Bivalirudin Infusion for Ventricular Infarction Limitation [NCT02565147]Phase 378 participants (Actual)Interventional2014-12-19Terminated(stopped due to Futility at the interim analysis.)
Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After Elective PCI in Patients With CHD (COBER Study) [NCT04120961]330 participants (Actual)Interventional2019-09-20Completed
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial [NCT01913483]Phase 3732 participants (Actual)Interventional2013-09-24Terminated
A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation. [NCT05984537]Phase 470 participants (Anticipated)Interventional2023-07-01Active, not recruiting
Anticoagulation in Patients Suffering From COVID-19 Disease-The Anti-Co Trial [NCT04445935]Phase 4100 participants (Anticipated)Interventional2020-06-28Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00433966 (7) [back to overview]Pharmacology Arm - Major Adverse Cardiovascular Events
NCT00433966 (7) [back to overview]Pharmacology Arm - Major Adverse Cardiovascular Events
NCT00433966 (7) [back to overview]Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
NCT00433966 (7) [back to overview]Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
NCT00433966 (7) [back to overview]Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
NCT00433966 (7) [back to overview]Stent Arm - Ischemic Target Lesion Revascularization
NCT00433966 (7) [back to overview]Stent Arm - Segment Binary Angiographic Restenosis
NCT00464087 (4) [back to overview]Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT01087723 (9) [back to overview]The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding
NCT01087723 (9) [back to overview]The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)
NCT01087723 (9) [back to overview]The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding
NCT01087723 (9) [back to overview]The Incidence of Death at 1 Year
NCT01087723 (9) [back to overview]The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])
NCT01087723 (9) [back to overview]The Incidence of Stroke
NCT01087723 (9) [back to overview]The Incidence of Thrombocytopenia
NCT01087723 (9) [back to overview]The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)
NCT01087723 (9) [back to overview]The Incidence of Minor Bleeding: TIMI and GUSTO
NCT01519518 (4) [back to overview]Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization
NCT01519518 (4) [back to overview]Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition
NCT01519518 (4) [back to overview]Stent Thrombosis Rate (ARC Definite or Probable)
NCT01519518 (4) [back to overview]Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition
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
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
NCT01651780 (12) [back to overview]Transient Ischemic Attack
NCT01651780 (12) [back to overview]Acute Kidney Injury
NCT01651780 (12) [back to overview]Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
NCT01651780 (12) [back to overview]NACE at 48 Hours or Before Hospital Discharge
NCT01651780 (12) [back to overview]Net Adverse Clinical Events (NACE) at up to 30 Days
NCT01651780 (12) [back to overview]Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
NCT01651780 (12) [back to overview]Acquired Thrombocytopenia
NCT01651780 (12) [back to overview]Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
NCT01651780 (12) [back to overview]Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
NCT01651780 (12) [back to overview]Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
NCT01651780 (12) [back to overview]Major Vascular Complications
NCT01651780 (12) [back to overview]New Onset Atrial Fibrillation/Flutter
NCT01848899 (5) [back to overview]Percent Change in Maximal Platelet Aggregation: ADP
NCT01848899 (5) [back to overview]Percent Change in Maximal Platelet Aggregation: Arachidonic Acid
NCT01848899 (5) [back to overview]Percent Change in Maximal Platelet Aggregation: Epinephrine
NCT01848899 (5) [back to overview]Thrombin Generation Test: After Coronary Angiography
NCT01848899 (5) [back to overview]Thrombin Generation Test: Baseline
NCT01913483 (3) [back to overview]Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
NCT01913483 (3) [back to overview]Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
NCT01913483 (3) [back to overview]Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
NCT02384070 (3) [back to overview]Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure
NCT02384070 (3) [back to overview]Thrombotic Complications
NCT02384070 (3) [back to overview]TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
NCT02565147 (9) [back to overview]CMR Assessment Of Infarct Size At Day 5
NCT02565147 (9) [back to overview]CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5
NCT02565147 (9) [back to overview]CMR Assessment Of LVEF At Day 90
NCT02565147 (9) [back to overview]Death At Day 90
NCT02565147 (9) [back to overview]Index Of Microcirculatory Resistance (IMR)
NCT02565147 (9) [back to overview]Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5
NCT02565147 (9) [back to overview]CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5
NCT02565147 (9) [back to overview]TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI
NCT02565147 (9) [back to overview]CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5
NCT03318393 (3) [back to overview]Percentage of Time Spent at Goal Anticoagulation
NCT03318393 (3) [back to overview]Number of Participants With One or More Major Bleeding Events
NCT03318393 (3) [back to overview]Number of Blood Products Transfused

