Page last updated: 2024-11-12

apixaban

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID10182969
CHEMBL ID231779
CHEBI ID72296
SCHEMBL ID118023
MeSH IDM0512702

Synonyms (96)

Synonym
HY-50667
eliquis (tn)
apixaban (jan/usan/inn)
D03213
503612-47-3
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
GG2 ,
bms-562247-01
eliquis
2P16
chembl231779 ,
apixaban ,
bdbm19023
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1h,4h,5h,6h,7h-pyrazolo[3,4-c]pyridine-3-carboxamide
bms-562247
chebi:72296 ,
AKOS005146204
bms 562247-01
bms562247-01
3z9y7uwc1j ,
bms562247
1h-pyrazolo(3,4-c)pyridine-3-carboxamide,4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-
bms 562247
1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1h-pyrazolo(3,4c)pyridine-3-carboxamide
unii-3z9y7uwc1j
apixaban [usan:inn:jan]
hsdb 8223
BCP9000310
apixabanum
FT-0686944
BCPP000396
apixaban,bms-562247-01
NCGC00346555-01
apixaban [vandf]
apixaban [orange book]
apixaban [ema epar]
apixaban [mart.]
apixaban [jan]
1h-pyrazolo(3,4-c)pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-( 4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-
1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyi)-4,5,6,7-tetrahydro-1h-pyrazolo(3,4-c)pyridine-3-carboxamide
apixaban [who-dd]
apixaban [usan]
apixaban [inn]
apixaban [mi]
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide?bms-562247; bms-562247-01
CS-0401
S1593
gtpl6390
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[3,4-c]pyridine-3-carboxamide
1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
DB06605
smr004676529
MLS006010026
SCHEMBL118023
PB10976
ME-0152
QNZCBYKSOIHPEH-UHFFFAOYSA-N
1-(4-methoxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo piperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
J-200194
c25h25n5o4
AC-26301
apixaban(bms-562247-01)
DTXSID80436500 ,
AB01565766_02
apixaban 13cd3
CCG-229675
EX-A048
HMS3655O07
mfcd11977295
NCGC00346555-08
SW220177-1
apixaban (bms 562247-01)
Q414462
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5-dihydropyrazolo[5,4-c]pyridine-3-carboxamide
503612-47-3, eliquis,
BCP02451
AMY1826
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
AR-270/43507990
NCGC00346555-05
nsc-784102
nsc784102
NCGC00346555-02
apixaban- bio-x
BM164185
SY097159
1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidyl)phenyl]-4,5,6,7-tetrahydro-1h-pyrazolo[3,4-c]pyridine-3-carboxamide
eliquis30-day starter pack
1h-pyrazolo(3,4-c)pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-
apixaban (mart.)
4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-
1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1h-pyrazolo(3,4-c)pyridine-3-carboxamide
dtxcid60387324
b01af02
Z195110238

Research Excerpts

Overview

Apixaban is a potent, direct, selective, and orally active inhibitor of coagulation factor Xa. It is a valid oral alternative to subcutaneous dalteparin for the treatment of patients with cancer-associated VTE.

ExcerptReferenceRelevance
"Apixaban is an oral, direct and highly selective factor Xa (FXa) inhibitor in late-stage clinical development for the prevention and treatment of thromboembolic diseases."( Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies.
Crain, EJ; Knabb, RM; Lam, PY; Luettgen, JM; Pinto, DJ; Wexler, RR; Wong, PC; Xin, B, 2008
)
3.23
"Apixaban is a potent, direct, selective, and orally active inhibitor of coagulation factor Xa. "( Apixaban inhibition of factor Xa: Microscopic rate constants and inhibition mechanism in purified protein systems and in human plasma.
He, K; Knabb, RM; Luettgen, JM; Pinto, DJ; Rendina, AR, 2011
)
3.25
"Oral apixaban is a valid oral alternative to subcutaneous dalteparin for the treatment of a large spectrum of patients with cancer-associated VTE."( Apixaban and Dalteparin for the Treatment of Venous Thromboembolism in Patients with Different Sites of Cancer.
Agnelli, G; Bauersachs, R; Becattini, C; Brenner, B; Connors, JM; Franco, L; Gussoni, G; Hamulyak, EN; Lambert, C; Mahé, I; Muñoz, A; Suero, MR; Torbicki, A, 2022
)
2.62
"Apixaban is an oral factor Xa inhibitor anticoagulant that requires no dose adjustment or monitoring."( Apixaban compared with warfarin to prevent thrombosis in thrombotic antiphospholipid syndrome: a randomized trial.
Armbruster, B; Aston, VT; Branch, DW; Elliott, CG; Groat, D; Kaplan, D; Lloyd, JF; Rondina, MT; Stevens, SM; Wang, TF; Wilson, EL; Woller, SC, 2022
)
2.89
"Apixaban is a direct oral anticoagulant (DOAC). "( Development of a Bayesian estimation tool to determine the optimal duration of apixaban discontinuation before a high-bleeding risk procedure.
Delavenne, X; Gibert, A; Janisset, L; Lanoiselée, J; Ollier, E; Pernod, G, 2022
)
2.39
"Apixaban is a possible alternative that is potentially better for compliance and requires no additional testing."( Apixaban: Alternative Anticoagulation for HeartMate 3 Ventricular Assist Device.
Avula, D; Costelle, D; Dunbar-Matos, C; Kahlon, T; Pahwa, S; Slaughter, MS; Trivedi, JR; Whitehouse, KR, 2022
)
2.89
"Apixaban is a direct factor Xa inhibitor that may be intended as an ideal alternative for the management of HIT."( An Open-Label, Single-Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin-Induced Thrombocytopenia.
Ansarinejad, N; Balouchzehi, S; Farasatinasab, M; Moghaddam, OM; Mohammadi, M; Nasiripour, S, 2022
)
1.66
"Apixaban is a factor Xa (FXa) inhibitor and standard-of-care anticoagulant with FXa Ki and plasma protein binding (free fraction) averages 0.08 nM and 0.13 in humans and 0.16 nM and 0.37 in rabbits, respectively. "( Calibration and validation of the rabbit model of electrolytic-mediated arterial thrombosis against the standard-of-care anticoagulant apixaban.
Crain, E; Wong, PC, 2022
)
2.37
"Apixaban is a direct-acting oral anticoagulant (DOAC) with a short half-life allowing for brief interruptions of anticoagulation for procedures."( The utilization and safety of apixaban for therapeutic anticoagulation in heart transplant population requiring routine endomyocardial biopsies.
Badiye, A; Baran, DA; Cameron, C; Herre, JM; Ingemi, AI; Lichvar, A; Lindauer, KE; McMahon, MR; Old, W; Sawey, EJ; Yao, A; Yehya, A, 2022
)
1.73
"Apixaban is a substrate for p-glycoprotein and is extensively metabolized by cytochrome P450 (CYP) 3A4. "( A Real-World Matched Cohort Study of the Effect of Concomitant Amiodarone or Diltiazem Administration on Apixaban Peak and Trough Concentrations.
Ainsworth, M; Bookstaver, DA; Gleaton, M; Milner, E, 2023
)
2.57
"Apixaban is an anticoagulant requiring less testing than warfarin which has been shown to be effective in other indications."( Apixaban Anticoagulation in Children and Young Adults Supported With the HeartMate 3 Ventricular Assist Device.
Blume, ED; Cetatoiu, MA; Daly, KP; Esteso, P; Fynn-Thompson, F; Hawkins, B; Kobayashi, RL; VanderPluym, C; Ventresco, C, 2023
)
3.07
"Apixaban is a superior direct oral anticoagulant exihibiting interindividual variability in concentration and response in the real world. "( Identification of genetic biomarkers associated with pharmacokinetics and pharmacodynamics of apixaban in Chinese healthy volunteers.
Bao, J; Cui, Y; Jiang, J; Liao, M; Liu, Z; Meng, X; Mu, G; Song, J; Wang, Z; Xiang, Q; Xie, Q; Zhang, F; Zhang, H; Zhao, X; Zhou, S, 2023
)
2.57
"Apixaban is a non-vitamin K antagonist oral anticoagulant (NOACs) recently emerged as an effective alternative to conventional vitamin K antagonists (VKAs) in the treatment of several thromboembolic disorders. "( Extracorporeal hemoadsorption therapy as a potential therapeutic option for rapid removal of Apixaban in high risk-surgical patients: a case report.
Angelini, A; Ballarini, M; Dalmastri, V; Grammatico, F; La Manna, G; Minerva, V; Pizzini, AM; Silingardi, M; Todeschini, P, 2023
)
2.57
"Apixaban is a direct-acting oral anticoagulant that selectively inhibits factor Xa. "( Administration of andexanet alfa for traumatic intracranial hemorrhage in the setting of massive apixaban overdose: A case report.
DelBianco, J; Jenniches, D; Kerns, AF; Philp, AS; Stripp, MP, 2023
)
2.57
"Apixaban (Eliquis) is a direct acting oral anticoagulant (DOAC) indicated for treatment of deep vein thrombosis, non-valvular atrial fibrillation, pulmonary embolism and postoperative venous thromboprophylaxis following hip or knee replacement. "( Apixaban-induced haematoma causing small bowel intussusception.
Berry, G; Rodriguez, JM; Santos, AP, 2019
)
3.4
"Apixaban acts as an inhibitor of blood clots formation."( Thrombin Aptamer-Modified Metal-Organic Framework Nanoparticles: Functional Nanostructures for Sensing Thrombin and the Triggered Controlled Release of Anti-Blood Clotting Drugs.
Chen, WH; Karmi, O; Nechushtai, R; Willner, B; Willner, I, 2019
)
1.24
" Apixaban is a safe alternative to LMWH for the treatment in patients with CAT. "( Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio Study.
Ageno, W; Agnelli, G; Bauersachs, R; Becattini, C; Cohen, A; Gussoni, G; Huisman, M; Vedovati, MC, 2021
)
1.89
"Oral apixaban is an effective alternative to enoxaparin as a thromboprophylactic drug for patients undergoing elective total knee replacement surgery."( Effectiveness of apixaban versus enoxaparin in preventing wound complications and deep venous thrombosis following total knee replacement surgery: A retrospective study.
Ali Hasan, M; Azeez Alsaadi, M; Tahseen Mehsen, J, 2021
)
1.47
"Apixaban is a safe alternative to conventionally used enoxaparin for chemoprophylaxis in patients undergoing THA or TKA."( Apixaban or enoxaparin: Which is better for thromboprophylaxis after total hip and total knee arthroplasty in Indian patients?
Banerjee, S; Elhence, A; Garg, PK; Kunal, K, 2022
)
2.89
"Apixaban is an oral, potent, highly selective, reversible and direct inhibitor of activated coagulation factor X, that is the end point of the intrinsic and extrinsic coagulation pathway. "( Apixaban - Metabolism, Pharmacologic Properties and Drug Interactions.
Dobrotova, M; Kubisz, P; Mokan, M; Samos, M; Stanciakova, L; Stasko, J, 2017
)
3.34
"Apixaban is an oral direct factor Xa inhibitor superior to warfarin at preventing stroke or systemic embolism and may stabilize coronary atherosclerosis."( Rationale and design of a randomized trial of apixaban vs warfarin to evaluate atherosclerotic calcification and vulnerable plaque progression.
Budoff, MJ; Li, D; Nakanishi, R; Nezarat, N; Osawa, K; Rahmani, S; Sheidaee, N; Win, TT, 2017
)
1.43
"Apixaban is a selective factor Xa inhibitor, approved for use in the prevention of stroke in patients with nonvalvular atrial fibrillation and in the prevention and treatment of acute VTE."( Quick reference guide to apixaban.
Handa, A; Hurst, KV; O'Callaghan, JM, 2017
)
1.48
"Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). "( Assessment of Apixaban Prescribing Patterns for Nonvalvular Atrial Fibrillation in Hospitalized Patients.
Davis, S; Gibson, CM; Scalese, MJ; Smith, CB, 2018
)
2.28
"Apixaban is a new oral anticoagulant characterized by good bioavailability and renal elimination accounting for only 25%, showing a safety profile and effectiveness in patients with renal impairment."( Apixaban: Effective and Safe in Preventing Thromboembolic Events in Patients with Atrial Fibrillation and Renal Failure.
Carbonara, S; Ciccone, MM; Corbo, F; Cortese, F; Franchini, C; Gesualdo, M; Pia Schiavone, BI; Ricci, G; Scicchitano, P, 2017
)
2.62
"Apixaban show to be an effective anticoagulant in patients with atrial fibrillation, even superior to warfarin in reducing the risk of stroke and systemic embolism regardless of the presence of renal insufficiency. "( Apixaban: Effective and Safe in Preventing Thromboembolic Events in Patients with Atrial Fibrillation and Renal Failure.
Carbonara, S; Ciccone, MM; Corbo, F; Cortese, F; Franchini, C; Gesualdo, M; Pia Schiavone, BI; Ricci, G; Scicchitano, P, 2017
)
3.34
"Apixaban is a non-vitamin K oral anticoagulant approved for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). "( Initial apixaban dosing in patients with atrial fibrillation.
Bollmann, A; Buchholz, A; Dagres, N; Dinov, B; Gorczynska, K; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2018
)
2.36
"Apixaban is a factor Xa inhibitor which is a non-vitamin K dependent oral anticoagulant known tocause the lowest rate of intracranial bleeding among the same kind of inibitors. "( Apixaban-induced subdural bleeding: case presentation and literature review.
Alayad, E; Aloraidi, A; Khairy, S, 2018
)
3.37
"Apixaban is a direct oral anticoagulant (DOAC) with a specific inhibition of activated factor X (FXa). "( Reversal of apixaban induced alterations in haemostasis by different coagulation factor concentrates in patients after hip or knee replacement surgery.
Johnen, E; Körber, MK; Krüger, K; Langer, E; Schmidt, K; Schmutzler, M; von Heymann, C; Wernecke, KD, 2019
)
2.34
"Apixaban is a direct oral anticoagulant, which inhibits factor Xa. "( Characteristics of Apixaban-Treated Patients, Evaluation of the Dose Prescribed, and the Persistence of Treatment: A Cohort Study in Catalonia.
Cortes, J; Giner-Soriano, M; Gomez-Lumbreras, A; Morros, R; Quijada-Manuitt, MA, 2018
)
2.25
"Apixaban is a favorably cost-effective alternative to warfarin in AF patients with normal kidney function and potentially cost-saving in those with renal impairment."( Cost-Utility Analysis of Apixaban versus Warfarin in Atrial Fibrillation Patients with Chronic Kidney Disease.
Alshogran, OY; Altawalbeh, SM; Smith, KJ, 2018
)
2.23
"Apixaban is an oral direct anti-Xa."( Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study.
Auger-Quittet, S; Bareau, B; Belhadj-Merzoug, K; Benboubker, L; Bosson, JL; Boyle, E; Cliquennois, M; Decaux, O; Fuzibet, JG; Karlin, L; Leleu, X; Leyronnas, C; Orsini-Piocelle, F; Pegourie, B; Pernod, G; Rey, P; Rodon, P; Royer, B; Slama, B; Tiab, M; Voog, E; Zarnitsky, C, 2019
)
2.68
"Apixaban is an oral, direct factor Xa inhibitor that inhibits both free and clot-bound factor Xa, and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism. "( Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.
Boyd, RA; Byon, W; Frost, CE; Garonzik, S, 2019
)
3.4
"Apixaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation and thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and under development for treatment of venous thromboembolism. "( Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, C; Lacreta, F; Mosqueda-Garcia, R; Nepal, S; Schuster, A; Shenker, A; Wang, J; Yu, Z, 2013
)
2.06
"Apixaban is an oral, direct, factor-Xa inhibitor approved for thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. "( Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, CE; LaCreta, FP; Pursley, J; Upreti, VV; Wang, J, 2013
)
2.05
"Apixaban is a safe, effective, and attractive alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. "( The safety and efficacy of apixaban : where do we stand in 2013?
Alexander, JH; de Souza Brito, F; Lopes, RD, 2013
)
2.13
"Apixaban is a new oral anticoagulant with a direct, specific and reversible inhibitory action on coagulation factor Xa and with demonstrated safety and efficacy in the prophylaxis and treatment of venous thromboembolism in several clinical studies involving thousands of patients subjected to major orthopedic surgery."( Apixaban in the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation.
Arellano-Rodrigo, E; Escolar, G; Galán, AM; Pujadas-Mestres, L, 2013
)
2.55
"Apixaban is a direct factor Xa inhibitor that has been shown in clinical trial use to safely reduce the composite of VTE and mortality rates in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA); however, the cost-effectiveness of apixaban treatment in Canadian settings has not been studied."( A Canadian study of the cost-effectiveness of apixaban compared with enoxaparin for post-surgical venous thromboembolism prevention.
El-Hadi, W; Kadambi, A; Patterson, J; Raymond, V; Revankar, N, 2013
)
1.37
"Apixaban is a direct inhibitor of factor Xa, and is a potential alternative for the treatment of acute venous thromboembolism. "( Evaluating the efficacy and safety of apixaban, a new oral anticoagulant, using Bayesian meta-analysis.
Malone, DC; Ross, D; Villa, LA, 2013
)
2.1
"Apixaban is a new oral anticoagulant with a specific inhibitory action on FXa. "( Reversal of apixaban induced alterations in hemostasis by different coagulation factor concentrates: significance of studies in vitro with circulating human blood.
Arellano-Rodrigo, E; Diaz-Ricart, M; Escolar, G; Fernandez-Gallego, V; Galan, AM; Lopez-Vilchez, I; Molina, P; Reverter, JC; Roquer, J; Sanz, VV, 2013
)
2.21
"Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies, respectively, and causes less bleeding than warfarin."( Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation.
Dorian, P; Hernandez, L; Iloeje, U; Kongnakorn, T; Kuznik, A; Lanitis, T; Lip, GY; Liu, LZ; Phatak, H; Rublee, DA, 2014
)
1.44
"Apixaban is a substrate for various cytochrome P450 isoenzymes and for P-glycoprotein, creating a risk of multiple drug-drug interactions."( Apixaban and atrial fibrillation: no clear advantage.
, 2014
)
2.57
"Apixaban was found to be a cost-effective alternative to warfarin and aspirin for stroke prevention in patients with AF in Sweden."( Cost-effectiveness of apixaban versus warfarin and aspirin in Sweden for stroke prevention in patients with atrial fibrillation.
De Geer, A; Jacobson, L; Kongnakorn, T; Lanitis, T, 2014
)
2.16
"Apixaban is an oral direct factor Xa inhibitor developed for the prophylaxis and treatment of thromboembolic disorders. "( Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays.
Baghaei, F; Berndtsson, M; Fagerberg Blixter, I; Faxälv, L; Gustafsson, KM; Hillarp, A; Lindahl, TL; Strandberg, K, 2014
)
2.1
"Apixaban is a novel oral anticoagulant associated with significantly lower hazard rates for stroke, major bleedings and treatment discontinuations, compared to VKAs."( Economic evaluation of apixaban for the prevention of stroke in non-valvular atrial fibrillation in the Netherlands.
Le, HH; Pompen, M; Postma, MJ; Rozenbaum, MH; Stevanović, J; Tieleman, RG, 2014
)
1.43
"Apixaban is a NOAC that selectively inhibits the coagulation factor Xa; it is approved for the prevention of VTE after total hip replacement and total knee replacement surgery."( Apixaban versus enoxaparin in elective major orthopedic surgery: a clinical review.
Benedetti, R; Caforio, M; Imberti, D; Maniscalco, P; Porcellini, G, 2015
)
2.58
"Apixaban is a newly developed direct oral anticoagulant targeting activated factor X (FXa). "( How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study.
Bassi, L; Chantarangkul, V; Legnani, C; Ludovici, S; Padovan, L; Peyvandi, F; Scalambrino, E; Testa, S; Tripodi, A, 2015
)
2.14
"Apixaban is a cost-effective alternative to aspirin for patients with AF in Belgium who decline or cannot tolerate VKA treatment."( Cost effectiveness of apixaban versus aspirin for stroke prevention in patients with non-valvular atrial fibrillation in Belgium.
Annemans, L; Kongnakorn, T; Lanitis, T; Lieven, A; Marbaix, S; Thijs, V, 2014
)
2.16
"Apixaban is an orally active inhibitor of coagulation factor Xa and is eliminated by multiple pathways, including renal and non-renal elimination. "( Effect of ketoconazole and diltiazem on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor.
Boyd, RA; Byon, W; Dias, C; Frost, CE; LaCreta, F; Schuster, AE; Shenker, A; Song, Y; Wang, J; Yu, Z; Zhang, D, 2015
)
2.1
"Apixaban is a direct inhibitor of coagulation factor Xa. "( [Proper use of apixaban: an outline for clinical practice].
Albaladejo, P; Deplanque, D; Fossati, F; Mahagne, MH; Mismetti, P; Mourad, JJ; Nguyen, P; Roy, P; Touze, E, 2014
)
2.2
"Apixaban is an oral, direct factor Xa inhibitor indicated for the prevention and treatment of thromboembolic disease. "( Randomized, blinded, placebo- and positive-controlled crossover study to determine the effect of multiple doses of apixaban on the QTc interval.
Boyd, R; Byon, W; Frost, C; LaCreta, F; Moore, K; Nepal, S; Reeves, RA, 2015
)
2.07
"Apixaban is a novel oral anticoagulant which is approved for the management of atrial fibrillation and venous thromboembolism prophylaxis. "( Meta-analysis on risk of bleeding with apixaban in patients with renal impairment.
Aryal, MR; Ghimire, S; Karmacharya, P; Pandit, A; Pathak, R; Poudel, DR; Shamoun, FE, 2015
)
2.13
"Apixaban is a direct oral anticoagulant (DOAC) targeting factor Xa and thus quenching thrombin generation and clot formation. "( How the direct oral anticoagulant apixaban affects thrombin generation parameters.
Padovan, L; Peyvandi, F; Scalambrino, E; Testa, S; Tripodi, A; Veena, C, 2015
)
2.14
"Apixaban is an oral factor Xa inhibitor with a rapid onset of action and predictable pharmacokinetics that allows a fixed dose regimen. "( Deep Vein Thrombosis and Pulmonary Embolism in the Apixaban Era: From Bench to Bedside.
Jezovnik, MK; Poredos, P, 2018
)
2.18
"Apixaban is a factor Xa inhibitor recently approved for the treatment and prevention of VTE in the United States."( Apixaban in Venous Thromboembolism in an Era of New Oral Anticoagulants.
Bongu, N; Chinnakotla, B; Kocheril, A; Turagam, MK; Velagapudi, P, 2015
)
2.58
"Apixaban is a new oral anticoagulant (NOACs: Novel Oral Anticoagulant), like dabigatran, rivaroxaban, and edoxaban. "( To Bleed or Not to Bleed: That is the Question. The Side Effects of Apixaban.
Ciccone, MM; Devito, F; Maiello, M; Palmiero, P; Zito, A, 2018
)
2.16
"Apixaban is a direct factor Xa inhibitor approved for the treatment and prevention of thromboembolic disease. "( Four-factor prothrombin complex concentrate reverses apixaban-associated bleeding in a rabbit model of acute hemorrhage.
Dickneite, G; Doerr, B; Herzog, E; Kaspereit, F; Krege, W; Mueller-Cohrs, J; Niebl, P, 2015
)
2.11
"Apixaban is a cost-effective alternative to warfarin and dabigatran and is dominant over rivaroxaban in AF patients from the perspective of the Portuguese national healthcare system. "( Cost-effectiveness of non-vitamin K antagonist oral anticoagulants for atrial fibrillation in Portugal.
Borges, M; Caldeira, D; Costa, J; Fiorentino, F; Gouveia, M; Inês, M; Lopes Pereira, C; Pinheiro, L; Vaz-Carneiro, A, 2015
)
1.86
"Apixaban is a substrate of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein. "( Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa.
Boyd, RA; Byon, W; Dias, C; Frost, C; LaCreta, F; Shenker, A; Vakkalagadda, B; Wang, J; Yu, Z; Zhang, D, 2016
)
2.14
"Apixaban is a safe and effective anticoagulant for VTE treatment. "( Pharmacodynamics, pharmacokinetics and clinical efficacy of apixaban in the treatment of thrombosis.
Chong, BH; Chong, JJ; Zheng, SS, 2016
)
2.12
"Apixaban was found to be a cost-effective strategy over warfarin (incremental cost-effectiveness ratio=$25 816) and dominated other anticoagulants."( Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.
Hayes, CJ; Martin, BC; Shah, A; Shewale, A, 2016
)
1.16
"Apixaban is a new oral anticoagulant with the potential to overcome these limitations."( Apixaban versus enoxaparin in the prevention of venous thromboembolism following total knee arthroplasty: a single-centre, single-surgeon, retrospective analysis.
Dickison, DM; King, DA; Pow, RE; Vale, PR, 2016
)
2.6
"Apixaban is likely to be a cost-effective alternative to warfarin for stroke prophylaxis in Chinese patients with NVAF in Hong Kong."( Cost-Effectiveness of Apixaban versus Warfarin in Chinese Patients with Non-Valvular Atrial Fibrillation: A Real-Life and Modelling Analyses.
Chan, EW; Cheung, BM; Lau, WC; Li, X; Lip, GY; Tse, VC; Wong, IC, 2016
)
2.19
"Apixaban is a novel oral anticoagulation agent that exerts its effect through direct factor Xa inhibition. "( Anti-Xa activity in apixaban overdose: a case report.
Barton, J; Graudins, A; Wong, A, 2016
)
2.2
"Apixaban is a direct inhibitor of Factor Xa that was approved in December 2012 by the US Food and Drug Administration (FDA) for the prevention of stroke in patients with non-valvular atrial fibrillation."( Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
John, J; Mezue, K; Obiagwu, C; Shani, J; Sharma, A; Yang, F, 2017
)
1.42
"Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment."( Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment.
Barasch, NS; Stanton, BE; Tellor, KB, 2017
)
2.16
"Apixaban is a promising candidate and may be a useful alternative to warfarin for thromboprophylaxis of mechanical heart valves. "( Apixaban Versus Warfarin for Mechanical Heart Valve Thromboprophylaxis in a Swine Aortic Heterotopic Valve Model.
Coleman, DM; Diaz, JA; Frost, CE; Grant, BT; Hawley, AE; Jackson, TO; Knabb, RM; Lester, PA; Mathues, AR; Myers, DD; Ramacciotti, E; Song, Y; Wakefield, TW, 2017
)
3.34
"Apixaban is an attractive anticoagulant for stroke prevention in patients with AF with or without anemia."( Anemia is associated with bleeding and mortality, but not stroke, in patients with atrial fibrillation: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.
Alexander, JH; Alings, M; De Caterina, R; Granger, CB; Hanna, M; Hylek, EM; Keltai, M; Lopes, RD; Steg, PG; Thomas, L; van Gilst, WH; Wallentin, L; Westenbrink, BD; Wojdyla, DM, 2017
)
1.38
"Apixaban is an oral, direct Factor Xa inhibitor that is being developed by Bristol-Myers Squibb Co and Pfizer Inc. "( Apixaban, an oral, direct inhibitor of activated Factor Xa.
Lip, GY; Shantsila, E, 2008
)
3.23
"Apixaban is an oral, direct factor Xa (FXa) inhibitor in late-stage clinical development. "( Favorable therapeutic index of the direct factor Xa inhibitors, apixaban and rivaroxaban, compared with the thrombin inhibitor dabigatran in rabbits.
Crain, EJ; Watson, CA; Wong, PC; Xin, B, 2009
)
2.03
"Apixaban is an oral, direct, and highly selective factor Xa inhibitor in late-stage clinical development for the prevention and treatment of thromboembolic diseases. "( In vitro assessment of metabolic drug-drug interaction potential of apixaban through cytochrome P450 phenotyping, inhibition, and induction studies.
Chen, SY; Frost, CA; Frost, CE; Goosen, TC; Grossman, SJ; He, K; Humphreys, WG; Ma, L; Maxwell, BD; Raghavan, N; Wang, L; Yao, M; Zhang, D, 2010
)
2.04
"Apixaban is an oral, direct, and highly selective factor Xa inhibitor in late-stage clinical development for the prevention and treatment of thromboembolic diseases. "( Effect of the direct factor Xa inhibitor apixaban in rat models of thrombosis and hemostasis.
Bostwick, JS; Schumacher, WA; Steinbacher, TE; Stewart, AB; Wong, PC; Xin, B, 2010
)
2.07
"Apixaban is an orally active, selective, direct-acting, reversible inhibitor of factor Xa that is under evaluation for the management of acute coronary syndromes (ACS). "( Apixaban in acute coronary syndromes.
Eikelboom, JW; Karthikeyan, G, 2011
)
3.25
"Apixaban is an oral, direct and highly selective factor Xa (FXa) inhibitor in late-stage clinical development. "( Apixaban, a direct factor Xa inhibitor, inhibits tissue-factor induced human platelet aggregation in vitro: comparison with direct inhibitors of factor VIIa, XIa and thrombin.
Jiang, X; Wong, PC, 2010
)
3.25
"Apixaban is an oral, direct factor Xa inhibitor under development for secondary prevention in acute coronary syndrome (ACS). "( Effect of apixaban, an oral and direct factor Xa inhibitor, on coagulation activity biomarkers following acute coronary syndrome.
Alexander, JH; Barrett, Y; Becker, RC; Harrington, RA; Mohan, P; Newby, LK; Wallentin, LC; Wang, J; Yang, H, 2010
)
2.21
"Apixaban is a potent, highly selective, reversible, oral, direct factor Xa (fXa) inhibitor in development for thrombosis prevention and treatment. "( Preclinical pharmacokinetics and pharmacodynamics of apixaban, a potent and selective factor Xa inhibitor.
Grace, JE; Grossman, SJ; He, B; He, K; Knabb, RM; Lam, PY; Luettgen, JM; Pinto, DJ; Wexler, RR; Wong, PC; Xin, B; Zhang, D, 2011
)
2.06
"Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin."( Apixaban versus warfarin in patients with atrial fibrillation.
Al-Khalidi, HR; Alexander, JH; Ansell, J; Atar, D; Avezum, A; Bahit, MC; Diaz, R; Easton, JD; Ezekowitz, JA; Flaker, G; Garcia, D; Geraldes, M; Gersh, BJ; Golitsyn, S; Goto, S; Granger, CB; Hanna, M; Hermosillo, AG; Hohnloser, SH; Horowitz, J; Hylek, EM; Jansky, P; Lewis, BS; Lopes, RD; Lopez-Sendon, JL; McMurray, JJ; Mohan, P; Pais, P; Parkhomenko, A; Verheugt, FW; Wallentin, L; Zhu, J, 2011
)
2.53
"Apixaban is a novel oral factor Xa inhibitor that recently completed evaluation in clinical trials for its use in the prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery. "( Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery.
Martin, MT; Nutescu, EA, 2011
)
2.12
"Apixaban is a promising new agent awaiting regulatory approval for its use in thromboprophylaxis after TKA."( Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery.
Martin, MT; Nutescu, EA, 2011
)
2.12
"Apixaban is a highly selective and potent Factor Xa Inhibitor with Ki=0 8nM to both free as well as prothrombinase bound FXa."( Apixaban: a new player in the anticoagulant class.
Agrawal, R; Dikshit, SN; Jain, P, 2012
)
2.54
"Apixaban is a highly selective, reversible, direct factor Xa inhibitor that inhibits both free factor Xa and prothrombinase activity, and clot-bound factor Xa activity. "( Apixaban: an oral direct factor-xa inhibitor.
Jiménez, D; Ramacciotti, E; Yusen, RD, 2012
)
3.26
"Apixaban is a potent, selective direct inhibitor of the coagulation factor Xa, recently approved in Europe for the prevention of venous thromboembolism (VTE) in adult patients after total hip replacement (THR) or total knee replacement (TKR) surgery."( Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery.
Gallerani, M; Imberti, D; Manfredini, R, 2012
)
1.4
"Apixaban is an anticoagulant drug that acts by directly inhibiting coagulation factor Xa. "( Practical use of apixaban in the prevention of venous thromboembolism after total knee or hip replacement.
Lassen, MR, 2012
)
2.16
"Apixaban (Eliquis™) is an orally active and selective direct inhibitor of factor Xa indicated for twice-daily use in the EU for the prevention of venous thromboembolism (VTE) in adults who have had knee or hip replacement surgery. "( Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery.
Deeks, ED, 2012
)
3.26
"Apixaban is an oral, direct, selective factor Xa inhibitor with a rapid onset of action. "( Apixaban: a novel oral inhibitor of factor Xa.
Nutescu, E, 2012
)
3.26
"Apixaban is a potent reversible inhibitor of the activated human coagulation factor X. "( [Apixaban].
Konstantinides, S; Münzel, T, 2012
)
2.73

Effects

Apixaban has a higher rate of major bleeding in patients with luminal GI cancer compared with patients with non-GI cancer. Apixaban does not require bridging with heparin which often necessitates long hospitalizations for patients with ESKD.

Apixaban has been shown in the AVERROES trial to be superior to aspirin in preventing stroke and systemic embolism. It has been approved in the EU for the prevention of venous thromboembolism (VTE) after hip or knee replacement.

ExcerptReferenceRelevance
"Apixaban has an additional advantage of not requiring bridging with heparin which often necessitates long hospitalizations for patients with ESKD."( Healthcare utilization differences between an apixaban-based and warfarin-based strategy for acute venous thromboembolism in patients with end-stage kidney disease.
Ardeshirrouhanifard, S; Brotman, DJ; Deitelzweig, SB; Ellenbogen, MI; Segal, JB; Streiff, MB, 2023
)
1.89
"Apixaban has a higher rate of major bleeding in patients with luminal GI cancer compared with patients with non-GI cancer and compared with enoxaparin in patients with luminal GI cancer. "( Bleeding in Patients With Gastrointestinal Cancer Compared With Nongastrointestinal Cancer Treated With Apixaban, Rivaroxaban, or Enoxaparin for Acute Venous Thromboembolism.
Brunton, N; Casanegra, AI; Froehling, DA; Hodge, DO; Houghton, DE; McBane, RD; Meverden, RA; Peterson, LG; Vlazny, DT; Wysokinski, WE, 2021
)
2.28
"Apixaban has a half-life of about 12 hours, and the normal dosage is 5 mg orally twice daily."( Apixaban: a new factor Xa inhibitor for stroke prevention in patients with nonvalvular atrial fibrillation.
Lam, S,
)
2.3
"Apixaban has been shown in the AVERROES trial to be superior to aspirin in preventing stroke and systemic embolism without significantly increasing the risk of major bleeding among patients with AF who are unsuitable for VKA therapy."( Cost effectiveness of apixaban versus aspirin for stroke prevention in patients with non-valvular atrial fibrillation in Belgium.
Annemans, L; Kongnakorn, T; Lanitis, T; Lieven, A; Marbaix, S; Thijs, V, 2014
)
1.44
"Apixaban has been recently approved to use for the treatment of deep vein thrombosis."( [Apixaban in the treatment of venous thrombosis associated with permanent pacemaker implantation].
Carrizo, S; Figueroa, JA; Vivero, A, 2015
)
2.05
"Apixaban has been approved in the EU for the prevention of venous thromboembolism (VTE) after hip or knee replacement."( Apixaban: first global approval.
Perry, C; Watson, J; Whiteside, G, 2011
)
2.53
"Apixaban has been studied in Phase II and Phase III trials for a variety of indications."( Apixaban for the prevention of stroke in atrial fibrillation.
Flaker, G; Littrell, R, 2012
)
2.54
"Apixaban has been extensively studied worldwide in about 12,000 patients in four clinical studies that have demonstrated the efficacy and safety of apixaban respect to enoxaparin for the prevention of thromboembolism after major orthopedic surgery."( Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery.
Gallerani, M; Imberti, D; Manfredini, R, 2012
)
1.4

Actions

Apixaban had a lower rate of CRNMB compared with rivaroxaban in patients with GI cancer (3.83 vs 9.40 per 100 person-years; P=.03). With apixaban lower costs per patient in TKR were generated, so it was the dominant treatment. Apixaban did not cause false-positive lupus anticoagulant results.

ExcerptReferenceRelevance
"Apixaban did not inhibit digoxin transport in Caco-2 cells."( Characterization of efflux transporters involved in distribution and disposition of apixaban.
Balimane, PV; Frost, CE; Gan, J; Han, YH; He, K; Herbst, JJ; Humphreys, WG; Kolb, J; Shou, W; Wang, L; Zhang, D, 2013
)
1.34
"Apixaban had a lower risk of recurrent VTE, MB, and CRNMB compared to warfarin."( Effectiveness and Safety of Apixaban Versus Warfarin Among Older Patients with Venous Thromboembolism with Different Demographics and Socioeconomic Status.
Cohen, AT; Dhamane, AD; Emir, B; Hlavacek, P; Keshishian, A; Lee, T; Luo, X; Rosenblatt, L; Sah, J; Yuce, H, 2021
)
1.64
"Apixaban showed a lower correlation coefficient for all TG parameters compared with rivaroxaban, and thrombin generation was less influenced by apixaban than rivaroxaban at plasma levels >100 ng/ml."( Influence of direct oral anticoagulants on thrombin generation on Ceveron TGA.
Behrendt, LC; Bönigk, H; Franke, D; Metze, M; Petros, S; Pfrepper, C; Siegemund, A; Siegemund, T, 2022
)
1.44
"Apixaban did not cause a missed diagnosis of protein S deficiency."( Apixaban Does Not Interfere With Protein S or Activated Protein C Resistance (Factor V Leiden) Testing Using aPTT-Based Methods.
Maryamchik, E; Van Cott, EM, 2020
)
2.72
"Apixaban had lower MB (Hazard Ratio [HR]:0.76; 95% CI:0.64-0.91) and similar recurrent VTE risks (HR:1.04; 95% CI:0.75-1.43) vs warfarin."( Safety and effectiveness of apixaban compared with warfarin among clinically-relevant subgroups of venous thromboembolism patients in the United States Medicare population.
Ferri, M; Guo, JD; Hlavacek, P; Keshishian, A; Mardekian, J; McBane, R; Poretta, T; Rosenblatt, L; Russ, C; Yuce, H, 2021
)
1.64
"Apixaban showed lower hemorrhagic risk alone (HR 0.24, 95% CI 0.10-0.55) and similar risk when administered with antiplatelets (HR 0.93, 95% CI 0.55-1.56)."( Safety of apixaban compared to warfarin in hemodialysis patients: Do antiplatelets make a difference?
Cooper, C; George, J; Ionescu, F; Mansuri, S; Petrescu, I, 2021
)
1.75
"Apixaban may have a lower risk of major bleeding and comparable risk of stroke when compared with warfarin in AF patients with ESRD."( Safety and Efficacy of Apixaban, Rivaroxaban, and Warfarin in End-Stage Renal Disease With Atrial Fibrillation: A Systematic Review and Meta-Analysis.
Abdullah, HM; Alam, M; Alraies, MC; Fischman, DL; Jafar, MS; Saeed, R; Ullah, W; van Zyl, M, 2021
)
2.37
"Apixaban had a lower rate of CRNMB compared with rivaroxaban in patients with GI cancer (3.83 vs 9.40 per 100 person-years; P=.03)."( Bleeding in Patients With Gastrointestinal Cancer Compared With Nongastrointestinal Cancer Treated With Apixaban, Rivaroxaban, or Enoxaparin for Acute Venous Thromboembolism.
Brunton, N; Casanegra, AI; Froehling, DA; Hodge, DO; Houghton, DE; McBane, RD; Meverden, RA; Peterson, LG; Vlazny, DT; Wysokinski, WE, 2021
)
1.56
"With apixaban lower costs per patient in TKR (-14 €) were generated, so it was the dominant treatment."( [Cost-effectiveness analysis of apixaban compared to dabigatran in the prevention of venous thromboembolism in patients subjected to total knee or hip replacement].
Betegón-Nicolás, L; de Salas-Cansado, M; Gómez-Arrayás, I; Gómez-Cerezo, JF; Rubio-Terrés, C; Suárez-Fernández, C,
)
0.87
"Apixaban did not cause false-positive lupus anticoagulant results."( Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays.
Baghaei, F; Berndtsson, M; Fagerberg Blixter, I; Faxälv, L; Gustafsson, KM; Hillarp, A; Lindahl, TL; Strandberg, K, 2014
)
1.38
"Apixaban yielded a lower NNT/year for preventing death than for primary-outcome prevention."( Non-vitamin K Oral Anticoagulants Versus Warfarin for Patients with Atrial Fibrillation: Absolute Benefit and Harm Assessments Yield Novel Insights.
Cheung, BM; Kumana, CR; Lauder, IJ; Siu, DC; Tse, HF, 2016
)
1.16
"Apixaban would generate more costs per patient for the NHS (€1,742 per patient) but savings would result from the social perspective (€2,887 saved per patient)."( [Cost-effectiveness analysis of apixaban versus acetylsalicylic acid in the prevention of stroke in patients with non-valvular atrial fibrillation in Spain].
Barón-Esquivias, G; Betegón-Nicolás, L; Canal-Fontcuberta, C; de Salas-Cansado, M; Escolar-Albaladejo, G; Rubio-Rodríguez, D; Rubio-Terrés, C; Zamorano, JL,
)
1.14
"Apixaban, a probable cause for the hepatocellular injury, was discontinued and replaced with intravenous unfractionated heparin to bridge anticoagulation with warfarin."( Apixaban-induced liver injury.
Alsaad, AA; Clarke, SA; Mack, A; Phillips, MB, 2016
)
2.6
"Apixaban had a lower risk of association with GI bleeding in the very elderly than dabigatran (HR, 0.45; 95% CI, 0.29-0.71) or rivaroxaban (HR, 0.39; 95% CI, 0.25-0.61)."( Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study.
Abraham, NS; Noseworthy, PA; Sangaralingham, LR; Shah, ND; Yao, X, 2017
)
1.18
"Apixaban also had lower major or clinically relevant bleeding (by 34%) compared with rivaroxaban."( Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation.
Larsen, TB; Lip, GY; Rasmussen, LH; Skjøth, F, 2012
)
1.1
"All apixaban groups had lower primary efficacy event rates than either comparator."( The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement.
Ansell, J; Davidson, BL; Deitchman, D; Gallus, A; Lassen, MR; Pineo, G, 2007
)
1.12

Treatment

Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA.

ExcerptReferenceRelevance
"In apixaban-treated patients, the D-dimer level in the left atrium was lower than in edoxaban-treated patients on the day of ablation, suggesting that the anticoagulant effect of apixaban on the left atrium is better than that of edoxaban in patients with AF."( Difference in left atrial D-dimer level in patients with atrial fibrillation treated with direct oral anticoagulant.
Fukuoka, H; Hoshida, S; Inoue, S; Inui, H; Minamisaka, T; Mine, K; Shinoda, Y; Tachibana, K; Ueno, K; Watanabe, T, 2021
)
1.24
"New apixaban treatment was followed for the first 6 months."( Direct costs in patients with nonvalvular atrial fibrillation newly indicated to apixaban: a retrospective prospective single arm cohort study.
Doležal, T; Doležalová, H; Herold, M; Lžičařová, L; Měrou, TAPS; Pilnáčková, B; Štrosová, D; Tužil, J; Typovská, V, 2022
)
1.43
"Apixaban treatment was discontinued, and mechanical ventilation was initiated."( Apixaban-Associated Diffuse Alveolar Hemorrhage in an Elderly Man with Multiple Complications.
Fukunaga, K; Hayashida, K; Ishii, M; Kajino, A; Kamata, H; Kishino, Y; Nishie, M; Otake, S; Ozawa, T; Saito, A; Terai, H, 2022
)
2.89
"Apixaban-treated patients exhibit more favourable fibrinolysis profiles than those taking warfarin or aspirin."( Apixaban enhances endogenous fibrinolysis in patients with atrial fibrillation.
Arachchillage, DRJ; Farag, M; Gorog, DA; Gue, Y; Lip, GYH; Spinthakis, N; Srinivasan, M; Wellsted, D, 2019
)
2.68
"Apixaban treatment initiation had minimal influence on the level of immunosuppression."( Apixaban Level and Its Influence on Immunosuppression and Graft Outcome in Kidney Transplant Recipients With Atrial Fibrillation.
Avni, S; Fuchs, S; Green, H; Nissan, R; Rahamimov, R; Rozen-Zvi, B; Spectre, G, 2021
)
2.79
"Apixaban treatment discontinuation occurred in a total of 122 patients during follow-up (12.5/100 patient-years in Kaplan-Meier analysis)."( Effectiveness and safety of apixaban therapy in daily-care patients with atrial fibrillation: results from the Dresden NOAC Registry.
Beyer-Westendorf, J; Helmert, S; Marten, S; Mizera, H; Reitter, A; Sahin, K; Tittl, L, 2017
)
1.47
"apixaban n = 4802 per treatment group)."( Comparative safety and effectiveness of dabigatran vs. rivaroxaban and apixaban in patients with non-valvular atrial fibrillation: a retrospective study from a large healthcare system.
Ahmad, A; Evans, A; Oh, K; Petrini, M; Rush, T; Schwartzman, E; Tang, W; Thompson, D; Villines, TC, 2019
)
1.47
"Apixaban treatment was associated with the most favourable safety profile of the NOACs, showing a statistically significantly reduced risk of 'major or clinically relevant non-major (CRNM) bleed' compared with rivaroxaban (0.47 [0.36, 0.61]), dabigatran (0.69 [0.51, 0.94]), and edoxaban (0.54 [0.41, 0.69])."( Comparison of the Novel Oral Anticoagulants Apixaban, Dabigatran, Edoxaban, and Rivaroxaban in the Initial and Long-Term Treatment and Prevention of Venous Thromboembolism: Systematic Review and Network Meta-Analysis.
Batson, S; Bird, A; Cohen, AT; Hamilton, M; Liu, X; Mitchell, SA; Phatak, H; Tushabe, D, 2015
)
1.4
"Apixaban treatment was associated with a nonsignificant trend toward reduction in the composite of clinical ischemic stroke and covert embolic-pattern infarction and did not increase the number of microbleeds in patients with atrial fibrillation compared with aspirin."( Effect of apixaban on brain infarction and microbleeds: AVERROES-MRI assessment study.
Avezum, A; Connolly, S; Dias, R; Diener, HC; Eikelboom, JW; Flaker, G; Gladstone, DJ; Hart, RG; Lewis, G; O'Donnell, MJ; Sharma, M; Smith, EE; Yusuf, S; Zhu, J, 2016
)
2.28
"Apixaban treatment was cost-effective compared to 6-month treatment with LMWH/VKA at an incremental cost-effectiveness ratio (ICER) of £6692 per QALY."( Cost-effectiveness of apixaban versus low molecular weight heparin/vitamin k antagonist for the treatment of venous thromboembolism and the prevention of recurrences.
Browne, C; Cohen, AT; Hamilton, M; Lanitis, T; Leipold, R; Quon, P; Rublee, D, 2017
)
1.49
"The apixaban treatment resulted in favorable and effective control of the patient's VTE on day33."( Successful management of venous thromboembolism with apixaban in a multiple myeloma patient on lenalidomide therapy.
Hamahata, K; Nohgawa, M; Oka, S; Shiragami, H; Takeuchi, S, 2017
)
1.19
"apixaban). In the treatment model, these inhibitors equally prevented growth of a preformed thrombus."( Favorable therapeutic index of the direct factor Xa inhibitors, apixaban and rivaroxaban, compared with the thrombin inhibitor dabigatran in rabbits.
Crain, EJ; Watson, CA; Wong, PC; Xin, B, 2009
)
1.31
"Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA (net difference, LYs: 0.13; QALYs: 0.11). "( Cost-effectiveness analysis of apixaban versus vitamin K antagonists for antithrombotic therapy in patients with atrial fibrillation after acute coronary syndrome or percutaneous coronary intervention in Spain.
Dhanda, D; Di Fusco, M; Kang, A; Kongnakorn, T; Polanco, C; Rivolo, S; Savone, M; Skandamis, A; Soto, J, 2021
)
1.26
"Treatment with apixaban was introduced, initially in a dose of 2.5 mg twice daily, as creatinine concentration was 2.0 mg/dl, and after 2 days - when creatinine concentration dropped, the dose was augmented to 5 mg twice a day."( Fast apixaban-related resolution of left ventricular thrombi in a patient with dilated cardiomyopathy.
Elikowski, W; Fertała, N; Kruzel, K; Małek-Elikowska, M; Zawodna, M, 2018
)
1.33
"Treatment with apixaban compared with warfarin for stroke prevention in patients with AF was associated with less reduction in thrombin generation and fibrin turnover. "( Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation.
Alexander, JH; Alings, M; Andersson, U; Christersson, C; De Caterina, R; Gersh, BJ; Granger, CB; Halvorsen, S; Hanna, M; Huber, K; Hylek, EM; Lopes, RD; Oh, BH; Siegbahn, A; Wallentin, L, 2019
)
1.27
"Treatment with apixaban compared to VKAs resulted in an ICER of €10,576 per quality adjusted life year (QALY). "( Economic evaluation of apixaban for the prevention of stroke in non-valvular atrial fibrillation in the Netherlands.
Le, HH; Pompen, M; Postma, MJ; Rozenbaum, MH; Stevanović, J; Tieleman, RG, 2014
)
1.07
"Treatment with apixaban versus placebo for 12 months significantly reduced symptomatic recurrent venous thromboembolism (VTE) or all-cause death without increasing the rate of major bleeding in the AMPLIFY-EXT trial. "( Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial.
Cohen, AT; Johnson, M; Liu, X; Mardekian, J; Phatak, H; Porcari, A; Thompson, J, 2016
)
1.08
"Treatment with apixaban (RR 0.23, 95% CrI 0.10, 0.55) or dabigatran (RR 0.55, 95% Crl 0.43, 0.71) was associated with a statistically significantly reduced risk of 'major or clinically relevant non-major bleed' compared with warfarin INR 2.0-3.0."( Comparison of the Non-VKA Oral Anticoagulants Apixaban, Dabigatran, and Rivaroxaban in the Extended Treatment and Prevention of Venous Thromboembolism: Systematic Review and Network Meta-Analysis.
Batson, S; Bird, A; Cohen, AT; Hamilton, M; Horblyuk, R; Li, S; Mitchell, SA, 2016
)
1.03

Toxicity

Apixaban is safe to use for anticoagulation of heart transplant recipients undergoing routine biopsies. Early administration of apixaban after onset of acute LVO in patients with NVAF was generally safe.

