A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) W...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004595-13

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)

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Extrait

The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial fibrillation as measured by the composite of stroke and non-central nervous system (non-CNS) systemic embolism. The principal safety objective of this study is to demonstrate that rivaroxaban is superior to dose adjusted warfarin as assessed by the composite of major and non-major clinically relevant bleeding events.


Critère d'inclusion

  • Prevention of Stroke and Non-CNS Systemic Embolism in Non-Valvular Atrial Fibrillation