Pharmacology Arm - Major Adverse Cardiovascular Events

Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) (NCT00433966)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Pharmacology Arm - Bivalirudin98
Pharmacology Arm - Unfractionated Heparin99

[back to top]

Pharmacology Arm - Major Adverse Cardiovascular Events

Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) (NCT00433966)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Pharmacology Arm - Bivalirudin379
Pharmacology Arm - Unfractionated Heparin377

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Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events

Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting). (NCT00433966)
Timeframe: 30 Days

InterventionParticipants (Count of Participants)
Pharmacology Arm - Bivalirudin166
Pharmacology Arm - Unfractionated Heparin218

[back to top] [back to top]

Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis

Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis (NCT00433966)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Stent Arm - Paclitaxel-Eluting Stent181
Stent Arm - Bare Metal Stent59

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Stent Arm - Ischemic Target Lesion Revascularization

Number of Participants With Ischemic Target Lesion Revascularization (NCT00433966)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Stent Arm - Paclitaxel-Eluting Stent98
Stent Arm - Bare Metal Stent54

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Stent Arm - Segment Binary Angiographic Restenosis

Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset). (NCT00433966)
Timeframe: 13 months

InterventionParticipants (Count of Participants)
Stent Arm - Paclitaxel-Eluting Stent102
Stent Arm - Bare Metal Stent76

[back to top]

Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis

Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis (NCT00464087)
Timeframe: during index hospitalization

Interventionparticipants (Number)
Heparin4
Bivalirudin4

[back to top]

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after randomization, during PCI

Interventionparticipants (Number)
Heparin0
Bivalirudin0

[back to top]

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after Fondaparinux administration, prior to randomization

Interventionparticipants (Number)
Heparin0
Bivalirudin0

[back to top]

The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after PCI

Interventionparticipants (Number)
Heparin0
Bivalirudin1

[back to top]

The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding

A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion. (NCT01087723)
Timeframe: Within 30 days

Interventionpercentage of participants (Number)
Bivalirudin5.1
Standard of Care: Heparins With Optional GPI8.5

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The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment. (NCT01087723)
Timeframe: Within 30 days

,
Interventionpercentage of participants (Number)
Major bleeding: TIMIMajor bleeding: GUSTO
Bivalirudin1.31.3
Standard of Care: Heparins With Optional GPI2.12.3

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The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding

A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI. (NCT01087723)
Timeframe: Within 30 days

Interventionpercentage of participants (Number)
Bivalirudin6.6
Standard of Care: Heparins With Optional GPI9.2

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The Incidence of Death at 1 Year

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. (NCT01087723)
Timeframe: Within 1 Year

Interventionpercentage of participants (Number)
Bivalirudin5.4
Standard of Care: Heparins With Optional GPI5.3

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The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis. (NCT01087723)
Timeframe: Within 30 days

Interventionpercentage of participants (Number)
Bivalirudin1.6
Standard of Care: Heparins With Optional GPI0.5

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The Incidence of Stroke

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma. (NCT01087723)
Timeframe: Within 30 days

Interventionpercentage of participants (Number)
Bivalirudin0.6
Standard of Care: Heparins With Optional GPI1.0

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The Incidence of Thrombocytopenia

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3. (NCT01087723)
Timeframe: Within 30 days

Interventionpercentage of participants (Number)
Bivalirudin0.7
Standard of Care: Heparins With Optional GPI1.4

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The Incidence of Minor Bleeding: TIMI and GUSTO

Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise. (NCT01087723)
Timeframe: Within 30 days

,
Interventionpercentage of participants (Number)
Minor bleeding: TIMIMinor bleeding: GUSTO
Bivalirudin6.56.5
Standard of Care: Heparins With Optional GPI11.211.0

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Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization

(NCT01519518)
Timeframe: 28 days

Interventionpercentage of total participants (Number)
Unfractionated Heparin5.7
Bivalirudin8.7