ExcerptReferenceRelevance
" Most adverse events were mild or moderate."( Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-.
Kanmuri, K; Ogawa, S; Shinohara, Y, 2011
)
0.61
"Dabigatran, an oral thrombin inhibitor, and rivaroxaban and apixaban, oral factor Xa inhibitors, have been found to be safe and effective in reducing stroke risk in patients with atrial fibrillation."( Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation.
Avorn, J; Choudhry, NK; Gagne, JJ; Patrick, AR; Schneeweiss, S, 2012
)
0.62
" Subjects underwent safety assessments and were monitored for adverse events (AEs)."( Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, C; Lacreta, F; Mosqueda-Garcia, R; Nepal, S; Schuster, A; Shenker, A; Wang, J; Yu, Z, 2013
)
0.62
"Multiple oral doses of apixaban were safe and well tolerated over a 10-fold dose range, with pharmacokinetics with low variability and concentration-related increases in clotting time measures."( Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, C; Lacreta, F; Mosqueda-Garcia, R; Nepal, S; Schuster, A; Shenker, A; Wang, J; Yu, Z, 2013
)
0.93
" Adverse events, vital signs and laboratory assessments were monitored."( Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, CE; LaCreta, FP; Pursley, J; Upreti, VV; Wang, J, 2013
)
0.6
" Only after the preceding dose was confirmed to be safe and well-tolerated subjects were enrolled into the next-higher-dose panel."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
0.63
"Apixaban was safe and well-tolerated in these healthy Japanese male subjects across the doses evaluated."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
2.07
"Apixaban was safe and well-tolerated in healthy Japanese subjects."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
2.07
" Left atrial ablation procedures under continuous oral anticoagulation with apixaban are feasible and as safe as under continuous oral anticoagulation with phenprocoumon."( Comparison of safety of left atrial catheter ablation procedures for atrial arrhythmias under continuous anticoagulation with apixaban versus phenprocoumon.
Ammar, S; Bourier, F; Buiatti, A; Deisenhofer, I; Dillier, R; Grebmer, C; Hessling, G; Kaess, BM; Kolb, C; Lennerz, C; Reents, T; Semmler, V, 2015
)
0.85
" Of importance, adverse event rates did not differ between the two groups after adjusting by a propensity score analysis."( Efficacy and safety of apixaban in the patients undergoing the ablation of atrial fibrillation.
Fujita, M; Hirai, M; Inden, Y; Ishikawa, S; Kato, H; Miyoshi, A; Murohara, T; Nagao, T; Ohguchi, S; Okumura, S; Shimano, M; Yamamoto, T; Yanagisawa, S; Yoshida, N, 2015
)
0.73
"The use of apixaban during the periprocedural period of AF ablation seemed as efficacious and safe as warfarin."( Efficacy and safety of apixaban in the patients undergoing the ablation of atrial fibrillation.
Fujita, M; Hirai, M; Inden, Y; Ishikawa, S; Kato, H; Miyoshi, A; Murohara, T; Nagao, T; Ohguchi, S; Okumura, S; Shimano, M; Yamamoto, T; Yanagisawa, S; Yoshida, N, 2015
)
1.12
"Compared with warfarin, periprocedural anticoagulation with dabigatran resulted in fewer minor hemorrhages and total adverse events after AF ablation."( Safety of novel oral anticoagulants compared with uninterrupted warfarin for catheter ablation of atrial fibrillation.
Armbruster, HL; Berger, RD; Calkins, H; Habibi, M; Khurram, IM; Lindsley, JP; Marine, JE; Moranville, MP; Spragg, DD, 2015
)
0.42
" Comparing the pharmacovigilance reports for the individual NOACs, more hepatic adverse events were reported for rivaroxaban than for dabigatran or apixaban."( Hepatotoxicity of New Oral Anticoagulants (NOACs).
Krähenbühl, S; Liakoni, E; Rätz Bravo, AE, 2015
)
0.62
" Bleeding is an adverse event in patients taking anticoagulants."( To Bleed or Not to Bleed: That is the Question. The Side Effects of Apixaban.
Ciccone, MM; Devito, F; Maiello, M; Palmiero, P; Zito, A, 2018
)
0.72
"Apixaban was as effective and safe as VKAs in the periprocedural period of CA."( Meta-Analysis of Efficacy and Safety of Apixaban in Patients Undergoing Catheter Ablation for Atrial Fibrillation.
Liu, Q; Lu, D; Shan, QJ; Wang, K; Zhang, QI, 2016
)
2.14
" Non-vitamin K antagonist oral anticoagulants (NOACs) have emerged as efficacious, safe and convenient stroke prevention agents."( Relative efficacy and safety of non-Vitamin K oral anticoagulants for non-valvular atrial fibrillation: Network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups.
Batson, S; Kachroo, S; Lip, GY; Liu, LZ; Liu, X; Mitchell, SA; Phatak, H, 2016
)
0.64
"Apixaban, one of the non-vitamin K antagonist oral anticoagulants, was reported to be effective and safe in stroke prevention in patients with atrial fibrillation (AF) based on the global randomized clinical trial, but data are limited on the efficacy and safety of apixaban in Japanese elderly patients."( Study design of J-ELD AF: A multicenter prospective cohort study to investigate the efficacy and safety of apixaban in Japanese elderly patients.
Akao, M; Okumura, K; Yamashita, T, 2016
)
2.09
"Anticoagulation with NOAC with a short period of periprocedural interruption without bridging with LMWH seems safe and well-tolerated."( Safety of novel oral anticoagulants in catheter ablation of atrial fibrillation.
Hansen, PS; Sanchez, R; Walfridsson, H, 2016
)
0.43
" This study evaluates the total complications and the impact of novel oral anticoagulants (NOACs) compared to phenprocoumon on adverse events in the setting of PVI using CB."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016
)
0.43
"The incidence of adverse events in PVI using the second-generation CB with the periprocedural administration of NAOCs was not significantly different compared to phenprocoumon."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016
)
0.43
" All NOACs seem to be safe and effective alternatives to warfarin in a routine care setting."( Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study.
Kjældgaard, JN; Larsen, TB; Lip, GY; Nielsen, PB; Skjøth, F, 2016
)
0.43
" In conclusion, DOACs are effective and safe for the extended treatment of VTE, and may reduce the risk of all-cause mortality."( Safety ad efficacy of direct oral anticoagulants for extended treatment of venous thromboembolism.
Benedetti, R; Fenoglio, L; Imberti, D; Pomero, F, 2016
)
0.43
"Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance."( Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.
Jaulent, MC; Koutkias, VG; Lillo-Le Louët, A, 2017
)
0.46
" We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter."( Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.
Jaulent, MC; Koutkias, VG; Lillo-Le Louët, A, 2017
)
0.46
" In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase."( Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.
Biagi, C; Conti, V; Donati, M; Melis, M; Monaco, L; Motola, D; Vaccheri, A; Venegoni, M, 2017
)
0.46
"Cerebrovascular adverse events collected by the Pharmaceutical and Medical Devices Agency (PMDA) during 2014 were analyzed to describe and compare efficacy and safety among patients prescribed DTI and FXa."( Evaluation of the Efficacy and Safety of Direct Oral Anticoagulants in Japanese Patients-Analysis of Pharmaceuticals and Medical Devices Agency Data.
Terayama, Y, 2017
)
0.46
" In addition, NOACs have been demonstrated to be safe and associated with a significant reduction in major and intracranial bleeding events."( [New oral anticoagulants in patients with atrial fibrillation: efficacy and safety data from the real world].
Di Pasquale, G; Riva, L, 2017
)
0.46
"End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials."( Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection.
Alexander, JH; Alexander, KP; Giraldez, RRCV; Guimarães, PO; Haque, G; James, SK; Lopes, RD; Stevens, SR; Wruck, L; Zimerman, A, 2017
)
0.46
" In conclusion, the use of apixaban is as safe and effective as warfarin for uninterrupted OA therapy during catheter-based ablation of AF."( Safety and Efficacy of Uninterrupted Apixaban Therapy Versus Warfarin During Atrial Fibrillation Ablation.
Doppalapudi, H; Gunter, A; Kumar, V; Maddox, WR; McElderry, T; Meggo, D; Pentecost, E; Pillai, A; Plumb, V; Schafer, P; Shah, RR; Yamada, T, 2017
)
1.03
" The secondary efficacy outcome was major adverse cardiovascular events (MACE; composite of myocardial infarction, stroke, and all-cause mortality)."( Meta-Analysis of the Safety and Efficacy of the Oral Anticoagulant Agents (Apixaban, Rivaroxaban, Dabigatran) in Patients With Acute Coronary Syndrome.
Arshad, A; Kaluski, E; Khan, SU; Nasir, F; Riaz, IB; Talluri, S, 2018
)
0.71
" Patients commenced on NOACs should be assessed and followed up in a multidisciplinary AF clinic to ensure safe and effective prescribing and stroke prevention."( Is the prescription right? A review of non-vitamin K antagonist anticoagulant (NOAC) prescriptions in patients with non-valvular atrial fibrillation. Safe prescribing in atrial fibrillation and evaluation of non-vitamin K oral anticoagulants in stroke pre
Burke, C; Collins, R; Coughlan, T; Egom, EE; McAuliffe, C; McHugh, J; Moore, D; Morrissey, E; O'Brien, J; Pharithi, RB; Ranganathan, D; Ryan, D; Vaughan, M, 2019
)
0.51
"The safety of the NOACs compared with warfarin was generally favourable across different patient subgroups, including those perceived to be at "high risk" for adverse outcomes."( The safety of NOACs in atrial fibrillation patient subgroups: A narrative review.
Lip, GYH, 2019
)
0.51
" Our data might give some assurance to clinicians that apixaban can be an effective and safe therapeutic option for treatment of patients with venous thromboembolism."( Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis.
Brown, J; Dawwas, GK; Dietrich, E; Park, H, 2019
)
1.06
"Our findings provide evidence that apixaban is efficacious and safe across the spectrum of weight, including in low- (≤60 kg) and high-weight patients (>120 kg)."( Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight.
Al-Khatib, SM; Alexander, JH; Atar, D; Bahit, MC; Ezekowitz, JA; Fudim, M; Granger, CB; Hanna, M; Hijazi, Z; Hohnloser, SH; Lopes, RD; Lopez-Sendon, JL; Wallentin, L; Wojdyla, DM, 2019
)
1.1
"Direct oral anticoagulants (DOACs) are at least as efficacious and safe as warfarin among non-valvular atrial fibrillation (NVAF) patients; limited evidence is available regarding NVAF patients with heart failure (HF)."( Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.
Amin, A; Dhamane, A; Di Fusco, M; Friend, K; Garcia Reeves, AB; Keshishian, A; Li, X; Luo, X; Mardekian, J; Nadkarni, A; Pan, X; Rosenblatt, L; Yuce, H, 2019
)
0.51
"We analyzed adverse event cases submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2013 to December 2018."( Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).
Choshen Cohen, L; Goldstein, R; Muszkat, M; Perlman, A; Singer, DE; Wanounou, M, 2019
)
0.51
"During this period, 9693 adverse event cases reported concomitant use of FXa-DOACs and AEDs."( Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).
Choshen Cohen, L; Goldstein, R; Muszkat, M; Perlman, A; Singer, DE; Wanounou, M, 2019
)
0.51
" The risks of ischemic stroke, intracranial hemorrhage (ICH), major bleeding, mortality, and composite adverse events were compared between NOACs and warfarin in all patients ≥ 65 years of age and, specifically, with different age strata (ie, 65-74, 75-89, ≥ 90 years)."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020
)
0.56
"Compared with warfarin, NOACs were associated with a significantly lower risk of adverse events, with heterogeneity in treatment effects among different age strata."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020
)
0.56
" Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction."( Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.
Babayan, LM; Behbakht, K; Breed, CA; Brennecke, A; Cheng, G; Corr, BR; Flink, D; Guntupalli, SR; Lefkowits, C; Matsuo, K; Ramzan, AA; Sheeder, J; Tayebnejad, A; Wheeler, LJ, 2020
)
0.87
"68), adverse events, medication adherence, or quality of life between the groups."( Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.
Babayan, LM; Behbakht, K; Breed, CA; Brennecke, A; Cheng, G; Corr, BR; Flink, D; Guntupalli, SR; Lefkowits, C; Matsuo, K; Ramzan, AA; Sheeder, J; Tayebnejad, A; Wheeler, LJ, 2020
)
0.87
" Early administration of apixaban (< 48 h), after onset of acute LVO in patients with NVAF, was generally safe compared with those who received it Late (≥ 48 h)."( Safety of Early Administration of Apixaban on Clinical Outcomes in Patients with Acute Large Vessel Occlusion.
Enomoto, Y; Ezura, M; Fukawa, N; Hatano, T; Imamura, H; Kamiya, Y; Kimura, N; Matsumoto, Y; Morimoto, M; Morimoto, T; Nonaka, T; Ohta, H; Ota, T; Sakai, N; Shibata, M; Shimamura, N; Shimizu, F; Takeuchi, M; Tanaka, K; Uchida, K; Yamagami, H; Yoshimura, S, 2021
)
1.2
"Our real-life data study suggests that secondary stroke prevention with DOACs is as effective and safe as primary prevention, both in standard and reduced doses, in a typical group of patients who are older than patients included in RCTs."( Effectiveness and Safety of Direct Oral Anticoagulants in the Secondary Stroke Prevention of Elderly Patients: Ljubljana Registry of Secondary Stroke Prevention.
Frol, S; Hudnik, LK; Oblak, JP; Šabovič, M; Sernec, LP, 2020
)
0.56
"Primary thromboprophylaxis with apixaban therapy seems to be safe and effective in patients with gastrointestinal cancers."( Efficacy and safety of apixaban for primary prevention in gastrointestinal cancers: A post-hoc analysis of the AVERT trial.
Caiano, L; Carrier, M; Ladha, D; Mallick, R; Wang, TF; Wells, PS, 2021
)
1.22
" These data suggest that apixaban may be safe to use for lung transplant patients, and larger studies are warranted to assess long-term outcomes as well as safety and efficacy of alternative DOACs."( A retrospective analysis of the safety and efficacy of apixaban use after lung transplant.
Ausloos, KA; Grazia, TJ; Lam, ILL; Naik, CA; Patel, RS; Reininger, KA; Rosenblatt, RL; Sam, T, 2021
)
1.17
" Setting FDA Adverse Event Reporting System (FAERS) database."( Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.
Cui, X; Guo, M; Thai, S; Wang, T; Wei, J; Xu, W; Zhao, Y; Zhou, J, 2021
)
0.92
" There were no unacceptable toxicities to report and no treatment-related adverse events."( Safety of apixaban for venous thromboembolic primary prophylaxis in patients with newly diagnosed malignant glioma.
Chan, K; Goodwin, A; Holmes, CE; Prasad, P; Ross, H; Thomas, AA; Wright, H, 2022
)
1.12
" We used weighted Cox proportional hazards models to estimate separately the hazard ratios (HRs) with 95% confidence intervals (CIs) of ischemic stroke, major bleeding, and major adverse limb events associated with the use of apixaban compared with rivaroxaban."( Effectiveness and Safety of Apixaban versus Rivaroxaban in Patients with Atrial Fibrillation and Type 2 Diabetes Mellitus.
Azoulay, L; Chowdhury, KR; Michaud, J; Renoux, C; Yin, H; Yu, OHY, 2022
)
1.2
"In conclusion, 30 days of postoperative apixaban appears to be safe and effective with minimal side effects while preventing thromboembolic events."( The Safety and Efficacy of Apixaban (Eliquis) in 5017 Post-bariatric Patients with 95.3% Follow-up: a Multicenter Study.
Belnap, L; Cottam, D; Medlin, W; Potts, J; Richards, C; Roslin, M; Surve, A; Uchal, M, 2022
)
1.29
"Heparin-induced thrombocytopenia (HIT) is a serious adverse drug reaction due to its related risk of life- and limb-threatening thrombosis."( An Open-Label, Single-Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin-Induced Thrombocytopenia.
Ansarinejad, N; Balouchzehi, S; Farasatinasab, M; Moghaddam, OM; Mohammadi, M; Nasiripour, S, 2022
)
0.94
"Apixaban is safe to use for anticoagulation of heart transplant recipients undergoing routine biopsies."( The utilization and safety of apixaban for therapeutic anticoagulation in heart transplant population requiring routine endomyocardial biopsies.
Badiye, A; Baran, DA; Cameron, C; Herre, JM; Ingemi, AI; Lichvar, A; Lindauer, KE; McMahon, MR; Old, W; Sawey, EJ; Yao, A; Yehya, A, 2022
)
2.45
"We investigated whether apixaban is safe for the prevention of further adverse events in non-valvular atrial fibrillation (NVAF) patients with intra-/extracranial artery stenosis (Stenosis group) compared with acute large vessel occlusion without intra-/extracranial artery stenosis (No stenosis group)."( Safety of Apixaban Monotherapy for Non-Valvular Atrial Fibrillation-Related Acute Stroke with Intra-/Extracranial Artery Stenosis.
Enomoto, Y; Ezura, M; Fukawa, N; Hatano, T; Koyanagi, M; Matsumoto, Y; Morimoto, M; Morimoto, T; Nonaka, T; Ogura, T; Ohta, H; Ota, T; Sakai, N; Shibata, M; Shimizu, F; Takeuchi, M; Uchida, K; Yamagami, H; Yoshimura, S, 2023
)
1.62
"Apixaban monotherapy appears safe for the prevention of further adverse events in the Stenosis group patients similar to the No stenosis group patients."( Safety of Apixaban Monotherapy for Non-Valvular Atrial Fibrillation-Related Acute Stroke with Intra-/Extracranial Artery Stenosis.
Enomoto, Y; Ezura, M; Fukawa, N; Hatano, T; Koyanagi, M; Matsumoto, Y; Morimoto, M; Morimoto, T; Nonaka, T; Ogura, T; Ohta, H; Ota, T; Sakai, N; Shibata, M; Shimizu, F; Takeuchi, M; Uchida, K; Yamagami, H; Yoshimura, S, 2023
)
2.76
" Poisson regression and Cox proportional hazard models were used to estimate adjusted adverse event rates."( Adverse events in low versus normal body weight patients prescribed apixaban for atrial fibrillation.
Ali, MA; Barnes, GD; DeCamillo, D; Haymart, B; Kaatz, S; Kong, X, 2023
)
1.15

Pharmacokinetics

Physiologically-based pharmacokinetic models for apixaban and rivaroxaban were developed to estimate the net effect of CYP3A induction, P-GP inhibition, and P-gp induction by rifampicin. Low body weight group had approximately 27% [90% confidence interval (CI): 8-51%] and 20% (90% CI: 11-42%) higher apixban maximum observed plasma concentration. High body weight had approximately 31% and 23% lower apixabans Cmax and AUC(0,∞) , respectively.

ExcerptReferenceRelevance
" While the anticoagulant effect of the new thrombin and FXa inhibitors is similar, differences in the pharmacokinetic and pharmacodynamic parameters may influence their use in clinical practice."( Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development.
Eriksson, BI; Quinlan, DJ; Weitz, JI, 2009
)
0.35
" Studies of apixaban in rabbits showed a good correlation between apixaban concentrations and inhibition of FXa activity, prolongation of prothrombin time and modified prothrombin time, with no lag time between these ex vivo pharmacodynamic markers and plasma drug levels."( Metabolism, pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban in rabbits.
Crain, EJ; He, B; He, K; Luettgen, JM; Raghavan, N; Wang, L; Wong, PC; Xin, B; Zhang, D, 2010
)
0.97
" The preclinical pharmacokinetic (PK) attributes of apixaban feature small volume of distribution (Vd), low systemic clearance (CL), and good oral bioavailability."( Preclinical pharmacokinetics and pharmacodynamics of apixaban, a potent and selective factor Xa inhibitor.
Grace, JE; Grossman, SJ; He, B; He, K; Knabb, RM; Lam, PY; Luettgen, JM; Pinto, DJ; Wexler, RR; Wong, PC; Xin, B; Zhang, D, 2011
)
0.87
"Compared with the reference body weight group, low body weight had approximately 27% [90% confidence interval (CI): 8-51%] and 20% (90% CI: 11-42%) higher apixaban maximum observed plasma concentration (Cmax) and area under the concentration-time curve extrapolated to infinity (AUC(0,∞)), respectively, and high body weight had approximately 31% (90% CI: 18-41%) and 23% (90% CI: 9-35%) lower apixaban Cmax and AUC(0,∞) , respectively."( Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.
Barrett, YC; Boyd, RA; Byon, W; Frost, CE; LaCreta, FP; Pursley, J; Upreti, VV; Wang, J, 2013
)
0.8
" The present method was successfully applied to a pharmacokinetic study following oral administration of apixaban."( Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: application to pharmacokinetic study.
Basset, T; Delavenne, X; Mismetti, P, 2013
)
0.91
" Though the anticoagulation efficacy of these NOACs has been characterized, differences in their pharmacokinetic and pharmacodynamic profiles have become a significant consideration in terms of drug selection and dosing."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013
)
0.6
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
"Articles reviewed focused on drugs affecting the permeability glycoprotein (P-gp) efflux transporter protein and/or cytochrome P (CYP) 450 3A4 enzymes, and pharmacodynamic DDIs when drugs are administered concomitantly."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
" Pharmacokinetic parameters, including peak plasma concentration (Cmax), time to Cmax (Tmax), area under the concentration-time curve from time 0 to infinity (AUCINF), and terminal half-life (T½), were derived from apixaban plasma concentration-time data."( Effect of activated charcoal on apixaban pharmacokinetics in healthy subjects.
Boyd, RA; Frost, C; Mondal, S; Tirucherai, G; Wang, J; Wang, X; Zhang, D, 2014
)
0.87
" Apixaban Cmax and Tmax were similar across treatments."( Effect of activated charcoal on apixaban pharmacokinetics in healthy subjects.
Boyd, RA; Frost, C; Mondal, S; Tirucherai, G; Wang, J; Wang, X; Zhang, D, 2014
)
1.6
"To assess pharmacokinetic and pharmacodynamic interactions between naproxen (a non-steroidal anti-inflammatory drug) and apixaban (an oral, selective, direct factor-Xa inhibitor)."( Evaluation of the effect of naproxen on the pharmacokinetics and pharmacodynamics of apixaban.
Barrett, YC; Boyd, RA; Byon, W; Frost, C; Gandhi, MD; LaCreta, F; Pursley, J; Shenker, A; Wang, J; Zhang, D, 2014
)
0.83
" The pharmacokinetics of apixaban and effect on pharmacodynamic variables (clotting assays and anti-Xa activity) were assessed on day 1 and day 7 of treatment."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
0.93
" The pharmacokinetic profile of apixaban following multiple twice-daily doses was linear, and exposure parameters such as C(max), observed at ~ 3 hours post-dose, and area under the plasma concentration-time curve increased in a dose-proportional manner."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
0.91
" Blood and urine samples were collected for pharmacokinetic and pharmacodynamic (blood only) analyses."( Effects of age and sex on the single-dose pharmacokinetics and pharmacodynamics of apixaban.
Barrett, YC; Frost, CE; Harris, SI; LaCreta, F; Schuster, A; Shenker, A; Song, Y; Wang, J, 2015
)
0.64
" All three pharmacodynamic measures exhibited a positive linear correlation with the plasma apixaban concentration."( Effects of age and sex on the single-dose pharmacokinetics and pharmacodynamics of apixaban.
Barrett, YC; Frost, CE; Harris, SI; LaCreta, F; Schuster, A; Shenker, A; Song, Y; Wang, J, 2015
)
0.86
"To determine pharmacokinetic and pharmacodynamic properties of the novel factor Xa inhibitor apixaban in clinically normal cats."( Pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban after oral and intravenous administration to cats.
Bright, JM; Martinez, CM; Myers, JA; Olver, CS; Wittenburg, LA, 2015
)
0.87
" Pharmacodynamic effects of apixaban were determined with a commercial assay for factor × activity, which measures endogenous factor Xa activity chromogenically."( Pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban after oral and intravenous administration to cats.
Bright, JM; Martinez, CM; Myers, JA; Olver, CS; Wittenburg, LA, 2015
)
0.95
" Pharmacokinetic analysis revealed moderate clearance, short half-life, and high bioavailability for apixaban."( Pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban after oral and intravenous administration to cats.
Bright, JM; Martinez, CM; Myers, JA; Olver, CS; Wittenburg, LA, 2015
)
0.87
" Blood samples were collected for determination of apixaban pharmacokinetic parameters, measures of clotting (prothrombin time, international normalized ratio, activated partial thromboplastin time), and anti-factor Xa (FXa) activity."( Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.
Boyd, RA; Chang, M; Frost, C; Marbury, TC; Pursley, J; Song, Y; Tirucherai, G; Wang, J; Wang, X; Zhang, D, 2016
)
0.94
" Secondary objectives included assessment of safety and tolerability as well as international normalized ratio (INR) and anti-factor Xa activity as pharmacodynamic endpoints."( Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of apixaban.
Boyd, RA; Byon, W; Chang, M; Frost, CE; LaCreta, F; Pursley, J; Shenker, A; Wang, J; Yu, Z, 2016
)
0.66
"These studies evaluate the relative bioavailability of crushed apixaban tablets and the effect of food on apixaban pharmacokinetic properties."( Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.
Chang, M; Frost, C; Frost, RJ; Kelly, A; LaCreta, F; Song, Y; Suzuki, A, 2016
)
0.9
" Cmax and AUC decreased by 21."( Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.
Chang, M; Frost, C; Frost, RJ; Kelly, A; LaCreta, F; Song, Y; Suzuki, A, 2016
)
0.66
" Current apixaban dosing recommendations for this patient population are based largely on a single-dose pharmacokinetic study of eight patients."( Clinical Application and Pharmacodynamic Monitoring of Apixaban in a Patient with End-Stage Renal Disease Requiring Chronic Hemodialysis.
Kufel, WD; Lehmann, DF; Miller, CD; Zayac, AS, 2016
)
1.1
"The objective was to characterise apixaban pharmacodynamic (PD) activity in umbilical cord (UC), paediatric, and adult plasma."( Apixaban pharmacodynamic activity in umbilical cord, paediatric, and adult plasma.
Adamczyk, R; Barrett, YC; Frost, C; Ramacciotti, E; Wang, J; Wang, Z; Yetman, RJ, 2017
)
2.18
" The pharmacokinetics in patients treated with standard and reduced doses of the four anticoagulants using liquid chromatography-tandem mass spectrometry was compared with the concentration ranges estimated using physiologically based pharmacokinetic modeling."( Pharmacokinetics of anticoagulants apixaban, dabigatran, edoxaban and rivaroxaban in elderly Japanese patients with atrial fibrillation treated in one general hospital.
Endo, S; Kishi, H; Kogiku, M; Noda, M; Notsu, Y; Ota, M; Shimizu, M; Takekawa, M; Yamazaki, H; Yamazaki-Nishioka, M, 2019
)
0.79
" Apixaban is rapidly absorbed, with maximum concentration occurring 3-4 h after oral administration, and has a half-life of approximately 12 h."( Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.
Boyd, RA; Byon, W; Frost, CE; Garonzik, S, 2019
)
2.87
" Physiologically-based pharmacokinetic models for apixaban and rivaroxaban were developed to estimate the net effect of CYP3A induction, P-gp inhibition, and P-gp induction by rifampicin."( Physiologically-Based Pharmacokinetic Modeling for the Prediction of a Drug-Drug Interaction of Combined Effects on P-glycoprotein and Cytochrome P450 3A.
Bonate, PL; Choules, MP; Komatsu, K; Otsuka, Y, 2020
)
0.81
"To develop a physiologically based pharmacokinetic (PBPK) model for apixaban, an oral anticoagulant with a narrow therapeutic index, and to predict PK profiles and potential drug-drug interactions (DDIs) in patients with renal impairment and paediatrics."( Developing a physiologically based pharmacokinetic model of apixaban to predict scenarios of drug-drug interactions, renal impairment and paediatric populations.
Chen, L; Ge, W; Tang, H; Xu, R; Yang, J, 2021
)
1.1
"Mild or moderate hepatic impairment had no clinically relevant impact on apixaban pharmacokinetic or pharmacodynamic measures, suggesting that dose adjustment may not be required."( Apixaban Pharmacokinetics and Pharmacodynamics in Subjects with Mild or Moderate Hepatic Impairment.
Frost, CE; Garonzik, SM; Ly, V, 2021
)
2.3
" The method was successfully applied to the pharmacokinetic study of CX3002 (30 mg) in healthy Chinese subjects."( A validated UPLC-MS/MS method for the determination of CX3002 in human plasma and its application to a pharmacokinetic study.
Chen, J; Hu, X; Hu, Y; Jiang, B; Lou, H; Ruan, Z; Shen, Y; Xu, Y; Yang, D, 2021
)
0.62
"To investigate single-dose pharmacokinetic (PK) and pharmacodynamic (PD) parameters of apixaban when administered to patients undergoing vertical sleeve gastrectomy (VSG) or Roux-en-Y gastric bypass (RYGB) and to determine whether the PK and PD parameters are affected by type of bariatric surgery and weight loss in the immediate and postoperative period up to 12 months."( The APB study: apixaban pharmacokinetics in bariatric patients before to 1 year after vertical sleeve gastrectomy or Roux-en-Y gastric bypass.
Canner, JP; Harris, C; Jurao, RA; Kickler, TS; Petty, BG; Prokopowicz, GP; Steele, KE; Streiff, MB, 2022
)
1.3
" A single dose of apixaban 10 mg was administered orally to kidney and lung transplant recipients maintained on either tacrolimus or cyclosporine, and pharmacokinetic parameters were compared to a reference cohort of 12 healthy subjects who used the same apixaban dose and pharmacokinetic blood sampling."( Pharmacokinetics of apixaban and tacrolimus or cyclosporine in kidney and lung transplant recipients.
Alcorn, J; Bashir, B; Douketis, JD; Fenton, ME; Kraft, WK; Mansell, H; Semchuk, W; Shoker, A; Tam, JS; Yao, S, 2022
)
1.38
" Further studies using physiologically based pharmacokinetic modelling are required to investigate the drug-drug interactions between these drugs."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023
)
0.91
" The developed dronedarone physiologically based pharmacokinetic (PBPK) model was verified using reported drug-drug interactions (DDIs) between dronedarone and CYP3A4 and P-gp substrates."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
0.93
" After oral administration APB and MET to rats, the comparison of pharmacokinetic parameters of APB in the single and co-administrated groups showed significant difference in AUC(0-t) from 730."( LC-MS/MS Method Assay for Simultaneous Determination of the Apixaban and Metformin in Rat Plasma: Assessment of Pharmacokinetic Drug-Drug Interaction Study.
Dong, W; Feng, T; Shang, K; Shen, X; Wang, F; Wang, L, 2023
)
1.15

Compound-Compound Interactions

Apixaban 10 mg was administered orally alone, in combination with 100 mg cyclosporine or 5 mg tacrolimus. Major bleedings were rare among patients with atrial fibrillation treated with dronedarone and apixaban or warfarin.

ExcerptReferenceRelevance
" We evaluated apixaban, a direct and highly selective factor Xa inhibitor, in combination with clinically relevant doses of aspirin and/or clopidogrel for prevention of arterial thrombosis in rabbits."( Arterial antithrombotic and bleeding time effects of apixaban, a direct factor Xa inhibitor, in combination with antiplatelet therapy in rabbits.
Crain, EJ; Watson, CA; Wong, PC, 2008
)
0.96
" The metabolic drug-drug interaction potential of apixaban was evaluated in vitro."( In vitro assessment of metabolic drug-drug interaction potential of apixaban through cytochrome P450 phenotyping, inhibition, and induction studies.
Chen, SY; Frost, CA; Frost, CE; Goosen, TC; Grossman, SJ; He, K; Humphreys, WG; Ma, L; Maxwell, BD; Raghavan, N; Wang, L; Yao, M; Zhang, D, 2010
)
0.85
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
" Phase I DDI studies have reported pharmacokinetic DDIs mediated by P-gp alone (dabigatran etexilate) or in combination with CYP3A4 enzymes (rivaroxaban and apixaban)."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.59
" No clinically relevant age- or sex-dependent difference in the apixaban pharmacokinetics and pharmacodynamics which would lead to the modification of the dose exists, apixaban may even be administered with or without food."( Apixaban - Metabolism, Pharmacologic Properties and Drug Interactions.
Dobrotova, M; Kubisz, P; Mokan, M; Samos, M; Stanciakova, L; Stasko, J, 2017
)
2.14
" This work aimed to assess potential P-gp-mediated drug-drug interactions between PDE5is and DOACs using in vitro methods."( In Vitro Assessment of Pharmacokinetic Drug-Drug Interactions of Direct Oral Anticoagulants: Type 5-Phosphodiesterase Inhibitors Are Inhibitors of Rivaroxaban and Apixaban Efflux by P-Glycoprotein.
Bertoletti, L; Delavenne, X; Delézay, O; Hodin, S; Jacqueroux, E; Margelidon-Cozzolino, V, 2018
)
0.68
"There have been concerns about bleeding risks for patients with atrial fibrillation treated with dronedarone in combination with new oral anticoagulants (NOACs)."( Safety of apixaban in combination with dronedarone in patients with atrial fibrillation.
Friberg, L, 2018
)
0.88
" All patients with atrial fibrillation who used dronedarone in combination with apixaban or warfarin during 2013-2016 were identified."( Safety of apixaban in combination with dronedarone in patients with atrial fibrillation.
Friberg, L, 2018
)
1.11
"Major bleedings were rare among patients with atrial fibrillation treated with dronedarone in combination with apixaban or warfarin."( Safety of apixaban in combination with dronedarone in patients with atrial fibrillation.
Friberg, L, 2018
)
1.09
" Apixaban 10 mg was administered orally alone, in combination with 100 mg cyclosporine or 5 mg tacrolimus."( Drug-Drug Interaction Study of Apixaban with Cyclosporine and Tacrolimus in Healthy Volunteers.
Bashir, B; Chervoneva, I; Kraft, WK; Stickle, DF, 2018
)
1.68
" NOAC have also been studied in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease, and reduced doses will presumably emerge as routine treatment also in these conditions."( [NOAC in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease].
Gottsäter, A, 2018
)
0.48
" To evaluate drug-drug interactions, the impact of ketoconazole, a known strong inhibitor of cytochrome P450 3A4 and P-glycoprotein, was studied."( Microdosed Cocktail of Three Oral Factor Xa Inhibitors to Evaluate Drug-Drug Interactions with Potential Perpetrator Drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2019
)
0.51
" This is the first study that has been conducted to evaluate drug-drug interactions with a drug class, and the low administered doses also allow evaluation in vulnerable target populations."( Microdosed Cocktail of Three Oral Factor Xa Inhibitors to Evaluate Drug-Drug Interactions with Potential Perpetrator Drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2019
)
0.51
"As an alternative to vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) are increasingly prescribed in combination with riociguat in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH)."( In vitro assessment of P-gp and BCRP transporter-mediated drug-drug interactions of riociguat with direct oral anticoagulants.
Bertoletti, L; Delavenne, X; Hodin, S; Jacqueroux, E; Margelidon-Cozzolino, V; Mercier, C, 2020
)
0.56
"Apixaban, a direct oral anticoagulant, has emerged over the past few years because it is considered to have a low risk of drug-drug interactions compared to vitamin K antagonists."( Drug interactions with apixaban: A systematic review of the literature and an analysis of VigiBase, the World Health Organization database of spontaneous safety reports.
Fernandez, S; Lenoir, C; Rollason, V; Samer, C, 2020
)
2.31
" The models were verified with observed clinical drug-drug interactions with CYP3A and P-gp inhibitors."( Physiologically-Based Pharmacokinetic Modeling for the Prediction of a Drug-Drug Interaction of Combined Effects on P-glycoprotein and Cytochrome P450 3A.
Bonate, PL; Choules, MP; Komatsu, K; Otsuka, Y, 2020
)
0.56
"To develop a physiologically based pharmacokinetic (PBPK) model for apixaban, an oral anticoagulant with a narrow therapeutic index, and to predict PK profiles and potential drug-drug interactions (DDIs) in patients with renal impairment and paediatrics."( Developing a physiologically based pharmacokinetic model of apixaban to predict scenarios of drug-drug interactions, renal impairment and paediatric populations.
Chen, L; Ge, W; Tang, H; Xu, R; Yang, J, 2021
)
1.1
"In this article, we present a case of apixaban elimination prolonged by 450% in a patient with coronavirus disease 2019 because of multiple conditions, including drug-drug interaction, severe inflammation, and acute kidney injury."( Severe Inflammation, Acute Kidney Injury, and Drug-Drug Interaction: Triple Penalty for Prolonged Elimination of Apixaban in Patients With Coronavirus Disease 2019: A Grand Round.
Botelho-Nevers, E; Delavenne, X; Demartin, AL; Launay, M; Mismetti, P; Ragey, SP, 2021
)
1.1
" Therefore, a drug-drug cocrystal of two antithrombotic agents with poor solubility was developed, which exhibited greatly improved solubility, bioavailability and superior stability, indicating a novel method to overcome the shortages of drug combination."( Cocrystal of Apixaban-Quercetin: Improving Solubility and Bioavailability of Drug Combination of Two Poorly Soluble Drugs.
Du, G; Jiao, L; Kong, D; Lu, Y; Song, J; Wang, H; Yang, D; Yang, H; Yang, S; Zhang, L; Zhao, X, 2021
)
0.99
" The aim of this study was to assess the potential P-gp-mediated drug-drug interactions between 11 tyrosine kinase inhibitors (TKIs) with apixaban and rivaroxaban."( Tyrosine kinase inhibitors and direct oral anticoagulants: In vitro evaluation of drug-drug interaction mediated by P-glycoprotein.
Bertoletti, L; Bin, V; Delavenne, X; Hodin, S; Lafaie, L; Saïb, S, 2022
)
0.92
" The developed dronedarone physiologically based pharmacokinetic (PBPK) model was verified using reported drug-drug interactions (DDIs) between dronedarone and CYP3A4 and P-gp substrates."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
0.93
" The results indicated that drug-drug interactions (DDI) occurred might be owing to APB affect one or all of OCTs, MATE1, MATE2-K."( LC-MS/MS Method Assay for Simultaneous Determination of the Apixaban and Metformin in Rat Plasma: Assessment of Pharmacokinetic Drug-Drug Interaction Study.
Dong, W; Feng, T; Shang, K; Shen, X; Wang, F; Wang, L, 2023
)
1.15
" In this study, first, a molecularly imprinted polymer combined with magnetic metal organic framework nanocomposite was prepared and then characterized using different techniques."( Selective extraction of apixaban from plasma by dispersive solid-phase microextraction using magnetic metal organic framework combined with molecularly imprinted polymer nanocomposite.
Afshar Mogaddam, MR; Farajzadeh, MA; Fathi, AA; Mohebbi, A; Sorouraddin, SM, 2023
)
1.22

Bioavailability

Apixaban is a new oral anticoagulant characterized by good bioavailability and renal elimination accounting for only 25%. The absolute oral bioavailability of apixaban is ~ 50%.

ExcerptReferenceRelevance
"Introduction of the phenyl piperidinone and phenyl pyridinone P4 moieties in the anthranilamide scaffold led to potent, selective, and orally bioavailable inhibitors of factor Xa."( Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
Chang, CH; Cheney, DL; Corte, JR; Fang, T; Gauuan, JF; Hadden, M; Han, W; He, K; Hu, Z; Jiang, XJ; Knabb, RM; Lam, PY; Li, YL; Luettgen, JM; Morin, PE; Orton, D; Pinto, DJ; Rendina, AR; Wexler, RR; Wong, PC, 2008
)
0.35
" Thus, apixaban is an orally bioavailable inhibitor of factor Xa with elimination pathways that include metabolism and renal excretion."( Apixaban metabolism and pharmacokinetics after oral administration to humans.
Bonacorsi, S; Chen, S; Frost, CE; He, K; Humphreys, WG; Pinto, D; Raghavan, N; Wong, PC; Yu, Z; Zhang, D; Zhang, H, 2009
)
2.25
" It is a potent, selective, reversible, and orally bioavailable FXa inhibitor that demonstrates antithrombotic efficacy, with a favorable pharmacokinetic profile."( Apixaban, an oral direct Factor Xa inhibitor: awaiting the verdict.
Ansell, J; Carreiro, J, 2008
)
1.79
" A set of compounds obtained from optimization of the R group and the C-3 substituent were orally bioavailable in dogs."( Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
He, K; King, SR; Knabb, RM; Lam, PY; Luettgen, JM; Qiao, JX; Rendina, AR; Wexler, RR; Wong, PC; Xin, B, 2009
)
0.35
" A class of highly potent, selective, efficacious and orally bioavailable direct factor Xa inhibitors was discovered."( Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
Arfsten, AE; Bao, L; Bauer, SM; Clizbe, LA; Edwards, ST; Fan, J; Goldman, EA; Hollenbach, SJ; Huang, W; Hutchaleelaha, A; Jia, ZJ; Kanter, J; Lambing, JL; Li, W; Pandey, A; Park, G; Probst, GD; Scarborough, RM; Sinha, U; Song, Y; Su, T; Wang, L; Wong, PW; Woolfrey, J; Wu, Y; Zhang, P; Zhu, BY, 2009
)
0.35
" Rabbits are commonly used in development of thrombosis disease models; however, unlike in other species, apixaban demonstrated poor oral bioavailability (F = 3%) and a high clearance rate (2."( Metabolism, pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban in rabbits.
Crain, EJ; He, B; He, K; Luettgen, JM; Raghavan, N; Wang, L; Wong, PC; Xin, B; Zhang, D, 2010
)
0.8
" Apixaban is well absorbed in rat, dog, and chimpanzee, with absolute oral bioavailability of approximately 50% or greater."( Preclinical pharmacokinetics and pharmacodynamics of apixaban, a potent and selective factor Xa inhibitor.
Grace, JE; Grossman, SJ; He, B; He, K; Knabb, RM; Lam, PY; Luettgen, JM; Pinto, DJ; Wexler, RR; Wong, PC; Xin, B; Zhang, D, 2011
)
1.53
"Concomitant medication with proton pump inhibitors, amiodarone, clarithromycin, and verapamil increased bioavailability whereas rifampicin decreased the bioavailability of dabigatran."( Relevance of P-glycoprotein in stroke prevention with dabigatran, rivaroxaban, and apixaban.
Finsterer, J; Stöllberger, C, 2015
)
0.64
" Selected compounds demonstrated oral bioavailability in rat IV/PO pharmacokinetic (PK) studies."( Development of a novel class of potent and selective FIXa inhibitors.
Andre, P; Araki, K; Bateman, TJ; Campeau, LC; Chen, YH; Desai, K; Ellsworth, K; Geissler, WM; Guo, L; Hruza, A; Jian, T; Meng, D; Nishimura, T; Nolting, AF; Orr, R; Parker, DL; Qian, X; Reichert, P; Sakurada, I; Sherer, EC; Shu, M; Smith, CJ; Sonatore, LM; Tschirret-Guth, R; Wood, HB; Zhang, T, 2015
)
0.42
" It is important to understand whether new formulations and/or methods of administration impact apixaban bioavailability and pharmacokinetic properties."( Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects.
Badawy, S; Frost, C; LaCreta, F; Perlstein, I; Song, Y; Wang, J; Wang, X, 2015
)
0.93
" Pharmacokinetic analysis revealed moderate clearance, short half-life, and high bioavailability for apixaban."( Pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban after oral and intravenous administration to cats.
Bright, JM; Martinez, CM; Myers, JA; Olver, CS; Wittenburg, LA, 2015
)
0.87
" Apixaban absolute oral bioavailability was 49 % when administered alone and 39 % following induction by rifampin."( Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa.
Boyd, RA; Byon, W; Dias, C; Frost, C; LaCreta, F; Shenker, A; Vakkalagadda, B; Wang, J; Yu, Z; Zhang, D, 2016
)
1.6
"Co-administration of apixaban with rifampin reduced apixaban exposure via both decreased bioavailability and increased systemic clearance."( Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa.
Boyd, RA; Byon, W; Dias, C; Frost, C; LaCreta, F; Shenker, A; Vakkalagadda, B; Wang, J; Yu, Z; Zhang, D, 2016
)
1.01
"These studies evaluate the relative bioavailability of crushed apixaban tablets and the effect of food on apixaban pharmacokinetic properties."( Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.
Chang, M; Frost, C; Frost, RJ; Kelly, A; LaCreta, F; Song, Y; Suzuki, A, 2016
)
0.9
"An open-label, randomized, crossover study in 33 healthy adults compared the bioavailability of 2 × 5-mg apixaban tablets administered whole (reference), crushed and suspended in 30 mL of water, and crushed and mixed with 30 g of applesauce."( Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.
Chang, M; Frost, C; Frost, RJ; Kelly, A; LaCreta, F; Song, Y; Suzuki, A, 2016
)
0.88
" This new oral anticoagulant represents an immediate-release form of peroral drug with quick dissolution, linear pharmacokinetics, good bioavailability and rapid onset and offset of action."( Apixaban - Metabolism, Pharmacologic Properties and Drug Interactions.
Dobrotova, M; Kubisz, P; Mokan, M; Samos, M; Stanciakova, L; Stasko, J, 2017
)
1.9
" Apixaban is a new oral anticoagulant characterized by good bioavailability and renal elimination accounting for only 25%, showing a safety profile and effectiveness in patients with renal impairment."( Apixaban: Effective and Safe in Preventing Thromboembolic Events in Patients with Atrial Fibrillation and Renal Failure.
Carbonara, S; Ciccone, MM; Corbo, F; Cortese, F; Franchini, C; Gesualdo, M; Pia Schiavone, BI; Ricci, G; Scicchitano, P, 2017
)
2.81
"Anticoagulation in patients with impaired kidney function can be challenging since drugs' pharmacokinetics and bioavailability are altered in this setting."( Chronic kidney disease and anticoagulation: from vitamin K antagonists and heparins to direct oral anticoagulant agents.
Baldovino, S; Fenoglio, R; Radin, M; Roccatello, D; Schreiber, K; Sciascia, S, 2017
)
0.46
" However, due to altered pharmacokinetics and bioavailability of these drugs in CKD, a significant risk of bleeding exists."( [The Multimorbid Patient: Use of New Oral Anticoagulants in Patients with Chronic Kidney Disease].
Mohebbi, N, 2018
)
0.48
" The absolute oral bioavailability of apixaban is ~ 50%."( Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.
Boyd, RA; Byon, W; Frost, CE; Garonzik, S, 2019
)
2.23
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" In this work, novel cocrystals, consisting of two antithrombotic drugs with poor solubility and low bioavailability in vivo, namely, apixaban (Apx) and quercetin (Que), were developed to discover a potential method to improve the poor solubility and internal absorption of the drug combination."( Cocrystal of Apixaban-Quercetin: Improving Solubility and Bioavailability of Drug Combination of Two Poorly Soluble Drugs.
Du, G; Jiao, L; Kong, D; Lu, Y; Song, J; Wang, H; Yang, D; Yang, H; Yang, S; Zhang, L; Zhao, X, 2021
)
1.19
"Direct-acting oral anticoagulants (DOACs) vary in bioavailability and sites of absorption in the gastrointestinal tract (GIT)."( Direct Acting Oral Anticoagulants Following Gastrointestinal Tract Surgery.
Alawaji, Z; Alkhani, M; Alyahya, Z; Hakeam, HA; Ofori, S, 2021
)
0.62
"Solid lipid nanoparticles (SLnPs) are usually utilized as lipid-based formulations for enhancing oral bioavailability of BCS class IV drugs."( Application of Design of Experiment in the Optimization of Apixaban-Loaded Solid Lipid Nanoparticles: In Vitro and In Vivo Evaluation.
Arafa, MF; El-Gizawy, SA; Osman, MA; Ramadan, SE, 2023
)
1.15

Dosage Studied

Apixaban has a half-life of about 12 hours, and the normal dosage is 5 mg orally twice daily. The hypothetical recommended dosage of dabigatran, rivaroxaban and apixaban according to renal function was determined at discharge.

