Dabigatran antithrombotics

Pradax - Pradaxa



Trial Studied treatment Control Patients Size Study type Results NCT

Acute coronary syndrome - anticoagulant in All ACS (including AMI) - direct factor Xa inhibitors in all type of patients - direct oral anticoagulant (DAO) in all type of patients

REDEEM, 2009dabigatranplacebo1874 (1501/373) NCT00621855

Atrial fibrillation - antithrombotics in primary prevention of thromboembolic events - direct antithrombins in all type of patients - direct oral anticoagulant (DAO) in all type of patients - antithrombotics in secondary prevention of thromboembolic events

phase 2 dabigatrandabigatranwarfarin standard doseNA Exploratory NCT01136408
RE-LY 110mg (2nd prevention subgroup) , 2010dabigatran 100mgwarfarinNA Exploratory
RE-LY (110mg), 2009dabigatran 110mgwarfarin standard dose12037 (6015/6022) Confirmatory - NCT00262600
RE-LY 150mg (2nd prevention subgroup) dabigatran 150mgwarfarinNA Exploratory
PETRO (150mg), 2007dabigatran 150mgwarfarin standard dose236 (166/70) Exploratory
RE-LY (150mg), 2009dabigatran 150mgwarfarin standard dose12098 (6076/6022) Confirmatory - NCT00262600

Post acute coronary syndromes - antithrombotics in all type of patients

REDEEM, 2009dabigatranplacebo1874 (1501/373) NCT00621855

Post myocardial infarction - antithrombotics in all type of patients

REDEEM, 2009dabigatranplacebo1874 (1501/373) NCT00621855

Thrombosis prevention - antithrombotics in orthopedic surgery - antithrombotics in elective major knee surgery - anticoagulant in orthopedic surgery - direct antithrombins in all type of patients - direct oral anticoagulant (DAO) in all type of patients - direct oral anticoagulant (DAO) in elective major knee surgery - direct oral anticoagulant (DAO) in orthopaedic surgery - antithrombotics in elective hip replacement - direct oral anticoagulant (DAO) in elective hip replacement

RE-NOVATE (150mg), 2007dabigatran 150mgenoxaparinhip surgery2336 (1174/1162) Confirmatory NCT00168818
RE-MODEL (150mg), 2007dabigatran 150mgenoxaparin (europe regimen)knee surgery1407 (708/699) Confirmatory
RE-MOBILIZE (150mg), 2008dabigatran 150mgenoxaparin (US regimen)knee surgery1753 (877/876) Confirmatory
RE-NOVATE 2dabigatran 220mgenoxaparinhip surgery2013 (1010/1003) Confirmatory NCT00657150
RE-NOVATE (220mg), 2007dabigatran 220mgenoxaparinhip surgery2319 (1157/1162) Confirmatory NCT00168818
RE-MODEL (220mg), 2007dabigatran 220mgenoxaparin (europe regimen)knee surgery1393 (694/699) Confirmatory
RE-MOBILIZE (220mg), 2008dabigatran 220mgenoxaparin (US regimen)knee surgery1738 (862/876) Confirmatory

Venous thrombosis - antithrombotics in all type of patients - direct oral anticoagulant (DAO) in all types of patients - antithrombotics in secondary prevention of VTE

RE-SONATE, 2011dabigatrandiscontinuation1343 (681/662) NCT00558259
RE-MEDY, 2011dabigatranwarfarin2856 (1430/1426) Confirmatory NCT00329238
RE-COVER, 2009heparin/dabigatranheparin/VKA2539 (1274/1265) Confirmatory NCT00291330
RE-COVER II, 2011heparin/dabigatranheparin/VKA2589 (1294/1295) NCT00680186