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Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition

(NCT01519518)
Timeframe: 28 days

Interventionpercentage of total participants (Number)
Unfractionated Heparin10.8
Bivalirudin9.2

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Stent Thrombosis Rate (ARC Definite or Probable)

(NCT01519518)
Timeframe: 28 days

Interventionpercentage of total participants (Number)
Unfractionated Heparin0.9
Bivalirudin3.4

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Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition

(NCT01519518)
Timeframe: 28 days

Interventionpercentage of total participants (Number)
Unfractionated Heparin3.1
Bivalirudin3.5

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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: 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: 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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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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Transient Ischemic Attack

The percentage of participants reporting transient ischemic attack is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

,
Interventionpercentage of participants (Number)
at 48 hours or before hospital dischargeat up to 30 days (±7 days) follow-up
Bivalirudin00
Unfractionated Heparin (UFH)00

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Acute Kidney Injury

The percentage of participants reporting acute kidney injury is presented. (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

,
Interventionpercentage of participants (Number)
at 48 hours or before hospital dischargeat up to 30 days (±7 days) follow-up
Bivalirudin10.918.8
Unfractionated Heparin (UFH)6.513.8

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Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge

"Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:~Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.~BARC 3c includes intracranial or intraocular bleeds that compromised vision.~BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.~BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause." (NCT01651780)
Timeframe: at 48 hours or discharge, whichever occurs first

Interventionpercentage of participants (Number)
Bivalirudin6.9
Unfractionated Heparin (UFH)9

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NACE at 48 Hours or Before Hospital Discharge

NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier

Interventionpercentage of participants (Number)
Bivalirudin8.9
Unfractionated Heparin (UFH)12.6

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Net Adverse Clinical Events (NACE) at up to 30 Days

The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. (NCT01651780)
Timeframe: up to 30 days after procedure

Interventionpercentage of participants (Number)
Bivalirudin14.4
Unfractionated Heparin (UFH)16.1

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Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge

The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented. (NCT01651780)
Timeframe: Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)

Interventionpercentage of participants (Number)
Bivalirudin: First Half of Study Site's Enrolled Participants6.4
Bivalirudin: Second Half of Study Site's Enrolled Participants6.4
UFH: First Half of Study Site's Enrolled Participants11.6
UFH: Second Half of Study Site's Enrolled Participants8.5

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Acquired Thrombocytopenia

The percentage of participants reporting acquired thrombocytopenia is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

,
Interventionpercentage of participants (Number)
at 48 hours or before hospital dischargeat up to 30 days (±7 days)
Bivalirudin16.624
Unfractionated Heparin (UFH)17.323.1

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Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor

The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented. (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

,
Interventionpercentage of participants (Number)
BARC 3a at 48 hours or hospital dischargeBARC types 1 and 2 at 48 hours or dischargeTIMI minor at 48 hours or hospital dischargeBARC 3a at 30 daysBARC types 1 and 2 at 30 daysTIMI minor at 30 days
Bivalirudin15.620.816.618.827.721.3
Unfractionated Heparin (UFH)13.321.114.317.325.619.3

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Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke

The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

,
Interventionpercentage of participants (Number)
MACE at 48 hours or before hospital dischargeDeath at 48 hours or before hospital dischargeMI at 48 hours or before hospital dischargeStroke at 48 hours or before hospital dischargeMACE at up to 30 daysDeath at up to 30 daysMI at up to 30 daysStroke at up to 30 days
Bivalirudin3.51.5027.74.70.53.5
Unfractionated Heparin (UFH)4.81.81.3284.81.82.8

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Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)

"Percentage of participants with major bleeding according to the following scales:~Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding~Thrombolysis in Myocardial Infarction (TIMI)=major bleeding~Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate~Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding" (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

,
Interventionpercentage of participants (Number)
VARC at 48 hours or before hospitalTIMI at 48 hours or before hospitalGUSTO at 48 hours or hospital dischargeACUITY/HORIZONS at 48 hours or hospital dischargeVARC at 30 daysTIMI at 30 daysGUSTO at 30 daysACUITY/HORIZONS at 30 days
Bivalirudin21.8413.92626.55.716.333.4
Unfractionated Heparin (UFH)19.66.511.624.424.67.314.629.6