ExcerptRelevanceReference
"To evaluate the safety and efficacy of apixaban, a potent, direct, oral inhibitor of FXa, in patients following total knee replacement (TKR), and to investigate dose-response relationships."( The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement.
Ansell, J; Davidson, BL; Deitchman, D; Gallus, A; Lassen, MR; Pineo, G, 2007
)
0.91
" Clopidogrel at 3 mg kg(-1) was dosed orally once daily for three days, with the last dose given 2 h before injury."( Arterial antithrombotic and bleeding time effects of apixaban, a direct factor Xa inhibitor, in combination with antiplatelet therapy in rabbits.
Crain, EJ; Watson, CA; Wong, PC, 2008
)
0.6
" Bile samples were also collected for 3 to 8 h after dosing from group 2 subjects."( Apixaban metabolism and pharmacokinetics after oral administration to humans.
Bonacorsi, S; Chen, S; Frost, CE; He, K; Humphreys, WG; Pinto, D; Raghavan, N; Wong, PC; Yu, Z; Zhang, D; Zhang, H, 2009
)
1.8
" These drugs have predictable pharmacokinetics that allow fixed dosing without laboratory monitoring, and are being compared with vitamin K antagonists or aspirin in phase III clinical trials [corrected]."( New anticoagulants for atrial fibrillation.
Eikelboom, J; O'Donnell, M; Sobieraj-Teague, M, 2009
)
0.35
"A model-based approach was used to integrate data from a phase II study in order to provide a quantitative rationale for selecting the apixaban dosage regimen for a phase III trial."( Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.
Feng, Y; Leil, TA; Mohan, P; Paccaly, A; Pfister, M; Zhang, L, 2010
)
0.9
" Depending on its dosage its effectiveness in comparison with vitamin K antagonists is equal or even better without disadvantages in safety."( [New oral anticoagulants: better than vitamin K antagonists?].
Alban, S; Völler, H; Westermann, D, 2010
)
0.36
" Efficacy and safety of oral anticoagulation is limited by a narrow therapeutical range as well as by inter- and intraindividual variability of INR-values due to genetic disposition, differences in alimentation, dosage errors, rare control of INR-levels and drug-interactions."( [Novel anticoagulants for stroke prevention in atrial fibrillation].
Baumhäkel, M; Böhm, M; Schirmer, SH, 2010
)
0.36
" These compounds present a convenient route of administration with predictable pharmacokinetics and pharmacodynamics that allow fixed dosing regimens without requiring coagulation monitoring."( Investigational factor Xa inhibitors for thrombosis and acute coronary syndromes.
Ageno, W; Romualdi, E, 2011
)
0.37
" Clinicians are increasingly being challenged with making uncertain anticoagulant dosing decisions, as the optimal dosing strategy for most anticoagulants in the obese patient population remains unknown."( Anticoagulating obese patients in the modern era.
Arya, R; Patel, JP; Roberts, LN, 2011
)
0.37
" In addition, we must be aware to have a deliberate evaluation for each result, even pharmacological profiles of each Xa inhibitors with a 12 hour half-life period shows similarity, the difference in twice-daily dosing with once a day, or the difference in severity of patients' atrial fibrillation risk factor each trial contains might affect the results of phase III trials."( [Current status and future of anti-Xa inhibitors].
Nagao, T, 2011
)
0.37
" The emergence of new anticoagulants that offer equal or superior efficacy, greater safety and the convenience of fixed oral dosing may make warfarin the less preferred option."( Prevention of stroke in patients with atrial fibrillation: anticoagulant and antiplatelet options.
Halperin, JL; Varughese, CJ, 2012
)
0.38
"5 mg twice daily initiated after surgery was generally more effective in preventing VTE in patients undergoing knee or hip replacement surgery than subcutaneous enoxaparin sodium initiated before surgery at the EU recommended dosage of 40 mg once daily, with apixaban conferring this benefit without significantly increasing the risk of bleeding."( Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery.
Deeks, ED, 2012
)
2
" These agents promise to be more convenient to administer with fixed dosing but still have equivalent efficacy and improved bleeding risk compared to warfarin."( Newer oral anticoagulant agents: a new era in medicine.
Goel, R; Srivathsan, K, 2012
)
0.38
" It has a plasma elimination half-life of 12 hours and has been administered in a twice-daily dosing regimen in clinical trials without the need for anticoagulation monitoring or dosage adjustment."( Apixaban: a novel oral inhibitor of factor Xa.
Nutescu, E, 2012
)
1.82
" They have a slow onset and offset of action, narrow therapeutic window, marked dose-response variability, and multiple food and drug interactions, and require frequent coagulation monitoring and dose adjustments."( Emerging anticoagulant therapies for atrial fibrillation: new options, new challenges.
Mangiafico, M; Mangiafico, RA, 2012
)
0.38
" Patients who met at least one caution or contraindication criteria were deemed "non-candidates"; potential dosage reductions of the new oral anticoagulants were not considered."( Analysis of the projected utility of dabigatran, rivaroxaban, and apixaban and their future impact on existing Hematology and Cardiology Anticoagulation Clinics at The Johns Hopkins Hospital.
Carter, KL; Kraus, PS; Ross, PA; Shermock, KM; Streiff, MB; Thomas, ML; Wellman, JC, 2012
)
0.62
" These newer agents possess a highly predictable pharmacokinetic-pharmacodynamic relationship, allowing for fixed dosing and no necessity for routine laboratory monitoring; additionally these agents have minimal drug interactions."( New anticoagulants for stroke prophylaxis in atrial fibrillation: assessing the impact on medication adherence.
Kopecky, S, 2012
)
0.38
" Linearity of dose-response and responsiveness to increasing dose in addition to standardization are other important issues to consider."( Laboratory tests and the new oral anticoagulants.
Tripodi, A, 2012
)
0.38
" The first, monitoring, implies laboratory testing to assess the drug's effect and to adjust the dosage to maintain anticoagulation within the therapeutic interval."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013
)
0.39
" The choice of tests is based on such characteristics as availability, linearity of the dose-response curve, standardization, and responsiveness to increasing drug dosage."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013
)
0.39
" The fecal elimination, IC, and systemic clearance of apixaban were increased upon AC administration in both BDC rats and dogs and were decreased in BDC rats dosed with GF-120918, a dual BCRP and P-gp inhibitor)."( Investigating the enteroenteric recirculation of apixaban, a factor Xa inhibitor: administration of activated charcoal to bile duct-cannulated rats and dogs receiving an intravenous dose and use of drug transporter knockout rats.
Frost, CE; Goosen, TC; He, K; Humphreys, WG; Rodrigues, AD; Wang, L; Wang, X; Zhang, D, 2013
)
0.89
" Apixaban has a half-life of about 12 hours, and the normal dosage is 5 mg orally twice daily."( Apixaban: a new factor Xa inhibitor for stroke prevention in patients with nonvalvular atrial fibrillation.
Lam, S,
)
2.48
" Rivaroxaban, apixaban, and dabigatran have different pharmacological characteristics, and guidance is needed on optimum doses and dosing intervals and the effects of renal or hepatic impairment, age, food, and other drugs."( Novel oral anticoagulants: clinical pharmacology, indications and practical considerations.
Graff, J; Harder, S, 2013
)
0.75
" Consequently, if renal function is impaired, there is a risk of drug accumulation that is highest for dabigatran followed by rivaroxaban and then apixaban and thus dosing recommendations are different."( Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban.
Böhm, M; Dichgans, M; Diener, HC; Ell, C; Endres, M; Epple, C; Grond, M; Laufs, U; Nickenig, G; Riess, H; Röther, J; Schellinger, PD; Spannagl, M; Steiner, T; Veltkamp, R, 2013
)
0.8
" In this review, we outline key pharmacokinetic and pharmacodynamic features of each compound and provide guidance on selection and dosing of the 3 NOACs relative to warfarin when considering OAC therapy for AF patients."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013
)
0.6
" However the choice of dosing regimens in different clinical conditions has been different for the various NOACs, and has been established on the basis of widely different considerations, including the clinical setting (venous versus arterial thrombosis), the indications (prophylaxis versus treatment), the likelihood of concomitant antiplatelet drugs, and marketing opportunities; these latter were based on the knowledge that patients' compliance is generally better with once daily than with twice daily dosing."( The new oral anticoagulants in atrial fibrillation: once daily or twice daily?
De Caterina, R; Renda, G,
)
0.13
" These new anticoagulants do not require strict and frequent laboratory monitoring, dosing adjustments, or dietary restrictions, and they incur fewer drug-drug interactions than warfarin."( Novel oral anticoagulants: a review of new agents.
Wanat, MA, 2013
)
0.39
"Pharmacogenetics-guided warfarin dosing is an alternative to standard clinical algorithms and new oral anticoagulants for patients with nonvalvular atrial fibrillation."( Cost-effectiveness of pharmacogenetics-guided warfarin therapy vs. alternative anticoagulation in atrial fibrillation.
Hughes, DA; Lane, S; Pink, J; Pirmohamed, M, 2014
)
0.4
" Advantages and disadvantages to using these newer agents are presented, as are dosing adjustments for renal and hepatic impairment."( Outpatient management of oral anticoagulation in atrial fibrillation.
Manning, JA, 2013
)
0.39
" In contrast to warfarin, most NOACs need dosage adjustments in renal impairment and are contraindicated in severe liver impairment, and there are no specific antidotes for treating NOAC-related over-anticoagulation."( New oral anticoagulants in practice: pharmacological and practical considerations.
Bajorek, B; Wang, Y, 2014
)
0.4
" They are at least as effective and as safe as conventional therapy (heparins and vitamin-K inhibitors) and have practical advantages, such as fixed dosing and no need for laboratory monitoring."( Direct oral anticoagulants in the treatment and long-term prevention of venous thrombo-embolism.
Bounameaux, H; Fontana, P; Goldhaber, SZ, 2014
)
0.4
" On day 7, peak plasma concentrations were reached ~ 3 hours postdose, and increases in peak plasma concentration (C(max)), trough plasma concentration, and area under the plasma concentration-time curve across one dosing interval (12 hours) were tested dose-proportional across the dose range."( Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects.
Frost, C; Fukase, H; Hiraoka, M; LaCreta, F; Pursley, J; Wang, J; Yamahira, N; Yu, Z, 2014
)
0.63
" In the studied dosing regimens, these drugs failed to show a net clinical benefit in addition to dual antiplatelet therapy."( Direct oral anticoagulants in acute coronary syndrome.
Ahrens, I; Bode, C, 2014
)
0.4
" Chromogenic anti-FXa assays showed linear dose-response curves with apixaban."( Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays.
Baghaei, F; Berndtsson, M; Fagerberg Blixter, I; Faxälv, L; Gustafsson, KM; Hillarp, A; Lindahl, TL; Strandberg, K, 2014
)
0.89
"Ease of dosing and simplicity of monitoring make new oral anticoagulants an attractive therapy in a growing range of clinical conditions."( Management of the bleeding patient receiving new oral anticoagulants: a role for prothrombin complex concentrates.
Baumann Kreuziger, LM; Dries, DJ; Keenan, JC; Morton, CT, 2014
)
0.4
" The development of apixaban reflects a strategy to optimize the clinical pharmacology profile, dosing posology, trial designs, and statistical analyses across multiple indications, and to seek alignment with global health authorities."( Development of apixaban: a novel anticoagulant for prevention of stroke in patients with atrial fibrillation.
Frost, C; Gupta, E; Hanna, MS; Knabb, R; Lawrence, JH; Mohan, P, 2014
)
1.08
" Practical advantages of NOACs over warfarin include fixed once- or twice-daily oral dosing without the need for coagulation monitoring, and few known or defined drug or food interactions."( Approach to the new oral anticoagulants in family practice: part 1: comparing the options.
Bell, AD; Douketis, J; Eikelboom, J; Liew, A, 2014
)
0.4
" This study examines the relative cost-effectiveness of dabigatran (BID dosing of 150 mg or 110 mg based on patient age), rivaroxaban, and apixaban from a UK payer perspective."( Comparison of the cost-effectiveness of new oral anticoagulants for the prevention of stroke and systemic embolism in atrial fibrillation in a UK setting.
Gonschior, AK; Heinrich-Nols, J; Kansal, AR; Noack, H; Sorensen, SV; Sunderland, T; Zheng, Y, 2014
)
0.6
"New oral anticoagulants require dosing adjustment according to renal function."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015
)
0.42
"Among the overall population, relative to Cockcroft-Gault, discordance in dabigatran dosage was 11."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015
)
0.42
" The RapidTEG activated clotting time test allowed the creation of a dose-response curve for all 3 NOACs."( Use of Thromboelastography (TEG) for Detection of New Oral Anticoagulants.
Dias, JD; Doorneweerd, DD; Norem, K; Omert, LA; Popovsky, MA; Thurer, RL, 2015
)
0.42
"To review current literature for target-specific oral anticoagulants (TSOACs) and provide critical analysis for dosing recommendations in special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015
)
0.42
" It is valuable to understand the rationale for labeled dosing recommendations in nonvalvular atrial fibrillation and venous thromboembolism treatment and prevention, particularly in patients that fall into special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015
)
0.42
" In this regard, novel oral anticoagulants (NOACs) have shown promise in the shift toward the "ideal" anticoagulant therapy, in that fixed dosing is the norm, drug interactions are few, food interactions are absent, onset is fairly immediate and offset predictable, and, in the majority of patients, therapeutic monitoring is not required."( Novel Anticoagulants in Atrial Fibrillation: A Primer for the Primary Physician.
Mookadam, F; Mookadam, M; Shamoun, FE,
)
0.13
" Further studies will be needed to determine pharmacokinetics and pharmacodynamics after multidose administration, effects of cardiac disease on pharmacokinetics and pharmacodynamics, dosing recommendations, and efficacy of apixaban for use in the treatment and prevention of thromboembolic disease in cats."( Pharmacokinetics and pharmacodynamics of the factor Xa inhibitor apixaban after oral and intravenous administration to cats.
Bright, JM; Martinez, CM; Myers, JA; Olver, CS; Wittenburg, LA, 2015
)
0.84
" The effect of interrupted apixaban on intraprocedural heparin dosing requirements and levels of achieved anticoagulation with heparin has not been well studied."( Effect of pre-procedural interrupted apixaban on heparin anticoagulation during catheter ablation for atrial fibrillation: a prospective observational study.
Bin Abdulhak, AA; Giocondo, M; Gupta, S; Kennedy, KF; Ramza, B; Wimmer, AP, 2015
)
0.99
"The direct oral anticoagulants (DOAC) dabigatran, rivaroxaban, and apixaban are increasingly prescribed in atrial fibrillation (AF) patients, although dosage in elderly patients, safety in chronic kidney disease, food- and drug-interactions, laboratory tests for monitoring, and antidote are not clarified."( A Probable Life-Saving Switch from Apixaban to Phenprocoumon.
Finsterer, J; Stöllberger, C, 2015
)
0.93
" The aim of the present study was to evaluate the hypothetical need for dosage adjustment (based on fluctuations in kidney function) of dabigatran, rivaroxaban and apixaban during the first 6 months after hospital discharge in patients with concomitant atrial fibrillation and heart failure."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.63
" The hypothetical recommended dosage of dabigatran, rivaroxaban and apixaban according to renal function was determined at discharge."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.67
"Among the overall study population, 44% of patients would have needed dabigatran dosage adjustment during follow-up, 35% would have needed rivaroxaban adjustment, and 29% would have needed apixaban dosage adjustment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.62
"The need for dosage adjustment of nonvitamin K oral anticoagulants during follow-up is frequent in patients with atrial fibrillation after acute decompensated heart failure, especially among older patients and those with renal impairment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.43
" The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form."( Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product.
Abdelkawy, M; El-Ragehy, NA; Hassan, NY; Tantawy, MA, 2016
)
0.89
" We also aimed to propose expected steady state peak and trough antifactor Xa activities for these agents based upon dosing regimens approved for nonvalvular atrial fibrillation."( Evaluation of a Heparin-Calibrated Antifactor Xa Assay for Measuring the Anticoagulant Effect of Oral Direct Xa Inhibitors.
Beyer, J; Fisher, S; Kiser, TH; Ko, A; Lind, SE; Trujillo, T, 2016
)
0.43
" Further research is needed to better understand appropriate dosing of patients with novel anticoagulants."( Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials.
Coleman, CI; Crivera, C; Fields, LE; Nguyen, E; Patel, MR; Peacock, WF; White, CM, 2016
)
0.85
" The hospital protocol for heparin infusions was reinstituted on hospital day 7, with dosage adjustments based on antifactor Xa levels."( Influence of apixaban on antifactor Xa levels in a patient with acute kidney injury.
VanOverschelde, B; Voss, G; Wendte, J, 2016
)
0.8
" His heparin dosage was successfully adjusted based on antifactor Xa levels and aPPTs."( Influence of apixaban on antifactor Xa levels in a patient with acute kidney injury.
VanOverschelde, B; Voss, G; Wendte, J, 2016
)
0.8
"All the newer oral anticoagulants compared were more effective than adjusted dosed warfarin."( Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.
Hayes, CJ; Martin, BC; Shah, A; Shewale, A, 2016
)
0.43
" However the peri-procedural dosing protocols used in various studies especially in terms of whether NOAC use is interrupted or uninterrupted during AF ablation, have significant inter-operator and inter-institution variability."( Are Some Anticoagulants More Equal Than Others? - Evaluating the Role of Novel Oral Anticoagulants in AF Ablation.
Fox, DJ; Sankaranarayanan, R,
)
0.13
"It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state."( Reversibility of Apixaban Anticoagulation with a Four-Factor Prothrombin Complex Concentrate in Healthy Volunteers.
Bachman, B; Chervoneva, I; Kraft, WK; Nagalla, S; Oppong, Y; Thomson, L, 2016
)
0.97
" Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention."( NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.
Kaminskas, E; Reiffel, JA; Reilly, P; Sager, P; Sarich, T; Seltzer, J; Weitz, JI, 2016
)
0.43
" Differences in the ACT before ablation and adequate initial heparin dosing in patients receiving non-vitamin K antagonist oral anticoagulants (NOACs) were examined."( Adequate Initial Heparin Dosage for Atrial Fibrillation Ablation in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants.
Higashiya, S; Hina, K; Kamikawa, S; Kawamura, H; Komtasubara, I; Kusachi, S; Murakami, M; Murakami, T; Yamaji, H, 2016
)
0.43
"A triple or dual therapy induced a comparable decrease in shed blood β-TG at 3 hours after therapy dosing but was more pronounced at steady-state conditions with the more intense treatment combination."( The effect of a dual or a triple antithrombotic therapy with apixaban on thrombus formation in vivo and in an ex vivo perfusion chamber model: An open-label, controlled, sequential study.
Bucher, S; Kapiotis, S; Kyrle, PA; Litschauer, B; Riesenhuber, M; Weisshaar, S; Wolzt, M, 2016
)
0.68
" In addition to familiarity with the dosing and monitoring of vitamin K antagonists, clinicians are accustomed to using vitamin K if there is a need to reverse the anticoagulant effect of vitamin K antagonists."( Management of Bleeding With Non-Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents.
Antman, EM; Giugliano, RP; Ruff, CT, 2016
)
0.43
" It is part of a family of novel oral anticoagulants (NOACs) which has advantage over warfarin of less dosing variability, rapid onset of action and no INR monitoring required."( Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
John, J; Mezue, K; Obiagwu, C; Shani, J; Sharma, A; Yang, F, 2017
)
0.7
" With similar efficacy, better safety, and the convenience of fixed dosing without the need for routine coagulation monitoring, guidelines now recommend DOACs over VKAs for VTE treatment in patients without active cancer."( Optimizing the safety of treatment for venous thromboembolism in the era of direct oral anticoagulants.
Jaffer, IH; Weitz, JI, 2016
)
0.43
" Current apixaban dosing recommendations for this patient population are based largely on a single-dose pharmacokinetic study of eight patients."( Clinical Application and Pharmacodynamic Monitoring of Apixaban in a Patient with End-Stage Renal Disease Requiring Chronic Hemodialysis.
Kufel, WD; Lehmann, DF; Miller, CD; Zayac, AS, 2016
)
1.1
" We collected data on type and dosage of anticoagulation; suspected or confirmed bleeding events, hospital admissions, and mortality; and pattern and management of vaginal bleeding events."( Management and outcomes of vaginal bleeding and heavy menstrual bleeding in women of reproductive age on direct oral anti-factor Xa inhibitor therapy: a case series.
Beyer-Westendorf, J; Hauswald-Dörschel, S; Marten, S; Michalski, F; Tittl, L, 2016
)
0.43
"Compared to enoxaparin (most commonly dosed 40 mg once daily), the relative risk (RR) of VTE was lowest for edoxaban 30 mg once daily (0."( Safety and Efficacy of New Anticoagulants for the Prevention of Venous Thromboembolism After Hip and Knee Arthroplasty: A Meta-Analysis.
Gage, BF; Ganti, BR; Lee, ED; Lin, H; Nunley, RM; Venker, BT, 2017
)
0.46
"Direct oral anticoagulants currently have no indication for monitoring even though there are data that imply that individual dosing can improve and add safety to the therapy."( Development of an UHPLC-UV-Method for Quantification of Direct Oral Anticoagulants: Apixaban, Rivaroxaban, Dabigatran, and its Prodrug Dabigatran Etexilate in Human Serum.
Boehr, S; Haen, E, 2017
)
0.68
"Surgical procedures under NOACS can be scheduled at the beginning of next dosing interval or omitted in low/minimal bleeding risk patients, so that only 2-3 NOAC doses are not administered."( [Management of NOAK administration during invasive or surgical interventions : When and how to pause and when to restart?]
Buerke, M; Hoffmeister, HM, 2017
)
0.46
" To ensure responsible use of these agents, every hospital needs a bleeding management algorithm that identifies patients eligible for reversal and outlines appropriate dosing regimens."( Reversal of Direct Oral Anticoagulants: Current Status and Future Directions.
Weitz, JI, 2017
)
0.46
" The fact that the NOACs don't require routine monitoring to assure that patients remain within the therapeutic range and have relatively simple dosing requirements and a safer risk profile makes them attractive substitutes to warfarin in HF patients with atrial fibrillation and other conditions (e."( Anticoagulation Therapy and NOACs in Heart Failure.
EncisoSilva, J; Greenberg, B; Schlueter, M; Thomas, I, 2017
)
0.46
" Much shorter half-life of NOACs raises the question of optimal dosing regimen."( [The Problem of Adherence to Anticoagulant Therapy and Ways to Its Solution].
Kobalava, ZD; Troitskaya, EA; Villewalde, SV, 2016
)
0.43
" The objective is to present a case report that illustrates there may be important dosing issues when considering the use of these agents in patients with the antiphospholipid syndrome."( Dosing considerations in the use of the direct oral anticoagulants in the antiphospholipid syndrome.
Hassell, K; Schofield, JR, 2018
)
0.48
"Despite a similar half-life, pharmacokinetics and pharmacodynamics, the manufacturer-recommended maintenance dosing of apixaban is twice daily and rivaroxaban once daily."( Dosing considerations in the use of the direct oral anticoagulants in the antiphospholipid syndrome.
Hassell, K; Schofield, JR, 2018
)
0.69
"We compared NOACs (as a group) to warfarin in non-valvular atrial fibrillation, studying all 12,694 patients starting NOAC treatment within the Swedish clinical register and dosing system Auricula, from July 1, 2011 to December 31, 2014, and matching them to 36,317 patients starting warfarin using propensity scoring."( Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study.
Byström, B; Norrving, B; Oldgren, J; Renlund, H; Själander, A; Sjögren, V; Svensson, PJ, 2017
)
0.46
" Identification of additional clinical and molecular determinants that more fully predict patients at risk for excessively high or low DOAC concentrations may enable a more precise DOAC dosing regimen for the individual patient."( Interpatient Variation in Rivaroxaban and Apixaban Plasma Concentrations in Routine Care.
Alfonsi, JE; Dresser, GK; Gryn, SE; Gulilat, M; Henderson, SL; Kim, RB; Leong-Sit, P; Lizotte, DJ; Rose, RV; Schwarz, UI; Skanes, AC; Tang, A; Teft, WA; Tirona, RG, 2017
)
0.72
"To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF."( Assessment of Apixaban Prescribing Patterns for Nonvalvular Atrial Fibrillation in Hospitalized Patients.
Davis, S; Gibson, CM; Scalese, MJ; Smith, CB, 2018
)
1.07
" Apixaban was dosed according to FDA labeling by providers in 83."( Assessment of Apixaban Prescribing Patterns for Nonvalvular Atrial Fibrillation in Hospitalized Patients.
Davis, S; Gibson, CM; Scalese, MJ; Smith, CB, 2018
)
1.75
" Off-label indications and dosage too low were the most common not per protocol reasons for apixaban and rivaroxaban prescriptions."( Comparison of Prescribing Practices with Direct Acting Oral Anticoagulant Protocols.
Carley, B; Draper, E; Griesbach, S; Krueger, K; Larson, T; Parkhurst, B, 2017
)
0.68
"Once-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) may increase patient adherence to treatment but may also be associated with a higher risk of bleeding."( Safety of once- or twice-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation: A NOAC-TR study.
Akyüz, A; Başaran, Ö; Berilgen, R; Çelik, O; Çetin, N; Coşar, S; Dereli, Y; Doğan, T; Doğan, V; Emren, SV; Enhoş, A; Ergene, O; Gürsul, E; İnci, S; Karaca, I; Karaca, Ö; Köseoğlu, C; Levent, F; Onrat, E; Otlu, YÖ; Özdemir, İH; Özmen, Ç; Sümerkan, M; Zoghi, M, 2018
)
0.48
"The direct oral anticoagulants (DOACs), also referred to as novel (or non-vitamin K antagonist) oral anticoagulants (NOACs), represent a major development in anticoagulation therapy due to their rapid onset of action, predictable dose-response with fixed doses and limited interactions with food and drugs."( An update on the bleeding risks associated with DOACs.
, 2017
)
0.46
" As an alternative to inconvenient and expensive injections of fondaparinux, personalized dosing of a direct oral anticoagulant was sought using clinical pharmacology techniques."( Personalized Anticoagulation: Guided Apixaban Dose Adjustment to Compensate for Pharmacokinetic Abnormalities Related to Short-Bowel Syndrome.
Kim, RB; Pollak, PT; Sun, GR, 2018
)
0.75
" Drug dosage changes and serum creatinine determinations were recorded during 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018
)
0.48
" Compliance with kidney function monitoring recommendations was associated with adequate NOAC dosage at 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018
)
0.48
"The aim of this study was to analyze adherence to current labeling instructions concerning initial apixaban dosing in clinical practice and identify factors associated with inappropriate dose reduction."( Initial apixaban dosing in patients with atrial fibrillation.
Bollmann, A; Buchholz, A; Dagres, N; Dinov, B; Gorczynska, K; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2018
)
1.13
"In clinical practice, apixaban dosing is frequently inconsistent with labeling."( Initial apixaban dosing in patients with atrial fibrillation.
Bollmann, A; Buchholz, A; Dagres, N; Dinov, B; Gorczynska, K; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2018
)
1.23
"There is limited evidence on patients' adherence and the impact of the prescribed dosing regimen in non-vitamin-K oral anticoagulants (NOACs)."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018
)
0.48
" Patients using a consistent dosage for at least 180 consecutive days were included."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018
)
0.48
"Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen."( Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).
Beyer-Westendorf, I; Beyer-Westendorf, J; Endig, S; Marten, S; Reitter, A; Tittl, L, 2018
)
0.48
" Future directions include identification of clinically relevant SNPs, and change in optimum dosage for patients who are carriers of significant variants."( Pharmacogenetics of novel oral anticoagulants: a review of identified gene variants & future perspectives.
Ašić, A; Marjanović, D; Mirat, J; Primorac, D, 2018
)
0.48
"To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age."( Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data.
Katada, J; Kohsaka, S; Saito, K; Terayama, Y, 2018
)
0.97
"The safety, efficacy, and optimal dosing regimen for apixaban at the time of AF ablation are uncertain."( A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation: The AEIOU Trial.
Allison, JS; Cannon, CP; Ellenbogen, KA; Hsieh, WH; Natale, A; Reynolds, MR; Richards, M; Sutherland, J; Weisberg, IL, 2018
)
1.01
" However, apixaban has specific dosing recommendations in CKD leading to use in clinical practice."( Safety and Efficacy of Apixaban Versus Warfarin in Patients With Advanced Chronic Kidney Disease.
Casey, AL; Dupre, KA; Schafer, JH; Staubes, BA, 2018
)
1.19
" Data are limited regarding both total dose and repeated dosing with this population."( Probable pulmonary embolism with repeat administration of prothrombin complex concentrate in a factor Xa inhibitor patient.
Cottingham, LG; Hughes, RE; King, GS; Ratliff, PD, 2018
)
0.48
" Ten of 39 patients (26%) were not receiving a DOAC dosage consistent with the package insert."( Evaluation of direct oral anticoagulants for the treatment of venous thromboembolism in the oncology population.
Hedvat, J; Howlett, C; McCloskey, J; Patel, R, 2018
)
0.48
" Additionally, in this case the interaction was managed with concentration-guided dosing of apixaban, suggesting this approach may represent a feasible strategy for managing patients requiring treatment with direct-acting oral anticoagulants and enzyme-inducing antiepileptic drugs."( Managing Direct Oral Anticoagulants in Patients With Antiepileptic Medication.
Dagan, G; Hochberg-Klein, S; Kalish, Y; Muszkat, M; Perlman, A, 2018
)
0.7
" We describe a patient diagnosed with anti-phospholipase A2 receptor antibody positive membranous nephropathy and recurrent VTE while on therapeutic dosing of apixaban."( Recurrent venous thromboembolism in primary membranous nephropathy despite direct Xa inhibitor therapy.
Crona, DJ; Derebail, VK; Mooberry, MJ; Nachman, PH; Reynolds, ML, 2019
)
0.71
"8%)] and peak [n = 16 (20%)] levels, especially octogenarians with the 5-mg bid dosage [n = 6 (30%) for trough and n = 8 (40%) for peak]."( Apixaban Levels in Octogenarian Patients with Non-valvular Atrial Fibrillation.
Cooper, L; Fuchs, S; Green, H; Grossman, A; Hershkovitz, A; Nakav, S; Nissan, R; Shimony, S; Shochat, T; Spectre, G, 2019
)
1.96
"High and above-range peak apixaban steady-state levels are highly prevalent in octogenarians receiving the appropriate dosage of 5 mg bid for NVAF stroke prevention."( Apixaban Levels in Octogenarian Patients with Non-valvular Atrial Fibrillation.
Cooper, L; Fuchs, S; Green, H; Grossman, A; Hershkovitz, A; Nakav, S; Nissan, R; Shimony, S; Shochat, T; Spectre, G, 2019
)
2.26
" The goal of our study was to evaluate the outcomes of our reduced dosing strategy with FEIBA in patients experiencing a DOAC-related bleeding event."( Effect of low and moderate dose FEIBA to reverse major bleeding in patients on direct oral anticoagulants.
Dager, WE; Nishijima, DK; Roberts, AJ, 2019
)
0.51
"Apixaban and rivaroxaban, both direct-acting oral anticoagulants, are being increasingly used in routine clinical practice because of their fixed dosing and favourable pharmacological profiles."( Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis.
Brown, J; Dawwas, GK; Dietrich, E; Park, H, 2019
)
2.25
" The observed effect could be a secondary consequence of dosage control or alternatively a result of different anticoagulant effects among the different medications."( Higher Incidence of Ischemic Stroke in Patients Taking Novel Oral Anticoagulants.
Cowperthwaite, M; Fanale, C; Nadasdy, Z; Ramakrishnan, A; Shpak, M, 2018
)
0.48
"In the past decade, direct-acting oral anticoagulants (DOAC) have been introduced to medical practice for several indications, with a wide range of dosing regimens."( Clinical pharmacist led hospital-wide direct oral anticoagulant stewardship program.
Aldouby-Bier, G; Fisher Negev, T; Hirsh-Raccah, B; Hochberg-Klein, S; Horwitz, E; Kalish, Y; Muszkat, M; Perlman, A, 2019
)
0.51
" dosing interval) or patient experiences while on treatment."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019
)
0.51
"Apixaban users had the highest overall adherence despite twice-daily dosing versus once-daily dosing for rivaroxaban."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019
)
1.96
" Furthermore, we evaluated the appropriateness of labeled and off-label dosing implemented for 348 patients using the obtainable PC threshold."( Rivaroxaban or Apixaban for Non-Valvular Atrial Fibrillation - Efficacy and Safety of Off-Label Under-Dosing According to Plasma Concentration.
Kino, M; Morii, I; Suwa, M, 2019
)
0.87
" Benefits of direct oral anticoagulants include a rapid onset of therapeutic effect, fixed dose-response relationships without the need for routine monitoring, a short half-life, and infrequent need for periprocedural bridging with a parenteral agent."( Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation: Update and Periprocedural Management.
Pickett, JD, 2019
)
0.51
"In plasma systems, the assay demonstrates dose-response between 0 and 5 nmol/L rivaroxaban and between 0 and 10 nmol/L apixaban."( An assay to measure levels of factor Xa inhibitors in blood and plasma.
Di Giuseppantonio, LR; Douketis, JD; Gross, PL; Kim, PY; Wu, C, 2019
)
0.72
" Andexanet alfa is administered via two different dosing regimens, standard and high dose, based on the specific FXa inhibitor, dose, and time since the patient's last dose of FXa inhibitor."( Andexanet Alfa (Andexxa) Formulary Review.
Beik, N; Connell, NT; Connors, JM; Giugliano, RP; Piazza, G; Reddy, P; Sylvester, KW, 2019
)
0.51
" Our goal was to determine the consequences of lower than recommended dosing on plasma apixaban concentrations during the clinical care of older adults with NVAF."( Apixaban Concentrations with Lower than Recommended Dosing in Older Adults with Atrial Fibrillation.
Alfonsi, JE; Dresser, GK; Gryn, SE; Gulilat, M; Kim, RB; Linton, B; Schwartz, JB; Schwarz, UI; Sukumar, S, 2019
)
2.18
" Overall, 48 patients received recommended dosing of 5 mg twice/day, and 42 received lower than recommended dosing."( Apixaban Concentrations with Lower than Recommended Dosing in Older Adults with Atrial Fibrillation.
Alfonsi, JE; Dresser, GK; Gryn, SE; Gulilat, M; Kim, RB; Linton, B; Schwartz, JB; Schwarz, UI; Sukumar, S, 2019
)
1.96
" The findings raise questions about the optimal dosing of apixaban in older adults with NVAF encountered outside of clinical trials and suggest a role for the monitoring of apixaban concentrations during care of patients that differ from those in randomized trials or when considering dosing outside of published guidelines."( Apixaban Concentrations with Lower than Recommended Dosing in Older Adults with Atrial Fibrillation.
Alfonsi, JE; Dresser, GK; Gryn, SE; Gulilat, M; Kim, RB; Linton, B; Schwartz, JB; Schwarz, UI; Sukumar, S, 2019
)
2.2
" To identify the prevalence, outcomes, and patient characteristics associated with off-label DOAC dosing during VTE treatment."( Real-world assessment of off-label direct oral anticoagulant dosing for venous thromboembolism.
Gustafson, WL; Jones, AE; Saunders, JA; Vazquez, SR; Witt, DM, 2019
)
0.51
" However, the complexity of DOAC dose regimens can still lead to dosing errors and potential bleeding-related or thromboembolic adverse events, especially in the elderly."( Burden of Inappropriate Prescription of Direct Oral Anticoagulants at Hospital Admission and Discharge in the Elderly: A Prospective Observational Multicenter Study.
Anfosso, M; Bruneau, A; Fernandez, C; Hindlet, P; Schwab, C, 2019
)
0.51
" The survey included questions regarding centers' demographics and posed a series of hypothetical clinical scenarios to gather centers' VTE treatment practices including choice of anticoagulant, dosing practices, duration decisions, and monitoring efforts."( Survey of current treatment practices for venous thromboembolism in patients with cystic fibrosis.
Jones, AE; Ratté, MT; Witt, DM; Young, DC, 2020
)
0.56
" The excess events with JNJ-9375 compared with apixaban were consistent across all JNJ-9375 dosing cohorts and there was no evidence of improved efficacy with higher JNJ-9375 doses."( Randomized phase 2 trial comparing JNJ-9375, a thrombin-directed antibody, with apixaban for prevention of venous thrombosis.
DiBattiste, PM; Francis, C; Fuji, T; Lassen, MR; Lee, M; Peters, G; Raskob, G; Roberts, RS; Segers, A; Strony, J; Swaim, RM; Tesfaye, F; Weitz, JI, 2019
)
1
"A quality by design (QbD) based high-resolution HPLC method is described for determination of impurities in apixaban (APX) in the tablet dosage form."( Stability-indicating RP-HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach.
Dongala, T; Jonnalagadda, SB; Katari, NK; Subramanian, VB, 2020
)
0.99
" Most patients who were taking NOACs had excellent adherence regardless of the dosing frequency."( NOAC Adherence of Patients with Atrial Fibrillation in the Real World: Dosing Frequency Matters?
Bae, HJ; Cho, YK; Choi, SW; Han, S; Hur, SH; Hwang, J; Jun, SW; Kim, H; Kim, IC; Lee, CH; Lee, SH; Nam, CW; Park, HS; Yoon, HJ, 2020
)
0.56
" The purpose of this study was to assess the impact of the route of administration and dosage regimen on the compliance to the prescription."( Extended thromboprophylaxis for hip or knee arthroplasty. Does the administration route and dosage regimen affect adherence? A cohort study.
Bautista, M; Bonilla, G; Castro, J; Llinás, A; Moreno, JP, 2020
)
0.56
" In addition, apixaban and rivaroxaban offer more than one dosing option, allowing tailoring of treatment to the patient's specific risk factor profile."( Broadening the Categories of Patients Eligible for Extended Venous Thromboembolism Treatment.
Schindewolf, M; Weitz, JI, 2020
)
0.92
" Using the Korean National Health Insurance Service database, we evaluated 16,568 patients with a new prescription of NOAC who are indicated for standard NOAC dosing and compared 4,536 patients with warfarin with respect to thromboembolic events (ischemic stroke or systemic embolization), all-cause mortality and major bleeding."( Pattern and Impact of Off-label Underdosing of Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation Who are Indicated for Standard Dosing.
Cho, MS; Kim, H; Kim, YJ; Lee, J; Nam, GB; Park, DW; Park, JJ; Yun, JE, 2020
)
0.56
" We observed substantial overlap in the range of exposure to apixaban 5 mg twice daily for patients with or without advanced chronic kidney disease, supporting conventional dosing in patients with CrCl 25 to 30 mL/min."( Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease.
Alexander, JH; Byon, W; Chertow, GM; Garonzik, S; Granger, CB; Hijazi, Z; Hohnloser, SH; Lopes, RD; Pokorney, SD; Stanifer, JW; Wallentin, L; Wojdyla, DM, 2020
)
2.24
"9%) patients receiving rivaroxaban were not initiated on the FDA-recommended 15 mg twice daily dosing for the first 21 days."( Use of apixaban and rivaroxaban in young adults with acute venous thromboembolism: a multi-center retrospective case series.
Barnes, GD; DeCamillo, D; Ellsworth, S; Kaatz, S, 2020
)
1.01
" However, warfarin requires regular monitoring and dosage adjustments and fails for many patients, causing thromboembolic and bleeding events."( Factor Xa inhibitors in patients with continuous-flow left ventricular assist devices.
Delgado, RM; Fedson, S; Frazier, OH; George, JK; Lamba, HK; Moctezuma-Ramirez, A; Nair, AP; Parikh, UM; Parikh, VY, 2020
)
0.56
"To review the literature on treatment of venous thromboembolism (VTE) and prevention of cardioembolic stroke with direct-acting oral anticoagulants (DOACs) in low- and high-body-weight patients and to make recommendations regarding agent selection and dosing in these patient populations."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020
)
0.56
"The selection and optimal dosing of DOACs in low- and high-body-weight patients has not yet been fully elucidated by clinical trials; however, evidence suggests that issues of both safety and efficacy in patients at the extremes of body weight may warrant careful consideration when selecting a DOAC for such patients."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020
)
0.56
" Prospective studies are needed to identify a superior reversal agent when comparing andexanet alfa to hospital standard of care (4F-PCC or aPCC) and to further explore the optimal dosing strategy for patients with ICH associated with apixaban or rivaroxaban use."( Treatment of adults with intracranial hemorrhage on apixaban or rivaroxaban with prothrombin complex concentrate products.
Atallah, S; Baje, M; Cang, W; Castillo, R; Chan, A; Derry, K; Groysman, L; Huang, W; Martin, R; Minokadeh, A; Nova, A; Schomer, K; Stern-Nezer, S; Zimmermann, LL, 2021
)
1.05
" Given the favourable safety profile of NOACs (especially if a reduced dosage of Apixaban or Rivaroxaban is initiated after at least six months of therapeutic anticoagulation), extended oral anticoagulation of indefinite duration should be considered for all patients with intermediate risk of recurrence."( [Antithrombotic Treatment of Pulmonary Embolism].
Ebner, M; Lankeit, M, 2020
)
0.78
" Factors significantly associated with increased odds of bleeding were an age > 80 years, inappropriately high dosing regimens, and modest anti-Xa levels (100-300 ng/mL) for rivaroxaban specifically."( Apixaban and rivaroxaban anti-Xa level utilization and associated bleeding events within an academic health system.
Dinh, A; Donahue, KR; Jakowenko, N; Nguyen, S; Ruegger, M; Salazar, E, 2020
)
2
"Older age and inappropriately high dosing regimens were associated with major bleeding in patients taking apixaban and rivaroxaban."( Apixaban and rivaroxaban anti-Xa level utilization and associated bleeding events within an academic health system.
Dinh, A; Donahue, KR; Jakowenko, N; Nguyen, S; Ruegger, M; Salazar, E, 2020
)
2.21
" A growing body of evidence shows that once-daily dosing improves adherence and persistence to therapy, without having an impact on bleeding risk."( Non-Vitamin K Antagonist Oral Anticoagulants and Factors Influencing the Ischemic and Bleeding Risk in Elderly Patients With Atrial Fibrillation: A Review of Current Evidence.
Haas, S; Patti, G, 2020
)
0.56
" Our study aimed to describe characteristics and dosing regimens in patients on apixaban or rivaroxaban who experienced a new or recurrent thrombosis."( Evaluation of characteristics and dosing regimens in patients with new or recurrent thrombosis on apixaban and rivaroxaban.
Donahue, KR; Dreucean, D; Nguyen, SN; Ruegger, MC; Salazar, E, 2021
)
1.07
" Only 37% of patients on warfarin had optimal dosing control, and they did not differ significantly in TTB, TTT, and OS from patients on DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020
)
0.56
" Patients receiving warfarin rarely obtain optimal dosing control, and experience significantly shorter survival compared with patients receiving DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020
)
0.56
"All KT patients should have been treated with the standard 5-mg bid apixaban dosage according to the clinical parameters; however, 7 were inappropriately treated with a reduced dosage (2."( Apixaban Level and Its Influence on Immunosuppression and Graft Outcome in Kidney Transplant Recipients With Atrial Fibrillation.
Avni, S; Fuchs, S; Green, H; Nissan, R; Rahamimov, R; Rozen-Zvi, B; Spectre, G, 2021
)
2.3
"Similar to nontransplant patients, KT patients administered the standard 5-mg bid dosage had apixaban levels that were well within the recommended manufacturers' expected ranges."( Apixaban Level and Its Influence on Immunosuppression and Graft Outcome in Kidney Transplant Recipients With Atrial Fibrillation.
Avni, S; Fuchs, S; Green, H; Nissan, R; Rahamimov, R; Rozen-Zvi, B; Spectre, G, 2021
)
2.28
" Therefore, uncertainty remains concerning benefits, dosing and timing of intake in haemodialysis population."( Apixaban in patients on haemodialysis: a single-dose pharmacokinetics study.
Bouillon, T; Coemans, M; Jacquemin, M; Kuypers, D; Meijers, B; Van den Bosch, I; Vanassche, T; Verhamme, P, 2021
)
2.06
"5 mg, although significance could only be reached for dosing pre-dialysis (2."( Apixaban in patients on haemodialysis: a single-dose pharmacokinetics study.
Bouillon, T; Coemans, M; Jacquemin, M; Kuypers, D; Meijers, B; Van den Bosch, I; Vanassche, T; Verhamme, P, 2021
)
2.06
" Further research is needed to determine the impact of ALM on bleeding complications and the potential role of ALM-guided dosing for sarcopenic patients."( Muscle Mass and Direct Oral Anticoagulant Activity in Older Adults With Atrial Fibrillation.
Afilalo, J; Afilalo, M; Bendayan, M; Blostein, M; Chen-Tournoux, A; Eintracht, S; MacNamara, E; Mardigyan, V; Rudski, L; Williamson, D, 2021
)
0.62
" Label adherence to apixaban dosing should be emphasized to achieve the best clinical outcomes for Asian patients with AF."( Off-label underdosed apixaban use in Asian patients with non-valvular atrial fibrillation.
Choi, EK; Han, KD; Jung, JH; Lee, SR; Lip, GYH; Oh, S; Park, SH, 2021
)
1.26
"Observational studies assessing direct oral anticoagulant (DOACs) dosage in atrial fibrillation (AF) reported that a lower proportion of patients received high-dose DOACs compared to those in randomized controlled trials (RCTs)."( Comparative effectiveness and safety of high-dose rivaroxaban and apixaban for atrial fibrillation: A propensity score-matched cohort study.
Brophy, JM; Côté, R; de Denus, S; Dorais, M; Dragomir, A; Dubé, MP; Lenglet, A; Perreault, S; Schnitzer, ME; Tardif, JC; White-Guay, B, 2021
)
0.86
" An apixaban dose score (ADS) was defined to account for apixaban dosage and the number of apixaban dose-reduction criteria."( Effect of Enzyme-Inducing Antiseizure Medications on the Risk of Sub-Therapeutic Concentrations of Direct Oral Anticoagulants: A Retrospective Cohort Study.
Choshen Cohen, L; Goldstein, R; Hakimian, D; Hirsh-Raccah, B; Kalish, Y; Matok, I; Muszkat, M; Perlman, A; Singer, DE, 2021
)
1.18
"1%), appropriate dosing (83."( Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe.
Al-Dakkak, I; Kahlon, R; Mayall, S; Shen, SW, 2021
)
0.9
"The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures."( Factor VIII Inhibitor Bypassing Activity (FEIBA) Reversal for Apixaban and Rivaroxaban in Patients With Acute Intracranial and Nonintracranial Hemorrhage.
Coffeen, SN; Hunt, AR; Ice, C; Parker, J; Shiltz, DL, 2021
)
0.86
" These differences between DOACs with almost equal half-life are probably partly due to the differences in dosing interval: twice a day (BID) versus once a day (QD)."( [Is one DOAC better than another?]
Pos, L, 2021
)
0.62
" DOAC dosing congruent with the package insert(s) was associated with a lower risk of thrombosis."( Less bleeding associated with apixaban versus other direct acting oral anticoagulation in solid organ transplant recipients.
Brown, RS; Hedvat, J; Jennings, DL; Lange, NW; Robbins, H; Salerno, DM; Scheffert, J; Thornberg, ME, 2021
)
0.91
" However, the efficacy and safety of different dosage in patients with renal dysfunction is still a clinical challenge."( Comparison of Low and Full Dose Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Renal Dysfunction (from a National Registry).
Barsheshet, A; Elis, A; Giladi, E; Goldenberg, I; Gurevitz, C; Klempfner, R; Kornowski, R, 2021
)
0.9
"Ciraparantag provides a dose-related reversal of anticoagulation induced by steady-state dosing of apixaban or rivaroxaban."( Ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly subjects.
Ansell, J; Bakhru, S; Freedman, D; Laulicht, BE; Tracey, G; Villano, S, 2022
)
1.19
" To what extent the observed increases in DOAC exposure in the older patients is the cause of their increased risk of bleeding, which could potentially be ameliorated by dosing titration, requires further investigation."( Assessment of exposure to direct oral anticoagulants in elderly hospitalised patients.
Avery, P; Biss, T; Kamali, F; Kampouraki, E; Wynne, H, 2021
)
0.62
" Trough and peak AXA values, PT, and APTT were measured at 10 mg BID dosage and then at 5 mg BID dosage."( Coagulation markers in patients with venous thromboembolism treated with 10 mg apixaban twice daily.
Fukushima, K; Hori, Y; Nishimura, K; Ono, R; Takahashi, H; Yamashita, D; Yamazaki, T, 2022
)
0.95
" The secondary outcome evaluated patients who reported time of last known DOAC dose within a preferred time frame of <12 h for once daily dosing DOAC therapy or < 6 h for twice daily dosing DOAC therapy."( Evaluation of direct oral anticoagulant use on thromboelastography in an emergency department population.
Jenrette, J; Ray, L; Schwarz, K; Trujillo, T, 2022
)
0.72
" Detailed pharmacokinetic studies are needed to determine the ideal apixaban dosage for future experiments and to enable extrapolation to the clinical situation."( Apixaban in a porcine model of mechanical valve thrombosis in pulmonary position-a pilot study.
Jacquemin, M; Langenaeken, T; Meuris, B; Nachtergaele, B; Rega, F; Truyers, I; Van Hauwermeiren, H; Van Hoof, L; Verhamme, P, 2022
)
2.4
"The FXIa inhibitor asundexian at doses of 20 mg and 50 mg once daily resulted in lower rates of bleeding compared with standard dosing of apixaban, with near-complete in-vivo FXIa inhibition, in patients with atrial fibrillation."( Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.
Caso, V; Connolly, SJ; Durdil, V; Fox, KAA; Gorog, DA; Jones, WS; Mundl, H; Neumann, C; Oldgren, J; Patel, MR; Piccini, JP; Viethen, T, 2022
)
1.16
" Secondary outcomes included new VTE while on apixaban, appropriateness of anticoagulation regimen with regards to FDA labeled dosing and frequency, anticoagulation regimen adjustments, and factor Xa inhibitor-specific anti-Xa levels if available."( Evaluation of outcomes with apixaban use for venous thromboembolism in hospitalized patients with end-stage renal disease receiving renal replacement therapy.
Chen, J; Dunne, I; Nguyen, S; Ruegger, M; Salazar, E; Samuel, L, 2022
)
1.27
" Peak and trough drug plasma concentrations were collected based on the dosing interval and pharmacokinetics of the drugs and quantified using high performance liquid chromatography."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023
)
0.91
"To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF)."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
1.18
" Using logistic regression, adjusted ORs with 95% CIs were calculated for the outcomes comparing apixaban/rivaroxaban use (appropriate or inappropriate dosing based on the product label criteria) and warfarin."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
1.16
" They should, therefore, be interpreted with caution, and prescribers should adhere to the dosing instructions in the respective Summary of Product Characteristics."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
0.95
" Reduced apixaban and rivaroxaban dosing regimens are recommended when dronedarone is co-administered to patients with AF."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
1.34
"There are no clear dosing recommendations when using apixaban for venous thromboembolism (VTE) treatment in patients with severe or end-stage renal disease; clinical trials excluded patients with a creatinine clearance (CrCl) <25 mL/min or on dialysis."( Evaluation of standard versus reduced dose apixaban for the treatment of venous thromboembolism in patients with severe renal disease (ESRD-VTE).
Abdo, C; Bang, SH; Barriga, A; Cadiz, CL; Huynh, B; Knueppel, P; McCart, T; Pon, T; Shin, J; Stevens, C; Troyer, C; Wilson, M; Yang, NT; Zhou, C, 2022
)
1.23
" Exclusions were an inappropriate dosage of apixaban or concomitant dronedarone, verapamil, ranolazine, naproxen, or both amiodarone and diltiazem."( A Real-World Matched Cohort Study of the Effect of Concomitant Amiodarone or Diltiazem Administration on Apixaban Peak and Trough Concentrations.
Ainsworth, M; Bookstaver, DA; Gleaton, M; Milner, E, 2023
)
1.39
" In this limited series, apixaban paired with a level-based dosing regimen and low-dose aspirin provided safe and effective antithrombosis with only one hemocompatibility-related event related to medication non-adherence."( Apixaban Anticoagulation in Children and Young Adults Supported With the HeartMate 3 Ventricular Assist Device.
Blume, ED; Cetatoiu, MA; Daly, KP; Esteso, P; Fynn-Thompson, F; Hawkins, B; Kobayashi, RL; VanderPluym, C; Ventresco, C, 2023
)
2.66
" The median initial peak apixaban level was 165 ng/mL (23-474; n = 125) in the prophylaxis subgroup and 153 ng/mL (30-450; n = 33) in the treatment subgroup; dosage was adjusted in response to levels in 25% of the patients."( Real-world use of apixaban for the treatment and prevention of thrombosis in children with cardiac disease.
Ankola, A; Cetatoiu, MA; Esch, JJ; Esteso, P; Gauvreau, K; Hawkins, B; Hellinger, A; Kobayashi, RL; VanderPluym, C; Ventresco, C; Williams, R, 2023
)
1.55
"Apixaban use was feasible with a low rate of adverse events across a diverse pediatric cardiac population using commercially available tablets dosed to weight and adjusted based on peak apixaban levels."( Real-world use of apixaban for the treatment and prevention of thrombosis in children with cardiac disease.
Ankola, A; Cetatoiu, MA; Esch, JJ; Esteso, P; Gauvreau, K; Hawkins, B; Hellinger, A; Kobayashi, RL; VanderPluym, C; Ventresco, C; Williams, R, 2023
)
2.69
"Recommendations for apixaban dosing on the basis of kidney function are inconsistent between the US Food and Drug Administration and European Medicines Agency for patients with atrial fibrillation."( Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease.
Chang, AR; Grams, ME; Inker, LA; McAdams-DeMarco, M; Shin, JI; Xu, Y, 2023
)
1.58
"5 mg, use of 5 mg apixaban was associated with a higher risk of bleeding in patients with atrial fibrillation and severe chronic kidney disease, with no difference in the risk of stroke/systemic embolism or death, supporting the apixaban dosing recommendations on the basis of kidney function by the European Medicines Agency, which differ from those issued by the US Food and Drug Administration."( Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease.
Chang, AR; Grams, ME; Inker, LA; McAdams-DeMarco, M; Shin, JI; Xu, Y, 2023
)
1.59
"Possible challenges in dosing non-vitamin K antagonist oral anticoagulants in nonvalvular atrial fibrillation (NVAF) and limited evidence in Saudi Arabia make it difficult to assess their appropriateness."( Appropriateness of rivaroxaban and apixaban dosing in hospitalized patients with a newly diagnosed nonvalvular atrial fibrillation at a single tertiary hospital.
Alshibani, M, 2023
)
1.19
" Target apixaban concentrations are reached under standard dosage regimens, but overexposure can rapidly occur in the presence of cumulative factors warranting the development of a predictive tool for tailoring apixaban exposure and its clinical utility in at-risk patients."( Population pharmacokinetics of apixaban in a real-life hospitalized population from the OptimAT study.
Csajka, C; Daali, Y; Favre, S; Fontana, P; Gaspar, F; Gosselin, P; Guidi, M; Lenoir, C; Reny, JL; Rollason, V; Samer, CF; Terrier, J, 2023
)
1.63
" Both dosing regimens of apixaban, standard or reduced, were accepted."( Apixaban reduces the risk of major and clinically relevant non-major bleeding compared to warfarin in patients with end stage renal disease; a systematic review and meta-analysis of ten studies.
Bezirgianidou, Z; Karatisidis, L; Misidou, C; Mprotsis, T; Pentidou, A; Spanoudakis, E; Zagoridis, K, 2023
)
2.66
[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 3.4.21.6 (coagulation factor Xa) inhibitorAn EC 3.4.21.* (serine endopeptidase) inhibitor that interferes with the action of coagulation factor Xa (EC 3.4.21.6).
[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 (4)

ClassDescription
pyrazolopyridine
piperidones
lactamCyclic amides of amino carboxylic acids, having a 1-azacycloalkan-2-one structure, or analogues having unsaturation or heteroatoms replacing one or more carbon atoms of the ring.
aromatic etherAny ether in which the oxygen is attached to at least one aryl substituent.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Effect of intestinal microbiome on anticoagulant response of vitamin K antagonists413

Protein Targets (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
EWS/FLI fusion proteinHomo sapiens (human)Potency0.02090.001310.157742.8575AID1259253
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Coagulation factor X (EC 3.4.21.6) (Stuart factor) (Stuart-Prower factor)Homo sapiens (human)Ki0.00010.00010.00010.0001AID977610
Coagulation factor XOryctolagus cuniculus (rabbit)Ki0.00020.00010.00020.0002AID302366
ProthrombinHomo sapiens (human)Ki2.32500.00000.78469.0000AID1797810; AID302354; AID458312
Coagulation factor XHomo sapiens (human)IC50 (µMol)0.22000.00030.593710.0000AID1323702; AID1470975
Coagulation factor XHomo sapiens (human)Ki0.19390.00000.47089.0000AID1180259; AID1797810; AID1802999; AID1803000; AID299798; AID302353; AID331785; AID351693; AID396701; AID458311; AID527394
Trypsin-1Homo sapiens (human)Ki4.20000.00001.76768.9000AID458313
Trypsin-2Homo sapiens (human)Ki4.20000.00430.94873.2900AID458313
Trypsin-3Homo sapiens (human)Ki4.20000.00430.94873.2900AID458313
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (42)

Processvia Protein(s)Taxonomy
positive regulation of protein phosphorylationProthrombinHomo sapiens (human)
proteolysisProthrombinHomo sapiens (human)
acute-phase responseProthrombinHomo sapiens (human)
cell surface receptor signaling pathwayProthrombinHomo sapiens (human)
G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell population proliferationProthrombinHomo sapiens (human)
regulation of cell shapeProthrombinHomo sapiens (human)
response to woundingProthrombinHomo sapiens (human)
negative regulation of platelet activationProthrombinHomo sapiens (human)
platelet activationProthrombinHomo sapiens (human)
regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell growthProthrombinHomo sapiens (human)
positive regulation of insulin secretionProthrombinHomo sapiens (human)
positive regulation of collagen biosynthetic processProthrombinHomo sapiens (human)
fibrinolysisProthrombinHomo sapiens (human)
negative regulation of proteolysisProthrombinHomo sapiens (human)
positive regulation of receptor signaling pathway via JAK-STATProthrombinHomo sapiens (human)
negative regulation of astrocyte differentiationProthrombinHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolProthrombinHomo sapiens (human)
regulation of cytosolic calcium ion concentrationProthrombinHomo sapiens (human)
cytolysis by host of symbiont cellsProthrombinHomo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionProthrombinHomo sapiens (human)
negative regulation of fibrinolysisProthrombinHomo sapiens (human)
antimicrobial humoral immune response mediated by antimicrobial peptideProthrombinHomo sapiens (human)
neutrophil-mediated killing of gram-negative bacteriumProthrombinHomo sapiens (human)
positive regulation of lipid kinase activityProthrombinHomo sapiens (human)
negative regulation of cytokine production involved in inflammatory responseProthrombinHomo sapiens (human)
positive regulation of protein localization to nucleusProthrombinHomo sapiens (human)
positive regulation of phospholipase C-activating G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
ligand-gated ion channel signaling pathwayProthrombinHomo sapiens (human)
positive regulation of reactive oxygen species metabolic processProthrombinHomo sapiens (human)
proteolysisCoagulation factor XHomo sapiens (human)
blood coagulationCoagulation factor XHomo sapiens (human)
positive regulation of cell migrationCoagulation factor XHomo sapiens (human)
positive regulation of TOR signalingCoagulation factor XHomo sapiens (human)
digestionTrypsin-1Homo sapiens (human)
extracellular matrix disassemblyTrypsin-1Homo sapiens (human)
proteolysisTrypsin-1Homo sapiens (human)
proteolysisTrypsin-2Homo sapiens (human)
digestionTrypsin-2Homo sapiens (human)
antimicrobial humoral responseTrypsin-2Homo sapiens (human)
extracellular matrix disassemblyTrypsin-2Homo sapiens (human)
positive regulation of cell growthTrypsin-2Homo sapiens (human)
collagen catabolic processTrypsin-2Homo sapiens (human)
positive regulation of cell adhesionTrypsin-2Homo sapiens (human)
proteolysisTrypsin-3Homo sapiens (human)
digestionTrypsin-3Homo sapiens (human)
antimicrobial humoral responseTrypsin-3Homo sapiens (human)
zymogen activationTrypsin-3Homo sapiens (human)
endothelial cell migrationTrypsin-3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (12)

Processvia Protein(s)Taxonomy
lipopolysaccharide bindingProthrombinHomo sapiens (human)
serine-type endopeptidase activityProthrombinHomo sapiens (human)
signaling receptor bindingProthrombinHomo sapiens (human)
calcium ion bindingProthrombinHomo sapiens (human)
protein bindingProthrombinHomo sapiens (human)
growth factor activityProthrombinHomo sapiens (human)
heparin bindingProthrombinHomo sapiens (human)
thrombospondin receptor activityProthrombinHomo sapiens (human)
serine-type endopeptidase activityCoagulation factor XHomo sapiens (human)
calcium ion bindingCoagulation factor XHomo sapiens (human)
protein bindingCoagulation factor XHomo sapiens (human)
phospholipid bindingCoagulation factor XHomo sapiens (human)
serine-type endopeptidase activityTrypsin-1Homo sapiens (human)
metal ion bindingTrypsin-1Homo sapiens (human)
metalloendopeptidase activityTrypsin-2Homo sapiens (human)
serine-type endopeptidase activityTrypsin-2Homo sapiens (human)
calcium ion bindingTrypsin-2Homo sapiens (human)
protein bindingTrypsin-2Homo sapiens (human)
serine-type peptidase activityTrypsin-2Homo sapiens (human)
serine-type endopeptidase activityTrypsin-3Homo sapiens (human)
calcium ion bindingTrypsin-3Homo sapiens (human)
protein bindingTrypsin-3Homo sapiens (human)
serine-type peptidase activityTrypsin-3Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (13)

Processvia Protein(s)Taxonomy
external side of plasma membraneProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular regionProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
endoplasmic reticulum lumenProthrombinHomo sapiens (human)
Golgi lumenProthrombinHomo sapiens (human)
plasma membraneProthrombinHomo sapiens (human)
extracellular exosomeProthrombinHomo sapiens (human)
blood microparticleProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
extracellular regionCoagulation factor XHomo sapiens (human)
endoplasmic reticulum lumenCoagulation factor XHomo sapiens (human)
Golgi lumenCoagulation factor XHomo sapiens (human)
plasma membraneCoagulation factor XHomo sapiens (human)
external side of plasma membraneCoagulation factor XHomo sapiens (human)
extracellular spaceCoagulation factor XHomo sapiens (human)
extracellular regionTrypsin-1Homo sapiens (human)
collagen-containing extracellular matrixTrypsin-1Homo sapiens (human)
blood microparticleTrypsin-1Homo sapiens (human)
extracellular spaceTrypsin-1Homo sapiens (human)
extracellular regionTrypsin-2Homo sapiens (human)
extracellular spaceTrypsin-2Homo sapiens (human)
extracellular matrixTrypsin-2Homo sapiens (human)
azurophil granule lumenTrypsin-2Homo sapiens (human)
extracellular spaceTrypsin-2Homo sapiens (human)
extracellular regionTrypsin-3Homo sapiens (human)
extracellular spaceTrypsin-3Homo sapiens (human)
tertiary granule lumenTrypsin-3Homo sapiens (human)
extracellular spaceTrypsin-3Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (189)

Assay IDTitleYearJournalArticle
AID1345896Human coagulation factor X (S1: Chymotrypsin)2008Journal of thrombosis and haemostasis : JTH, May, Volume: 6, Issue:5
Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies.
AID527437Drug excretion in rat urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527411Antithrombotic activity in iv dosed rabbit assessed as restoration of integrated blood flow2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID396709Anticoagulant activity in rabbit plasma assessed as drug level required to double prothrombin time2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1470974Inhibition of human F10a assessed as decrease in p-nitroaniline cleavage from pefachrome F10a at 0.5 uM preincubated for 10 mins followed by substrate addition measured after 20 mins relative to control2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID1180262Volume of distribution at steady state in dog at 0.5 mg/kg, iv and 0.2 mg/kg, po administered as cassette dosing2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID1214673Apparent permeability from mucosal to serosal in rat colon at 200 uM by LC/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID527421Drug excretion in human feces 2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1180259Inhibition of purified human factor Xa2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID396708Oral bioavailability in dog at 0.2 mg/kg2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID302366Binding affinity to rabbit F10a2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID302353Binding affinity to human F10a2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1323706Anticoagulant activity in rabbit plasma assessed as increase in activated partial thromboplastin time2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID527392Volume of distribution at steady state in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1214672Apparent permeability from mucosal to serosal in rat ileum at 200 uM by LC/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1252515Anticoagulant activity in iv dosed rat AV shunt model assessed as decrease in clot weight administered every 0.5 hrs2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252515Anticoagulant activity in iv dosed rat AV shunt model assessed as decrease in clot weight administered every 0.5 hrs2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID458312Inhibition of human factor 2a2010Bioorganic & medicinal chemistry letters, Feb-15, Volume: 20, Issue:4
Phenyltriazolinones as potent factor Xa inhibitors.
AID299799Anticoagulant activity in human plasma assessed as concentration required to double prothrombin time2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
SAR and X-ray structures of enantiopure 1,2-cis-(1R,2S)-cyclopentyldiamine and cyclohexyldiamine derivatives as inhibitors of coagulation Factor Xa.
AID1470970Anticoagulant activity in rabbit plasma assessed as concentration required to double activated partial thromboplastin time2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID1252167Anticoagulant activity in 10 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252167Anticoagulant activity in 10 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID527409Clearance in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID302358Volume of distribution at steady state in dog at 0.4 mg/kg, iv and 0.2 mg/kg, po2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID331785Inhibition of human factor 10a2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID302364Aqueos solubility in saline2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID527420Drug excretion in human urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1323703Anticoagulant activity in healthy human plasma assessed as increase in prothrombin time2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID1871813Anticoagulant activity in rabbit plasma assessed as prothrombin time2022European journal of medicinal chemistry, Jan-15, Volume: 228Progress of thrombus formation and research on the structure-activity relationship for antithrombotic drugs.
AID396705Volume of distribution at steady state in dog at 0.5 mg/kg, iv and 0.2 mg/kg, po2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID527399Anticoagulant activity in human platelet assessed as concentration required to double prothrombin time2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1252164Anticoagulant activity in 0.3 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252164Anticoagulant activity in 0.3 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID527440Drug excretion in mouse feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527441Drug excretion in mouse urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID299798Inhibition of human factor 10a2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
SAR and X-ray structures of enantiopure 1,2-cis-(1R,2S)-cyclopentyldiamine and cyclohexyldiamine derivatives as inhibitors of coagulation Factor Xa.
AID527434Protein binding in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID331786Anticoagulant activity in human plasma assessed as concentration required to double prothrombin time2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID527442Drug excretion in rabbit feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527393Clearance in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1214671Apparent permeability from mucosal to serosal in rat jejunum at 200 uM by LC/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID527438Drug excretion in dog feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID302361Apparent permeability across Caco-2 cells2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1214609Oral bioavailability in rat2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1180263Half life in dog at 0.2 mg/kg, po administered as cassette dosing2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID331791Bioavailability in dog at 0.02 to 0.5 mg/kg, po2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID1252159Anticoagulant activity in 0.1 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252159Anticoagulant activity in 0.1 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID527398Anticoagulant activity in human platelet assessed as concentration required to double activated partial prothrombin time2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1470975Inhibition of human F10a assessed as decrease in p-nitroaniline cleavage from pefachrome F10a preincubated for 10 mins followed by substrate addition measured after 20 mins2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID302357Clearance in dog at 0.4 mg/kg, iv and 0.2 mg/kg, po2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1252163Anticoagulant activity in 10 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252163Anticoagulant activity in 10 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID1470976Inhibition of thrombus formation in Sprague-Dawley rat at 10 mg/kg, po after 2 hrs relative to control2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID527407Oral bioavailability in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1323707Antithrombotic activity in rat venous thrombus model assessed as inhibition of thrombus formation relative to control2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID527444Volume of distribution in chimpanzee2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527430Antithrombotic activity in rabbit venous thrombosis model2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID458313Inhibition of human trypsin2010Bioorganic & medicinal chemistry letters, Feb-15, Volume: 20, Issue:4
Phenyltriazolinones as potent factor Xa inhibitors.
AID1323702Inhibition of human coagulation factor 10a assessed as reduction in p-nitroaniline cleavage from pefachrome substrate preincubated for 10 mins followed by substrate addition measured after 20 mins2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID1214674Apparent permeability from serosal to mucosal in rat jejunum at 200 uM by LC/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID527433Protein binding in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527435Protein binding in chimpanzee2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1252160Anticoagulant activity in 0.3 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252160Anticoagulant activity in 0.3 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID1323704Anticoagulant activity in rabbit plasma assessed as increase in prothrombin time2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID1214586Inhibition of P-gp in human Caco2 cells assessed as effect on rhodamine123 efflux2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID396706Clearance in dog at 0.5 mg/kg, iv and 0.2 mg/kg, po2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1180260Apparent permeability from apical to basolateral side of the human Caco2 cells2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID1180264Oral bioavailability in dog at 0.2 mg/kg administered as cassette dosing2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID1252512Anticoagulant activity in human corn trypsin inhibitor citrated platelet poor plasma assessed as reduction of tissue factor-induced thrombin generation at 1 to 20 pM after 5 mins2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252512Anticoagulant activity in human corn trypsin inhibitor citrated platelet poor plasma assessed as reduction of tissue factor-induced thrombin generation at 1 to 20 pM after 5 mins2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID396700Anticoagulant activity in human plasma assessed as drug level required to double prothrombin time2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1214613Ratio of Cmax in milk to plasma in lactating rat2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1252168Anticoagulant activity in 20 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252168Anticoagulant activity in 20 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID1214585Inhibition of P-gp in human Caco2 cells assessed as reduction in digoxin efflux at 12.5 uM2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1214612Ratio of drug level in brain to blood in po dosed rat2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID351693Inhibition of Factor 10a2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
AID1252165Anticoagulant activity in 1 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252165Anticoagulant activity in 1 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID396710Antithrombotic activity against iv dosed rabbit arterio-venous shunt model assessed as inhibition of thrombus formation2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1214611Oral bioavailability in human2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID396699Apparent permeability from apical to basolateral side of human Caco-2 cells2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID458311Inhibition of human factor 10a2010Bioorganic & medicinal chemistry letters, Feb-15, Volume: 20, Issue:4
Phenyltriazolinones as potent factor Xa inhibitors.
AID1252166Anticoagulant activity in 3 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252166Anticoagulant activity in 3 pM tissue factor stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID527410Volume of distribution at steady state in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527394Inhibition of factor 10a2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID351695Anticoagulant activity in human plasma assessed as concentration required to double the thrombin generation time2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
AID1470969Anticoagulant activity in rabbit plasma assessed as concentration required to double prothrombin time2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID331807Inhibition of thrombus formation in rabbit arteriovenous-shunt thrombosis model2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID527443Drug excretion in rabbit urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1470971Anticoagulant activity in human plasma assessed as concentration required to double prothrombin time2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID527428Antithrombotic activity in rabbit arteriovenous-shunt thrombosis model measured per hr2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1252161Anticoagulant activity in 1 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252161Anticoagulant activity in 1 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID396707Half life in dog at 0.2 mg/kg, po2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID527432Oral bioavailability in chimpanzee2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID302354Inhibition of human thrombin2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID458314Anticoagulant activity in rabbit plasma assessed as concentration required to double prothrombin time by aggregometer2010Bioorganic & medicinal chemistry letters, Feb-15, Volume: 20, Issue:4
Phenyltriazolinones as potent factor Xa inhibitors.
AID1323705Anticoagulant activity in healthy human plasma assessed as increase in activated partial thromboplastin time2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Design, synthesis, and structure-activity relationship of novel and effective apixaban derivatives as FXa inhibitors containing 1,2,4-triazole/pyrrole derivatives as P2 binding element.
AID302362Inhibition of thrombus formation in rabbit arteriovenous shunt thrombosis model2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID331788Clearance in dog at 0.02 to 0.5 mg/kg, iv and po2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID331790Volume of distribution at steady state in dog at 0.02 to 0.5 mg/kg, iv and po2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID302359Half life in dog at 0.2 mg/kg, po2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID396701Binding affinity to human coagulation factor 10a2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1214583Inhibition of P-gp in human Caco2 cells assessed as reduction in digoxin efflux at 50 uM2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1470972Anticoagulant activity in human plasma assessed as concentration required to double activated partial thromboplastin time2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID331789Half life in dog at 0.02 to 0.5 mg/kg, po2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Structure-activity relationships of anthranilamide-based factor Xa inhibitors containing piperidinone and pyridinone P4 moieties.
AID1180275Anticoagulant activity in human plasma assessed as concentration required to double prothrombin time2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID1214670Apparent permeability from mucosal to serosal in rat duodenum at 200 uM by LC/MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID396712Protein binding in rabbit plasma2009Bioorganic & medicinal chemistry letters, Jan-15, Volume: 19, Issue:2
Highly efficacious factor Xa inhibitors containing alpha-substituted phenylcycloalkyl P4 moieties.
AID1214610Oral bioavailability in dog2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID302360Oral bioavailability in dog at 0.2 mg/kg, po2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID527445Clearance in chimpanzee2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1222793Dissociation constant, pKa of the compound2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Which metabolites circulate?
AID302356Anticoagulant potency in human plasma assessed as concentration required to double prothrombin time2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID302365Protein binding in human serum by equilibrium dialysis2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1470973Inhibition of human F10a assessed as decrease in p-nitroaniline cleavage from pefachrome F10a at 5 uM preincubated for 10 mins followed by substrate addition measured after 20 mins relative to control2017Bioorganic & medicinal chemistry, 05-15, Volume: 25, Issue:10
Design, synthesis, and biological activity of novel tetrahydropyrazolopyridone derivatives as FXa inhibitors with potent anticoagulant activity.
AID1214608Permeability by PAMPA method2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1214614Ratio of AUC in milk to plasma in lactating rat2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID527419Half life in po dosed human2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1214584Inhibition of P-gp in human Caco2 cells assessed as reduction in digoxin efflux at 25 uM2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Characterization of efflux transporters involved in distribution and disposition of apixaban.
AID1252162Anticoagulant activity in 3 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-01, Volume: 25, Issue:21
Development of a novel class of potent and selective FIXa inhibitors.
AID1252162Anticoagulant activity in 3 pM recombinant coagulation factor 11a stimulated human CTI-citrated plasma assessed as inhibition of thrombin generation incubated for 5 mins by calibrated automated thrombogram analysis2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Development of a novel tricyclic class of potent and selective FIXa inhibitors.
AID1180261Clearance in dog at 0.5 mg/kg, iv and 0.2 mg/kg, po administered as cassette dosing2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Orally bioavailable factor Xa inhibitors containing alpha-substituted gem-dimethyl P4 moieties.
AID527439Drug excretion in dog urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527436Drug excretion in rat feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID302368Anticoagulant potency in human plasma assessed as concentration required to double activated partial thromboplastin time2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1802999FXa Inhibition Assay from Article 10.3109/14756366.2010.535793: \\Apixaban inhibition of factor Xa: Microscopic rate constants and inhibition mechanism in purified protein systems and in human plasma.\\2011Journal of enzyme inhibition and medicinal chemistry, Aug, Volume: 26, Issue:4
Apixaban inhibition of factor Xa: Microscopic rate constants and inhibition mechanism in purified protein systems and in human plasma.
AID1797810Enzyme Assay and Determination of the Inhibition Constants. from Article 10.1021/jm070245n: \\Discovery of 1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro- 1H-pyrazolo[3,4-c]pyridine-3-carboxamide (Apixaban, BMS-562247), a Hi2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1803000FXa Inhibition Assay (in prothrombinase) from Article 10.3109/14756366.2010.535793: \\Apixaban inhibition of factor Xa: Microscopic rate constants and inhibition mechanism in purified protein systems and in human plasma.\\2011Journal of enzyme inhibition and medicinal chemistry, Aug, Volume: 26, Issue:4
Apixaban inhibition of factor Xa: Microscopic rate constants and inhibition mechanism in purified protein systems and in human plasma.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID977610Experimentally measured binding affinity data (Ki) for protein-ligand complexes derived from PDB2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
AID1811Experimentally measured binding affinity data derived from PDB2007Journal of medicinal chemistry, Nov-01, Volume: 50, Issue:22
Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation fa
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,319)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's33 (1.42)29.6817
2010's1629 (70.25)24.3611
2020's657 (28.33)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 119.97