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Major Vascular Complications

The percentage of participants reporting a major vascular complications as defined by VARC is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

,
Interventionpercentage of participants (Number)
at 48 hours or before hospital dischargeat up to 30 days (±7 days) follow-up
Bivalirudin8.79.2
Unfractionated Heparin (UFH)99.5

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New Onset Atrial Fibrillation/Flutter

The percentage of participants reporting new onset atrial fibrillation/flutter is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

,
Interventionpercentage of participants (Number)
at 48 hours or before hospital dischargeat up to 30 days (±7 days) follow-up
Bivalirudin3.25.4
Unfractionated Heparin (UFH)2.54

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Percent Change in Maximal Platelet Aggregation: ADP

Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP (NCT01848899)
Timeframe: 1 hour

InterventionPercent change (Median)
Ioxaglate Arm-3
Iodixanol Arm.05

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Percent Change in Maximal Platelet Aggregation: Arachidonic Acid

Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid (NCT01848899)
Timeframe: 1 hour

InterventionPercent change (Median)
Ioxaglate Arm38.1
Iodixanol Arm36.0

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Percent Change in Maximal Platelet Aggregation: Epinephrine

Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine (NCT01848899)
Timeframe: Baseline to 1 hour

InterventionPercent change (Median)
Ioxaglate Arm5.4
Iodixanol Arm25.7

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Thrombin Generation Test: After Coronary Angiography

The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. (NCT01848899)
Timeframe: 1 hour

InterventionnM*minutes (Median)
Ioxaglate Arm649
Iodixanol Arm681

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Thrombin Generation Test: Baseline

The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus. (NCT01848899)
Timeframe: baseline

InterventionnM*minutes (Median)
Ioxaglate Arm1810
Iodixanol Arm1682

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Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration

"Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation." (NCT01913483)
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first

,
Interventionparticipants (Number)
Bleed (BARC ≥ Type 2)TIMI majorTIMI minorDeathMIStroke/TIAAmputationURVNACE
Bivalirudin4704000027
Unfractionated Heparin4241100026

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Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)

"BARC ≥3 includes:~Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.~Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.~Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death." (NCT01913483)
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first

Interventionpercentage of participants (Number)
Bivalirudin1.5
Unfractionated Heparin1.6

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Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30

"Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation." (NCT01913483)
Timeframe: Study drug initiation (Day 1) up to 30 days

,
Interventionparticipants (Number)
Bleed (BARC ≥ Type 2)Bleed (BARC ≥ Type 3)DeathMIStroke/TIAAmputationURVMACE (Death/MI/Stroke/Amputation/URV)NACE
Bivalirudin536201891822
Unfractionated Heparin5173125111923

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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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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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CMR Assessment Of Infarct Size At Day 5

Size of cardiac infarct, expressed as grams, as assessed by CMR. The use of CMR has dramatically improved the ability for accurate infarct size estimations and is therefore currently considered the gold standard. The number of participants and their mean reported infarct size, as grams, at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI

InterventionGrams (Mean)
PPCI With Bivalirudin25.0
PPCI With Heparin27.1

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CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5

Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI

InterventionPercentage of Blood (Mean)
PPCI With Bivalirudin48.5
PPCI With Heparin48.6

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CMR Assessment Of LVEF At Day 90

Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 90 are presented. (NCT02565147)
Timeframe: 90 days post PPCI

InterventionPercentage of Blood (Mean)
PPCI With Bivalirudin54.6
PPCI With Heparin49.1

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Death At Day 90

Participant survival during the clinical follow-up period is presented as the number of participants with reported death at 90 days post PPCI. (NCT02565147)
Timeframe: 90 days post PPCI

InterventionParticipants (Number)
PPCI With Bivalirudin0
PPCI With Heparin1

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Index Of Microcirculatory Resistance (IMR)

"IMR, a predictor of clinical outcome, is a readily available, quantitative, and reproducible method for invasively assessing coronary microvascular function. It is measured using the thermodilution technique and defined as mean distal coronary pressure, expressed in millimeters (mm) of mercury (Hg), multiplied by the mean hyperemic transit time (s) (mmHg*s). Higher IMR values indicate poorer microcirculation and are associated with a worse clinical outcome. A cutoff point of 32 (associated with better clinical outcomes) was selected as the threshold. Only participants at study locations with previous experience in IMR measurements participated in this sub study.~The number of participants and their mean reported IMR at the end of PPCI are presented." (NCT02565147)
Timeframe: 1 day (end of PPCI)