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 Index119.97 (24.57)
Research Supply Index7.89 (2.92)
Research Growth Index6.55 (4.65)
Search Engine Demand Index221.83 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (119.97)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials255 (10.60%)5.53%
Reviews636 (26.44%)6.00%
Case Studies247 (10.27%)4.05%
Observational133 (5.53%)0.25%
Other1,134 (47.15%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (265)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Effect of Ticagrelor and Apixaban With or Without Acetylsalicylic Acid on Markers of Coagulation Activation at the Site of Thrombus Formation in Vivo in Healthy Male Subjects and in an ex Vivo Perfusion Chamber Model at High and Low Shear Rate [NCT02080858]Phase 140 participants (Actual)Interventional2014-05-31Completed
Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States [NCT05841446]Phase 154 participants (Actual)Interventional2021-03-02Completed
A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study [NCT00320255]Phase 2130 participants (Actual)Interventional2006-06-30Completed
Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation: a Prospective, Controlled, Randomized Pilot Study [NCT02889562]Phase 2/Phase 356 participants (Actual)Interventional2016-09-30Completed
A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Kn [NCT03251482]Phase 2308 participants (Actual)Interventional2017-11-13Completed
Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome [NCT04666454]Phase 21,000 participants (Anticipated)Interventional2020-12-14Recruiting
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism [NCT03988842]Phase 44 participants (Actual)Interventional2019-07-25Terminated(stopped due to COVID-19 pandemic)
"ORBIT Versus HAS-BLED Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants." [NCT05975320]100 participants (Anticipated)Observational2023-08-31Not yet recruiting
Treatment Patterns and Clinical Outcomes Among Venous Thromboembolism Patients Treated With Anticoagulants After the Entry of Non-vitamin K Antagonist Oral Anticoagulants in Korea [NCT05022563]55,759 participants (Actual)Observational2021-08-31Completed
Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation. [NCT04297150]700 participants (Anticipated)Observational2020-06-18Active, not recruiting
Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices [NCT03119116]31,336 participants (Actual)Observational2017-05-15Completed
RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial [NCT02942407]Phase 4154 participants (Actual)Interventional2016-12-31Completed
Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study [NCT03181386]Phase 360 participants (Actual)Interventional2017-05-03Completed
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation [NCT05757869]Phase 315,500 participants (Anticipated)Interventional2023-04-11Recruiting
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus [NCT02982590]Phase 327 participants (Actual)Interventional2016-11-30Completed
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects [NCT03310021]Phase 2108 participants (Actual)Interventional2017-08-28Completed
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembol [NCT02981472]Phase 2192 participants (Actual)Interventional2017-01-19Completed
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism [NCT00633893]Phase 32,711 participants (Actual)Interventional2008-05-31Completed
Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET) [NCT03196349]Phase 444 participants (Actual)Interventional2018-08-01Terminated(stopped due to Lack of enrollment)
Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance [NCT02238470]1,000 participants (Actual)Observational [Patient Registry]2012-04-30Completed
Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED) [NCT06144866]1,000 participants (Anticipated)Observational [Patient Registry]2020-05-01Recruiting
Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs DOACs) [NCT03568916]227,579 participants (Actual)Observational2016-11-30Completed
Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban [NCT03136510]60 participants (Anticipated)Interventional2016-09-30Recruiting
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03961334]Phase 3620 participants (Anticipated)Interventional2019-12-05Recruiting
Effectiveness and Safety of Oral Anticoagulants Among Obese Patients With Non-Valvular Atrial Fibrillation in the Veterans Affairs Population With Medicare [NCT04681482]107,383 participants (Actual)Observational2020-11-02Completed
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism. [NCT03129555]Phase 45,000 participants (Anticipated)Interventional2023-04-01Recruiting
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF). [NCT03129490]Phase 411,000 participants (Anticipated)Interventional2023-04-01Recruiting
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study) [NCT04432220]Phase 4840 participants (Anticipated)Interventional2020-07-28Recruiting
Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden [NCT03684395]68,056 participants (Actual)Observational2016-06-15Completed
Development of Precision Medicine Platform for Pharmacogenomics of Novel Oral Anticoagulants (NOACs) [NCT04056143]500 participants (Anticipated)Observational2019-01-02Recruiting
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial [NCT03463317]Phase 41,512 participants (Anticipated)Interventional2018-02-28Recruiting
SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE [NCT05838664]1 participants (Anticipated)Observational2023-07-07Active, not recruiting
Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database [NCT05038228]1 participants (Actual)Observational2022-08-01Active, not recruiting
Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study [NCT02066454]Phase 3105 participants (Anticipated)Interventional2014-04-30Recruiting
An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation [NCT02227550]Phase 4676 participants (Actual)Interventional2014-12-31Completed
Early Post-marketing Study of Eliquis (Apixaban) [NCT02153424]0 participants (Actual)Observational2014-04-30Withdrawn(stopped due to Business objectives have changed.)
The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF) [NCT04437654]Phase 41,800 participants (Anticipated)Interventional2020-07-28Recruiting
Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation [NCT04151680]100 participants (Anticipated)Observational [Patient Registry]2019-12-01Recruiting
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon [NCT03563937]64,920 participants (Actual)Observational2018-06-15Completed
Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial [NCT02048865]Phase 2575 participants (Actual)Interventional2014-03-24Completed
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis [NCT04874428]Phase 124 participants (Anticipated)Interventional2021-05-19Recruiting
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study [NCT03045406]Phase 31,168 participants (Actual)Interventional2017-04-13Active, not recruiting
Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis [NCT02945280]Phase 452 participants (Actual)Interventional2017-02-22Terminated(stopped due to COVID-19 resource allocation)
Apixaban for the Secondary Prevention of Thromboembolism: a Prospective Randomized Outcome Pilot Study Among Patients With the AntiphosPholipid Syndrome [NCT02295475]Phase 448 participants (Actual)Interventional2014-12-10Completed
[NCT02309970]90 participants (Anticipated)Observational2014-12-31Not yet recruiting
A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy [NCT01758432]Phase 254 participants (Actual)Interventional2012-12-31Completed
Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Apixaban Reversal by Ciraparantag as Measured by WBCT [NCT03288454]Phase 260 participants (Actual)Interventional2017-08-30Completed
Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects [NCT02262520]Phase 124 participants (Actual)Interventional2006-01-31Completed
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications [NCT04662515]300 participants (Anticipated)Observational2016-06-01Recruiting
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects [NCT03083704]Phase 1153 participants (Actual)Interventional2017-02-26Completed
Randomized Trial to Test the Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women [NCT02829957]Phase 2/Phase 319 participants (Actual)Interventional2016-09-30Completed
Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis Trial [NCT02818868]700 participants (Actual)Observational2016-07-31Completed
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE [NCT05171049]Phase 31,655 participants (Anticipated)Interventional2022-05-05Recruiting
A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrilla [NCT03715725]70,000 participants (Actual)Observational2018-10-31Terminated(stopped due to After feasibility assessment and due to delays in data receipt study was terminated)
Antithrombotic Therapy After Left Atrial Appendage Occlusion: Double Antiplatelet Therapy vs Apixaban [NCT05632445]Phase 4160 participants (Actual)Interventional2019-05-01Completed
A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrill [NCT03398434]Phase 20 participants (Actual)Interventional2018-10-16Withdrawn(stopped due to Trial cancelled before First Patient First Visit (no patient enrolled))
Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial [NCT05208398]Phase 350 participants (Actual)Interventional2018-02-18Completed
A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Le [NCT02369653]Phase 3512 participants (Actual)Interventional2015-10-22Completed
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter [NCT01195727]Phase 113 participants (Actual)Interventional2011-07-26Terminated
A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis [NCT03590743]Phase 45 participants (Actual)Interventional2019-02-19Terminated(stopped due to Lack of participant enrollment)
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092]811 participants (Actual)Interventional2016-12-13Completed
A Descriptive Non-interventional Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice for Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation [NCT05262322]234 participants (Actual)Observational2019-02-15Completed
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome [NCT04278729]Phase 122 participants (Actual)Interventional2021-04-14Completed
Comparison of Efficacy and Safety Among DAbigatran, RIvaroxaban, and ApixabaN in Patients HavinG Non-Valvular Atrial Fibrillation in Taiwan (DARING-AF Study) [NCT02666157]Phase 43,672 participants (Anticipated)Interventional2016-01-31Recruiting
Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial [NCT05973188]Phase 4141 participants (Anticipated)Interventional2023-05-01Recruiting
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism [NCT00643201]Phase 35,614 participants (Actual)Interventional2008-07-31Completed
Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome [NCT00831441]Phase 37,484 participants (Actual)Interventional2009-03-31Terminated
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study. [NCT02611635]382 participants (Actual)Observational2016-02-02Completed
REal-World Treatment Outcomes of Oral-Anticoagulants Among Patients With Atrial Fibrillation - Patient Survey - RETAF-PS [NCT05471830]600 participants (Actual)Observational2022-11-30Completed
Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects [NCT05491460]Phase 124 participants (Anticipated)Interventional2022-07-01Active, not recruiting
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs [NCT04262492]500 participants (Anticipated)Observational [Patient Registry]2020-10-21Recruiting
A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery [NCT00097357]Phase 2/Phase 31,238 participants (Actual)Interventional2004-10-31Completed
A Multi-center Observative Study of Apixaban After Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation [NCT04550637]200 participants (Anticipated)Observational [Patient Registry]2022-07-04Recruiting
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Int [NCT02415400]Phase 44,614 participants (Actual)Interventional2015-06-04Completed
Eliquis Acute Stroke Safety Evaluation [NCT04435418]100 participants (Actual)Observational [Patient Registry]2017-03-01Completed
Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study [NCT03200613]Phase 28 participants (Actual)Interventional2017-09-01Terminated(stopped due to study not feasible due to too slow recruitment)
Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin [NCT03189069]36,000 participants (Actual)Observational2016-10-06Completed
HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID): a National Platform Trial [NCT04801940]Phase 32,631 participants (Anticipated)Interventional2021-05-19Recruiting
Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects [NCT04809818]Phase 164 participants (Anticipated)Interventional2021-03-21Recruiting
Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis [NCT05532878]50 participants (Anticipated)Observational2020-12-01Recruiting
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study) [NCT00452530]Phase 33,221 participants (Actual)Interventional2007-06-30Completed
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial [NCT05735639]Phase 46,660 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation [NCT00412984]Phase 320,976 participants (Actual)Interventional2006-12-31Completed
Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2 [NCT03839355]Phase 334 participants (Actual)Interventional2018-12-19Terminated(stopped due to Study terminated due to slower than anticipated enrollment.)
Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S [NCT02769078]14,201 participants (Actual)Observational2014-11-30Completed
Post-Discharge Treatment Patterns and Outcomes in Patients With Venous Thromboembolism [NCT05795062]47,029 participants (Actual)Observational2023-03-10Completed
Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb [NCT04229264]Phase 3200 participants (Anticipated)Interventional2020-01-09Recruiting
Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis [NCT02672709]Phase 47 participants (Actual)Interventional2016-04-30Completed
Optimal Dosing of Apixaban in Patients at Risk of Elevated Drug Levels: A Study Evaluating a Strategy of Apixaban Drug Level Measurement and Dose Reduction in Patients With Atrial Fibrillation Who Are at Risk of Elevated Drug Levels [NCT02809469]Phase 2120 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study [NCT04006093]Phase 124 participants (Actual)Interventional2019-12-08Completed
Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial [NCT04696120]Phase 2200 participants (Anticipated)Interventional2021-03-02Not yet recruiting
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial [NCT03568890]Phase 4510 participants (Anticipated)Interventional2018-09-01Recruiting
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence [NCT04042155]1,600 participants (Anticipated)Observational [Patient Registry]2019-07-29Recruiting
A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome. [NCT00313300]Phase 21,741 participants (Actual)Interventional2006-05-31Completed
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization. [NCT00457002]Phase 36,758 participants (Actual)Interventional2007-06-30Completed
Venous Thromboembolism Prophylaxis With Apixaban in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma Receiving Induction Therapy With an Immunomodulatory-based Regimen [NCT04106700]Phase 260 participants (Actual)Interventional2019-04-12Terminated(stopped due to Low recruitment)
A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban [NCT04142658]Phase 3863 participants (Actual)Interventional2020-05-01Terminated(stopped due to Safety)
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial [NCT03968393]Phase 42,800 participants (Anticipated)Interventional2019-06-14Recruiting
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study [NCT02607371]198 participants (Actual)Observational2015-08-27Completed
Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care [NCT04099238]3,739 participants (Actual)Observational2019-10-01Completed
Pharmacokinetics of Apixaban in Nephrotic Syndrome [NCT02599532]Phase 121 participants (Actual)Interventional2017-04-30Completed
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study [NCT02581176]Phase 4300 participants (Actual)Interventional2016-04-30Completed
Apixaban Versus Antiplatelet Drugs or no Antithrombotic Drugs After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation: A Randomised Phase II Clinical Trial [NCT02565693]Phase 2101 participants (Actual)Interventional2014-09-30Completed
Venous Thromboembolism Prevention in Outpatients With Glioma [NCT05683808]Phase 240 participants (Anticipated)Interventional2023-01-16Not yet recruiting
Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis [NCT02664649]Phase 31,510 participants (Anticipated)Interventional2016-08-26Completed
A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Antic [NCT00423319]Phase 35,407 participants (Actual)Interventional2007-03-31Completed
Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial [NCT05419583]60 participants (Anticipated)Interventional2022-11-14Recruiting
A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery [NCT00371683]Phase 33,608 participants (Actual)Interventional2006-11-30Completed
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery [NCT03907046]Phase 3700 participants (Anticipated)Interventional2020-01-28Recruiting
Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical [NCT05088928]Phase 240 participants (Anticipated)Interventional2022-03-01Not yet recruiting
APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study [NCT02640222]321,501 participants (Actual)Observational2014-01-01Completed
Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery [NCT04479579]Phase 453 participants (Actual)Interventional2021-02-22Completed
Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy [NCT04645550]Phase 4120 participants (Actual)Interventional2020-11-22Completed
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF) [NCT03642509]750 participants (Anticipated)Interventional2019-01-01Recruiting
Safety and Effectiveness of Apixaban in Very Elderly Patients With NVAF Compared to Warfarin Using Administrative Claims Data [NCT05438888]77,814 participants (Actual)Observational2022-07-01Completed
Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS Apixaban [NCT03448783]12 participants (Anticipated)Observational2018-01-02Recruiting
The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism [NCT03292666]39,603 participants (Actual)Observational2010-01-01Completed
A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF [NCT00787150]Phase 2222 participants (Actual)Interventional2008-06-30Completed
Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation [NCT02935855]Phase 4300 participants (Actual)Interventional2015-09-30Completed
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study [NCT02286414]159 participants (Actual)Observational2015-02-28Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition [NCT06043297]Phase 130 participants (Actual)Interventional2023-02-23Completed
Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial [NCT00496769]Phase 36,421 participants (Actual)Interventional2007-08-31Completed
Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention [NCT01885585]100 participants (Actual)Observational2014-07-31Completed
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation [NCT01885598]3,335 participants (Actual)Observational2013-07-10Completed
COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation [NCT04642430]Phase 43,018 participants (Anticipated)Interventional2021-07-06Recruiting
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism [NCT03266783]Phase 42,760 participants (Anticipated)Interventional2017-12-13Recruiting
Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation [NCT05679024]Phase 31,400 participants (Anticipated)Interventional2023-02-17Recruiting
A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients [NCT04243122]Phase 244 participants (Actual)Interventional2021-02-17Active, not recruiting
Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [NCT00562289]Phase 3664 participants (Actual)Interventional2007-12-31Completed
Pharmacokinetics, Pharmacodynamics and Safety of Apixaban on Hemodiafiltration [NCT04952792]Phase 211 participants (Actual)Interventional2021-05-20Completed
A Phase I Placebo-Controlled, Open-Label, Crossover Study to Assess the Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra in Healthy Volunteers [NCT02270918]Phase 112 participants (Actual)Interventional2014-11-30Completed
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation [NCT02007655]6,372 participants (Actual)Observational2013-09-01Completed
Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study [NCT02714855]2,081 participants (Actual)Observational2015-10-31Completed
Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial [NCT02633774]200 participants (Anticipated)Interventional2015-11-30Recruiting
Real-world Comparative Effectiveness of Apixaban Versus VKA [NCT02687854]18,591 participants (Actual)Observational2016-02-12Completed
A Phase 2, Placebo-Controlled, Randomized, Double-Blinded, Multicenter, Study To Evaluate The Bleeding Profile Of 2.5 Mg And 5.0 Mg BID Apixaban In Combination With Standard Therapy In Patients With Recent (≤7 Days) Acute Coronary Syndrome (ACS) [NCT00852397]Phase 2151 participants (Actual)Interventional2009-04-30Terminated(stopped due to See termination reason in detailed description.)
The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism [NCT02833987]59,525 participants (Actual)Observational2015-03-31Completed
Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients [NCT02792335]28,000 participants (Actual)Observational2012-01-31Completed
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome [NCT04850378]Phase 1/Phase 280 participants (Anticipated)Interventional2021-03-25Recruiting
A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers [NCT00914641]Phase 116 participants (Actual)Interventional2009-06-30Completed
Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT05304455]40 participants (Actual)Interventional2022-04-01Completed
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial [NCT04700826]Phase 43,000 participants (Anticipated)Interventional2021-06-01Recruiting
Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19 [NCT04736901]90 participants (Actual)Observational2020-12-01Completed
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants [NCT02912234]Phase 120 participants (Actual)Interventional2016-09-30Completed
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects [NCT02074358]Phase 143 participants (Actual)Interventional2014-02-28Completed
"A Pilot Study of an Oral Anticoagulant Apixaban for theTreatment of Venous Thromboembolism in Children and Adolescents" [NCT04041843]Phase 225 participants (Actual)Interventional2017-06-02Completed
Randomized Controlled Trial of Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism [NCT04168203]Phase 4600 participants (Anticipated)Interventional2021-03-01Active, not recruiting
Direct Oral Anticoagulant Therapy With the HeartMate 3 LVAD: A Pilot Study [NCT04974684]45 participants (Anticipated)Interventional2022-02-01Recruiting
Pilot Randomized Study of the Sidlenafil Efficacy in Combination With Oral Anticoagulants in the Treatment of Patients With Intermediate-high Risk of Pulmonary Embolism [NCT02946944]Phase 1100 participants (Anticipated)Interventional2016-10-31Recruiting
Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage [NCT03153150]Phase 3203 participants (Actual)Interventional2018-03-28Completed
Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients With Child B Liver Cirrhosis [NCT05869591]Phase 232 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Apixaban Discontinuation Prior to Major Surgery [NCT02935751]130 participants (Anticipated)Observational2016-10-31Completed
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study [NCT03456648]Phase 224 participants (Actual)Interventional2016-09-25Completed
A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Tr [NCT03276143]Phase 2813 participants (Actual)Interventional2017-09-21Completed
Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System [NCT03026556]42,534 participants (Actual)Observational2016-12-29Completed
A Phase II Study to Evaluate the Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) [NCT03594045]Phase 25 participants (Actual)Interventional2018-12-18Terminated(stopped due to Withdrawal of funding by sponsor)
A Phase I, Randomized, Single-Dose, Open-Label, Four-Way Crossover Study to Evaluate the Comparative Bioavailability of Apixaban for TAH3311 Oral Dissolving Film Versus ELIQUIS® Oral Tablet in Healthy Male and Female Subjects [NCT05995119]Early Phase 112 participants (Actual)Interventional2022-12-05Completed
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF) [NCT03996772]Phase 3350 participants (Anticipated)Interventional2019-06-03Recruiting
Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects [NCT02034578]Phase 175 participants (Actual)Interventional2011-07-31Completed
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study [NCT03271450]416,000 participants (Anticipated)Observational2017-07-01Enrolling by invitation
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis [NCT05701917]300 participants (Anticipated)Interventional2023-01-06Recruiting
Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified? [NCT04002011]Phase 20 participants (Actual)Interventional2022-03-09Withdrawn(stopped due to Submission process abandoned. No patient enrolled.)
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis [NCT01340586]Phase 118 participants (Actual)Interventional2011-06-30Completed
An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects [NCT01437839]Phase 122 participants (Actual)Interventional2011-09-30Completed
The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis [NCT04981327]Phase 31,300 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Anticoagulation Strategies for the Treatment of Acute Venous Thromboembolism in Medicare Fee For-Service Patients With End-Stage Renal Disease Using USRDS Data [NCT04818151]14,914 participants (Actual)Observational2021-01-01Completed
A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Preventio [NCT05643573]Phase 314,830 participants (Actual)Interventional2022-12-05Active, not recruiting
Effectiveness and Safety of Rivaroxaban Compared With Apixaban in Cancer-Associated Venous Thromboembolism: A Head-to-Head (H2H) Analysis of the United States Cohort of the Observational Study in Cancer Associated Thrombosis for Rivaroxaban (H2H-OSCAR-US) [NCT05461807]2,437 participants (Actual)Observational2022-07-14Completed
OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial [NCT03759938]3,478 participants (Anticipated)Interventional2019-06-18Recruiting
FREEDOM COVID Anticoagulation Strategy Randomized Trial [NCT04512079]Phase 43,460 participants (Actual)Interventional2020-09-08Completed
COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge [NCT04650087]Phase 31,219 participants (Actual)Interventional2021-02-15Completed
The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study [NCT04198844]0 participants (Actual)Observational2019-11-18Withdrawn(stopped due to Interaction term analysis result was not significant and thus comparative effectiveness for primary and secondary outcomes could not be considered per protocol.)
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms [NCT04192916]442 participants (Actual)Observational2019-09-01Completed
A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the [NCT01675076]Phase 3663 participants (Actual)Interventional2013-01-31Completed
APB Study: Apixaban Pharmacokinetics in Bariatric Patients [NCT02406885]Phase 433 participants (Actual)Interventional2017-07-19Completed
The Safety of Oral Apixaban (Eliquis) Versus Subcutaneous Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy; a Prospective Randomized Open Blinded End-point (PROBE) Design [NCT02366871]Phase 2400 participants (Actual)Interventional2015-04-28Completed
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) [NCT02701062]Phase 4562 participants (Actual)Interventional2016-02-29Completed
APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) [NCT03441633]51,690 participants (Actual)Observational2016-02-18Completed
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants [NCT02754154]321,182 participants (Actual)Observational2014-12-31Completed
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF: The CORRAL-AF Study [NCT04684212]2,931 participants (Anticipated)Interventional2023-12-01Not yet recruiting
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers [NCT05723510]Phase 187 participants (Actual)Interventional2023-03-06Completed
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) [NCT01884350]Phase 41,217 participants (Actual)Interventional2013-10-15Completed
Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation [NCT04218266]Phase 2755 participants (Actual)Interventional2020-01-30Completed
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition [NCT04344717]Phase 484 participants (Anticipated)Interventional2020-12-20Recruiting
Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension [NCT04007289]Phase 3166 participants (Anticipated)Interventional2019-06-24Recruiting
APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer [NCT03678506]Phase 4800 participants (Actual)Interventional2018-08-16Terminated(stopped due to The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval [CI], 4.5-11.2))
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder [NCT01707394]Phase 149 participants (Actual)Interventional2013-01-10Completed
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427]695 participants (Actual)Observational2012-11-30Completed
A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy [NCT03080883]Phase 3370 participants (Actual)Interventional2017-07-14Active, not recruiting
Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis. [NCT04462003]Phase 3100 participants (Anticipated)Interventional2019-07-03Recruiting
Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis [NCT00252005]Phase 2520 participants Interventional2005-11-30Completed
A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Dire [NCT05152420]Phase 1105 participants (Actual)Interventional2021-10-29Completed
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study [NCT02559856]Phase 472 participants (Actual)Interventional2016-05-31Completed
Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy [NCT02958969]Phase 450 participants (Actual)Interventional2018-02-28Completed
A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers [NCT03509883]Phase 194 participants (Actual)Interventional2018-04-26Completed
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma [NCT02749617]Phase 22 participants (Actual)Interventional2016-08-09Terminated(stopped due to Study was stopped due to lack of enrollment.)
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735]15 participants (Actual)Interventional2017-01-13Terminated(stopped due to Due to lack of recruitment of eligible participants)
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data [NCT05264168]41,875 participants (Actual)Observational2021-05-03Completed
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data [NCT05256797]529,536 participants (Actual)Observational2021-05-03Completed
Replication of the ARISTOTLE Anticoagulant Trial in Healthcare Claims Data [NCT04593030]220,518 participants (Actual)Observational2020-09-01Completed
Study of Bioavailability of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects [NCT02034565]Phase 148 participants (Actual)Interventional2010-02-28Completed
Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults [NCT02345343]100 participants (Anticipated)Observational2015-05-04Completed
Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects [NCT02262533]Phase 115 participants (Actual)Interventional2007-06-30Completed
A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE) [NCT04128254]Phase 41,000 participants (Anticipated)Interventional2020-01-31Not yet recruiting
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction [NCT04504318]Phase 1/Phase 2106 participants (Anticipated)Interventional2020-08-12Recruiting
The efficAcy and Safety of aPixaban In REal-world Practice in Korean Frail Patients With Atrial Fibrillation: a Prospective Multicenter Non-interventional, Observational Study: ASPIRE Study [NCT05773222]2,500 participants (Anticipated)Observational [Patient Registry]2019-08-12Active, not recruiting
Avoiding Anticoagulation After IntraCerebral Haemorrhage [NCT03243175]Phase 3300 participants (Anticipated)Interventional2019-01-24Recruiting
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03148457]2,013 participants (Actual)Interventional2017-11-06Completed
Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in High-risk Patients With Acute Non-disabling Cerebrovascular Events (ADANCE): Rationale, Objectives, and Design [NCT01924325]Phase 2/Phase 310,000 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque [NCT02090075]Phase 466 participants (Actual)Interventional2014-09-30Completed
Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants [NCT02664155]Phase 3203 participants (Actual)Interventional2016-10-19Terminated(stopped due to recruiting difficulties)
Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation [NCT02608099]Phase 4300 participants (Actual)Interventional2015-11-30Completed
DIrect Oral Anticoagulant for Antithrombotic Management Of mechaNical Aortic Valve Implanted Patients for Valvular Heart Disease Study [NCT05687448]Phase 41,044 participants (Anticipated)Interventional2023-03-31Not yet recruiting
The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial [NCT04284839]Phase 36,215 participants (Anticipated)Interventional2021-07-18Recruiting
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices [NCT04865978]Phase 230 participants (Actual)Interventional2021-12-14Completed
A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage [NCT04891861]Phase 3100 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Hydroxychloroquine and Apixaban: Analysis of Physiological Parameters for the Prevention of Complications in Patients With Infection With the New Coronavirus (Covid-19). A Randomized Clinical Trial [NCT04788355]Phase 3176 participants (Actual)Interventional2020-07-01Completed
A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism [NCT02585713]Phase 3300 participants (Actual)Interventional2015-11-20Completed
Monotherapy Anticoagulation To Expedite Home Treatment of Venous [NCT03404635]1,300 participants (Actual)Observational2017-08-04Completed
A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3) [NCT03100071]70 participants (Anticipated)Observational2017-05-15Recruiting
VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe) [NCT04618913]1 participants (Anticipated)Observational2020-12-14Active, not recruiting
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial [NCT04746339]Phase 4411 participants (Actual)Interventional2021-03-04Terminated(stopped due to Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.)
A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion [NCT02100228]Phase 41,500 participants (Actual)Interventional2014-07-14Completed
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179]27 participants (Actual)Interventional2014-06-30Completed
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring [NCT01706146]Phase 459 participants (Actual)Interventional2012-10-31Completed
Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation [NCT02283294]Phase 391 participants (Actual)Interventional2015-04-30Completed
Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the St [NCT03254147]53,969 participants (Actual)Observational2017-10-15Completed
Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism [NCT04477837]150 participants (Anticipated)Observational [Patient Registry]2020-10-15Recruiting
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT [NCT02464969]Phase 4250 participants (Anticipated)Interventional2015-11-22Recruiting
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data [NCT04736719]19,002 participants (Actual)Observational2020-09-22Completed
THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA [NCT03572972]64,684 participants (Actual)Observational2018-01-31Completed
Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data [NCT04808934]0 participants (Actual)Observational2020-06-01Withdrawn(stopped due to Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.)
A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancrea [NCT03139487]Phase 2176 participants (Anticipated)Interventional2017-08-07Recruiting
Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK [NCT03847181]45,164 participants (Actual)Observational2019-02-28Completed
PARADOX Trial: A Prospective, Double-Blind, Randomized Controlled Trial in Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli [NCT02378623]Phase 20 participants (Actual)Interventional2015-05-31Withdrawn(stopped due to Sponsor withdrew funding - May 2016)
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation [NCT05035277]Phase 3360 participants (Anticipated)Interventional2021-12-04Recruiting
Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE [NCT03965741]97,765 participants (Actual)Observational2019-05-30Completed
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis (SAFE-D) [NCT03987711]Phase 2151 participants (Actual)Interventional2019-12-10Completed
Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control [NCT03073265]109 participants (Actual)Observational2017-05-08Completed
Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS Randomized Trial) [NCT02427126]Phase 3352 participants (Actual)Interventional2015-12-31Completed
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke [NCT03192215]Phase 31,015 participants (Actual)Interventional2018-01-19Terminated(stopped due to The DSMB halted the trial prematurely due to futility without any safety concerns.)
An Exploratory Study of the Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy [NCT04191928]Phase 14 participants (Actual)Interventional2020-03-03Completed
Pharmacokinetics of Apixaban and Tacrolimus or Cyclosporine in Kidney and Lung Transplant Recipients [NCT04023760]Phase 414 participants (Actual)Interventional2019-06-26Completed
A Phase I, Open-Label, Crossover, Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus in Healthy Volunteers [NCT03083782]Phase 112 participants (Actual)Interventional2017-04-18Completed
A Phase IV, Open-Label, Multi-center Study to Evaluate the Safety of Apixaban in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery [NCT01884337]Phase 4557 participants (Actual)Interventional2015-03-24Completed
Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation [NCT01938248]Phase 44,012 participants (Actual)Interventional2015-05-31Completed
[NCT05187286]0 participants Expanded AccessAvailable
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury [NCT05484557]60 participants (Anticipated)Interventional2023-09-06Recruiting
A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study [NCT03935451]Early Phase 160 participants (Anticipated)Interventional2021-09-01Recruiting
Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese [NCT01780987]Phase 380 participants (Actual)Interventional2013-01-31Completed
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty [NCT04878497]1,000,000 participants (Anticipated)Observational2021-03-30Active, not recruiting
COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis [NCT04498273]Phase 3657 participants (Actual)Interventional2020-09-07Terminated(stopped due to an event rate lower than anticipated)
A Randomized Trial of the Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery: a Pilot Study [NCT05006287]Phase 2100 participants (Anticipated)Interventional2021-10-01Not yet recruiting
Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents (ADAPT AF-DES) [NCT04250116]Phase 4960 participants (Anticipated)Interventional2020-04-28Recruiting
Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics [NCT04249401]134,897 participants (Actual)Observational2020-03-01Completed
Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis [NCT03692065]Phase 31,767 participants (Actual)Interventional2018-10-11Active, not recruiting
A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment [NCT02933697]Phase 3108 participants (Actual)Interventional2017-06-20Completed
International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism [NCT03778502]300 participants (Anticipated)Observational [Patient Registry]2019-10-01Recruiting
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With NVAF With a History of Stroke or Transient Ischemic Attack - a Nationwide Retrospective Observational Study Using Claims Data in Japan [NCT05321810]10,000 participants (Actual)Observational2022-04-15Completed
Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects [NCT02101112]Phase 169 participants (Actual)Interventional2014-03-31Completed
Apixaban for Prevention of Post-angioplasty Thrombosis of Hemodialysis Vascular Access [NCT04489849]Phase 4150 participants (Anticipated)Interventional2020-03-14Recruiting
Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus [NCT03232398]Phase 340 participants (Actual)Interventional2018-01-01Completed
Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study [NCT02450682]Phase 20 participants (Actual)Interventional2016-02-29Withdrawn
Bioavailability of Apixaban Oral Solution Administered Through a Nasogastric Tube in the Presence of Boost® Plus and Apixaban Administered as Crushed Tablet Through a Nasogastric Tube Relative to Apixaban Oral Solution in Healthy Subjects [NCT02034591]Phase 137 participants (Actual)Interventional2011-10-31Completed
Impact of Daily Prophylaxis Dose Anticoagulation With a Factor Xa Inhibitor (Apixaban) in Patients With Sickle Cell Disease [NCT02179177]Phase 316 participants (Actual)Interventional2015-01-31Terminated(stopped due to funding has been exhausted)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00313300 (10) [back to overview]Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
NCT00313300 (10) [back to overview]Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
NCT00313300 (10) [back to overview]Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
NCT00313300 (10) [back to overview]Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
NCT00313300 (10) [back to overview]Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
NCT00313300 (10) [back to overview]Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
NCT00313300 (10) [back to overview]Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
NCT00313300 (10) [back to overview]Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
NCT00313300 (10) [back to overview]Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
NCT00313300 (10) [back to overview]Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
NCT00320255 (12) [back to overview]Number of Participants With All-Cause Death
NCT00320255 (12) [back to overview]Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
NCT00320255 (12) [back to overview]Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
NCT00320255 (12) [back to overview]Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
NCT00320255 (12) [back to overview]Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
NCT00320255 (12) [back to overview]Number of Participants With Deep Vein Thrombosis
NCT00320255 (12) [back to overview]Number of Participants With Distal Deep Vein Thrombosis
NCT00320255 (12) [back to overview]Number of Participants With Nonfatal Pulmonary Embolism
NCT00320255 (12) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis
NCT00320255 (12) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
NCT00320255 (12) [back to overview]Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
NCT00320255 (12) [back to overview]Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
NCT00371683 (24) [back to overview]Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period
NCT00371683 (24) [back to overview]Mean Change From Baseline in Heart Rate During the Treatment Period
NCT00371683 (24) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
NCT00371683 (24) [back to overview]Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period
NCT00371683 (24) [back to overview]Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period
NCT00371683 (24) [back to overview]Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period
NCT00371683 (24) [back to overview]Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects
NCT00371683 (24) [back to overview]Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period
NCT00371683 (24) [back to overview]Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period
NCT00371683 (24) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population
NCT00371683 (24) [back to overview]Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population
NCT00371683 (24) [back to overview]Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With All-Cause Death During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period
NCT00371683 (24) [back to overview]Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With Events of All-Cause Death During the Intended Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With Net-Clinical Benefit During Treatment Period
NCT00412984 (19) [back to overview]Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Adjudicated All-Cause Death During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period
NCT00412984 (19) [back to overview]Rate of All Bleeding Events During Treatment Period
NCT00412984 (19) [back to overview]Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period
NCT00412984 (19) [back to overview]Rate of Net-Clinical Benefit During Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period
NCT00412984 (19) [back to overview]Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period
NCT00412984 (19) [back to overview]Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period
NCT00412984 (19) [back to overview]Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period
NCT00412984 (19) [back to overview]Number of Participants With All Bleeding Events During Treatment Period
NCT00423319 (14) [back to overview]Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period
NCT00423319 (14) [back to overview]Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
NCT00423319 (14) [back to overview]Number of Participants With a Bleeding-related Adverse Event During the Treatment Period
NCT00423319 (14) [back to overview]Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)
NCT00423319 (14) [back to overview]Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)
NCT00423319 (14) [back to overview]Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period
NCT00423319 (14) [back to overview]Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period
NCT00423319 (14) [back to overview]Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)
NCT00423319 (14) [back to overview]Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period
NCT00423319 (14) [back to overview]Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period
NCT00423319 (14) [back to overview]Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period
NCT00423319 (14) [back to overview]Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period
NCT00423319 (14) [back to overview]Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period
NCT00423319 (14) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome
NCT00452530 (7) [back to overview]Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)
NCT00452530 (7) [back to overview]Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)
NCT00452530 (7) [back to overview]Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)
NCT00452530 (7) [back to overview]Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome
NCT00452530 (7) [back to overview]Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period
NCT00452530 (7) [back to overview]Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period
NCT00452530 (7) [back to overview]Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM
NCT00457002 (32) [back to overview]Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
NCT00457002 (32) [back to overview]Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of All Bleeding During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
NCT00457002 (32) [back to overview]Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated PE With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
NCT00457002 (32) [back to overview]Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
NCT00457002 (32) [back to overview]Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
NCT00457002 (32) [back to overview]Incidence of Major Bleeding During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Mean Change From Baseline in Heart Rate in Treated Participants
NCT00457002 (32) [back to overview]Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
NCT00457002 (32) [back to overview]Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
NCT00457002 (32) [back to overview]Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
NCT00457002 (32) [back to overview]Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
NCT00496769 (9) [back to overview]Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
NCT00496769 (9) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
NCT00496769 (9) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
NCT00496769 (9) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
NCT00496769 (9) [back to overview]Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality
NCT00496769 (9) [back to overview]Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
NCT00496769 (9) [back to overview]Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
NCT00496769 (9) [back to overview]Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
NCT00496769 (9) [back to overview]Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
NCT00633893 (22) [back to overview]Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated Total Bleeding During the Treatment Period - Treated Participants
NCT00633893 (22) [back to overview]Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
NCT00633893 (22) [back to overview]Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
NCT00633893 (22) [back to overview]Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
NCT00633893 (22) [back to overview]Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Major Bleeding During the Treatment Period - Treated Population
NCT00633893 (22) [back to overview]Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
NCT00633893 (22) [back to overview]Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
NCT00633893 (22) [back to overview]Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
NCT00643201 (21) [back to overview]Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period
NCT00643201 (21) [back to overview]Incidence of All-Cause Death During the Intended Treatment Period
NCT00643201 (21) [back to overview]Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period
NCT00643201 (21) [back to overview]Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
NCT00643201 (21) [back to overview]Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
NCT00643201 (21) [back to overview]Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
NCT00643201 (21) [back to overview]Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
NCT00643201 (21) [back to overview]Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
NCT00643201 (21) [back to overview]Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
NCT00643201 (21) [back to overview]Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
NCT00643201 (21) [back to overview]Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
NCT00643201 (21) [back to overview]Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
NCT00643201 (21) [back to overview]Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
NCT00643201 (21) [back to overview]Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
NCT00643201 (21) [back to overview]Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
NCT00643201 (21) [back to overview]Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
NCT00787150 (14) [back to overview]Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
NCT00787150 (14) [back to overview]Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
NCT00787150 (14) [back to overview]Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
NCT00787150 (14) [back to overview]Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
NCT00787150 (14) [back to overview]Number of Participants With Total Bleeding Events During the Treatment Period
NCT00787150 (14) [back to overview]Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
NCT00787150 (14) [back to overview]Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
NCT00787150 (14) [back to overview]Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
NCT00787150 (14) [back to overview]Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
NCT00787150 (14) [back to overview]Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
NCT00787150 (14) [back to overview]Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
NCT00787150 (14) [back to overview]Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
NCT00787150 (14) [back to overview]Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
NCT00787150 (14) [back to overview]Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
NCT00831441 (12) [back to overview]Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
NCT00831441 (12) [back to overview]Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
NCT00831441 (12) [back to overview]Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
NCT00831441 (12) [back to overview]Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
NCT00831441 (12) [back to overview]Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
NCT00831441 (12) [back to overview]Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.
NCT00852397 (8) [back to overview]Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.
NCT01340586 (26) [back to overview]Mean Renal Clearance (CLR) of BMS-730823
NCT01340586 (26) [back to overview]Mean Plasma Terminal Half-life (T-Half) of BMS-730823
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823
NCT01340586 (26) [back to overview]Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823
NCT01340586 (26) [back to overview]Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823
NCT01340586 (26) [back to overview]Percentage of Apixaban Extracted During Hemodialysis
NCT01340586 (26) [back to overview]Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Percentage of BMS-730823 Extracted During Hemodialysis
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban
NCT01340586 (26) [back to overview]Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823
NCT01340586 (26) [back to overview]Mean Hemodialysis Clearance (CLD) of Apixaban
NCT01340586 (26) [back to overview]Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation
NCT01340586 (26) [back to overview]Number of Participants With Laboratory Marked Abnormalities
NCT01340586 (26) [back to overview]Mean Hemodialysis Clearance (CLD) of BMS-730823
NCT01340586 (26) [back to overview]Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban
NCT01340586 (26) [back to overview]Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban
NCT01340586 (26) [back to overview]Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)
NCT01340586 (26) [back to overview]Mean Percent Dose of Apixaban Recovered in Urine (%UR)
NCT01340586 (26) [back to overview]Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban
NCT01340586 (26) [back to overview]Mean Renal Clearance (CLR) of Apixaban
NCT01706146 (2) [back to overview]Bleeding Incidence
NCT01706146 (2) [back to overview]Number of Days on Anticoagulation
NCT01758432 (9) [back to overview]Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
NCT01758432 (9) [back to overview]Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
NCT01758432 (9) [back to overview]Andexanet Apparent Terminal Elimination Half-life (t1/2)
NCT01758432 (9) [back to overview]Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
NCT01758432 (9) [back to overview]Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
NCT01758432 (9) [back to overview]Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
NCT01758432 (9) [back to overview]Andexanet Maximum Observed Plasma Concentration (Cmax)
NCT01758432 (9) [back to overview]Andexanet Total Systemic Clearance (CL)
NCT01758432 (9) [back to overview]Andexanet Total Volume of Distribution (Vss)
NCT01780987 (6) [back to overview]Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
NCT01780987 (6) [back to overview]Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period
NCT01780987 (6) [back to overview]Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period
NCT01780987 (6) [back to overview]Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
NCT01780987 (6) [back to overview]Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
NCT01780987 (6) [back to overview]Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
NCT01884337 (2) [back to overview]Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days
NCT01884337 (2) [back to overview]Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days
NCT01884350 (6) [back to overview]Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks
NCT01884350 (6) [back to overview]Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen
NCT01884350 (6) [back to overview]Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period
NCT01884350 (6) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
NCT01884350 (6) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
NCT01884350 (6) [back to overview]Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks
NCT01999179 (5) [back to overview]PTS Assessment Completion
NCT01999179 (5) [back to overview]Number of Participants With Post-thrombotic Syndrome
NCT01999179 (5) [back to overview]Number of Participants With Recurrent Thrombosis
NCT01999179 (5) [back to overview]Biomarker Sample Collection
NCT01999179 (5) [back to overview]Number of Participants With Major Bleeding
NCT02034565 (5) [back to overview]Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
NCT02034565 (5) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs
NCT02034565 (5) [back to overview]Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban
NCT02034565 (5) [back to overview]Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
NCT02034565 (5) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT02034578 (8) [back to overview]Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings
NCT02034578 (8) [back to overview]Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests
NCT02034578 (8) [back to overview]Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban
NCT02034578 (8) [back to overview]Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban
NCT02034578 (8) [back to overview]Mean Plasma Elimination Half-Life (T-HALF) of Apixaban
NCT02034578 (8) [back to overview]Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
NCT02034578 (8) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death
NCT02034578 (8) [back to overview]Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban
NCT02034591 (6) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
NCT02034591 (6) [back to overview]Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban
NCT02034591 (6) [back to overview]Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
NCT02034591 (6) [back to overview]Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
NCT02034591 (6) [back to overview]Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
NCT02034591 (6) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT02074358 (28) [back to overview]Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population
NCT02074358 (28) [back to overview]Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population
NCT02074358 (28) [back to overview]Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]Mean Change From Baseline Temperature on Day 4 and Day 7
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4
NCT02074358 (28) [back to overview]Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4
NCT02074358 (28) [back to overview]Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4
NCT02074358 (28) [back to overview]Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4
NCT02074358 (28) [back to overview]Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4
NCT02074358 (28) [back to overview]Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4
NCT02074358 (28) [back to overview]Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4
NCT02074358 (28) [back to overview]Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo
NCT02074358 (28) [back to overview]Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7
NCT02074358 (28) [back to overview]Mean Change From Baseline in Heart Rate on Day 4 and Day 7
NCT02074358 (28) [back to overview]Mean Change From Baseline in Respiration Rate on Day 4 and Day 7
NCT02090075 (2) [back to overview]Coronary Plaque on CT Angiography
NCT02090075 (2) [back to overview]Coronary Artery Calcium (CAC) Score
NCT02100228 (11) [back to overview]Duration of Hospital Stay of Participants
NCT02100228 (11) [back to overview]Number of Participants Who Used Image Guidance Approach
NCT02100228 (11) [back to overview]Number of Participants With Acute Stroke Event
NCT02100228 (11) [back to overview]Number of Participants With All Cause Death
NCT02100228 (11) [back to overview]Number of Participants With Clinically Relevant Non-Major Bleeding Events
NCT02100228 (11) [back to overview]Number of Participants With Major Bleeding Event
NCT02100228 (11) [back to overview]Number of Participants With Systemic Embolism Event
NCT02100228 (11) [back to overview]Time to First Attempt of Cardioversion
NCT02100228 (11) [back to overview]Number of Cardioversion Attempt of Participants
NCT02100228 (11) [back to overview]Number of Participants With Their Rhythm Status
NCT02100228 (11) [back to overview]Number of Participants With Different Type of Cardioversion Events
NCT02101112 (7) [back to overview]Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
NCT02101112 (7) [back to overview]Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
NCT02101112 (7) [back to overview]Relative Bioavailability (Frel) of Apixaban
NCT02101112 (7) [back to overview]Terminal Plasma Half-life (T-HALF) of Apixaban
NCT02101112 (7) [back to overview]Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
NCT02101112 (7) [back to overview]Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion
NCT02101112 (7) [back to overview]Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban
NCT02179177 (3) [back to overview]Number of Hospitalizations During Treatment
NCT02179177 (3) [back to overview]Change in Pain as Measured by Visual Analog Scale (VAS)
NCT02179177 (3) [back to overview]Daily Pain Scores While Hospitalized as Measured by VAS
NCT02283294 (2) [back to overview]Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA
NCT02283294 (2) [back to overview]Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT
NCT02366871 (6) [back to overview]Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events
NCT02366871 (6) [back to overview]Number of Participants With Incidence of Major Bleeding
NCT02366871 (6) [back to overview]Change in Quality of Life From Baseline to 28 Days Post-op
NCT02366871 (6) [back to overview]Number of Participants With a Patient Satisfaction Assessment
NCT02366871 (6) [back to overview]Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
NCT02366871 (6) [back to overview]Number of Participants Who Met Medication Adherence Rates
NCT02369653 (22) [back to overview]The Number of Participants With Non-fatal Pulmonary Embolism (PE)
NCT02369653 (22) [back to overview]The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
NCT02369653 (22) [back to overview]The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
NCT02369653 (22) [back to overview]The Number of Participants With Minor Bleeding Events
NCT02369653 (22) [back to overview]The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
NCT02369653 (22) [back to overview]The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
NCT02369653 (22) [back to overview]The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
NCT02369653 (22) [back to overview]The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
NCT02369653 (22) [back to overview]The Number of Participants With an Arterial Thromboembolic Event
NCT02369653 (22) [back to overview]The Number of Participants With a CVAD-Related Infection
NCT02369653 (22) [back to overview]The Number of Participants Needing Catheter Replacements During the Study
NCT02369653 (22) [back to overview]The Number of Participant Deaths
NCT02369653 (22) [back to overview]Maximum Observed Concentration (Cmax)
NCT02369653 (22) [back to overview]The Number of Participants With Adjudicated Major Bleeding
NCT02369653 (22) [back to overview]Area Under the Concentration-Time Curve [AUC(TAU)]
NCT02369653 (22) [back to overview]Anti-FXa Activity
NCT02369653 (22) [back to overview]Anti-FXa Activity
NCT02369653 (22) [back to overview]Trough Observed Concentration (Cmin)
NCT02369653 (22) [back to overview]The Number Participants Experiencing Superficial Vein Thrombosis Events
NCT02369653 (22) [back to overview]The Number of Platelet Transfusions Needed During the Study
NCT02369653 (22) [back to overview]The Number of Participants With Venous Thromboembolism (VTE)-Related-death
NCT02369653 (22) [back to overview]The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
NCT02406885 (3) [back to overview]Change in Pharmacokinetics as Assessed by Cmax (Max Concentration)
NCT02406885 (3) [back to overview]Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC)
NCT02406885 (3) [back to overview]Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity)
NCT02415400 (7) [back to overview]The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA
NCT02415400 (7) [back to overview]Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA
NCT02415400 (7) [back to overview]The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period
NCT02415400 (7) [back to overview]The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin
NCT02415400 (7) [back to overview]The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA
NCT02415400 (7) [back to overview]The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin
NCT02415400 (7) [back to overview]The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period
NCT02585713 (3) [back to overview]6 Month Bleeding Rate
NCT02585713 (3) [back to overview]Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
NCT02585713 (3) [back to overview]Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
NCT02608099 (16) [back to overview]Number of Patients With Cardiovascular Death
NCT02608099 (16) [back to overview]Number of Patients With Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Cardiovascular Death
NCT02608099 (16) [back to overview]Number of Patients With TIAs or Non-Hemorrhagic Strokes
NCT02608099 (16) [back to overview]Number of Patients With TIAs or Non-Hemorrhagic Strokes
NCT02608099 (16) [back to overview]Number of Patients With Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Major Bleeding
NCT02608099 (16) [back to overview]Number of Patients With Major Bleeding
NCT02608099 (16) [back to overview]Number of Patients With Death
NCT02608099 (16) [back to overview]Number of Patients With Death
NCT02608099 (16) [back to overview]Number of Patients With Composite of Major Bleeding and Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Composite of Major Bleeding and Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
NCT02608099 (16) [back to overview]Number of Patients With Clinically-Significant Bleeding
NCT02608099 (16) [back to overview]Number of Patients With Clinically-Significant Bleeding
NCT02701062 (8) [back to overview]Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
NCT02701062 (8) [back to overview]Number of Perioperative Complications Associated With AtriClip Placement
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
NCT02701062 (8) [back to overview]Number of Subjects With Intraoperative Successful Exclusion of LAA.
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
NCT02744092 (11) [back to overview]Cumulative Rates of Major Bleeding
NCT02744092 (11) [back to overview]Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02829957 (9) [back to overview]Number of Participants With Major Hemorrhage
NCT02829957 (9) [back to overview]Number of Participants With Venous Thromboembolism (VTE)
NCT02829957 (9) [back to overview]Number of Patients That Held Drug for Menorrhagia
NCT02829957 (9) [back to overview]PBAC Scores
NCT02829957 (9) [back to overview]Number of Participants Who Crossed Over to Another Anticoagulant
NCT02829957 (9) [back to overview]Number of Participants Who Discontinued Planned Drug Administration
NCT02829957 (9) [back to overview]Hemoglobin Concentration
NCT02829957 (9) [back to overview]Number of Participants With Clinically Relevant Non-major Bleeding
NCT02829957 (9) [back to overview]Physical Component Summary of Standard From 36
NCT02889562 (5) [back to overview]Total Post-operative Length of Stay
NCT02889562 (5) [back to overview]Units of Blood Given After Initiation of Anticoagulation Medication
NCT02889562 (5) [back to overview]Time in Therapeutic Range of INR, if on Warfarin
NCT02889562 (5) [back to overview]Number of Participants With Thromboembolytic Events
NCT02889562 (5) [back to overview]Number of Participants With Strokes
NCT02942407 (10) [back to overview]Number of Participants Experiencing Systemic Embolism
NCT02942407 (10) [back to overview]Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality
NCT02942407 (10) [back to overview]Number of Participants Experiencing Stroke or Systemic Embolism
NCT02942407 (10) [back to overview]Number of Participants Experiencing Stroke
NCT02942407 (10) [back to overview]Number of Participants Experiencing Mortality
NCT02942407 (10) [back to overview]Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
NCT02942407 (10) [back to overview]Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
NCT02942407 (10) [back to overview]Apixaban Plasma Concentration, Cmin
NCT02942407 (10) [back to overview]Apixaban Plasma Concentration, Cmax
NCT02942407 (10) [back to overview]Persistence of Therapy
NCT02958969 (4) [back to overview]Frequency of Major and Clinically Relevant Non-major Bleeding
NCT02958969 (4) [back to overview]Frequency of Symptomatic Venous Thromboembolism
NCT02958969 (4) [back to overview]Frequency of All-cause Mortality
NCT02958969 (4) [back to overview]Frequency of Atherothrombotic Events
NCT02981472 (15) [back to overview]The Number of Participants With Adjudicated Major Bleeding
NCT02981472 (15) [back to overview]The Number of Participants With Adjudicated CRNM Bleeding
NCT02981472 (15) [back to overview]The Number of Participant Deaths in the Study
NCT02981472 (15) [back to overview]Maximum Observed Concentration (Cmax)
NCT02981472 (15) [back to overview]Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
NCT02981472 (15) [back to overview]Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
NCT02981472 (15) [back to overview]Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
NCT02981472 (15) [back to overview]The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
NCT02981472 (15) [back to overview]The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
NCT02981472 (15) [back to overview]Chromogenic FX Assay (Apparent FX Level)
NCT02981472 (15) [back to overview]Anti-FXa Activity
NCT02981472 (15) [back to overview]Trough Observed Concentration (Cmin)
NCT02981472 (15) [back to overview]Time of Maximum Observed Concentration (Tmax)
NCT02981472 (15) [back to overview]The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
NCT02981472 (15) [back to overview]The Number of Participants With All Adjudicated Bleeding
NCT02982590 (4) [back to overview]Change of Left Ventricular Thrombosis (LVT) by More Than 50%
NCT02982590 (4) [back to overview]Clinically Definite Cardiac Embolic Ischemic Stroke
NCT02982590 (4) [back to overview]Life Threatening Bleeding
NCT02982590 (4) [back to overview]Percent Change in Left Ventricular Thrombus (LVT) Size
NCT03026556 (13) [back to overview]Overall Major Bleeding
NCT03026556 (13) [back to overview]Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
NCT03026556 (13) [back to overview]TIA
NCT03026556 (13) [back to overview]Upper GI Bleeding
NCT03026556 (13) [back to overview]Major Intracranial Bleeding
NCT03026556 (13) [back to overview]Major GI Bleeding
NCT03026556 (13) [back to overview]Major Extracranial Bleeding
NCT03026556 (13) [back to overview]Lower GI Bleeding
NCT03026556 (13) [back to overview]Ischemic Stroke
NCT03026556 (13) [back to overview]Hemorrhagic Stroke
NCT03026556 (13) [back to overview]All-cause Mortality
NCT03026556 (13) [back to overview]Major Urogenital Bleeding
NCT03026556 (13) [back to overview]Major Other Bleeding
NCT03080883 (3) [back to overview]Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm
NCT03080883 (3) [back to overview]CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
NCT03080883 (3) [back to overview]Proportion of Patients Who Experienced at Least One Bleeding Event
NCT03196349 (7) [back to overview]Number of Subjects With Recurrent Venous Thromboembolism (VTE)
NCT03196349 (7) [back to overview]Number of Subjects With Clinically Relevant Bleeding Events
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Major Bleeding
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Clinically Relevant Non-major Bleeding
NCT03196349 (7) [back to overview]Number of Subjects With Premature Termination of Study Medication
NCT03196349 (7) [back to overview]Number of Subjects Experiencing All-cause Mortality
NCT03251482 (13) [back to overview]Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Death (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Major Bleeding Event (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Distal DVT (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Proximal and Distal DVT (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
NCT03251482 (13) [back to overview]Number of Participants With Major VTE (CEC-adjudicated)
NCT03254147 (2) [back to overview]The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
NCT03254147 (2) [back to overview]The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
NCT03310021 (6) [back to overview]Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.
NCT03310021 (6) [back to overview]Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.
NCT03441633 (10) [back to overview]Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
NCT03441633 (10) [back to overview]Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NCT03441633 (10) [back to overview]International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03441633 (10) [back to overview]Number of Participants by Comedications
NCT03441633 (10) [back to overview]Number of Participants by Comorbidity
NCT03441633 (10) [back to overview]Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
NCT03441633 (10) [back to overview]Risk of Bleeding Events: HAS-BLED Score
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHA2DS2Vasc Score
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHADS2 Score
NCT03441633 (10) [back to overview]Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03509883 (16) [back to overview]AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
NCT03509883 (16) [back to overview]T-Half - Terminal Plasma Half Life.
NCT03509883 (16) [back to overview]AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
NCT03509883 (16) [back to overview]Number of Participants With Out-of Range Vital Signs: Blood Pressure
NCT03509883 (16) [back to overview]Tmax - Time of Maximum Observed Plasma Concentration
NCT03509883 (16) [back to overview]Number of Participants With Out-of Range ECG Evaluations
NCT03509883 (16) [back to overview]Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
NCT03509883 (16) [back to overview]Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
NCT03509883 (16) [back to overview]Number of Participants With a Given Clinical Laboratory Abnormality
NCT03509883 (16) [back to overview]Physical Measurement - Height
NCT03509883 (16) [back to overview]Frel - Relative Bioavailability
NCT03509883 (16) [back to overview]Physical Measurement - Weight
NCT03509883 (16) [back to overview]Physical Measurement - Body Mass Index (BMI)
NCT03509883 (16) [back to overview]Number of Participants With Out-of Range Vital Signs: Temperature
NCT03509883 (16) [back to overview]Number of Participants With Out-of Range Vital Signs: Respiration Rate
NCT03509883 (16) [back to overview]Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03594045 (8) [back to overview]Time to Platelet Recovery
NCT03594045 (8) [back to overview]Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban
NCT03594045 (8) [back to overview]Cumulative Incidence of Major Bleeding
NCT03594045 (8) [back to overview]Cumulative Incidence of Limb Amputation
NCT03594045 (8) [back to overview]Cumulative Incidence of All Cause Mortality
NCT03594045 (8) [back to overview]Composite Cumulative Incidence of New TEC and Major Bleeding
NCT03594045 (8) [back to overview]Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC
NCT03594045 (8) [back to overview]Cumulative Incidence of New Thromboembolic Complications (TEC)
NCT04218266 (5) [back to overview]Number of Participants With ISTH Major Bleeding
NCT04218266 (5) [back to overview]Number of Participants With ISTH Minor Bleeding
NCT04218266 (5) [back to overview]Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding
NCT04218266 (5) [back to overview]Number of Participants With All Bleeding
NCT04218266 (5) [back to overview]Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding
NCT04498273 (1) [back to overview]Hospitalization for Cardiovascular/Pulmonary Events
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants
NCT04681482 (8) [back to overview]Time in Therapeutic Range (TTR) During Follow-up Period
NCT04681482 (8) [back to overview]Charlson Comorbidity Index (CCI)
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants
NCT04681482 (8) [back to overview]Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants
NCT05022563 (60) [back to overview]Number of Participants Who Switched to Another Anticoagulant Therapy
NCT05022563 (60) [back to overview]Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Interruption in Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Overall Index Anticoagulant Treatment Duration
NCT05022563 (60) [back to overview]Time to Treatment Discontinuation
NCT05022563 (60) [back to overview]Time to Treatment Interruption
NCT05022563 (60) [back to overview]Time to Treatment Switch
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months

Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses

Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B. (NCT00313300)
Timeframe: first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study

Interventionpercentage of participants (Number)
Placebo10.5
Apixaban 2.5mg BID20.6
Apixaban 10mg QD22.5

[back to top]

Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B

Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007

Interventionpercentage of participants (Number)
Placebo0.8
Apixaban 2.5mg BID5.0
Apixaban 10mg QD5.6
Apixaban 10mg BID7.8
Apixaban 20 mg QD7.3

[back to top]

Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses

Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups. (NCT00313300)
Timeframe: From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study

Interventionpercentage of participants (Number)
Placebo3.0
Apixaban 2.5mg BID5.7
Apixaban 10mg QD7.9

[back to top]

Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B

Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure. (NCT00313300)
Timeframe: Day of randomization and ends on high dose termination date, 1-Oct-2007

Interventionparticipants (Number)
Placebo16
Apixaban 2.5mg BID6
Apixaban 10mg QD4
Apixaban 10mg BID8
Apixaban 20 mg QD7

[back to top]

Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B

Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007

Interventionpercentage of participants (Number)
Placebo0.0
Apixaban 2.5mg BID0.8
Apixaban 10mg QD0.0
Apixaban 10mg BID2.9
Apixaban 20 mg QD4.1

[back to top]

Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses

Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). (NCT00313300)
Timeframe: from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study

Interventionpercentage of participants (Number)
Placebo0.8
Apixaban 2.5mg BID1.6
Apixaban 10mg QD1.9

[back to top]

Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants

Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B (NCT00313300)
Timeframe: Day of randomization to 182 days after day of randomization (183 days)

Interventionparticipants (Number)
Placebo54
Apixaban 2.5mg BID24
Apixaban 10mg QD20

[back to top]

Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B

Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure. (NCT00313300)
Timeframe: Day of randomization up to high dose termination, 1-Oct-2007

Interventionparticipants (Number)
Placebo16
Apixaban 2.5mg BID6
Apixaban 10mg QD4
Apixaban 10mg BID8
Apixaban 20 mg QD7

[back to top]

Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants

Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B. (NCT00313300)
Timeframe: Randomization to 182 days after randomization (183 days)

Interventionparticipants (Number)
Placebo53
Apixaban 2.5mg BID24
Apixaban 10mg QD19

[back to top]

Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B

Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group). (NCT00313300)
Timeframe: From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007

Interventionpercentage of participants (Number)
Placebo6.1
Apixaban 2.5mg BID15.1
Apixaban 10mg QD17.6
Apixaban 10mg BID24.2
Apixaban 20 mg QD23.9

[back to top]

Number of Participants With All-Cause Death

(NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo0
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding

"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:~A decrease in hemoglobin of 20 g/L or more or~Required transfusion of 2 or more units of packed red blood cells or whole blood, or~Occurred in a critical site~Contributed to death.~CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:~Skin hematoma~Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention~Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract~Any other bleeding type that was considered to have clinical consequences." (NCT00320255)
Timeframe: From first dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo1
Cohort 1: Apixaban, 5 mg1
Cohort 1: Apixaban, 10 mg1
Cohort 1: Apixaban, 20 mg4
Cohort 2: Placebo2
Cohort 2: Apixaban, 5 mg3

[back to top] [back to top]

Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death

"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo4
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg1
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top] [back to top]

Number of Participants With Deep Vein Thrombosis

"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo4
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg1
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Distal Deep Vein Thrombosis

"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo1
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Nonfatal Pulmonary Embolism

"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo1
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Proximal Deep Vein Thrombosis

"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo3
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death

"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 30 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo3
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixaban, 5 mg0

[back to top]

Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)

"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels." (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

InterventionParticipants (Number)
Cohort 1: Placebo1
Cohort 1: Apixaban, 5 mg0
Cohort 1: Apixaban, 10 mg0
Cohort 1: Apixaban, 20 mg0
Cohort 2: Placebo0
Cohort 2: Apixiban, 5 mg0