InterventionmmHg*s (Mean)
PPCI With Bivalirudin43.49
PPCI With Heparin68.66

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Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5

"The NACE at 5 days is the composite of major bleeding (Bleeding Academic Research Consortium Type 3 or greater [BARC type ≥3]), death, re-infarction, and ischaemia driven revascularization (IDR).~In brief, BARC ≥3 includes: Type 3a-3c, clinical, laboratory, and/or imaging evidence of bleeding; Type 4, coronary artery bypass grafting-related bleeding; Type 5, fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.~A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.~The percentage of participants with in-hospital NACE up to Day 5 is presented." (NCT02565147)
Timeframe: 5 days post PPCI or at discharge, whichever occurs first

InterventionPercentage of Participants (Number)
PPCI With Bivalirudin7.1
PPCI With Heparin8.3

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CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5

"Early and late assessment of MVO, expressed as grams, as assessed by CMR. MVO is an established complication of coronary reperfusion therapy for acute myocardial infarction. MVO occurs in the setting of reperfusion following prolonged myocardial ischemia and provides incremental prognostic information beyond infarct size, to which it is related. Early MVO is a prolonged (approximately 60 s) perfusion deficit in dynamic gadolinium (Gd) first-pass images that is determined within 2 minutes (min) of administration of the Gd-based contrast agent. Late MVO is usually assessed as a hypointense infarct core on late-Gd-enhancement images acquired 10 min after contrast administration.~The number of participants and their mean reported early and late MVO, as grams, at Day 5 are presented." (NCT02565147)
Timeframe: 5 days post PPCI

,
InterventionGrams (Mean)
CMR Early MVO AssessmentCMR Late MVO Assessment
PPCI With Bivalirudin5.33.7
PPCI With Heparin7.74.2

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TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI

"TIMI flow (grade 0-3) is an angiographic determination of briskness of epicardial coronary blood flow: TIMI 0 flow (no perfusion); TIMI 1 flow (penetration without perfusion); TIMI 2 flow (partial reperfusion); TIMI 3 flow (complete perfusion/normal flow).~MBG (grade 0-3) is an angiographic method for determination of blood flow in the distal myocardial vascular bed. Blush grades: 0 = failure of dye to enter the micro-vasculature; 1 = dye slowly enters but fails to exit the micro-vasculature; 2 = delayed entry and exit of dye from the micro-vasculature; 3 = normal entry and exit of dye from the micro-vasculature. Blush that is only mildly intense throughout the washout phase, but fades minimally, is also classified as grade 3.~The number of participants and their mean reported TIMI flow and MBG grades at the end of PPCI are presented." (NCT02565147)
Timeframe: 1 day (end of PPCI)

,
InterventionUnits on a Scale (Mean)
TIMI Flow GradeMBG
PPCI With Bivalirudin2.81.8
PPCI With Heparin2.81.5

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CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5

MSI is a CMR-derived parameter of myocardial recovery and treatment efficacy that allows comparisons among infarcts of different sizes. MSI is calculated as the difference between the area at risk (AAR) and the final infarct size, divided by the AAR, and it is expressed as a percentage of AAR. An MSI of 100% indicates maximum treatment success, whereas an MSI of 0% indicates no treatment benefit. The number of participants and their mean-reported MSI at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI

InterventionPercentage of AAR (Mean)
PPCI With Bivalirudin39.4
PPCI With Heparin51.2

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Percentage of Time Spent at Goal Anticoagulation

(NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks

Interventionpercentage of time (Median)
Unfractionated Heparin Group0.63
Bivalirudin Group0.49

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Number of Participants With One or More Major Bleeding Events

Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding (NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks

Interventionparticipants (Number)
Unfractionated Heparin Group7
Bivalirudin Group7

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Number of Blood Products Transfused

Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate (NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks

,
Interventionmls/kg/day (Median)
pRBCsPlateletsFFPCryoprecipitate
Bivalirudin Group6.294.551.150.1
Unfractionated Heparin Group12.213.580.160

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