[back to top]

Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00320255)
Timeframe: First dose to 2 days following last dose of study drug

,,,,,
InterventionParticipants (Number)
DeathsSAEsBleeding AEsDiscontinuations due to AEs
Cohort 1: Apixaban, 10 mg03114
Cohort 1: Apixaban, 20 mg05124
Cohort 1: Apixaban, 5 mg16154
Cohort 1: Placebo2967
Cohort 2: Apixaban, 5 mg0020
Cohort 2: Placebo0111

[back to top]

Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID2.13
Enoxaparin 30 mg SC Injection q 12 Hours1.97

[back to top]

Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period

A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients. (NCT00371683)
Timeframe: Post last dose of study drug to Day 72 (60 days)

,
Interventionpercentage of participants (Number)
MI/StrokeMIStrokeThrombocytopenia
Apixaban 2.5mg BID0.060.060.000.00
Enoxaparin 30 mg SC Injection q 12 Hours0.060.060.000.00

[back to top]

Mean Change From Baseline in Heart Rate During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm). (NCT00371683)
Timeframe: Baseline to last dose of study drug, plus 2 days

,
Interventionbpm (Mean)
Heart Rate Day 1 (n=240,237)Heart Rate Day 2 (n=1575,1574)Heart Rate Day 3 (n=1490,1498)Heart Rate Day 4 (n=127,134)Heart Rate Day 12 (n=1495, 1462)
Apixaban 2.5mg BID2.34.64.57.6-0.3
Enoxaparin 30 mg SC Injection q 12 Hours2.74.55.09.4-0.1

[back to top]

Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg). (NCT00371683)
Timeframe: Baseline to last dose of study drug, plus 2 days

,
InterventionmmHg (Mean)
Diastolic BP Day 1 (n=240, 237)Diastolic BP Day 2 (n=1577, 1574)Diastolic BP Day 3 (n=1489,1498)Diastolic BP Day 4 (n=127,134)Diastolic BP Day 12 (n=1495,1463)Systolic BP Day 1 (n=240,237)Systolic BP Day 2 (n=1577,1574)Systolic BP Day 3 (n=1489,1498)Systolic BP Day 4 (n=127,134)Systolic BP Day 12 (n=1495,1463)
Apixaban 2.5mg BID-0.41.72.30.67.31.55.44.72.89.1
Enoxaparin 30 mg SC Injection q 12 Hours-0.91.52.10.37.5-0.74.24.31.48.9

[back to top]

Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period

Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days

,
Interventionparticipants (Number)
Calcium low (n=1569,1562)Calcium high (n=1569,1562)Chloride low (n=1568,1562)Chloride high (n=1568,1562)Bicarbonate low (n=1568,1561)Potassium low(n=1568,1559)Potassium high(n=1568,1559)Sodium low (n=1568,1562)Sodium high (n=1568,1562)
Apixaban 2.5mg BID10110115426232
Enoxaparin 30 mg SC Injection q 12 Hours51171135620390

[back to top] [back to top]

Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days

,
Interventionparticipants (Number)
Hemoglobin low (n=1561,1549)Hematocrit low (n=1558,1547)Platelet count low (n=1556,1543)Erythrocytes low (n=1557,1547)Leukocytes low(n=1583,1572)Leukocytes high(n=1583,1572)Basophils high (n=1577, 1564)Eosinophils high (n=1577, 1564)Lymphocytes low (n=1577,1564)Lymphocytes high (n=1577,1564)Monocytes high (n=1577,1564)Neutrophils low (n=1577,1564)
Apixaban 2.5mg BID38613561308214032125244
Enoxaparin 30 mg SC Injection q 12 Hours392157914911210213117445

[back to top] [back to top]

Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period

A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID2.05
Enoxaparin 30 mg SC Injection q 12 Hours1.64

[back to top]

Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period

ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From first dose to last dose, plus 2 days (12 days, plus 2)

,
Interventionpercentage of participants (Number)
MI/StrokeMIStrokeThrombocytopenia
Apixaban 2.5mg BID0.060.060.000.00
Enoxaparin 30 mg SC Injection q 12 Hours0.310.250.130.13

[back to top]

Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects

An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization. (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID8.99
Enoxaparin 30 mg SC Injection q 12 Hours8.85

[back to top]

Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days

,
Interventionparticipants (Number)
ALP high (n=1573,1563)ALT high (n=1573,1562)AST high (n=1573,1562)Bilirubin direct high (n=1563,1553)Bilirubin total high(n=1572,1562)Creatinine high (n=1569,1562)
Apixaban 2.5mg BID42332963217
Enoxaparin 30 mg SC Injection q 12 Hours55454054828

[back to top]

Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period

Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN. (NCT00371683)
Timeframe: First dose to last dose of study drug (12 days), plus 2 days

,
Interventionparticipants (Number)
Fasting Glucose low (n=611, 579)Fasting Glucose high (n=611, 579)Total Protein low (n=1568,1562)CK high (n=1573,1563)Uric Acid high (n=1567,1562)
Apixaban 2.5mg BID8545275222
Enoxaparin 30 mg SC Injection q 12 Hours5285134512

[back to top]

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00371683)
Timeframe: First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)

,
Interventionparticipants (Number)
SAEBleeding AEAEs leading to discontinuationDeaths
Apixaban 2.5mg BID123110603
Enoxaparin 30 mg SC Injection q 12 Hours123144585

[back to top]

Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period

ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72. (NCT00371683)
Timeframe: Last dose of study drug to Day 72 (60 days)

,
Interventionpercentage of participants (Number)
Major Bleeding (n=1563, 1553)CR N-M Bleeding (n=1563, 1553)Major or CR N-M Bleeding (n=1563, 1553)Any Bleeding (n=1563, 1553)
Apixaban 2.5mg BID0.130.260.380.90
Enoxaparin 30 mg SC Injection q 12 Hours0.130.450.581.29

[back to top]

Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population

ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days. (NCT00371683)
Timeframe: First dose of study drug to last dose, plus 2 days post last dose

,
Interventionpercentage of participants (Number)
Major Bleeding (n=1596, 1588)CR N-M Bleeding (n=1596, 1588)Major or CR N-M Bleeding(n=1596, 1588)Any Bleeding (n=1596, 1588)
Apixaban 2.5mg BID0.692.192.885.33
Enoxaparin 30 mg SC Injection q 12 Hours1.392.964.286.80

[back to top]

Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period

An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

,
Interventionpercentage of participants (Number)
PE (Fatal or Non-Fatal) (n=1599, 1596)Non-Fatal PE (n=1599, 1596)All DVT n=1142, 1122Symptomatic DVT (n=1599, 1596)Asymptomatic DVT (n=1139,1115)Symptomatic Proximal DVT (n=1599,1596)Symptomatic Distal DVT (n=1599,1596)
Apixaban 2.5mg BID1.000.887.790.197.550.130.06
Enoxaparin 30 mg SC Injection q 12 Hours0.440.448.200.447.620.190.38

[back to top]

Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period

ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

,
Interventionpercentage of participants (Number)
Proximal DVT (n=1254, 1207)Distal DVT (n=1146, 1133)Asymptomatic Proximal DVT (n=1252, 1204)Asymptomatic Distal DVT (n=1145, 1127)
Apixaban 2.5mg BID0.727.240.567.16
Enoxaparin 30 mg SC Injection q 12 Hours0.918.030.667.54

[back to top]

Event Rate for Participants With All-Cause Death During the Intended Treatment Period

Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID0.19
Enoxaparin 30 mg SC Injection q 12 Hours0.19

[back to top] [back to top]

Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID1.25
Enoxaparin 30 mg SC Injection q 12 Hours1.00

[back to top] [back to top] [back to top]

Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period

ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). (NCT00371683)
Timeframe: From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization

Interventionpercentage of participants (Number)
Apixaban 2.5mg BID9.90
Enoxaparin 30 mg SC Injection q 12 Hours10.60

[back to top]

Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period

ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionparticipants (Number)
Apixaban327
Warfarin462

[back to top]

Number of Participants With Events of All-Cause Death During the Intended Treatment Period

Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death). (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

Interventionparticipants (Number)
Apixaban603
Warfarin669

[back to top]

Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period

Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionparticipants (Number)
Apixaban613
Warfarin877

[back to top]

Number of Participants With Net-Clinical Benefit During Treatment Period

Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionparticipants (Number)
Apixaban459
Warfarin608

[back to top]

Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period

For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

Interventionparticipants (Number)
Apixaban229
Warfarin285

[back to top]

Rate of Adjudicated All-Cause Death During the Intended Treatment Period

All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death). (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

InterventionNumber of events per 100 patient years (Number)
Apixaban3.52
Warfarin3.94

[back to top]

Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period

Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

InterventionNumber of events per 100 patient years (Number)
Apixaban2.13
Warfarin3.09

[back to top]

Rate of All Bleeding Events During Treatment Period

"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death." (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionnumber of events per 100 patient years (Number)
Apixaban18.08
Warfarin25.82

[back to top]

Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period

Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

,
InterventionNumber of events per 100 patient years (Number)
Ischemic or Unspecified Stroke (n=162, 175)Hemorrhagic Stroke (n=40, 78)Systemic Embolism (n=15, 17)Myocardial Infarction (n=90, 102)
Apixaban0.970.240.090.53
Warfarin1.050.470.100.61

[back to top]

Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period

Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

InterventionNumber of events per 100 patient years (Number)
Apixaban1.27
Warfarin1.60

[back to top]

Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period

(NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

InterventionNumber of events per 100 patient years (Number)
Apixaban3.21
Warfarin4.06

[back to top]

Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period

Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionnumber of events / 100 patient years (Number)
Apixaban4.07
Warfarin6.01

[back to top]

Rate of Net-Clinical Benefit During Treatment Period

Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

InterventionNumber of events per 100 patient years (Number)
Apixaban3.01
Warfarin4.09

[back to top]

Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period

AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

,
Interventionparticipants (Number)
AESAEBleeding AEDiscontinuations due to AEDeaths
Apixaban740631822288688429
Warfarin752133022961758468

[back to top]

Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period

All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. (NCT00412984)
Timeframe: "Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."

,
Interventionparticipants (Number)
Ischemic or Unspecified StrokeHemorrhagic StrokeSystemic Embolism
Apixaban1593815
Warfarin1737616

[back to top]

Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period

Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

,
InterventionNumber of events per 100 patient years (Number)
Severe (n=80, 172))Severe or Moderate (n=199, 328)
Apixaban0.521.29
Warfarin1.132.18

[back to top]

Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period

Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

,
InterventionNumber of events per 100 patient years (Number)
Major (n=148, 256)Major or Minor (n=239, 370)
Apixaban0.961.55
Warfarin1.692.46

[back to top]

Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period

Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5. (NCT00412984)
Timeframe: "Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."

,
InterventionNumber of events per 100 patient years (Number)
Stroke / SE / Major Bleeding (n=521, 666)Stroke / SE / All-Cause Death (ACD) (n=752, 837)Stroke / SE / Major Bleeding / ACD (n=1009, 1168)Stroke / SE / MI / ACD (n=810, 906)Ischemic or Unspecified Stroke / ACD (n=725, 796)Hemorrhagic Stroke / ACD (n=622, 703)SE / ACD (n=613, 679)MI / ACD (n=663, 740)
Apixaban3.174.496.134.854.323.683.633.93
Warfarin4.115.047.205.494.784.204.054.43

[back to top]

Number of Participants With All Bleeding Events During Treatment Period

All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death. (NCT00412984)
Timeframe: "Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."

Interventionparticipants (Number)
Apixaban2356
Warfarin3060

[back to top] [back to top]

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx ULN if preRx >ULN use > 1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or 1.25*ULN, or if preRx ULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx ULN if preRx >ULN use >1.05 *preRx or < LLN. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

,
InterventionParticipants (Number)
Alkaline phosphatase, high (n=2631, 2618)Alanine aminotransferase, high (n=2629, 2616)Aspartate aminotransferase, high (n=2629, 2616)Bilirubin, direct, high (n=2622, 2604)Bilirubin, total, high (n=2630, 2617)Blood urea nitrogen (BUN), high (n=2618, 2598)Creatinine, high (n=2618, 2598)Calcium, total, low (n=2618, 2598)Calcium, total, high (n=2618, 2598)Chloride, serum, low (n=2615, 2594)Bicarbonate, low (n=2615, 2595)Potassium, serum, low (n=2614, 2594)Potassium, serum, high (n=2614, 2594)Sodium, serum, low (n=2615, 2594)Sodium, serum, high (n=2615, 2594)
Apixaban, 2.5 mg BID Plus Placebo55507314524192170687361295
Enoxaparin, 40 mg QD Plus Placebo578373139121725181687347234

[back to top] [back to top] [back to top] [back to top] [back to top]

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or 400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0; (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

,
InterventionParticipants (Number)
Hemoglobin, low (n=2605, 2587)Hematocrit, low (n=2554, 2536)Platelet count, low (n=2597, 2576)Erythrocytes, low (n=2558, 2540)Leukocytes, low (n=2632, 2617)Leukocytes, high (n=2632, 2617)Basophils (absolute), high (n=2629, 2613)Eosinophils (absolute), high (n=2629, 2613)Lymphocytes (absolute), low (n=2629, 2613)Lymphocytes (absolute), high (n=2629, 2613)Monocytes (absolute), high (n=2629, 2613)Neutrophils (absolute), low (n=2629, 2613)
Apixaban, 2.5 mg BID Plus Placebo218912746131054385175383395
Enoxaparin, 40 mg QD Plus Placebo2218135091377543603703823114

[back to top]

Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)

preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx ULN if preRx >ULN use >2*preRx or 5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

,
InterventionParticipants (Number)
Glucose, fasting serum, high (n=14, 17)Protein, total, low (n=2618, 2596)Protein, total, high (n=2618, 2596)Creatine kinase, high (n=2630, 2616)Uric acid, high (n=2618, 2597)Blood, urine, high (n=2588, 2568)Glucose, urine, high (n=2588, 2568)Leukocyte esterase, urine, high (n=21, 41)Protein, urine (n=2588, 2568)Red blood cells (RBC), urine, high (n=1310, 1230)White blood cells (WBC),urine, high (n=1311, 1228)
Apixaban, 2.5 mg BID Plus Placebo074736152275680169216217
Enoxaparin, 40 mg QD Plus Placebo175216423234764168173229

[back to top]

Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period

Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

,
InterventionParticipants (Number)
ParaesthesiaHypoaesthesiaBurning sensationPeroneal nerve palsyHypotoniaDysarthriaParesisCervicobrachial syndromeCoordination abnormalHypertoniaNeuropathy peripheralPeripheral nerve lesionRadiculitisParalysisMuscular weaknessNerve injuryFemoral nerve injurySciatic nerve injuryPeroneal nerve injuryDiplopiaGait disturbance
Apixaban, 2.5 mg BID Plus Placebo32297543211111107211011
Enoxaparin, 40 mg QD Plus Placebo193556411101210111100100

[back to top]

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period

Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 2 days after the last dose of study drug

,
InterventionPercentage of events/patients evaluted (Number)
Major bleedingCRNMMajor or CRNMAny bleeding
Apixaban, 2.5 mg BID Plus Placebo0.824.084.8311.71
Enoxaparin, 40 mg QD Plus Placebo0.684.515.0412.56

[back to top] [back to top]

Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period

Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3. (NCT00423319)
Timeframe: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose

,
InterventionPercent of events/patients evaluated (Number)
MI/strokeMIStrokeThrombocytopenia
Apixaban, 2.5 mg BID Plus Placebo0.220.190.040.07
Enoxaparin, 40 mg QD Plus Placebo0.260.110.150.11

[back to top] [back to top]

Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. (NCT00423319)
Timeframe: First dose of study drug (presurgery) through 30 days after the last dose of study drug

,
InterventionParticipants (Number)
SAEsBleeding AEsDeath
Apixaban, 2.5 mg BID Plus Placebo18152
Enoxaparin, 40 mg QD Plus Placebo18210

[back to top]

Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx ULN if preRx >ULN use >1.2*preRx or 400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

,
InterventionParticipants (Number)
Hemoglobin, low (n=1424, 1442)Hematocrit, low n=(1369, 1396)Platelet count, low (n=1413, 1425)Erythrocytes, low (n=1368, 1396)Leukocytes, low (n=1457, 1471)Leukocytes, high (n=1457, 1471)Basophils (absolute), high (n=1448, 1465)Eosinophils (absolute), high (n=1448, 1465)Lymphocytes (absolute), low (n=1448, 1465)Lymphocytes (absolute), high (n=1448, 1465)Monocytes (absolute), high (n=1448, 1465)Neutrophils (absolute), low (n=1448, 1465)Alkaline phosphatase (ALP), high (n=1465, 1476)Alanine aminotransferase (ALT), high (n=1459,1472)Aspartate aminotransferase (AST) , high (n=1459,14Bilirubin, direct (high) (n=1447,1457)Bilirubin, total (high) (n=1461,1476)Blood urea nitrogen (BUN) (high)(n=1447,1458)Creatinine (high) (n=1447,1458)
Apixaban, 2.5 mg BID + Placebo112766876902719324320315515323487151517
Enoxaparin, 40 mg QD + Placebo11787235735262134602150223126267691723

[back to top]

Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)

preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up

,
InterventionParticipants (Number)
Blood, urine (high) (n=1421, 1430)Glucose, urine (high) (n=1421, 1429)Protein, urine (high) (n=1421, 1430)Red blood cells, urine (high) (n=441, 385)White blood cells, urine (high)(n=441, 386)
Apixaban, 2.5 mg BID + Placebo16916060133101
Enoxaparin, 40 mg QD + Placebo11315489116102

[back to top]

Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRxULN if preRx >ULN use >1.25*preRx or 1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRxULN if preRx>ULN use >1.1*preRx or 1.05*ULN, or if preRx ULN if preRx>ULN use >1.05*preRx or 1.1*ULN, or if preRx ULN if preRx >ULN use 1.1*preRx or 5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx ULN. (NCT00452530)
Timeframe: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up

,
InterventionParticipants (Number)
Calcium, total (low) (n=1447, 1457)Chloride, serum (low)(n=1442, 1454)Bicarbonate (low) (n=1435, 1447)Potassium, serum (low) (n=1438, 1453)Potassium, serum (high)(n=1438, 1453)Sodium, serum (low) (n=1442, 1454)Sodium, serum (high) (n=1442, 1454)Glucose, fasting serum (low) (n=715, 713)Glucose, fasting serum (high) (n=715, 713)Protein, total (low) (n=1447, 1457Creatine kinase (CK) (high) (n=1463, 1476)Uric acid (high) (n=1446, 1458)
Apixaban, 2.5 mg BID + Placebo510383451846223661
Enoxaparin, 40 mg QD + Placebo9034140100125243652

[back to top]

Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs. (NCT00452530)
Timeframe: Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug

,
InterventionParticipants (Number)
SAEBleeding AEDiscontinuations due to AEsDeaths
Apixaban, 2.5 mg BID + Placebo7290402
Enoxaparin, 40 mg QD + Placebo88112440

[back to top] [back to top] [back to top]

Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM

Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. (NCT00452530)
Timeframe: Days 1 to 12

,
InterventionPercentage of events/patients evaluated (Number)
Major bleeding (n=9, 14)CRNM (n=44, 58)Major bleeding or CRNM (n=53, 72)Any bleeding
Apixaban, 2.5 mg BID + Placebo0.602.933.536.93
Enoxaparin, 40 mg QD + Placebo0.933.854.778.36

[back to top] [back to top]

Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

InterventionEvent Rate (%): (Number)
Apixaban 2.5 mg2.26
Enoxaparin 40 mg1.90

[back to top]

Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg7.16
Enoxaparin 40 mg6.83

[back to top]

Incidence of All Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of drug to last dose of drug plus 2 days

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg7.73
Enoxaparin 40 mg6.81

[back to top] [back to top]

Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period

Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg6.44
Enoxaparin 40 mg6.63

[back to top]

Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period

A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg2.36
Enoxaparin 40 mg2.12

[back to top]

Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.22
Enoxaparin 40 mg0.24

[back to top]

Incidence of Adjudicated PE With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.22
Enoxaparin 40 mg0.24

[back to top]

Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg2.40
Enoxaparin 40 mg2.50

[back to top]

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg6.44
Enoxaparin 40 mg6.50

[back to top] [back to top]

Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period

Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.00
Enoxaparin 40 mg0.15

[back to top]

Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.15
Enoxaparin 40 mg0.49

[back to top]

Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants

Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
Interventionparticipants (Number)
Glucose Fasting <0.9*LLN (N=284,287)Glucose Fasting > 1.5*ULN (N=284,287)Total Protein < 0.9 *LLN (N=2864, 2890)Total Protein > 1.1*ULN (N=2864, 2890)Creatine kinase >5*ULN U/L(N=2856, 2888)Uric acid > 1.5* ULN (N=2862, 2889)
Apixaban 2.5 mg5397816847
Enoxaparin 40 mg3305181044

[back to top] [back to top] [back to top] [back to top]

Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg3.11
Enoxaparin 40 mg3.46

[back to top]

Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.15
Enoxaparin 40 mg0.37

[back to top]

Incidence of Major Bleeding During the Treatment Period in Treated Participants

Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg0.47
Enoxaparin 40 mg0.19

[back to top]

Mean Change From Baseline in Heart Rate in Treated Participants

Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
Interventionbpm (Mean)
Hospital Discharge (N=1606,1622)Day 30 of treatment (N=2225,2299)
Apixaban 2.5 mg-5.4-4.0
Enoxaparin 40 mg-5.1-4.3

[back to top]

Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days

InterventionEvent Rate (%) (Number)
Apixaban 2.5 mg2.67
Enoxaparin 40 mg2.08

[back to top]

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants

Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths. (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)

,
Interventionparticipants (Number)
AEsSAEsBleeding AEsDiscontinuations Due to AEDeaths
Apixaban 2.5 mg1871611244290131
Enoxaparin 40 mg1910601221262133

[back to top]

Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements

Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)

,
Interventionparticipants (Number)
Neurologic AEsNeurologic SAEsLiver-related AEsLiver-related SAEs
Apixaban 2.5 mg4551279
Enoxaparin 40 mg42114212

[back to top] [back to top]

Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants

Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
Interventionparticipants (Number)
Calcium < 0.8*LLN (N=2861, 2893)Calcium > 1.2*ULN (N=2861, 2893)Chloride < 0.9*LLN (N=2861, 2886)Chloride > 1.1*ULN (N=2861, 2886)Bicarbonate < 0.75*LLN (N=2831, 2855)Bicarbonate > 1.25*ULN (N=2831, 2855)Potassium < 0.9*LLN (N=2851, 2878)Potassium > 1.1*ULN (N=2851, 2878)Sodium < 0.95*LLN (N=2862, 2888)Sodium > 1.05*ULN (N=2862, 2888)
Apixaban 2.5 mg632555661140239
Enoxaparin 40 mg832516458137256

[back to top]

Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants

Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
InterventionEvent Rate (%) (Number)
MI or stoke (N=3183, 3216)MI (N=3184, 3217)Stroke (N=3183, 3216)Thrombocytopenia (N=3184, 3217)
Apixaban 2.5 mg0.380.220.160.19
Enoxaparin 40 mg0.370.120.250.09

[back to top]

Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period

Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
InterventionmmHg (Mean)
Day of Discharge from Hospital (N=1607, 1625)Day 30 of Treatment + 2 (N=2227,2301)
Apixaban 2.5 mg-1.00.0
Enoxaparin 40 mg-0.4-0.5

[back to top]

Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants

Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
Interventionparticipants (Number)
Hemoglobin >2 g/dL decrease (N=2835, 2871)Hematocrit <0.75*PreRx (N=2688, 2722)Platelet Count < 100*10^9 c/L (N=2761, 2799)Erythrocytes <0.75*PreRx c/µL (N=2697, 2730)Leukocytes <0.75*LLN (N= 2835, 2869)Leukocytes > 1.25*ULN (N=2835, 2869)Abs Eosinophils > 0.75*10^3 c/µL (N=20, 24)Abs Lymphocytes < 0.750*10*3 c/ µL (N=20, 24)Abs Monocytes > 2000/MM^3 (N= 19, 25)
Apixaban 2.5 mg1332392864331141
Enoxaparin 40 mg981771655283120

[back to top]

Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants

Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
Interventionparticipants (Number)
Alkaline phosphatase U/L > 2*ULN(N=2866, 2895)ALT U/L > 3*ULN (N=2827, 2861)AST U/L > 3*ULN (N=2831, 2863)Bilirubin Direct mg/dL > 1.5*ULN (N=2782, 2821)Bilirubin Total mg/dL > 2*ULN (N=2853, 2884)BUN mg/dL > 1.5*ULN (N=2864, 2891)Creatinine mg/dL > 1.5*ULN (N=2862, 2892)
Apixaban 2.5 mg35232412317194150
Enoxaparin 40 mg47332910615188156

[back to top]

Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period

Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days

,
InterventionmmHg (Mean)
Discharge from Hospital (N=1607, 1625)Day 30 of Treatment + 2 (N=2227, 2301)
Apixaban 2.5 mg-3.0-2.3
Enoxaparin 40 mg-2.4-2.9

[back to top]

Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period

Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010

,
InterventionPercentage of events per year (Number)
Major bleedingMajor or CRNM bleedingAll bleeding
Acetylsalicylic Acid, 81-324 mg Once Daily0.923.248.32
Apixaban, 2.5 or 5 mg Twice Daily1.414.4610.85

[back to top]

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

,
InterventionParticipants (Number)
AEsSAEsBleeding AEsDiscontinuations due to AEDeaths
Acetylsalicylic Acid, 81-324 mg Once Daily1925804259362115
Apixaban, 2.5 or 5 mg Twice Daily183365728126691

[back to top]

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BLULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BLULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BLULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

,
InterventionParticipants (Number)
Creatine kinase, low (n=2780, 2758)Creatine kinase, high (n=2780, 2758)Protein (total), low (n=103, 109)Protein (total), high (n=103, 109)Uric acid, low (n=386, 390)Uric acid, high (n=386, 390)Glucose (urine), low (n=2, 3)Glucose (urine), high (n=2, 3)Protein (urine), low (n=3, 5)Protein (urine), high (n=3, 5)Blood (urine), low (n=3, 5)Blood (urine), high (n=3, 5)Leukocyte esterase (urine), low (n=3,5)Leukocyte esterase (urine), high (n=3,5)Red blood cells (RBC) (urine), low (n=2,2)RBC (urine), high (n=2,2)White blood cells (urine), low (n=2,2)WBC (urine), high (n=2,2)
Acetylsalicylic Acid, 81-324 mg Once Daily0250000010100000000
Apixaban, 2.5 or 5 mg Twice Daily0130001000101000100

[back to top]

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BLULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BLULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BLULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BLULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BLULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

,
InterventionParticipants (Number)
Sodium (serum), low (n=1768, 1740)Sodium (serum), high (n=1768, 1740)Potassium (serum), low (n=1763, 1737)Potassium (serum), high (n=1763, 1737)Chloride (serum), low (n=1768, 1740)Chloride (serum), high (n=1768, 1740)Calcium (total), low (n=106, 109)Calcium (total), high (n=106, 109)Bicarbonate, low (n=1664, 1619)Bicarbonate, high (n=1664, 1619)
Acetylsalicylic Acid, 81-324 mg Once Daily62828310000
Apixaban, 2.5 or 5 mg Twice Daily21620000000

[back to top]

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality

BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BLULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN. (NCT00496769)
Timeframe: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

,
InterventionParticipants (Number)
Hemoglobin, low (n=1956, 1893)Hemoglobin, high (n=1956, 1893)Hematocrit, low (n=1728, 1687)Hematocrit, high (n=1728, 1687)Erythrocytes, low (n=1728, 1687)Erythrocytes, high (n=1728, 1687)Platelet count, low (n=2148, 2098)Platelet count, high (n=2148, 2098)Leukocytes, low (n=1738, 1698)Leukocytes, high (n=1738, 1698)Neutrophils (absolute), low (n=2170, 2138)Neutrophils (absolute), high (n=2170, 2138)Eosinophils (absolute), low (n=2170, 2138)Eosinophils (absolute), high (n=2170, 2138)Basophils (absolute), low (n=2170, 2138)Basophils (absolute), high (n=2170, 2138)Monocytes (absolute), low (n=2170, 2138)Monocytes (absolute), high (n=2170, 2138)Lymphocytes (absolute), low (n=2170, 2138)Lymphocytes (absolute), high (n=2170, 2138)Alkaline phosphatase (ALP), low (n=2781, 2758)ALP, high (n=2781, 2758)Aspartate phosphatase (AST), low (n=2779, 2753)AST, high (n=2779, 2753)Alanine aminotransferase (ALT), low (n=2779, 2753)ALT, high (n=2779, 2753)Bilirubin (total), low (n=2781, 2758)Bilirubin (total), high (n=2781, 2758)Bilirubin (direct), low (n=2773, 2750)Bilirubin (direct), high (n=2773, 2750)Blood urea nitrogen (BUN), low (n=2201, 2172)BUN, high (n=2201, 2172)Creatinine, low (n=2209, 2178)Creatinine, high (n=2209, 2178)
Acetylsalicylic Acid, 81-324 mg Once Daily12009012010014181006800026250270330310430248050071
Apixaban, 2.5 or 5 mg Twice Daily13101301207012142004800005240340280230300241042067

[back to top]

Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death

Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

,
InterventionPercentage of events per year (Number)
All-cause death (n=111, 140)Net clinical benefit (n=163, 220)Vascular death (n=84, 96)
Acetylsalicylic Acid, 81-324 mg Once Daily4.427.133.03
Apixaban, 2.5 or 5 mg Twice Daily3.515.232.65

[back to top]

Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

InterventionPercentage of events per year (Number)
Apixaban, 2.5 or 5 mg Twice Daily10.85
Acetylsalicylic Acid, 81-324 mg Once Daily8.32

[back to top]

Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.) (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

InterventionPercentage of events (Number)
Apixaban, 2.5 or 5 mg Twice Daily1.62
Acetylsalicylic Acid, 81-324 mg Once Daily3.63

[back to top]

Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm. (NCT00496769)
Timeframe: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

InterventionPercentage of events per year (Number)
Apixaban, 2.5 or 5 mg Twice Daily4.21
Acetylsalicylic Acid, 81-324 mg Once Daily6.35

[back to top] [back to top]

Adjudicated Total Bleeding During the Treatment Period - Treated Participants

All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.1119
Apixaban 5 mg0.1492
Placebo0.0896

[back to top]

Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation

PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0095
Apixaban 5 mg0.0049
Placebo0.0181

[back to top]

Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation

PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0274
Apixaban 5 mg0.0308
Placebo0.0446

[back to top]

Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation

DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0262
Apixaban 5 mg0.0308
Placebo0.0398

[back to top]

Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation

DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0083
Apixaban 5 mg0.0049
Placebo0.0169

[back to top] [back to top]

Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation

DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0226
Apixaban 5 mg0.0344
Placebo0.0869

[back to top]

Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants

All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0893
Apixaban 5 mg0.1208
Placebo0.0702

[back to top]

Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants

Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0298
Apixaban 5 mg0.0419
Placebo0.0230

[back to top]

Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants

Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 Months

Interventionproportion of participants (Number)
Apixaban 2.5 mg0.0321
Apixaban 5 mg0.0432
Placebo0.0266

[back to top] [back to top]

Adjudicated Major Bleeding During the Treatment Period - Treated Population

Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0024
Apixaban 5 mg0.0012
Placebo0.0048

[back to top] [back to top] [back to top] [back to top]

Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation

VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event. (NCT00633893)
Timeframe: Day 1 up to 12 Months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0381
Apixaban 5 mg0.0418
Placebo0.1158

[back to top]

Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation

All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months

,,
Interventionparticipants (Number)
First event: Participants with nonfatal DVTFirst event: Participants with nonfatal PEFirst event: All-Cause DeathCV-related Death (included in all-cause total)VTE-related Death (included in all-cause total)Participants with event: nonfatal DVTParticipants with event: nonfatal PEParticipants with event: All cause death
Apixaban 2.5 mg67602687
Apixaban 5 mg74303844
Placebo53131137531514

[back to top] [back to top] [back to top]

Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation

DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted. (NCT00633893)
Timeframe: Day 1 up to 12 Months

Interventionproportion of participants (Number)
Apixaban 2.5 mg0.0071
Apixaban 5 mg0.0098
Placebo0.0639

[back to top]

Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation

VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. (NCT00633893)
Timeframe: Day 1 up to 12 months

InterventionProportion of participants (Number)
Apixaban 2.5 mg0.0226
Apixaban 5 mg0.0172
Placebo0.0929

[back to top] [back to top]

Incidence of All-Cause Death During the Intended Treatment Period

Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information). (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0157
Enoxaparin + Warfarin0.0198

[back to top]

Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0385
Enoxaparin + Warfarin0.0800

[back to top]

Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.1502
Enoxaparin + Warfarin0.2514

[back to top]

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants

Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00643201)
Timeframe: First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued

,
Interventionparticipants (Number)
AESAEBleeding AE or SAEDiscontinued Due to AE or SAEDeath
Apixaban179541741516237
Enoxaparin + Warfarin192341069519944

[back to top] [back to top] [back to top]

Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests

All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

,
Interventionparticipants (Number)
Blood in Urine High (N=2289, 2273)Glucose in Urine High (N=2289, 2273)Leukocyte Esterase in Urine High (N=2289, 2273)Protein in Urine High (N=2289, 2273)RBC + WBC in Urine High (N=1685, 1719)RBC in Urine High (N=1293, 1389)WBC in Urine High (N=1354, 1361)
Apixaban854610541359111274
Enoxaparin + Warfarin1273110250361140263

[back to top]

Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests

Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

,
Interventionparticipants (Number)
BUN High (N=517, 523)Creatinine High (N=2601, 2596)ALT High (N=2601, 2598)ALP High (N=2601, 2598)AST High (N=2601, 2598)Direct Bilirubin High (N=2601, 2593)Total Bilirubin High (N=2601, 2597)
Apixaban247523540288
Enoxaparin + Warfarin7371452740217

[back to top]

Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests

Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

,
Interventionparticipants (Number)
Erthrocytes Low (N=2599, 2593)Hematocrit Low (N=2588, 2587)Hemoglobin Low (N=2599, 2593)Platelet Count Low (N=2594, 2589)Leukocytes Low (N=2528, 2519)Leukocytes High (N=2528, 2519)Absolute Basophils High (N=2594,2589)Absolute Eosinophils High (N=2594,2589)Absolute Lyphocytes Low (N=2594,2589)Absolute Lyphocytes High (N=2594,2589)Absolute Monocytes High (N=2594,2589)Absolute Neutrophils Low (N=2594,2589)
Apixaban23269623412618494419
Enoxaparin + Warfarin1720101134115279763220

[back to top]

Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests

Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

,
Interventionparticipants (Number)
Bicarbonate Low (N=2600,2593)Bicarbonate High (N=2600,2593)Total Calcium Low (N=2601,2596)Total Calcium High (N=2601,2596)Chloride Low Total Calcium Low (N=2601,2596)Chloride Low Total Calcium High (N=2601,2596)Potassium Low (N=2601,2596)Potassium High (N=2601,2596)Sodium Low (N=2601,2596)
Apixaban4417312502619104
Enoxaparin + Warfarin3111101131222264

[back to top]

Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests

Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

,
Interventionparticipants (Number)
Creatine Kinase High (N=2601, 2596)Uric Acid High (N=2601, 2596)Total Protein Low (N=2601, 2596)Total Protein High (N=2601, 2596)
Apixaban206150
Enoxaparin + Warfarin243160

[back to top]

Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death

VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded. (NCT00643201)
Timeframe: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0322
Enoxaparin + Warfarin0.0395

[back to top] [back to top] [back to top] [back to top]

Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants

All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0056
Enoxaparin + Warfarin0.0182

[back to top]

Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants

Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug). (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0430
Enoxaparin + Warfarin0.0971

[back to top]

Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants

Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received. (NCT00643201)
Timeframe: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.1170
Enoxaparin + Warfarin0.1878

[back to top]

Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period

DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). (NCT00643201)
Timeframe: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0084
Enoxaparin + Warfarin0.0133

[back to top]

Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period

PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). (NCT00643201)
Timeframe: Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)

Interventionproportion of participants (Number)
Apixaban0.0104
Enoxaparin + Warfarin0.0095

[back to top]

Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban

Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

,
InterventionInternational normalized ratio (Mean)
Week 0 (n=72, 71)0 hour post dose at Week 1 (n=67, 70)2 hours post dose at Week 1 (n=68, 70)4 hours post dose at Week 1 (n=38, 35)0 hour post dose at Week 8 (n=67, 66)2 hours post dose at Week 8 (n=67, 66)4 hours post dose at Week 8 (n=35, 29)
Apixaban 2.5mg BID1.761.301.331.301.271.371.34
Apixaban 5.0 mg BID1.721.341.481.511.381.611.59

[back to top]

Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period

Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event. (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin1
Apixaban 2.5mg BID0
Apixaban 5.0 mg BID0

[back to top]

Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period

Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin3
Apixaban 2.5mg BID1
Apixaban 5.0 mg BID1

[back to top]

Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban

Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated. (NCT00787150)
Timeframe: Week 0, Week 1, Week 8

,,
Interventionpmol/L (Mean)
Week 0 (n=75, 72, 71)Week 1 (n=75, 68, 70)Week 8 (n=68, 67, 66)
Apixaban 2.5mg BID0133.8152.9
Apixaban 5.0 mg BID91.4137.0121.1
Warfarin144.0100.40

[back to top]

Number of Participants With Total Bleeding Events During the Treatment Period

Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding. (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin13
Apixaban 2.5mg BID9
Apixaban 5.0 mg BID17

[back to top]

Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban

Sample at 4 hours postdose was to be taken if possible. (NCT00787150)
Timeframe: 0, 2, 4 hours postdose at Week 1 and Week 8

,
Interventionng/mL (Mean)
0 hour post dose at Week 1 (n=68, 70)2 hours post dose at Week 1 (n=68, 70)4 hours post dose at Week 1 (n=38, 35)0 hour post dose at Week 8 (n=67, 66)2 hours post dose at Week 8 (n=67, 66)4 hours post dose at Week 8 (n=35, 29)
Apixaban 2.5mg BID53.3199.43104.0962.83120.16110.58
Apixaban 5.0 mg BID119.34201.80224.40137.79250.53244.55

[back to top]

Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period

"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin3
Apixaban 2.5mg BID0
Apixaban 5.0 mg BID0

[back to top]

Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban

Below the limit of quantification (BLQ) was assigned the value 0 for calculation. (NCT00787150)
Timeframe: Week 0, Week 1, Week 8

,,
Interventionng/mL (Mean)
Week 0 (n=75, 72, 71)Week 1 (n=75, 68, 70)Week 8 (n=68, 67, 66)
Apixaban 2.5mg BID297.8209.9227.0
Apixaban 5.0 mg BID196.4237.0203.5
Warfarin240.4245.2209.9

[back to top]

Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban

Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

,
Interventionng/mL (Mean)
Week 0 (n=72, 71)0 hour post dose at Week 1 (n=68, 69)2 hours post dose at Week 1 (n=68, 70)4 hours post dose at Week 1 (n=38, 35)0 hour post dose at Week 8 (n=67, 65)2 hours post dose at Week 8 (n=67, 66)4 hours post dose at Week 8 (n=35, 29)
Apixaban 2.5mg BID045.2994.9099.0756.81114.97103.61
Apixaban 5.0 mg BID0111.19187.58213.24130.12236.36237.78

[back to top]

Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban

Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

,
InterventionSecond (Mean)
Week 0 (n=72, 71)0 hour post dose at Week 1 (n=67, 70)2 hours post dose at Week 1 (n=68, 70)4 hours oist dose at Week 1 (n=38, 35)0 hour post dose at Week 8 (n=67, 66)2 hours post dose at Week 8 (n=67, 66)4 hours post dose at Week 8 (n=35, 29)
Apixaban 2.5mg BID34.5133.2633.0432.0033.8334.6732.75
Apixaban 5.0 mg BID32.9833.2435.1935.3635.6537.9236.46

[back to top]

Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period

"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin3
Apixaban 2.5mg BID0
Apixaban 5.0 mg BID0

[back to top]

Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period

"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day." (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin0
Apixaban 2.5mg BID0
Apixaban 5.0 mg BID0

[back to top]

Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period

Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00787150)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
Warfarin4
Apixaban 2.5mg BID1
Apixaban 5.0 mg BID1

[back to top]

Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban

Sample at 4 hours postdose was to be taken if possible. (NCT00787150)
Timeframe: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

,
Interventionsecond (Mean)
Week 0 (n=72, 71)0 hour post dose at Week 1 (n=67, 70)2 hours post dose at Week 1 (n=68, 70)4 hours post dose at Week 1 (n=38, 35)0 hour post dose at Week 8 (n=67, 66)2 hours post dose at Week 8 (n=67, 66)4 hours post dose at Week 8 (n=35, 29)
Apixaban 2.5mg BID14.5412.2212.4612.3612.0912.6812.47
Apixaban 5.0 mg BID14.4112.5413.2813.4812.7413.8313.85

[back to top]

Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants

Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo13.96
Apixaban 5 mg BID13.20

[back to top]

Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants

Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo16.33
Apixaban 5 mg BID39.98

[back to top]

Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants

Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). (NCT00831441)
Timeframe: Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo4.21
Apixaban 5 mg BID3.95

[back to top]

Event Rate of Stroke During the Intended Treatment Period - Randomized Participants

Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo1.85
Apixaban 5 mg BID1.65

[back to top]

Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants

Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination. (NCT00831441)
Timeframe: Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo2.21
Apixaban 5 mg BID1.61

[back to top]

Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants

MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice. (NCT00831441)
Timeframe: Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo9.20
Apixaban 5 mg BID8.59

[back to top]

Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants

TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo0.91
Apixaban 5 mg BID2.40

[back to top]

Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants

ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo2.04
Apixaban 5 mg BID5.13

[back to top]

Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants

ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days. (NCT00831441)
Timeframe: From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo2.29
Apixaban 5 mg BID6.15

[back to top]

Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants

Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo17.95
Apixaban 5 mg BID16.92

[back to top]

Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants

Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). (NCT00831441)
Timeframe: Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo14.27
Apixaban 5 mg BID13.97

[back to top]

Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants

"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.~CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)." (NCT00831441)
Timeframe: Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years

Interventionpercentage of participants/100-pt years (Number)
Placebo15.65
Apixaban 5 mg BID15.48

[back to top]

Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.

TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). (NCT00852397)
Timeframe: Week 0 to Week 24

InterventionPercentage of Participants (Number)
Placebo0
Apixaban 2.5 mg BID2.0
Apixaban 5.0 mg BID2.0

[back to top]

Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.

"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.~ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding." (NCT00852397)
Timeframe: Week 0 to Week 24

,,
InterventionPercentage of Participants (Number)
ISTH defined CRNMISTH defined minor bleeding
Apixaban 2.5 mg BID2.036.7
Apixaban 5.0 mg BID040.8
Placebo2.031.4

[back to top]

Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.

(NCT00852397)
Timeframe: For 30 days after Week 24 or the discontinuation of study drug

InterventionPercentage of Participants (Number)
Placebo0
Apixaban 2.5 mg BID0
Apixaban 5.0 mg BID2

[back to top]

Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.

Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. (NCT00852397)
Timeframe: Week 0 to Week 24

InterventionPercentage of Participants (Number)
Placebo2.0
Apixaban 2.5 mg BID4.1
Apixaban 5.0 mg BID4.1

[back to top]

Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.

Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. (NCT00852397)
Timeframe: Week 0 to Week 24

InterventionPercentage of Participants (Number)
Placebo0
Apixaban 2.5 mg BID2.0
Apixaban 5.0 mg BID4.1

[back to top]

Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.

All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions. (NCT00852397)
Timeframe: Week 0 to Week 24

InterventionPercentage of Participants (Number)
Placebo33.3
Apixaban 2.5 mg BID38.8
Apixaban 5.0 mg BID44.9

[back to top]

Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.

"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).~TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding." (NCT00852397)
Timeframe: Week 0 to Week 24

,,
InterventionPercentage of Participants (Number)
TIMI defined minor bleedingTIMI defined minimal bleeding
Apixaban 2.5 mg BID2.038.8
Apixaban 5.0 mg BID2.040.8
Placebo033.3

[back to top]

Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.

Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]). (NCT00852397)
Timeframe: From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])

InterventionPercentage of Participants (Number)
Placebo1.9
Apixaban 2.5 mg BID0
Apixaban 5.0 mg BID2.0

[back to top]

Mean Renal Clearance (CLR) of BMS-730823

Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

InterventionmL/min (Geometric Mean)
Normal Renal Function6.36
ESRD Dose Before HemodialysisNA
ESRD Dose After HemodialysisNA

[back to top]

Mean Plasma Terminal Half-life (T-Half) of BMS-730823

Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data. (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

Interventionhours (Mean)
ESRD Maintained With HemodialysisNA

[back to top]

Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823

The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

Interventionng*h/mL (Mean)
Normal Renal FunctionNA
ESRD Dose Before HemodialysisNA
ESRD Dose After HemodialysisNA

[back to top]

Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban

The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Normal Renal Function1265
ESRD Dose Before Hemodialysis1474
ESRD Dose After Hemodialysis1717

[back to top]

Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Normal Renal Function205
ESRD Dose Before Hemodialysis746
ESRD Dose After Hemodialysis953

[back to top]

Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban

Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionhours (Median)
Normal Renal Function2.00
ESRD Dose Before Hemodialysis2.00
ESRD Dose After Hemodialysis2.00

[back to top]

Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Normal Renal Function1205
ESRD Dose Before Hemodialysis1430
ESRD Dose After Hemodialysis1673

[back to top]

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823

Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionng/mL (Geometric Mean)
Normal Renal Function10.8
ESRD Dose Before Hemodialysis15.9
ESRD Dose After Hemodialysis20.0

[back to top]

Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823

Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionhours (Median)
Normal Renal Function9.00
ESRD Dose Before Hemodialysis15.00
ESRD Dose After Hemodialysis21.00

[back to top]

Percentage of Apixaban Extracted During Hemodialysis

The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage. (NCT01340586)
Timeframe: 2 to 6 hours post-dose

Interventionpercentage of apixaban extracted (Mean)
ESRD Maintained With Hemodialysis-1.1

[back to top]

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban

Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

Interventionng/mL (Geometric Mean)
Normal Renal Function125.6
ESRD Dose Before Hemodialysis98.9
ESRD Dose After Hemodialysis113.6

[back to top]

Percentage of BMS-730823 Extracted During Hemodialysis

The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage. (NCT01340586)
Timeframe: 2 to 6 hours post-dose

Interventionpercentage of BMS-730823 extracted (Mean)
ESRD Maintained With Hemodialysis-19.9

[back to top]

Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban

Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer. (NCT01340586)
Timeframe: 2 to 6 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Blood entering dialyzerBlood exiting dialyzer
ESRD Maintained With Hemodialysis309312

[back to top]

Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823

Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer. (NCT01340586)
Timeframe: 2 to 6 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Blood entering dialyzerBlood exiting dialyzer
ESRD Maintained With Hemodialysis15.017.7

[back to top]

Mean Hemodialysis Clearance (CLD) of Apixaban

Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 2 to 6 hours post-dose

InterventionmL/min (Geometric Mean)
ESRD Maintained With Hemodialysis17.7

[back to top]

Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation

"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.~AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling." (NCT01340586)
Timeframe: From Day 1 to 30 days post study discontinuation

,
Interventionparticipants (Number)
DeathsSAEsAEs leading to discontinuation
ESRD Maintained With Hemodialysis000
Normal Renal Function000

[back to top]

Number of Participants With Laboratory Marked Abnormalities

"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-RxULN).~Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)." (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

,
Interventionparticipants (Number)
BUNPlatelet countCreatinePotassiumPhosphorusLactate dehydrogenase
ESRD Maintained With Hemodialysis411111
Normal Renal Function000000

[back to top]

Mean Hemodialysis Clearance (CLD) of BMS-730823

Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 2 to 6 hours post-dose

InterventionmL/min (Mean)
ESRD Maintained With HemodialysisNA

[back to top]

Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban

The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionmaximum percent change from baseline (Mean)
Normal Renal Function19.9
ESRD Dose Before Hemodialysis7.0
ESRD Dose After Hemodialysis23.0

[back to top]

Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban

The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionmaximum percent change from baseline (Mean)
Normal Renal Function31.5
ESRD Dose Before Hemodialysis16.6
ESRD Dose After Hemodialysis16.8

[back to top]

Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban

The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionmaximum percent change from baseline (Mean)
Normal Renal Function32.4
ESRD Dose Before Hemodialysis16.9
ESRD Dose After Hemodialysis17.4

[back to top]

Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban

Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL). (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

InterventionIU/mL (Mean)
Normal Renal Function1.47
ESRD Dose Before Hemodialysis1.03
ESRD Dose After Hemodialysis1.29

[back to top]

Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)

Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1. (NCT01340586)
Timeframe: 2 to 6 hours post-dose

Interventionpercent of dose recovered in dialysate (Mean)
ESRD Maintained With Hemodialysis6.68

[back to top]

Mean Percent Dose of Apixaban Recovered in Urine (%UR)

The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered. (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

Interventionpercent of dose recovered in urine (Mean)
Normal Renal Function18.397
ESRD Dose Before Hemodialysis0.145
ESRD Dose After Hemodialysis0.181

[back to top]

Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban

Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours. (NCT01340586)
Timeframe: From 24 hours pre-dose to 72 hours post-dose

Interventionhours (Mean)
Normal Renal Function20.0
ESRD Dose Before Hemodialysis12.5
ESRD Dose After Hemodialysis12.7

[back to top]

Mean Renal Clearance (CLR) of Apixaban

Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min). (NCT01340586)
Timeframe: 24 hours pre-dose to 72 hours post-dose

InterventionmL/min (Geometric Mean)
Normal Renal Function11.263
ESRD Dose Before Hemodialysis0.020
ESRD Dose After Hemodialysis0.020

[back to top]

Bleeding Incidence

To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation. (NCT01706146)
Timeframe: up to 12 months

Interventionparticipants (Number)
Non-Coumadin Oral Anticoagulant3

[back to top]

Number of Days on Anticoagulation

Assess subject anticoagulant utilization and number of days on anticoagulation (NCT01706146)
Timeframe: up to 12 months

Interventiondays (Mean)
Non-Coumadin Oral Anticoagulant24.9

[back to top]

Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration

Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

Intervention% change in unbound apixaban concentrat. (Mean)
Module 1 Placebo-5
Module 1 ( 90 mg)-51
Module 1 (210 mg)-54
Module 1 (420 mg)-72
Module 1 (420 mg Bolus + 180 mg Infusion)-79
Module 1 (420 mg Bolus + 180 mg Bolus)-89
Module 1 (420 mg Bolus + 480 mg Infusion)-84

[back to top]

Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionng*hr/mL (Mean)
Module 1 PlaceboNA
Module 1 ( 90 mg)23400
Module 1 (210 mg)49200
Module 1 (420 mg)93500
Module 1 (420 mg Bolus + 180 mg Infusion)131000
Module 1 (420 mg Bolus + 180 mg Bolus)155000
Module 1 (420 mg Bolus + 480 mg Infusion)213000

[back to top]

Andexanet Apparent Terminal Elimination Half-life (t1/2)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionhr (Mean)
Module 1 PlaceboNA
Module 1 ( 90 mg)5.51
Module 1 (210 mg)5.12
Module 1 (420 mg)5.02
Module 1 (420 mg Bolus + 180 mg Infusion)4.35
Module 1 (420 mg Bolus + 180 mg Bolus)5.79
Module 1 (420 mg Bolus + 480 mg Infusion)6.45

[back to top]

Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration

Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay. (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

InterventionPercent change in thrombin generation (Mean)
Module 1 Placebo28.11
Module 1 ( 90 mg)76.58
Module 1 (210 mg)137.50
Module 1 (420 mg)120.95
Module 1 (420 mg Bolus + 180 mg Infusion)222.56
Module 1 (420 mg Bolus + 180 mg Bolus)196.29
Module 1 (420 mg Bolus + 480 mg Infusion)191.77

[back to top]

Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration

Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma) (NCT01758432)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

InterventionPercent change in anti-fXa activity (Mean)
Module 1 Placebo-7.06
Module 1 ( 90 mg)-67.79
Module 1 (210 mg)-78.51
Module 1 (420 mg)-95.04
Module 1 (420 mg Bolus + 180 mg Infusion)-94.03
Module 1 (420 mg Bolus + 180 mg Bolus)-93.07
Module 1 (420 mg Bolus + 480 mg Infusion)-92.82

[back to top]

Andexanet Time of Maximum Observed Plasma Concentration (Tmax)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionhr (Median)
Module 1 PlaceboNA
Module 1 ( 90 mg)0.07
Module 1 (210 mg)0.15
Module 1 (420 mg)0.27
Module 1 (420 mg Bolus + 180 mg Infusion)0.43
Module 1 (420 mg Bolus + 180 mg Bolus)0.27
Module 1 (420 mg Bolus + 480 mg Infusion)0.28

[back to top]

Andexanet Maximum Observed Plasma Concentration (Cmax)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionng/mL (Mean)
Module 1 PlaceboNA
Module 1 ( 90 mg)21200
Module 1 (210 mg)42800
Module 1 (420 mg)81400
Module 1 (420 mg Bolus + 180 mg Infusion)93300
Module 1 (420 mg Bolus + 180 mg Bolus)88000
Module 1 (420 mg Bolus + 480 mg Infusion)90800

[back to top]

Andexanet Total Systemic Clearance (CL)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

InterventionL (Mean)
Module 1 PlaceboNA
Module 1 ( 90 mg)3.93
Module 1 (210 mg)4.29
Module 1 (420 mg)4.60
Module 1 (420 mg Bolus + 180 mg Infusion)4.70
Module 1 (420 mg Bolus + 180 mg Bolus)NA
Module 1 (420 mg Bolus + 480 mg Infusion)4.30

[back to top]

Andexanet Total Volume of Distribution (Vss)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach. (NCT01758432)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

InterventionL (Mean)
Module 1 PlaceboNA
Module 1 ( 90 mg)6.97
Module 1 (210 mg)6.18
Module 1 (420 mg)6.26
Module 1 (420 mg Bolus + 180 mg Infusion)5.11
Module 1 (420 mg Bolus + 180 mg Bolus)NA
Module 1 (420 mg Bolus + 480 mg Infusion)4.01

[back to top]

Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods

All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis [ISTH] Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. (NCT01780987)
Timeframe: Baseline to Week 24

Interventionparticipants (Number)
Apixaban7
Unfractionated Heparin (UFH)/Warfarin17

[back to top] [back to top]

Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period

Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. (NCT01780987)
Timeframe: Baseline to Week 24

Interventionparticipants (Number)
Apixaban0
Unfractionated Heparin (UFH)/Warfarin2

[back to top]

Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period

Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. (NCT01780987)
Timeframe: Baseline to Week 24

Interventionparticipants (Number)
Apixaban3
Unfractionated Heparin (UFH)/Warfarin11

[back to top]

Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)

Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24

,
Interventionparticipants (Number)
CUS - Week 2 (n=22, n=22)CTV - Week 12 (n=20, n=21)CUS - Week 12 (n=21, n=22)CUS - Week 24 (n=20, n=22)
Apixaban1000
Unfractionated Heparin (UFH)/Warfarin2001

[back to top]

Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)

Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24

,
Interventionparticipants (Number)
CTPA - Week 2 (n=18, n=17)CTPA - Week 12 (n=18, n=16)CTPA - Week 24 (n=16, n=15)
Apixaban000
Unfractionated Heparin (UFH)/Warfarin001

[back to top]

Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days

VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism. (NCT01884337)
Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

InterventionParticipants (Count of Participants)
Total Knee Replacement (TKR)1
Total Hip Replacement (THR)1

[back to top]

Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days

"TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that~1) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis" (NCT01884337)
Timeframe: 2 weeks + 2 days for TKR, 5 weeks + 2 days for THR

,
InterventionParticipants (Count of Participants)
Major BleedingClinically Relevant Non-Major BleedingMajor or Clinically Relevant Non-Major BleedingAny Bleeding
Total Hip Replacement (THR)0111
Total Knee Replacement (TKR)0000

[back to top]

Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks

Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value <= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value <= 0.2). Odds ratios are presented for predictors of non-adherence. (NCT01884350)
Timeframe: Week 24

,
InterventionOdds ratio (Number)
<=2 Alcoholic Drink/Day Average vs None>=3 Alcoholic Drink/Day Average vs NoneMini-mental state examination scoreHigher mgmt., adm. and professional jobs vs UKSOC1Higher professional occupations vs UKSOC1Intermediate occupations vs UKSOC1Large employers and mgmt. and adm. jobs vs UKSOC1Lower mgmt., adm. and professional jobs vs UKSOC1Lower supervisory and tech. occupations vs UKSOC1Never worked and long-term unemployed vs UKSOC1Routine occupations vs UKSOC1Semi-routine occupations vs UKSOC1Paroxysmal vs Persistant Atrial FibrillationPermanent vs Persistant Atrial FibrillationVKA Naïve vs Non-Naïve
Apixaban (Additional Educational Program)0.9943.782NANANANANANANANANANA1.9111.8461.686
Apixaban (Primary SOC Information)1.2514.2680.8080.8270.8981.2302.8230.9483.5871.2890.5080.4501.6262.560NA

[back to top]

Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen

The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days. (NCT01884350)
Timeframe: Day 1 up to week 24

Interventionpercentage of days (Mean)
Apixaban (Primary SOC Information)91.64
Apixaban (Additional Educational Program)91.88

[back to top]

Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period

The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days. (NCT01884350)
Timeframe: Week 24 to Week 48

Interventionpercentage (Mean)
Apixaban (Primary SOC Information)87.59
Apixaban (Additional Educational Program)88.41
Apixaban (Secondary SOC)87.51

[back to top] [back to top] [back to top]

Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks

The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence *100 / total number of eligible days for the time period. (NCT01884350)
Timeframe: Day 1 to Week 12, Week 12 to Week 24

,
Interventionpercentage (Mean)
Day 1 to Week 12Week 12 to Week 24
Apixaban (Additional Educational Program)93.090.9
Apixaban (Primary SOC Information)93.790.3

[back to top]

PTS Assessment Completion

Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant17

[back to top]

Number of Participants With Post-thrombotic Syndrome

The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

[back to top]

Number of Participants With Recurrent Thrombosis

Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

[back to top]

Biomarker Sample Collection

Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year

Interventionparticipants (Number)
Low-molecular-weight Heparin or Direct Oral Anticoagulant7

[back to top]

Number of Participants With Major Bleeding

Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant1

[back to top]

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban Tablet2668.310
Treatment B: Apixaban Oral Solution2784.366

[back to top] [back to top]

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban

Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban Tablet2712.477
Treatment B: Apixaban Oral Solution2848.968

[back to top]

Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban

Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL) (NCT02034565)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention

Interventionng/mL (Geometric Mean)
Treatment A: Apixaban Tablet293.994
Treatment B: Apixaban Oral Solution287.164

[back to top]

Number of Participants With Marked Laboratory Abnormalities

Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events. (NCT02034565)
Timeframe: Pre-study screen (Day -1) to Day 8 or day of study discharge

,
Interventionparticipants (Number)
Leukocytes, LowAbsolute Neutrophils + Bands, LowWBC, Urine, High
Arm A: Apixaban Tablet110
Arm B: Apixaban Oral Solution111

[back to top]

Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings

12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge. (NCT02034578)
Timeframe: Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3

,,
Interventionparticipants (Number)
ECGVital SignsPhysical Examination
5 mg Apixaban Via NGT Followed by Infant Formula (C)000
5mg Apixaban Via NGT Followed by D5W (B)000
5mg Apixaban Via Oral Syringe (A)000

[back to top]

Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests

Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX. (NCT02034578)
Timeframe: Screening, Day -1, Day 4 of Periods, 1, 2, and 3

Interventionparticipants (Number)
Low LeukocytesHigh LymphocytesLow Neutrophils plus bandsHigh Creatine KinaseBlood in Urine
5mg Apixaban11511

[back to top]

Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban

Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3

Interventionng*h/mL (Geometric Mean)
5mg Apixaban Via Oral Syringe (A)1269.784
5mg Apixaban Via NGT Followed by D5W (B)1226.339
5 mg Apixaban Via NGT Followed by Infant Formula (C)1166.572

[back to top]

Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban

Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3

Interventionng/mL (Geometric Mean)
5mg Apixaban Via Oral Syringe (A)190.873
5mg Apixaban Via NGT Followed by D5W (B)181.862
5 mg Apixaban Via NGT Followed by Infant Formula (C)153.693

[back to top]

Mean Plasma Elimination Half-Life (T-HALF) of Apixaban

Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3

Interventionh (Mean)
5mg Apixaban Via Oral Syringe (A)10.5
5mg Apixaban Via NGT Followed by D5W (B)10.4
5 mg Apixaban Via NGT Followed by Infant Formula (C)10.6

[back to top]

Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban

Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h). (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3

Interventionh (Median)
5mg Apixaban Via Oral Syringe (A)0.517
5mg Apixaban Via NGT Followed by D5W (B)1.000
5 mg Apixaban Via NGT Followed by Infant Formula (C)1.00

[back to top]

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT02034578)
Timeframe: Day 1 to Day 12

,,
Interventionparticipants (Number)
Discontinuation Due to AESAEDeathAdverse Events
5 mg Apixaban Via NGT Followed by Infant Formula (C)0003
5mg Apixaban Via NGT Followed by D5W (B)0004
5mg Apixaban Via Oral Syringe (A)0002

[back to top]

Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban

Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL. (NCT02034578)
Timeframe: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3

Interventionng*h/mL (Geometric Mean)
5mg Apixaban Via Oral Syringe (A)1292.775
5mg Apixaban Via NGT Followed by D5W (B)1250.913
5 mg Apixaban Via NGT Followed by Infant Formula (C)1192.387

[back to top] [back to top]

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban

AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention

Interventionng*h/mL (Geometric Mean)
Treatment A1397.666
Treatment B1136.380

[back to top]

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban

AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention

Interventionng*h/mL (Geometric Mean)
Treatment A1397.666
Treatment C1327.248

[back to top]

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention

,
Interventionng*h/mL (Geometric Mean)
Treatment A1372.836
Treatment B1112.493
Treatment A1372.836
Treatment C1300.728

[back to top]

Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban

Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL) (NCT02034591)
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention

,
Interventionng/mL (Geometric Mean)
Treatment A179.116
Treatment B122.145
Treatment A179.116
Treatment C158.371

[back to top]

Number of Participants With Marked Laboratory Abnormalities

Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2 (NCT02034591)
Timeframe: Day 1 to 30 days after last dose of study drug

,,
Interventionparticipants (Number)
LeukocytesBasophilsEosinophilsBlood, UrineRBC, UrineWBC, Urine
Treatment A010100
Treatment B101122
Treatment C000011

[back to top]

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used. (NCT02074358)
Timeframe: Day 1 to 30 days Post Last Dose

,,
Interventionparticipants (Number)
Adverse EventsSAEsDiscontinuation due to AEsDeath
Treatment A: Apixaban + Placebo1000
Treatment B: Apixaban + Cofact (4-Factor PCC)5000
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2000

[back to top]

Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population

Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms. (NCT02074358)
Timeframe: Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)

,,
Interventionparticipants (Number)
Leukocytes High (n=15,15,15)ALT High (n=15,15,15)Bilirubin Direct High (n=4,4,4)Bilirubin Total High (n=15,15,15)Blood in Urine (n=15,15,15)Red Blood Cells in Urine (n=5,7,6)White Blood Cells in Urine (n=5,7,6)
Treatment A: Apixaban + Placebo0122110
Treatment B: Apixaban + Cofact (4-Factor PCC)1121102
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)0022200

[back to top]

Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF

Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms. (NCT02074358)
Timeframe: Day -1 first treatment period, Days 4 and 7 each treatment period

,,
Interventionparticipants (Number)
PR >200 msec (n=15,15,15)QRS > 120 msec (n=15,15,15)QT > 500 msec (n=15,15,15)QTcF > 450 msec (n=15,15,15)Change from Baseline >30 msec in QT (n=15,15,15)Change from Baseline >30 msec in QTcF (n=15,15,15)
Treatment A: Apixaban + Placebo000030
Treatment B: Apixaban + Cofact (4-Factor PCC)000020
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)000030

[back to top]

PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.

,,
Interventionfraction (Mean)
INR (Neoplastin CI+) (n=15,14,15)INR (Recombiplastin 2G) (n=15,14,15)
Treatment A: Apixaban + Placebo0.2900.460
Treatment B: Apixaban + Cofact (4-Factor PCC)0.1030.216
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)0.1300.281

[back to top]

PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

,,
Interventionfraction (Mean)
INR (Neoplastin CI+) (n=15, 14, 15)INR (Recombiplastin 2G) (n=15, 14, 15)
Treatment A: Apixaban + Placebo-0.0150.032
Treatment B: Apixaban + Cofact (4-Factor PCC)-0.213-0.207
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-0.185-0.144

[back to top]

PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

,,
Interventionseconds (Mean)
PT (Neoplastin CI+) (n=15, 14, 15)PT (Recombiplastin 2G) (n=15, 14, 15)aPTT (n=15, 14, 15)
Treatment A: Apixaban + Placebo-0.210.351.13
Treatment B: Apixaban + Cofact (4-Factor PCC)-1.85-2.249.60
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-1.68-1.543.43

[back to top]

PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.

,,
Interventionseconds (Mean)
PT (Neoplastin CI+) (n=15,14,15)PT (Recombiplastin 2G) (n=15,14,15)aPTT (n=15, 14, 15)
Treatment A: Apixaban + Placebo2.744.947.49
Treatment B: Apixaban + Cofact (4-Factor PCC)1.172.3015.87
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)1.313.019.68

[back to top]

PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.

,,
Interventionminutes (Mean)
TGA Lag Time (n=15,14,15)TGA Time to Peak (n=15,14,15)
Treatment A: Apixaban + Placebo3.566.42
Treatment B: Apixaban + Cofact (4-Factor PCC)3.367.90
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)3.4010.81

[back to top]

Mean Change From Baseline Temperature on Day 4 and Day 7

Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment

,,
InterventionC (Mean)
Temperature Day 4 (n=15,15,15)Temperature Day 7 (n=15,15,15)
Treatment A: Apixaban + Placebo-0.15-0.20
Treatment B: Apixaban + Cofact (4-Factor PCC)-0.14-0.08
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-0.22-0.17

[back to top]

PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period." (NCT02074358)
Timeframe: Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)

InterventionnM*minute (Mean)
Treatment A: Apixaban + Placebo-708.0
Treatment B: Apixaban + Cofact (4-Factor PCC)-276.3
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-607.7

[back to top]

Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. (NCT02074358)
Timeframe: Day 4

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban + Placebo1972
Treatment B: Apixaban + Cofact (4-Factor PCC)2049
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2014

[back to top]

Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. (NCT02074358)
Timeframe: Day 4

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban + Placebo2546
Treatment B: Apixaban + Cofact (4-Factor PCC)2594
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2592

[back to top]

Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL. (NCT02074358)
Timeframe: Day 4

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban + Placebo2537
Treatment B: Apixaban + Cofact (4-Factor PCC)2583
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2585

[back to top]

Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL) (NCT02074358)
Timeframe: Day 4

Interventionng*h/mL (Geometric Mean)
Treatment A: Apixaban + Placebo1965
Treatment B: Apixaban + Cofact (4-Factor PCC)2046
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2010

[back to top]

Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4

Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL). (NCT02074358)
Timeframe: Day 4

Interventionng/mL (Geometric Mean)
Treatment A: Apixaban + Placebo291
Treatment B: Apixaban + Cofact (4-Factor PCC)310
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)290

[back to top]

Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours. (NCT02074358)
Timeframe: Day 4

Interventionhours (Median)
Treatment A: Apixaban + Placebo2.00
Treatment B: Apixaban + Cofact (4-Factor PCC)2.00
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)2.00

[back to top]

Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL). (NCT02074358)
Timeframe: Day 4

Interventionng/mL (Geometric Mean)
Treatment A: Apixaban + Placebo86.0
Treatment B: Apixaban + Cofact (4-Factor PCC)93.7
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)95.5

[back to top]

Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4

Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours (NCT02074358)
Timeframe: Day 4

Interventionhours (Mean)
Treatment A: Apixaban + Placebo10.9
Treatment B: Apixaban + Cofact (4-Factor PCC)10.8
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)11.0

[back to top]

PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

InterventionU/mL (Mean)
Treatment A: Apixaban + Placebo-0.368
Treatment B: Apixaban + Cofact (4-Factor PCC)-0.607
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-0.538

[back to top]

PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.

InterventionnM (Mean)
Treatment A: Apixaban + Placebo-196.1
Treatment B: Apixaban + Cofact (4-Factor PCC)-174.9
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-202.7

[back to top]

PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM). (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

InterventionnM (Mean)
Treatment A: Apixaban + Placebo11.1
Treatment B: Apixaban + Cofact (4-Factor PCC)32.1
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)4.7

[back to top]

PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min. (NCT02074358)
Timeframe: Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.

InterventionnM/min (Mean)
Treatment A: Apixaban + Placebo-63.7
Treatment B: Apixaban + Cofact (4-Factor PCC)-63.6
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-71.5

[back to top]

PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes. (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

,,
Interventionminutes (Mean)
TGA Lag Time (n=15, 14, 15)TGA Time to Peak (n=15, 14, 15)
Treatment A: Apixaban + Placebo-0.16-1.29
Treatment B: Apixaban + Cofact (4-Factor PCC)-0.380.06
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-0.323.32

[back to top]

PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min). (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.

InterventionnM/min (Mean)
Treatment A: Apixaban + Placebo3.4
Treatment B: Apixaban + Cofact (4-Factor PCC)3.4
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-3.2

[back to top]

Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo

"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min)." (NCT02074358)
Timeframe: Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)

InterventionnM*min (Mean)
Treatment A: Apixaban + Placebo95.8
Treatment B: Apixaban + Cofact (4-Factor PCC)521.0
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)186.3

[back to top]

Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7

Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment

,,
InterventionmmHg (Mean)
Systolic BP Day 4 (n=15,15,15)Systolic BP Day 7 (n=15,15,15)Diastolic BP Day 4 (n=15,15,15)Diastolic BP Day 7 (n=15,15,15)
Treatment A: Apixaban + Placebo0.92.1-2.1-0.1
Treatment B: Apixaban + Cofact (4-Factor PCC)-2.13.7-3.30.0
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-2.91.3-3.1-0.1

[back to top]

Mean Change From Baseline in Heart Rate on Day 4 and Day 7

Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment

,,
Interventionbpm (Mean)
Heart Rate Day 4 (n=15,15,15)Heart Rate Day 7 (n=15,15,15)
Treatment A: Apixaban + Placebo-4.3-1.8
Treatment B: Apixaban + Cofact (4-Factor PCC)-4.90.4
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-5.5-2.1

[back to top]

Mean Change From Baseline in Respiration Rate on Day 4 and Day 7

Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose. (NCT02074358)
Timeframe: Screening, Day -1 first treatment period, Days 4 and 7 post treatment

,,
Interventionbreaths per minute (Mean)
Respirate Rate Day 4 (n=15,15,15)Respirate Rate Day 7 (n=15,15,15)
Treatment A: Apixaban + Placebo-0.7-0.4
Treatment B: Apixaban + Cofact (4-Factor PCC)-1.3-0.3
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)-1.4-0.5

[back to top]

Coronary Plaque on CT Angiography

To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation. The scale is based upon volume of plaque in the coronary arteries, with zero being no plaque and a higher number being more plaque. There is no scale or maximum measure, this is a linear measure of atherosclerosis volume in the coronary arteries and more is worse. None is best, any plaque is considered worse, and a higher plaque volume represents more atherosclerosis. An individual of average health will have a score of 50. (NCT02090075)
Timeframe: 1 year

Interventionunits on a scale (Mean)
Apixaban47
Warfarin54

[back to top]

Coronary Artery Calcium (CAC) Score

amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome. (NCT02090075)
Timeframe: 1 year

Interventionunits on a scale (Mean)
Apixaban66
Warfarin31

[back to top]

Duration of Hospital Stay of Participants

Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Interventionhours (Median)
Apixaban45.36
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)49.47

[back to top]

Number of Participants Who Used Image Guidance Approach

An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Interventionparticipants (Number)
Apixaban383
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)399

[back to top]

Number of Participants With Acute Stroke Event

An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma). (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Interventionparticipants (Number)
Apixaban0
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)6

[back to top]

Number of Participants With All Cause Death

(NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Interventionparticipants (Number)
Apixaban2
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)1

[back to top]

Number of Participants With Clinically Relevant Non-Major Bleeding Events

Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Interventionparticipants (Number)
Apixaban11
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)13

[back to top]

Number of Participants With Major Bleeding Event

Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Interventionparticipants (Number)
Apixaban3
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)6

[back to top]

Number of Participants With Systemic Embolism Event

Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Interventionparticipants (Number)
Apixaban0
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)0

[back to top]

Time to First Attempt of Cardioversion

Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Interventiondays (Median)
Apixaban2.0
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)2.0

[back to top]

Number of Cardioversion Attempt of Participants

Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

,
Interventionparticipants (Number)
No Cardioversion Attempt1 Cardioversion AttemptMore than 2 Cardioversion Attempts
Apixaban23448831
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)22449627

[back to top]

Number of Participants With Their Rhythm Status

Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute). (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

,
Interventionparticipants (Number)
Normal SinusAtrial FibrillationAtrial Flutter
Apixaban17153
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)27046

[back to top]

Number of Participants With Different Type of Cardioversion Events

Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

,
Interventionparticipants (Number)
ElectricalPharmacologic
Apixaban46135
Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)46430

[back to top]

Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban

Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose

Interventionng*h/mL (Geometric Mean)
Apixaban, 10 mg (Whole Tablets)2461
Apixaban, 10 mg (Crushed and Suspended in Water)2528
Apixaban, 10 mg (Crushed and Mixed With Applesauce)2055

[back to top]

Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose

Interventionng*h/mL (Geometric Mean)
Apixaban, 10 mg (Whole Tablets)2423
Apixaban, 10 mg (Crushed and Suspended in Water)2488
Apixaban, 10 mg (Crushed and Mixed With Applesauce)2015

[back to top]

Relative Bioavailability (Frel) of Apixaban

Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet). (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose

Interventionratio (Geometric Mean)
Apixaban, 10 mg (Crushed and Suspended in Water)1.03
Apixaban, 10 mg (Crushed and Mixed With Applesauce)0.836

[back to top]

Terminal Plasma Half-life (T-HALF) of Apixaban

Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body. (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose

Interventionhours (Mean)
Apixaban, 10 mg (Whole Tablets)12.4
Apixaban, 10 mg (Crushed and Suspended in Water)12.2
Apixaban, 10 mg (Crushed and Mixed With Applesauce)12.5

[back to top]

Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban

Time of maximum observed plasma concentration (Tmax) measured in hours (h) (NCT02101112)
Timeframe: Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose

Interventionhours (Median)
Apixaban, 10 mg (Whole Tablets)2.00
Apixaban, 10 mg (Crushed and Suspended in Water)2.00
Apixaban, 10 mg (Crushed and Mixed With Applesauce)2.00

[back to top]

Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion

Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT02101112)
Timeframe: Randomization to May 2014; approximately 6 weeks

,,
Interventionparticipants (Number)
DeathsSAEsDrug-related AEsDiscontinuation due to AE
Apixaban, 10 mg (Crushed and Mixed With Applesauce)0000
Apixaban, 10 mg (Crushed and Suspended in Water)0011
Apixaban, 10 mg (Whole Tablets)0000

[back to top]

Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban

Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL) (NCT02101112)
Timeframe: Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose

Interventionng/mL (Geometric Mean)
Apixaban, 10 mg (Whole Tablets)236
Apixaban, 10 mg (Crushed and Suspended in Water)249
Apixaban, 10 mg (Crushed and Mixed With Applesauce)186

[back to top]

Number of Hospitalizations During Treatment

(NCT02179177)
Timeframe: up to 8 months

Interventionhospitalizations (Mean)
Apixaban3
Placebo1.5

[back to top]

Change in Pain as Measured by Visual Analog Scale (VAS)

"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other." (NCT02179177)
Timeframe: Month 1 to Month 8

Interventionscore on a scale (Mean)
Apixaban-1
Placebo0

[back to top]

Daily Pain Scores While Hospitalized as Measured by VAS

"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other. Secondary analysis will be performed to evaluate differences when patients are hospitalized and on study drug versus placebo." (NCT02179177)
Timeframe: up to 8 months

Interventionscore on a scale (Mean)
Apixaban6.4
Placebo6.6

[back to top]

Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA

(NCT02283294)
Timeframe: 180 days

InterventionParticipants (Count of Participants)
Apixaban7
Warfarin12

[back to top]

Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT

(NCT02283294)
Timeframe: 180 days

InterventionParticipants (Count of Participants)
Apixaban5
Warfarin6

[back to top]

Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events

Participants were monitored for up to 90 days. This is the number of participants with bleeding events that did not meet the ISTH criteria but still required intervention. This is the number of participants who had at least one non-major bleeding event during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care first dose of medication to day 90 (+/- 14 days) post-op/standard of care

InterventionParticipants (Count of Participants)
Oral Apixaban12
Subcutaneous Enoxaparin19

[back to top]

Number of Participants With Incidence of Major Bleeding

The International Society on Thrombosis and Hemostasis criteria (ISTH) will be used to assess incidence of major bleeding. Participants were monitored for up to 90 days. This is the number of participants who have had at least one major bleeding incidence during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care

InterventionParticipants (Count of Participants)
Oral Apixaban1
Subcutaneous Enoxaparin1

[back to top]

Change in Quality of Life From Baseline to 28 Days Post-op

This was measured through a validated health survey (SF-8™) provided by a healthcare company (Optum®), which measured overall physical and mental well-being, with responses ranging from none to very, not at all to extremely, etc. Change was calculated as the difference at baseline versus 28 days post op. The score was 0-100 and a higher score was considered a better outcome. (NCT02366871)
Timeframe: At baseline, and visit 4, which is 28 days (+/- 4 days) post-op/standard of care

,
Interventionscore on a scale (Median)
physical score-baselinephysical score-visit 4Physical changemental score-baselinemental score-visit 4Mental change
Oral Apixaban50.739.2-5.950.750.70.8
Subcutaneous Enoxaparin49.738.5-6.249.749.30.0

[back to top]

Number of Participants With a Patient Satisfaction Assessment

Participants were monitored at the 28 (+/- 4) day post-op visit. This was measured through administering a participant satisfaction questionnaire ranging from strongly agree to strongly disagree.This is the number of participants that completed the questionnaire in response to agreeing it was difficult to remember to take the medication, agreeing that there was pain associated with the medication, and agreeing that the medication was easy to use. (NCT02366871)
Timeframe: On visit 4, which is 28 days (+/- 4 days) post-op/standard of care

InterventionParticipants (Count of Participants)
Difficult remembering to take medication72102815Difficult remembering to take medication72102814Pain associated with taking the medication72102814Pain associated with taking the medication72102815Was medication easy to take72102814Was medication easy to take72102815
AgreeNeutralDisagree
Oral Apixaban23
Subcutaneous Enoxaparin23
Oral Apixaban16
Subcutaneous Enoxaparin15
Oral Apixaban149
Subcutaneous Enoxaparin149
Oral Apixaban4
Subcutaneous Enoxaparin92
Oral Apixaban10
Subcutaneous Enoxaparin25
Oral Apixaban173
Subcutaneous Enoxaparin70
Oral Apixaban186
Subcutaneous Enoxaparin110
Oral Apixaban2
Subcutaneous Enoxaparin21
Oral Apixaban0
Subcutaneous Enoxaparin56

[back to top]

Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

Participants were monitored for up to 90 days. Both DVTs and PEs will be measured using the Wells criteria, ultrasound, and/or CT. This is the number of participants who had at least one DVT or PE during the time of observation. (NCT02366871)
Timeframe: Day 1 post-op/standard of care to day first dose of medication 90 (+/- 14 days) post-op/standard of care

InterventionParticipants (Count of Participants)
Oral Apixaban2
Subcutaneous Enoxaparin3

[back to top]

Number of Participants Who Met Medication Adherence Rates

Participants were monitored for up to 28 days. This was measured through self-report, patient diaries, and the return of all medication bottles/syringes. This was the number of participants that did not miss more than 2 days of study medication over 28 days (less than 4 pills or 2 injections missed). (NCT02366871)
Timeframe: Day 1 post-op/standard of care first dose of medication to Day 28 (+/- 4 days) post-op/standard of care

InterventionParticipants (Count of Participants)
Oral Apixaban173
Subcutaneous Enoxaparin164

[back to top]

The Number of Participants With Non-fatal Pulmonary Embolism (PE)

The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban0
Standard of Care0

[back to top] [back to top]

The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)

The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 40 days after first dose

InterventionParticipants (Count of Participants)
Apixaban27
Standard of Care38

[back to top]

The Number of Participants With Minor Bleeding Events

"The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee.~Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban37
Standard of Care20

[back to top]

The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)

"The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee~CRNM bleeding is defined as bleeding that satisfies one or both of the following:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban13
Standard of Care5

[back to top]

The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use

The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban0
Standard of Care0

[back to top]

The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)

"The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee.~CRNM bleeding is defined as bleeding that satisfies one or both of the following:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban11
Standard of Care3

[back to top]

The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)

The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban0
Standard of Care1

[back to top]

The Number of Participants With an Arterial Thromboembolic Event

The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban0
Standard of Care0

[back to top] [back to top]

The Number of Participants Needing Catheter Replacements During the Study

The number of participants needing catheter replacements during the study (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban3
Standard of Care2

[back to top]

The Number of Participant Deaths

The number of participant deaths adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)

InterventionParticipants (Count of Participants)
Apixaban1
Standard of Care3

[back to top]

Maximum Observed Concentration (Cmax)

The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose

Interventionng/mL (Geometric Mean)
Participants Weight Range ≥ 35 kg56.5
Participants Weight Range 25 to < 35 kg63.6
Participants Weight Range 18 to < 25 kg61.4
Participants Weight Range 10.5 to < 18 kg54.2

[back to top]

The Number of Participants With Adjudicated Major Bleeding

"The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or~bleeding that requires surgical intervention in an operating suite, including interventional radiology." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban2
Standard of Care2

[back to top]

Area Under the Concentration-Time Curve [AUC(TAU)]

The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose

Interventionng•h/mL (Geometric Mean)
Participants Weight Range ≥ 35 kg470
Participants Weight Range 25 to < 35 kg510
Participants Weight Range 18 to < 25 kg453
Participants Weight Range 10.5 to < 18 kg416

[back to top]

Anti-FXa Activity

Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy (NCT02369653)
Timeframe: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.

,,
InterventionAnti-FXa activity (ng/mL) (Mean)
Day 7 (Predose)Day 7 (2.5 hours)Day 8Day 15
Participants Weight Range ≥ 35 kg55.378.755.270.2
Participants Weight Range 10.5 to < 18 kg44.287.54864.8
Participants Weight Range 18 to < 25 kg52.877.547.563.9

[back to top]

Anti-FXa Activity

Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy (NCT02369653)
Timeframe: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.

InterventionAnti-FXa activity (ng/mL) (Mean)
Day 7 (Predose)Day 7 (2.5 hours)Day 15
Participants Weight Range 25 to < 35 kg62.272.175.3

[back to top]

Trough Observed Concentration (Cmin)

The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. (NCT02369653)
Timeframe: pre-dose, 1-4 hours post dose

Interventionng/mL (Geometric Mean)
Participants Weight Range ≥ 35 kg18.8
Participants Weight Range 25 to < 35 kg18.1
Participants Weight Range 18 to < 25 kg12
Participants Weight Range 10.5 to < 18 kg12.9

[back to top]

The Number Participants Experiencing Superficial Vein Thrombosis Events

"The number participants experiencing superficial vein thrombosis events.~Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban4
Standard of Care2

[back to top]

The Number of Platelet Transfusions Needed During the Study

"The number of platelet transfusions needed during the study.~The events are not adjudicated. A subject could have more than one platelet transfusion." (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionPlatelet Transfusions (Number)
Apixaban266
Standard of Care248

[back to top] [back to top]

The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)

The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee (NCT02369653)
Timeframe: From first dose up to approximately 34 days after first dose

InterventionParticipants (Count of Participants)
Apixaban4
Standard of Care6

[back to top]

Change in Pharmacokinetics as Assessed by Cmax (Max Concentration)

To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline. (NCT02406885)
Timeframe: Baseline and 12 months

Interventionng/ml (Mean)
APB Study: Apixaban Pharmacokinetics in VSG5.3
APB Study: Apixaban Pharmacokinetics in RYGB-6.7

[back to top]

Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC)

To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in AUC (ng*h/ml) between 12 months and baseline. (NCT02406885)
Timeframe: Baseline to 12 months

Interventionng*h/ml (Mean)
APB Study: Apixaban Pharmacokinetics in VSG-168.25
APB Study: Apixaban Pharmacokinetics in RYGB-166.34

[back to top]

Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity)

"To determine the durability or change in pharmacodynamics of apixaban in patients with obesity following one of two bariatric surgical procedures. Reported data is the difference between 12 months and baseline. Factor Xa levels is measured in percent activity." (NCT02406885)
Timeframe: Baseline and 12 months

InterventionPercent Activity (Mean)
APB Study: Apixaban Pharmacokinetics in VSG-7.3
APB Study: Apixaban Pharmacokinetics in RYGB-15.7

[back to top]

The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA

"Time to first occurrence during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Apixaban15.85
Vitamin K Antagonist17.17

[back to top]

Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA

"Time to first occurrence during the time the participants were treated with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Apixaban24.66
Vitamin K Antagonist35.79

[back to top]

The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period

"Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.~N is the number of participants with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Acetylsalicylic Acid Film Coated Tablet40.51
Placebo Matching Acetylsalicylic Acid Film Coated Tablet21.03

[back to top]

The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin

"Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Acetylsalicylic Acid Film Coated Tablet15.28
Placebo Matching Acetylsalicylic Acid Film Coated Tablet17.73

[back to top]

The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA

"Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Apixaban57.24
Vitamin K Antagonist69.19

[back to top]

The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin

"Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Acetylsalicylic Acid Film Coated Tablet65.72
Placebo Matching Acetylsalicylic Acid Film Coated Tablet60.56

[back to top]

The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period

"Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year." (NCT02415400)
Timeframe: Approximately 6 months

InterventionPercentage per year (Number)
Apixaban24.66
Vitamin K Antagonist35.79

[back to top]

6 Month Bleeding Rate

The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months

Interventionpercentage of patients (Number)
Arm A (Apixaban)0
Arm B (Dalteparin)2.1

[back to top]

Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE). (NCT02585713)
Timeframe: Up to 3 months post-treatment

Interventionmonths (Median)
Arm A (Apixaban)NA
Arm B (Dalteparin)NA

[back to top]

Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed

A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. (NCT02585713)
Timeframe: Up to 6 months

Interventionpercentage of patients (Number)
Arm A (Apixaban)7.0
Arm B (Dalteparin)8.1

[back to top]

Number of Patients With Cardiovascular Death

Cardiovascular death is included in this measurement. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher." (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban14
Uninterrupted Apixaban17

[back to top]

Number of Patients With Cardiovascular Death

Cardiovascular death is included in this measurement. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With TIAs or Non-Hemorrhagic Strokes

This measurement includes TIAs or non-hemorrhagic strokes. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban1
Uninterrupted Apixaban1

[back to top]

Number of Patients With TIAs or Non-Hemorrhagic Strokes

Number of Patients who had TIAs or non-hemorrhagic strokes. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban1
Uninterrupted Apixaban1

[back to top]

Number of Patients With Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With Major Bleeding

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban3
Uninterrupted Apixaban2

[back to top]

Number of Patients With Major Bleeding

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban3
Uninterrupted Apixaban2

[back to top]

Number of Patients With Death

Death is included in this measurement. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With Death

Death is included in this measurement. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban0
Uninterrupted Apixaban0

[back to top]

Number of Patients With Composite of Major Bleeding and Thrombotic Events

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban3
Uninterrupted Apixaban2

[back to top]

Number of Patients With Composite of Major Bleeding and Thrombotic Events

"Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher." (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban3
Uninterrupted Apixaban2

[back to top]

Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher." (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban14
Uninterrupted Apixaban17

[back to top]

Number of Patients With Clinically-Significant Bleeding

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. (NCT02608099)
Timeframe: Randomization to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban14
Uninterrupted Apixaban17

[back to top]

Number of Patients With Clinically-Significant Bleeding

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. (NCT02608099)
Timeframe: Enrollment to 1 month post catheter ablation

InterventionParticipants (Count of Participants)
Interrupted Apixaban17
Uninterrupted Apixaban17

[back to top]

Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 Days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC15.8
AtriClip Without OAC6.7
Combined AtriClip8.5
Standard of Care With OAC14.8
Standard of Care Without OAC7.5
Combined Standard of Care8.6

[back to top]

Number of Perioperative Complications Associated With AtriClip Placement

Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. (NCT02701062)
Timeframe: Within any 24 hour period during the first 2 days post-index procedure

Interventionperioperative complications reported (Number)
AtriClip®0

[back to top]

Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 days post index procedure

Interventionpercent of participants (Number)
AtriClip With OAC19.6
AtriClip Without OAC8.2
Standard of Care With OAC16.0
Standard of Care Without OAC6.5
Combined Standard of Care9.9

[back to top]

Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 30 days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC5.0
AtriClip Without OAC5.1
Standard of Care With OAC0.0
Standard of Care Without OAC8.0
Combined Standard of Care7.8

[back to top]

Number of Subjects With Intraoperative Successful Exclusion of LAA.

Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. (NCT02701062)
Timeframe: Intraoperative period

Interventionpercentage of participants (Number)
Total Patients, No Flow and No StumpTotal Patients, No Flow with Stump <= 5mmTotal Patients, No Flow with Stump <= 10mm
AtriClip®82.295.498.9

[back to top] [back to top] [back to top] [back to top] [back to top] [back to top] [back to top] [back to top]

Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 6-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.6
Randomized Arm 2 (LMWH)11.3
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)10.1

[back to top]

Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 3 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.7
Randomized Arm 2 (LMWH)53.3
Preference Cohort 1 (DOACs)55.8
Preference Cohort 2 (LMWH)54.9

[back to top]

Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.5
Randomized Arm 2 (LMWH)54.1
Preference Cohort 1 (DOACs)54.9
Preference Cohort 2 (LMWH)53.1

[back to top]

Cumulative Non-Fatal VTE Recurrence at 6 Months (%)

To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE. (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)6.1
Randomized Arm 2 (LMWH)8.8
Preference Cohort 1 (DOACs)7.5
Preference Cohort 2 (LMWH)4.1

[back to top]

Cumulative Rates of Major Bleeding

To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living). (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)5.2
Randomized Arm 2 (LMWH)5.6
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)7.6

[back to top]

Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)

To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form) (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)21.5
Randomized Arm 2 (LMWH)18.4
Preference Cohort 1 (DOACs)16.3
Preference Cohort 2 (LMWH)23.8

[back to top]

Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 3-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.2
Randomized Arm 2 (LMWH)10.7
Preference Cohort 1 (DOACs)10.3
Preference Cohort 2 (LMWH)10.5

[back to top]

Number of Participants With Major Hemorrhage

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

[back to top]

Number of Participants With Venous Thromboembolism (VTE)

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

[back to top]

Number of Patients That Held Drug for Menorrhagia

(NCT02829957)
Timeframe: 1, 2, and 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

[back to top]

PBAC Scores

"Measure Description: A PBAC Score of < 100 indicates a normal menstrual cycle. The lowest possible score would be zero. Higher values indicate worse outcomes. The higher theoretical range value cannot be calculated. The scoring mechanism is as follows;~Towels~1 point for each lightly stained towel~5 points or each moderately soiled towel~20 points if the towel is completely saturated with blood~Tampons~1 point for each lightly stained tampon~5 points for each moderately soiled tampon~10 points if the tampon is completely saturated with blood~Clots~1 point for small clots~5 points for large clots" (NCT02829957)
Timeframe: 3 months

Interventionscore on a scale (Median)
Rivaroxaban292
Apixaban146

[back to top]

Number of Participants Who Crossed Over to Another Anticoagulant

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban3
Apixaban1

[back to top]

Number of Participants Who Discontinued Planned Drug Administration

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban4
Apixaban2

[back to top]

Hemoglobin Concentration

Measure Description: Normal hemoglobin range for adult women - 12 - 16 g/dL. Lower levels indicate worse outcomes. (NCT02829957)
Timeframe: 3 months

Interventiong/dl (Median)
Rivaroxaban12.8
Apixaban13.25

[back to top]

Number of Participants With Clinically Relevant Non-major Bleeding

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban3
Apixaban0

[back to top]

Physical Component Summary of Standard From 36

The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. (NCT02829957)
Timeframe: 3 months

InterventionScore (Median)
Rivaroxaban55.5
Apixaban45.6

[back to top]

Total Post-operative Length of Stay

This will be measured from the date/time of the end of the subject's surgery until the date/time of the patient's discharge from the hospital. This will be measured in hours, to the nearest tenth of an hour. (NCT02889562)
Timeframe: 30 days

Interventionhours (Mean)
Apixaban167.5
Warfarin143.1

[back to top]

Units of Blood Given After Initiation of Anticoagulation Medication

Units of blood or blood products given after the first dose of anticoagulation. (NCT02889562)
Timeframe: 30 days

Interventiontotal units of blood (Number)
Apixaban6
Warfarin2

[back to top]

Time in Therapeutic Range of INR, if on Warfarin

Time in therapeutic range of INR, if on warfarin, (eg. 2-3), measured as a percentage and defined for each patient using the Rosendaal equation (NCT02889562)
Timeframe: 30 days

Interventionpercentage (Mean)
Warfarin56.8

[back to top]

Number of Participants With Thromboembolytic Events

Efficacy will be measured by the freedom from thromboembolytic events during the study period. Events relating to thromboembolytic events will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm. (NCT02889562)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Apixaban0
Warfarin0

[back to top]

Number of Participants With Strokes

Efficacy will be measured by the freedom from stroke during the study period. Events relating to stroke will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm. (NCT02889562)
Timeframe: 30 days

Interventionparticipants (Number)
Apixaban0
Warfarin0

[back to top]

Number of Participants Experiencing Systemic Embolism

"Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.~Clinical presentation would include:~Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease.~Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred.~Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban0
Warfarin0

[back to top]

Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality

"Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis~Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban27
Warfarin29

[back to top]

Number of Participants Experiencing Stroke or Systemic Embolism

Number of participants experiencing adjudicated stroke or systemic embolism. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban2
Warfarin2

[back to top]

Number of Participants Experiencing Stroke

"Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours.~Events with neurologic deficit lasting for < 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well.~A retinal ischemic event (embolism, infarction) will be considered a stroke" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban2
Warfarin2

[back to top]

Number of Participants Experiencing Mortality

Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban21
Warfarin13

[back to top]

Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding

"Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis.~Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds.~Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionParticipants (Count of Participants)
Apixaban21
Warfarin16

[back to top]

Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Interventionng*h/mL (Geometric Mean)
Apixaban 2.5 mg507
Apixaban 5mg868

[back to top]

Apixaban Plasma Concentration, Cmin

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Interventionng/mL (Geometric Mean)
Apixaban 2.5 mg28.2
Apixaban 5mg49.7

[back to top]

Apixaban Plasma Concentration, Cmax

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Interventionng/mL (Geometric Mean)
Apixaban 2.5 mg59.7
Apixaban 5 mg97.9

[back to top]

Persistence of Therapy

Evaluate days between time from initiation to discontinuation of randomized therapy. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

InterventionDays (Mean)
Apixaban304.4
Warfarin279.6

[back to top]

Frequency of Major and Clinically Relevant Non-major Bleeding

"Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12).~Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug." (NCT02958969)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Apixaban3

[back to top]

Frequency of Symptomatic Venous Thromboembolism

Symptomatic deep vein thrombosis or pulmonary embolism (NCT02958969)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Apixaban0

[back to top]

Frequency of All-cause Mortality

All-cause mortality at 6 months will be recorded. Cause of death will be classified as related to cancer, myocardial infarction, PE, other cardiovascular or other disease state. Death will be attributed to PE if there is evidence to support an association with PE. (NCT02958969)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Apixaban0

[back to top]

Frequency of Atherothrombotic Events

6-month rates of myocardial infarction and stroke will be calculated. (NCT02958969)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Apixaban0

[back to top]

The Number of Participants With Adjudicated Major Bleeding

"The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS~bleeding that requires surgical intervention in an operating suite, including interventional radiology" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)1

[back to top]

The Number of Participants With Adjudicated CRNM Bleeding

"The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)2

[back to top]

The Number of Participant Deaths in the Study

The number of participant deaths in the study. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban0
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)0

[back to top]

Maximum Observed Concentration (Cmax)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg185
Participants Weight Range 9 to < 12 kg218
Participants Weight Range 12 to < 18 kg222
Participants Weight Range 18 to < 25 kg244
Participants Weight Range 25 to < 35 kg249
Participants Weight Range ≥ 35 kg203

[back to top]

Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events

"The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.~CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room." (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban1
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)3

[back to top]

Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng • h/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg1460
Participants Weight Range 9 to < 12 kg1840
Participants Weight Range 12 to < 18 kg1610
Participants Weight Range 18 to < 25 kg1760
Participants Weight Range 25 to < 35 kg1840
Participants Weight Range ≥ 35 kg1630

[back to top]

Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score

"Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization

,
InterventionScore on a scale (Mean)
BASELINE CHILD REPORTED - 6 MONTHSPOST BASELINE CHILD REPORTED - 6 MONTHSBASELINE CHILD REPORTED - 12 MONTHSPOST BASELINE CHILD REPORTED - 12 MONTHSBASELINE PARENT REPORTED - 6 MONTHSPOST BASELINE PARENT REPORTED - 6 MONTHSBASELINE PARENT REPORTED - 12 MONTHSPOST BASELINE PARENT REPORTED - 12 MONTHS
Apixaban24.3522.8122.5021.5237.9732.3238.3731.10
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)26.4522.5725.3218.0139.0237.9439.3633.61

[back to top] [back to top]

The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)

"Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).~Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization

,
InterventionScore on a scale (Mean)
GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - BASELINEGENERAL-SPECIFIC MODULE ASSESSED BY CHILD - MONTH 12GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - BASELINEGENERAL-SPECIFIC MODULE ASSESSED BY PARENT - MONTH 12HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - BASELINEHEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - MONTH 12TREATMENT II ASSESSED BY CHILD - BASELINETREATMENT II ASSESSED BY CHILD - MONTH 12PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - BASELINEPERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - MONTH 12TREATMENT ANXIETY ASSESSED BY CHILD - BASELINETREATMENT ANXIETY ASSESSED BY CHILD - MONTH 12COGNITIVE PROBLEMS ASSESSED BY CHILD - BASELINECOGNITIVE PROBLEMS ASSESSED BY CHILD - MONTH 12COMMUNICATION ASSESSED BY CHILD - BASELINECOMMUNICATION ASSESSED BY CHILD - MONTH 12HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - BASELINEHEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - MONTH 12TREATMENT II ASSESSED BY PARENT - BASELINETREATMENT II ASSESSED BY PARENT - MONTH 12PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - BASELINEPERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - MONTH 12TREATMENT ANXIETY ASSESSED BY PARENT - BASELINETREATMENT ANXIETY ASSESSED BY PARENT - MONTH 12COGNITIVE PROBLEMS ASSESSED BY PARENT - BASELINECOGNITIVE PROBLEMS ASSESSED BY PARENT - MONTH 12COMMUNICATION ASSESSED BY PARENT - BASELINECOMMUNICATION ASSESSED BY PARENT - MONTH 12
Apixaban69.6473.3765.6170.0065.3469.4687.3991.7775.5180.5680.5280.7169.8568.2466.1570.3163.6866.3791.4190.3079.1679.3861.4464.0360.2958.6965.5768.20
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)60.7164.8165.4270.3264.7063.4485.6886.2778.4481.3760.3160.3153.2453.5363.5557.2867.7169.0085.2783.8079.6674.3356.2757.7761.6058.5367.3366.17

[back to top]

Chromogenic FX Assay (Apparent FX Level)

"Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.~125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose

InterventionPercent (Mean)
Day 1 (PREDOSE)Day 1 (4 HRS POSTDOSE)Week 2 (PREDOSE)Week 2 (2 HRS POSTDOSE)Month 3 (2 HRS POSTDOSE)Month 6 (PREDOSE)
Apixaban58.8718.9035.8821.2618.2536.57

[back to top]

Anti-FXa Activity

"Anti-FXa Activity was measured to assess participant plasma apixaban levels.~125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Mean)
Day 1 (4 HRS POSTDOSE)Week 2 (PREDOSE)Week 2 (2 HRS POSTDOSE)Month 3 (2 HRS POSTDOSE)Month 6 (PREDOSE)
Apixaban147.6986.24242.34228.8866.93

[back to top]

Trough Observed Concentration (Cmin)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionng/mL (Geometric Mean)
Participants Weight Range 6 to < 9 kg57.9
Participants Weight Range 9 to < 12 kg82.7
Participants Weight Range 12 to < 18 kg64.3
Participants Weight Range 18 to < 25 kg67.4
Participants Weight Range 25 to < 35 kg73.1
Participants Weight Range ≥ 35 kg72.7

[back to top]

Time of Maximum Observed Concentration (Tmax)

(NCT02981472)
Timeframe: From first dose up to 6 months after first dose

Interventionhours (Median)
Participants Weight Range 6 to < 9 kg2.24
Participants Weight Range 9 to < 12 kg2.47
Participants Weight Range 12 to < 18 kg1.72
Participants Weight Range 18 to < 25 kg1.74
Participants Weight Range 25 to < 35 kg1.65
Participants Weight Range ≥ 35 kg1.85

[back to top]

The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding

The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban7
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)1

[back to top]

The Number of Participants With All Adjudicated Bleeding

The number of participants with all adjudicated bleeding events (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)

InterventionParticipants (Count of Participants)
Apixaban47
Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA)23

[back to top]

Change of Left Ventricular Thrombosis (LVT) by More Than 50%

Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms. (NCT02982590)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Warfarin Sodium77.7
Apixaban61.5

[back to top]

Clinically Definite Cardiac Embolic Ischemic Stroke

Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan (NCT02982590)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Warfarin Sodium0
Apixaban1

[back to top]

Life Threatening Bleeding

Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. (NCT02982590)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Warfarin Sodium1
Apixaban0

[back to top]

Percent Change in Left Ventricular Thrombus (LVT) Size

Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment (NCT02982590)
Timeframe: 3 months

Interventionpercentage of change (Mean)
Warfarin Sodium-61.45
Apixaban-65.08

[back to top]

Overall Major Bleeding

"The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.82
Rivaroxaban (Dabigatran vs Rivaroxaban)2.24
Dabigatran (Dabigatran vs Apixaban)1.69
Apixaban (Dabigatran vs Apixaban)1.24

[back to top]

Stroke Overall (Hemorrhagic, Ischemic, Uncertain)

"The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:~The day of discontinuation of the index NOAC exposure;~The day before a switch to an anticoagulant different from the index exposure;~The day before a change in dose for the index NOAC;~The end of continuous eligibility of a patient in the health plan (disenrollment);~The end of the study observation period; or~The date of death of the patient." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.52
Rivaroxaban (Dabigatran vs Rivaroxaban)0.69
Dabigatran (Dabigatran vs Apixaban)0.46
Apixaban (Dabigatran vs Apixaban)0.36

[back to top]

TIA

"The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.26
Rivaroxaban (Dabigatran vs Rivaroxaban)0.20
Dabigatran (Dabigatran vs Apixaban)0.28
Apixaban (Dabigatran vs Apixaban)0.17

[back to top]

Upper GI Bleeding

"The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.41
Rivaroxaban (Dabigatran vs Rivaroxaban)0.55
Dabigatran (Dabigatran vs Apixaban)0.37
Apixaban (Dabigatran vs Apixaban)0.34

[back to top]

Major Intracranial Bleeding

"The event rate of major intracranial bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.27
Rivaroxaban (Dabigatran vs Rivaroxaban)0.41
Dabigatran (Dabigatran vs Apixaban)0.24
Apixaban (Dabigatran vs Apixaban)0.21

[back to top]

Major GI Bleeding

"The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.45
Rivaroxaban (Dabigatran vs Rivaroxaban)1.66
Dabigatran (Dabigatran vs Apixaban)1.36
Apixaban (Dabigatran vs Apixaban)0.92

[back to top]

Major Extracranial Bleeding

"The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.55
Rivaroxaban (Dabigatran vs Rivaroxaban)1.83
Dabigatran (Dabigatran vs Apixaban)1.44
Apixaban (Dabigatran vs Apixaban)1.03

[back to top]

Lower GI Bleeding

"The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.08
Rivaroxaban (Dabigatran vs Rivaroxaban)1.17
Dabigatran (Dabigatran vs Apixaban)0.98
Apixaban (Dabigatran vs Apixaban)0.58

[back to top]

Ischemic Stroke

"The event rate of ischemic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.5
Rivaroxaban (Dabigatran vs Rivaroxaban)0.54
Dabigatran (Dabigatran vs Apixaban)0.39
Apixaban (Dabigatran vs Apixaban)0.36

[back to top]

Hemorrhagic Stroke

"The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.03
Rivaroxaban (Dabigatran vs Rivaroxaban)0.16
Dabigatran (Dabigatran vs Apixaban)0.07
Apixaban (Dabigatran vs Apixaban)NA

[back to top]

All-cause Mortality

"The event rate of all-cause mortality in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.54
Rivaroxaban (Dabigatran vs Rivaroxaban)1.37
Dabigatran (Dabigatran vs Apixaban)1.46
Apixaban (Dabigatran vs Apixaban)1.25

[back to top]

Major Urogenital Bleeding

"The event rate of major urogenital bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)NA
Rivaroxaban (Dabigatran vs Rivaroxaban)0.01
Dabigatran (Dabigatran vs Apixaban)NA
Apixaban (Dabigatran vs Apixaban)NA

[back to top]

Major Other Bleeding

"The event rate of major other bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.13
Rivaroxaban (Dabigatran vs Rivaroxaban)0.18
Dabigatran (Dabigatran vs Apixaban)0.11
Apixaban (Dabigatran vs Apixaban)0.13

[back to top]

Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm

For the secondary outcome analysis, the time from starting treatment to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) outcome will be analyzed using the same method described in the section for primary outcome plan. For this outcome, death without DVT/PE and adverse events leading to termination of treatment will be treated as the competing risks. (NCT03080883)
Timeframe: 12 months

Interventionproportion of participants (Number)
Group I (2.5mg Dose Apixaban)5.8
Group II (5mg Dose Apixaban)7.1

[back to top]

CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk

Incidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 12 months between treatment arms will be estimated along with a 95% confidence interval (NCT03080883)
Timeframe: 12 months

Interventionproportion of participants (Number)
Group I (2.5mg Dose Apixaban)9.6
Group II (5mg Dose Apixaban)13.5

[back to top]

Proportion of Patients Who Experienced at Least One Bleeding Event

Incidence of major bleeding and clinically relevant non-major bleeding will be estimated using the cumulative incidence function (CIF) with death without major bleeding or clinically relevant non-major bleeding and with adverse events that results in termination of treatment (including vascular events) as competing risks. The time to event is defined as the time from randomization to the first occurrence of a major bleeding, a clinically relevant non-major bleeding, death without major bleeding or clinically relevant non-major bleeding, or an adverse event that results in termination of treatment. Patients who were lost to follow-up, who withdrew informed consent before the end of the predefined study duration will be censored at the last day the patient had a complete assessment for study outcomes within the intended study period. The difference in the incidences of the combined endpoint at 6 months between treatment arms will be estimated along with a 95% confidence interval. (NCT03080883)
Timeframe: 6 months

Interventionproportion of participants (Number)
Group I (2.5mg Dose Apixaban)4.9
Group II (5mg Dose Apixaban)5.8

[back to top]

Number of Subjects With Recurrent Venous Thromboembolism (VTE)

Primary efficacy outcome of recurrent VTE (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban1
Rivaroxaban0

[back to top]

Number of Subjects With Clinically Relevant Bleeding Events

Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB)) (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

[back to top]

Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)

MI, ischemic stroke, peripheral arterial embolism (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin1
Apixaban0
Rivaroxaban0

[back to top]

Number of Subjects Experiencing Major Bleeding

Major bleeding (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

[back to top]

Number of Subjects Experiencing Clinically Relevant Non-major Bleeding

Clinically relevant non-major bleeding (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

[back to top]

Number of Subjects With Premature Termination of Study Medication

Premature termination of study medication (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

[back to top]

Number of Subjects Experiencing All-cause Mortality

All cause mortality (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

[back to top]

Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)

Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo1
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo2
JNJ-64179375 1.8 mg/kg and Apixaban Placebo1
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)

Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo1
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo2
JNJ-64179375 1.8 mg/kg and Apixaban Placebo1
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Death (CEC-adjudicated)

Number of participants with death (adjudicated by CEC) were reported. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo0
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo0
JNJ-64179375 1.8 mg/kg and Apixaban Placebo0
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Major Bleeding Event (CEC-adjudicated)

Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo0
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo0
JNJ-64179375 1.8 mg/kg and Apixaban Placebo0
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)

Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma. (NCT03251482)
Timeframe: Up to Day 10 and 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo1
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo2
JNJ-64179375 1.8 mg/kg and Apixaban Placebo1
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Minimal Bleeding Events (CEC-adjudicated)

Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo2
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo4
JNJ-64179375 1.8 mg/kg and Apixaban Placebo0
Apixaban 2.5 mg and JNJ-64179375 Placebo IV4

[back to top]

Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)

Number of participants with nonfatal PE (adjudicated by CEC) were reported. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo0
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo0
JNJ-64179375 1.8 mg/kg and Apixaban Placebo0
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)

Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo10
JNJ-64179375 0.6 mg/kg and Apixaban Placebo9
JNJ-64179375 1.2 mg/kg and Apixaban Placebo9
JNJ-64179375 1.8 mg/kg and Apixaban Placebo31
Apixaban 2.5 mg and JNJ-64179375 Placebo IV6

[back to top]

Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)

Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo2
JNJ-64179375 0.6 mg/kg and Apixaban Placebo0
JNJ-64179375 1.2 mg/kg and Apixaban Placebo5
JNJ-64179375 1.8 mg/kg and Apixaban Placebo1
Apixaban 2.5 mg and JNJ-64179375 Placebo IV4

[back to top]

Number of Participants With Distal DVT (CEC-adjudicated)

Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

,,,,
InterventionParticipants (Count of Participants)
AsymptomaticSymptomatic
Apixaban 2.5 mg and JNJ-64179375 Placebo IV61
JNJ-64179375 0.3 mg/kg and Apixaban Placebo80
JNJ-64179375 0.6 mg/kg and Apixaban Placebo70
JNJ-64179375 1.2 mg/kg and Apixaban Placebo80
JNJ-64179375 1.8 mg/kg and Apixaban Placebo241

[back to top]

Number of Participants With Proximal and Distal DVT (CEC-adjudicated)

Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

,,,,
InterventionParticipants (Count of Participants)
AsymptomaticSymptomatic
Apixaban 2.5 mg and JNJ-64179375 Placebo IV00
JNJ-64179375 0.3 mg/kg and Apixaban Placebo10
JNJ-64179375 0.6 mg/kg and Apixaban Placebo00
JNJ-64179375 1.2 mg/kg and Apixaban Placebo10
JNJ-64179375 1.8 mg/kg and Apixaban Placebo40

[back to top]

Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)

Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

,,,,
InterventionParticipants (Count of Participants)
AsymptomaticSymptomatic
Apixaban 2.5 mg and JNJ-64179375 Placebo IV00
JNJ-64179375 0.3 mg/kg and Apixaban Placebo10
JNJ-64179375 0.6 mg/kg and Apixaban Placebo20
JNJ-64179375 1.2 mg/kg and Apixaban Placebo00
JNJ-64179375 1.8 mg/kg and Apixaban Placebo32

[back to top]

Number of Participants With Major VTE (CEC-adjudicated)

Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups. (NCT03251482)
Timeframe: Up to Day 10 to 14 (visit observation period)

InterventionParticipants (Count of Participants)
JNJ-64179375 0.3 mg/kg and Apixaban Placebo2
JNJ-64179375 0.6 mg/kg and Apixaban Placebo2
JNJ-64179375 1.2 mg/kg and Apixaban Placebo1
JNJ-64179375 1.8 mg/kg and Apixaban Placebo7
Apixaban 2.5 mg and JNJ-64179375 Placebo IV0

[back to top]

The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Age <=64Age 65-74Age >=75
Patients Prescribed With Non-warfarin Oral Anti Coagulants143584

[back to top]

The Number of Patients With Cardiac Tamponade and Pericardiocentesis.

The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Patients Prescribed With Non-warfarin Oral Anti Coagulants1

[back to top]

Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.

The change in thrombin generation from baseline to its EOB peak. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

InterventionnM.min (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet1145.03
Cohort 1 Apixaban 5 mg BID/Placebo179.94
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet1337.28
Cohort 2 Rivaroxaban 15 mg BID/Placebo209.99
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet758.92
Cohort 3 Edooxaban 60 mg QD/Placebo215.71
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet815.07
Cohort 4 Edooxaban 60 mg QD/Placebo48.59
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet1244.30
Cohort 5 Apixaban 5 mg BID/Placebo103.13
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet1177.47
Cohort 6 Apixaban 10 mg BID/Placebo0.16
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet781.42
Cohort 7 Edoxaban 30 mg QD/Placebo67.97
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet1184.62
Cohort 8 Apixaban 10 mg BID/Placebo2.69
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet1306.23
Cohort 9 Rivaroxaban 15 mg BID/Placebo117.50
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet902.17
Cohort 10 Edoxaban 60 mg QD/Placebo-92.82

[back to top]

Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.

The percent change from baseline in anti-FXa activity at its end of bolus (EOB) nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-94.50
Cohort 1 Apixaban 5 mg BID/Placebo-14.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-97.50
Cohort 2 Rivaroxaban 15 mg BID/Placebo-18.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-65.50
Cohort 3 Edooxaban 60 mg QD/Placebo-16.00
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-22.50
Cohort 4 Edooxaban 60 mg QD/Placebo-15.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-94.00
Cohort 5 Apixaban 5 mg BID/Placebo-10.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-96.00
Cohort 6 Apixaban 10 mg BID/Placebo-18.00
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-58.00
Cohort 7 Edoxaban 30 mg QD/Placebo-8.00
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-94.50
Cohort 8 Apixaban 10 mg BID/Placebo-5.00
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-95.00
Cohort 9 Rivaroxaban 15 mg BID/Placebo-11.00
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-73.00
Cohort 10 Edoxaban 60 mg QD/Placebo-4.00

[back to top]

Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.

The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-94.50
Cohort 1 Apixaban 5 mg BID/Placebo-29.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-98.00
Cohort 2 Rivaroxaban 15 mg BID/Placebo-37.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-81.00
Cohort 3 Edooxaban 60 mg QD/Placebo-47.50
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-75.50
Cohort 4 Edooxaban 60 mg QD/Placebo-37.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-93.00
Cohort 5 Apixaban 5 mg BID/Placebo-34.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-97.00
Cohort 6 Apixaban 10 mg BID/Placebo-31.00
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-52.50
Cohort 7 Edoxaban 30 mg QD/Placebo-37.00
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-92.00
Cohort 8 Apixaban 10 mg BID/Placebo-24.00
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-93.50
Cohort 9 Rivaroxaban 15 mg BID/Placebo-37.00
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-63.50
Cohort 10 Edoxaban 60 mg QD/Placebo-27.00

[back to top]

Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.

The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOB nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-93.00
Cohort 1 Apixaban 5 mg BID/Placebo-11.94
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-97.72
Cohort 2 Rivaroxaban 15 mg BID/Placebo-28.57
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-78.20
Cohort 3 Edooxaban 60 mg QD/Placebo-17.60
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-56.05
Cohort 4 Edooxaban 60 mg QD/Placebo-2.49
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-94.45
Cohort 5 Apixaban 5 mg BID/Placebo5.80
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-93.57
Cohort 6 Apixaban 10 mg BID/Placebo-12.94
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-70.88
Cohort 7 Edoxaban 30 mg QD/Placebo-5.48
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-91.61
Cohort 8 Apixaban 10 mg BID/Placebo-0.32
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-95.51
Cohort 9 Rivaroxaban 15 mg BID/Placebo-14.02
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-75.80
Cohort 10 Edoxaban 60 mg QD/Placebo-17.91

[back to top]

Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.

The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOI nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-92.940
Cohort 1 Apixaban 5 mg BID/Placebo-33.550
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-98.650
Cohort 2 Rivaroxaban 15 mg BID/Placebo-39.390
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-85.005
Cohort 3 Edooxaban 60 mg QD/Placebo-48.710
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-81.040
Cohort 4 Edooxaban 60 mg QD/Placebo-42.755
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-93.495
Cohort 5 Apixaban 5 mg BID/Placebo-31.830
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-96.65
Cohort 6 Apixaban 10 mg BID/Placebo-29.02
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-62.72
Cohort 7 Edoxaban 30 mg QD/Placebo-24.34
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-90.63
Cohort 8 Apixaban 10 mg BID/Placebo-31.45
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-94.89
Cohort 9 Rivaroxaban 15 mg BID/Placebo-37.82
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-67.10
Cohort 10 Edoxaban 60 mg QD/Placebo-34.25

[back to top]

Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.

The change in thrombin generation from baseline to its EOI peak. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

InterventionnM.min (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet1000.630
Cohort 1 Apixaban 5 mg BID/Placebo171.220
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet1329.580
Cohort 2 Rivaroxaban 15 mg BID/Placebo207.590
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet804.405
Cohort 3 Edooxaban 60 mg QD/Placebo347.535
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet910.935
Cohort 4 Edooxaban 60 mg QD/Placebo236.610
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet1130.575
Cohort 5 Apixaban 5 mg BID/Placebo118.130
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet1119.41
Cohort 6 Apixaban 10 mg BID/Placebo108.67
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet833.46
Cohort 7 Edoxaban 30 mg QD/Placebo175.72
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet1058.09
Cohort 8 Apixaban 10 mg BID/Placebo138.14
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet1173.38
Cohort 9 Rivaroxaban 15 mg BID/Placebo293.15
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet793.44
Cohort 10 Edoxaban 60 mg QD/Placebo-72.69

[back to top]

Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). (NCT03441633)
Timeframe: Day 1

,,,,,,,,,
InterventionParticipants (Count of Participants)
Missing18.5 - 25 kg per m^2 (Normal)Less than (<) 18.5 kg per m^2 (Underweight)25 - 30 kg per m^2 (Overweight)Greater than (>) 30 kg per m^2 (Obese)
Acenocoumarol: Naive689844711411007410628
Acenocoumarol: Non-Naive343006860
Apixaban: Naive14244231212291624
Apixaban: Non Naive2612536493410
Dabigatran: Naive96027210735878
Dabigatran: Non-Naive1781448306317
Rivaroxaban: Naive17464641612891617
Rivaroxaban: Non-Naive3112710482498
Warfarin: Naive5092956712764
Warfarin: Non-Naive8778211977

[back to top]

Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionmilligrams per day (Median)
Apixaban: Naive15.0
Apixaban: Non Naive30.0
Acenocoumarol: Naive16.0
Acenocoumarol: Non-Naive16.0
Warfarin: Naive53.0
Warfarin: Non-Naive16.0
Dabigatran: Naive22.0
Dabigatran: Non-Naive22.0
Rivaroxaban: Naive21.0
Rivaroxaban: Non-Naive28.0

[back to top]

International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionratio (Mean)
Acenocoumarol: Naive2.5
Acenocoumarol: Non-Naive2.5
Warfarin: Naive2.5
Warfarin: Non-Naive2.6

[back to top]

Number of Participants by Comedications

Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine. (NCT03441633)
Timeframe: Up to 30 days after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive4712
Apixaban: Non Naive1406
Acenocoumarol: Naive32212
Acenocoumarol: Non-Naive188
Warfarin: Naive2286
Warfarin: Non-Naive352
Dabigatran: Naive2855
Dabigatran: Non-Naive947
Rivaroxaban: Naive5132
Rivaroxaban: Non-Naive1532

[back to top]

Number of Participants by Comorbidity

Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive3695
Apixaban: Non Naive1316
Acenocoumarol: Naive26450
Acenocoumarol: Non-Naive173
Warfarin: Naive1819
Warfarin: Non-Naive318
Dabigatran: Naive2030
Dabigatran: Non-Naive870
Rivaroxaban: Naive3731
Rivaroxaban: Non-Naive1417

[back to top]

Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive881
Apixaban: Non Naive236
Acenocoumarol: Naive11326
Acenocoumarol: Non-Naive85
Warfarin: Naive1009
Warfarin: Non-Naive127
Dabigatran: Naive1002
Dabigatran: Non-Naive248
Rivaroxaban: Naive1191
Rivaroxaban: Non-Naive322

[back to top]

Risk of Bleeding Events: HAS-BLED Score

Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionbleed per 100 participants-year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.7
Acenocoumarol: Naive2.2
Acenocoumarol: Non-Naive2.5
Warfarin: Naive1.9
Warfarin: Non-Naive2.4
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.6
Rivaroxaban: Non-Naive2.6

[back to top]

Risk of Thromboembolic Events: CHA2DS2Vasc Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive3.0
Apixaban: Non Naive4.4
Acenocoumarol: Naive3.2
Acenocoumarol: Non-Naive3.7
Warfarin: Naive2.9
Warfarin: Non-Naive3.9
Dabigatran: Naive2.7
Dabigatran: Non-Naive4.0
Rivaroxaban: Naive2.7
Rivaroxaban: Non-Naive4.1

[back to top]

Risk of Thromboembolic Events: CHADS2 Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.8
Acenocoumarol: Naive1.9
Acenocoumarol: Non-Naive2.3
Warfarin: Naive1.8
Warfarin: Non-Naive2.5
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.5
Rivaroxaban: Non-Naive2.6

[back to top]

Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventiondays (Median)
Acenocoumarol: Naive60.2
Acenocoumarol: Non-Naive59.6
Warfarin: Naive66.2
Warfarin: Non-Naive58.9

[back to top]

AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time (NCT03509883)
Timeframe: Day 1 to Day 8

Interventionng*h/mL (Geometric Mean)
Treatment A714.7
Treatment B787.9

[back to top]

T-Half - Terminal Plasma Half Life.

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of time required to reach to half of plasma concentration (NCT03509883)
Timeframe: Day 1 to Day 8

Interventionh (hours) (Geometric Mean)
Treatment A8.81
Treatment B7.91

[back to top]

AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time (NCT03509883)
Timeframe: Day 1 to Day 8

Interventionng*h/mL (Geometric Mean)
Treatment A695.9
Treatment B769.2

[back to top]

Number of Participants With Out-of Range Vital Signs: Blood Pressure

"Number of participants with Out-of Range Blood Pressure changes as follows:~Systolic Blood Pressure (SBP) mmHg < 90 and change from baseline < -20 > 140 and change from baseline > 20~Diastolic Blood Pressure (DBP) mmHg < 55 and change from baseline < -10 > 90 and change from baseline > 10" (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
SBP < 90 and change from baseline < -20SBP >140 and change from baseline >20DBP < 55 and change from baseline < -10DBP >90 and change from baseline >10
Treatment A0000
Treatment B0010

[back to top]

Tmax - Time of Maximum Observed Plasma Concentration

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration (NCT03509883)
Timeframe: Day 1 to Day 8

Interventionh (hours) (Geometric Mean)
Treatment A2.30
Treatment B0.98

[back to top]

Number of Participants With Out-of Range ECG Evaluations

Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec) (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
PR Interval Baseline ≤ 200PR Interval Baseline >200PR Interval Maximum on Treatment ≤ 200PR Interval Maximum on Treatment >200QRS Interval Baseline ≤ 120QRS Interval Baseline >200QRS Interval Maximum on Treatment ≤ 120QRS Interval Maximum on Treatment > 120QT Interval Baseline ≤ 500QT Interval Baseline >500QT Interval Maximum on Treatment ≤ 500QT Interval Maximum on Treatment > 500QT Interval Increase from Baseline ≤ 30QT Interval Increase from Baseline > 30QTcF Interval Baseline ≤ 450QTcF Interval Baseline >450QTcF Interval Maximum on Treatment ≤ 450QTcF Interval Maximum on Treatment > 450QTcF Interval Increase from Baseline ≤ 30QTcF Interval Increase from Baseline > 30
Treatment A300291300300300300291300300300
Treatment B300300300300300300291300300300

[back to top]

Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation

Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation (NCT03509883)
Timeframe: Day 1 to Day 38

,
InterventionParticipants (Number)
Adverse EventsSerious Adverse EventsAdverse Events leading to Discontinuation
Treatment A700
Treatment B300

[back to top]

Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration (NCT03509883)
Timeframe: Day 1 to Day 8

Interventionng/mL (Geometric Mean)
Treatment A77.4
Treatment B99.3

[back to top]

Number of Participants With a Given Clinical Laboratory Abnormality

Assessment of clinical laboratory abnormalities (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
hemoglobin abnormal lowHematocrit abnormal lowPlatelet count abnormal lowplatelet count abnormal highLeukocytes abnormal lowLeukocytes Abnormal highNeutrophils (Absolute) Abnormal lowLymphocytes abnormal lowLymphocytes Abnormal highMonocytes (Absolute) Abnormal HighBasophils (absolute) Abnormal HighEosinophils (absolute) Abnormal HighProthrombin Time (PT) Abnormal HighInternational Normalized Ratio (INR) Abnormal HighAlkaline Phosphate (ALP) Abnormal HighAspartate Aminotransferase (AST) Abnormal HighAlanine Aminotransferase (ALT) Abnormal HighBilirubin, Total Abnormal HighBlood Urea Nitrogen (BUN) Abnormal HighCreatinine Abnormal HighSodium Abnormal LowSodium, Serum Abnormal HighPotassium Abnormal LowPotassium, Serum Abnormal HighChloride, Serum Abnormal LowChloride, Serum Abnormal HighCalcium, Serum Abnormal LowCalcium, Serum Abnormal HighPhosphorus, Inorganic Abnormal LowPhosphorus, Inorganic Abnormal HighGlucose, Fasting Serum Abnormal LowGlucose, Fasting Serum Abnormal HighProtein, Total Abnormal LowProtein, Total Abnormal HighAlbumin Abnormal LowLactate Dehydrogenase (LDH) Abnormal HighProtein, Urine Abnormal HighGlucose, Urine Abnormal HighBlood, Urine Abnormal HighWBC, Urine Abnormal HighRBC, Urine Abnormal High
Treatment A00000020000000000000000000000000000000221
Treatment B00000010000000000000000000000000000000220

[back to top]

Physical Measurement - Height

Average height of all participants treated (NCT03509883)
Timeframe: Pre-treatment Screening

Interventioncentimeter (cm) (Mean)
Treatment A173.23
Treatment B165.86

[back to top]

Frel - Relative Bioavailability

The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation (NCT03509883)
Timeframe: Day 1 to Day 8

InterventionPercentage (Geometric Mean)
Treatment B110.24

[back to top]

Physical Measurement - Weight

Average weight of all participants treated (NCT03509883)
Timeframe: Pre-treatment screening to Day 8

,
Interventionkilograms (kg) (Mean)
Pre-treatmentDay 1Day 8
Treatment A78.0977.8376.15
Treatment B165.8671.4770.64

[back to top]

Physical Measurement - Body Mass Index (BMI)

Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2. (NCT03509883)
Timeframe: Pre-treatment Screening to Day 8

,
Interventionkilograms / Meters² (kg/m²) (Mean)
Pre-treatmentDay 1Day 8
Treatment A22.9625.8725.31
Treatment B25.8525.8425.55

[back to top]

Number of Participants With Out-of Range Vital Signs: Temperature

"Number of participants with Out-of Range temperature changes as follows:~Temperature is measured in Degrees centigrade (°C)~>38.3°C Change from baseline > 1.6°C >38.3°C or change from baseline > 1.6°C" (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
>38.3°Cchange from baseline > 1.6°C>38.3°C or change from baseline > 1.6°C
Treatment A000
Treatment B000

[back to top]

Number of Participants With Out-of Range Vital Signs: Respiration Rate

"Number of participants with Out-of Range respiration rate changes as follows:~Respiration Rate is measured by number of respiration per min (rpm) > 16 rpm Change from baseline >10 rpm > 16 rpm or change from baseline > 10 rpm" (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
>16 rpmchange from baseline > 10 rpm>16 or change from baseline >10 rpm
Treatment A101
Treatment B101

[back to top]

Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)

"Number of participants with Out-of Range Heart Rate changes as follows:~< 55 and change from baseline < -16 >100 and change from baseline > 10" (NCT03509883)
Timeframe: Day 1 to Day 8

,
Interventionparticipants (Number)
<55 and change from baseline < -16>100 and change from baseline > 10
Treatment A00
Treatment B00

[back to top]

Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.70
Apixaban vs Dabigatran (Dabigatran)8.65
Apixaban vs Rivaroxaban (Apixaban)7.77
Apixaban vs Rivaroxaban (Rivaroxaban)9.86
Dabigatran vs Rivaroxaban (Dabigatran)8.18
Dabigatran vs Rivaroxaban (Rivaroxaban)9.36

[back to top]

Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.97
Apixaban vs Warfarin (Warfarin)14.73
Dabigatran vs Warfarin (Dabigatran)8.57
Dabigatran vs Warfarin (Warfarin)13.77
Rivaroxaban vs Warfarin (Rivaroxaban)9.55
Rivaroxaban vs Warfarin (Warfarin)14.23

[back to top]

Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.67
Apixaban vs Dabigatran (Dabigatran)4.06
Apixaban vs Rivaroxaban (Apixaban)3.73
Apixaban vs Rivaroxaban (Rivaroxaban)4.54
Dabigatran vs Rivaroxaban (Dabigatran)3.83
Dabigatran vs Rivaroxaban (Rivaroxaban)4.35

[back to top]

Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.75
Apixaban vs Warfarin (Warfarin)6.93
Dabigatran vs Warfarin (Dabigatran)3.86
Dabigatran vs Warfarin (Warfarin)6.61
Rivaroxaban vs Warfarin (Rivaroxaban)4.42
Rivaroxaban vs Warfarin (Warfarin)6.85

[back to top]

Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.75
Apixaban vs Dabigatran (Dabigatran)7.47
Apixaban vs Rivaroxaban (Apixaban)7.35
Apixaban vs Rivaroxaban (Rivaroxaban)7.48
Dabigatran vs Rivaroxaban (Dabigatran)7.01
Dabigatran vs Rivaroxaban (Rivaroxaban)7.31

[back to top]

Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.66
Apixaban vs Warfarin (Warfarin)13.52
Dabigatran vs Warfarin (Dabigatran)7.2
Dabigatran vs Warfarin (Warfarin)13.53
Rivaroxaban vs Warfarin (Rivaroxaban)7.18
Rivaroxaban vs Warfarin (Warfarin)12.89

[back to top]

Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)0.20
Apixaban vs Dabigatran (Dabigatran)0.25
Apixaban vs Rivaroxaban (Apixaban)0.20
Apixaban vs Rivaroxaban (Rivaroxaban)0.28
Dabigatran vs Rivaroxaban (Dabigatran)0.24
Dabigatran vs Rivaroxaban (Rivaroxaban)0.26

[back to top]

Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.11
Apixaban vs Dabigatran (Dabigatran)0.74
Apixaban vs Rivaroxaban (Apixaban)1.05
Apixaban vs Rivaroxaban (Rivaroxaban)1.15
Dabigatran vs Rivaroxaban (Dabigatran)0.71
Dabigatran vs Rivaroxaban (Rivaroxaban)1.14

[back to top]

Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.23
Apixaban vs Dabigatran (Dabigatran)4.18
Apixaban vs Rivaroxaban (Apixaban)3.28
Apixaban vs Rivaroxaban (Rivaroxaban)4.59
Dabigatran vs Rivaroxaban (Dabigatran)3.97
Dabigatran vs Rivaroxaban (Rivaroxaban)4.25

[back to top]

Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.44
Apixaban vs Warfarin (Warfarin)6.2
Dabigatran vs Warfarin (Dabigatran)4.17
Dabigatran vs Warfarin (Warfarin)5.56
Rivaroxaban vs Warfarin (Rivaroxaban)4.32
Rivaroxaban vs Warfarin (Warfarin)5.78

[back to top]

Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.39
Apixaban vs Dabigatran (Dabigatran)1.12
Apixaban vs Rivaroxaban (Apixaban)1.35
Apixaban vs Rivaroxaban (Rivaroxaban)1.43
Dabigatran vs Rivaroxaban (Dabigatran)1.08
Dabigatran vs Rivaroxaban (Rivaroxaban)1.41

[back to top]

Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.1
Apixaban vs Warfarin (Warfarin)1.73
Dabigatran vs Warfarin (Dabigatran)0.78
Dabigatran vs Warfarin (Warfarin)1.71
Rivaroxaban vs Warfarin (Rivaroxaban)1.18
Rivaroxaban vs Warfarin (Warfarin)1.72

[back to top]

Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.37
Apixaban vs Warfarin (Warfarin)2.38
Dabigatran vs Warfarin (Dabigatran)1.17
Dabigatran vs Warfarin (Warfarin)2.31
Rivaroxaban vs Warfarin (Rivaroxaban)1.47
Rivaroxaban vs Warfarin (Warfarin)2.37

[back to top]

Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)6.99
Apixaban vs Dabigatran (Dabigatran)6.84
Apixaban vs Rivaroxaban (Apixaban)6.60
Apixaban vs Rivaroxaban (Rivaroxaban)6.58
Dabigatran vs Rivaroxaban (Dabigatran)6.37
Dabigatran vs Rivaroxaban (Rivaroxaban)6.43

[back to top]

Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)0.18
Apixaban vs Warfarin (Warfarin)0.78
Dabigatran vs Warfarin (Dabigatran)0.24
Dabigatran vs Warfarin (Warfarin)0.75
Rivaroxaban vs Warfarin (Rivaroxaban)0.27
Rivaroxaban vs Warfarin (Warfarin)0.74

[back to top]

Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)6.9
Apixaban vs Warfarin (Warfarin)11.8
Dabigatran vs Warfarin (Dabigatran)6.53
Dabigatran vs Warfarin (Warfarin)11.92
Rivaroxaban vs Warfarin (Rivaroxaban)6.29
Rivaroxaban vs Warfarin (Warfarin)11.19

[back to top]

Time to Platelet Recovery

The time to platelet recovery serves as a surrogate index of the activity of apixaban. (NCT03594045)
Timeframe: From the start of treatment until time of platelet recovery, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionDays (Median)
Apixaban for HITT2

[back to top]

Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban

New TEC (NCT03594045)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Cumulative Incidence of Major Bleeding

Major Bleeding (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Cumulative Incidence of Limb Amputation

(NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Cumulative Incidence of All Cause Mortality

Death due to any cause during treatment or the follow-up period following treatment. (NCT03594045)
Timeframe: From the start of treatment until the time of death or until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Composite Cumulative Incidence of New TEC and Major Bleeding

Composite cumulative incidence (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC

Composite cumulative incidence (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Cumulative Incidence of New Thromboembolic Complications (TEC)

New TEC during the study. (NCT03594045)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT

InterventionParticipants (Count of Participants)
Apixaban for HITT0

[back to top]

Number of Participants With ISTH Major Bleeding

ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

InterventionParticipants (Count of Participants)
Asundexian 20 mg0
Asundexian 50 mg0
Apixaban0

[back to top]

Number of Participants With ISTH Minor Bleeding

All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

InterventionParticipants (Count of Participants)
Asundexian 20 mg10
Asundexian 50 mg9
Asundexian Pooled19
Apixaban20

[back to top]

Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding

ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation. (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

InterventionParticipants (Count of Participants)
Asundexian 20 mg3
Asundexian 50 mg1
Asundexian Pooled4
Apixaban6

[back to top]

Number of Participants With All Bleeding

Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5). (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

InterventionParticipants (Count of Participants)
Asundexian 20 mg12
Asundexian 50 mg10
Asundexian Pooled22
Apixaban26

[back to top]

Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding

"ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.~ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation." (NCT04218266)
Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

InterventionParticipants (Count of Participants)
Asundexian 20 mg3
Asundexian 50 mg1
Asundexian Pooled4
Apixaban6

[back to top]

Hospitalization for Cardiovascular/Pulmonary Events

The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment. (NCT04498273)
Timeframe: 45 days

Interventionparticipants (Number)
Apixaban 2.5mg1
Apixaban 5mg1
Asprin0
Placebo0

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvent Rate Per 100 Participant-Years (Number)
Warfarin8.44
Apixaban5.12

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvent Rate Per 100 Participant-Years (Number)
Warfarin6.48
Apixaban4.52

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants

Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvents Per 100 Participant-Years (Number)
Warfarin5.52
Apixaban3.94

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants

Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 [3.5 years]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (>=) 1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvents Per 100 Participant-Years (Number)
Warfarin7.27
Apixaban4.06

[back to top]

Time in Therapeutic Range (TTR) During Follow-up Period

TTR was computed using INR values among warfarin participants during the follow-up. TTR was calculated based on the percentage of time a participant remained in therapeutic range evaluated during the entire follow-up period. TTR >=65 percent (%) was observed as good and TTR less than (<) 65% was observed as poor. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionPercentage of time (Median)
Warfarin14

[back to top]

Charlson Comorbidity Index (CCI)

"CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity." (NCT04681482)
Timeframe: Baseline (6 months prior to index date)

InterventionUnits on a scale (Mean)
Warfarin3.13
Apixaban2.55
Dabigatran2.21
Rivaroxaban2.49

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants

Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvents Per 100 Participant-Years (Number)
Warfarin2.09
Apixaban1.51

[back to top]

Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants

Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1. (NCT04681482)
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

InterventionEvents Per 100 Participant-Years (Number)
Warfarin1.51
Apixaban0.92

[back to top]

Number of Participants Who Switched to Another Anticoagulant Therapy

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy1273173
NOAC-Based Therapy: Apixaban31933
NOAC-Based Therapy: Dabigatran27630
NOAC-Based Therapy: Edoxaban20426
NOAC-Based Therapy: Rivaroxaban1777208
PAC Only535208
Warfarin-Based Therapy1541144

[back to top]

Number of Participants Who Completely Discontinued Index Anticoagulant Treatment

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy198262570
NOAC-Based Therapy: Apixaban2828279
NOAC-Based Therapy: Dabigatran1028115
NOAC-Based Therapy: Edoxaban1164147
NOAC-Based Therapy: Rivaroxaban141701968
PAC Only45341449
Warfarin-Based Therapy4707444

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban3002610000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran4111200000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1012600001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban28101342020201

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13524

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only541012121010

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy22631117201001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban1310200000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000201000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0010100000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban122101123001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy12000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only120002000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran3011600003

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy1085897851271308

[back to top]

Number of Participants With Interruption in Index Anticoagulant Treatment

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy8169961
NOAC-Based Therapy: Apixaban965115
NOAC-Based Therapy: Dabigatran49251
NOAC-Based Therapy: Edoxaban43938
NOAC-Based Therapy: Rivaroxaban5973728
PAC Only1226401
Warfarin-Based Therapy3429172

[back to top]

Overall Index Anticoagulant Treatment Duration

Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban96104
NOAC Based Therapy: Dabigatran137105
NOAC Based Therapy: Edoxaban164123
NOAC-Based Therapy140111
NOAC-Based Therapy: Rivaroxaban128102
PAC Only334
Warfarin-Based Therapy13980

[back to top]

Time to Treatment Discontinuation

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy119101
NOAC-Based Therapy: Apixaban8499
NOAC-Based Therapy: Dabigatran134118
NOAC-Based Therapy: Edoxaban154112
NOAC-Based Therapy: Rivaroxaban11997
PAC Only225
Warfarin-Based Therapy12975

[back to top]

Time to Treatment Interruption

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy129137
NOAC-Based Therapy: Apixaban86123
NOAC-Based Therapy: Dabigatran137119
NOAC-Based Therapy: Edoxaban130159
NOAC-Based Therapy: Rivaroxaban128134
PAC Only361
Warfarin-Based Therapy163129

[back to top]

Time to Treatment Switch

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy17976
NOAC-Based Therapy: Apixaban6644
NOAC-Based Therapy: Dabigatran10560
NOAC-Based Therapy: Edoxaban8798
NOAC-Based Therapy: Rivaroxaban9953
PAC Only2749
Warfarin-Based Therapy5736

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13623

[back to top] [back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0000000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0001000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy200100000000

[back to top] [back to top] [back to top] [back to top] [back to top] [back to top] [back to top]

Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy53133285661268715881213389
NOAC-Based Therapy: Apixaban5050126141012303113
NOAC-Based Therapy: Dabigatran23199587001201
NOAC-Based Therapy: Edoxaban201817476000100
NOAC-Based Therapy: Rivaroxaban4210233407995512940172775
PAC Only45209171100447220955109
Warfarin-Based Therapy2761589262457911121512

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy63736351130010

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban11010200000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only102954516171006

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy361130

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban4192311102

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban61191410010

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1010000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0010100000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0003000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy17023012000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only5111127000000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy5111

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban105115822113

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1020100001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran2112100001

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0004201000

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy26314318310012

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only146511510362182529

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban481330152588411

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban2143901000

[back to top]

Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy118257771691307240452362122666450
NOAC-Based Therapy: Apixaban1341235084039654014773
NOAC-Based Therapy: Dabigatran724818141334209112
NOAC-Based Therapy: Edoxaban5353252011280011553
NOAC-Based Therapy: Rivaroxaban9015537113823217232129287525142
PAC Only2018734625291383441140891904834
Warfarin-Based Therapy4210258781331041587117111416

[back to top]

Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy105571089
NOAC-Based Therapy: Apixaban1213125
NOAC-Based Therapy: Dabigatran60646
NOAC-Based Therapy: Edoxaban81791
NOAC-Based Therapy: Rivaroxaban7209773
PAC Only75221
Warfarin-Based Therapy4393217

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only125163636481115

[back to top]

Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy591599

[back to top]

Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban2390290
NOAC Based Therapy: Dabigatran1225120
NOAC Based Therapy: Edoxaban1395148
NOAC-Based Therapy198482405
NOAC-Based Therapy: Rivaroxaban140371770
PAC Only222673
Warfarin-Based Therapy6313388

[back to top]