A Phase 2, Randomized, Parallel group, Dose finding, Multicentre, Multinational study of the safety, Tolerability and pilot efficacy of three blinded doses of the Oral Factor Xa Inhibitor Betrixaban compared with Open Label Dose adjusted Warfarin in patients with non-valvular Atrial Fibrillation (EXPLORE Xa)
To assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular AF.
Randomized, parallel group design, multicenter, active comparator, dose-finding (Phase 2) study of patients with documented non-valvular AF.
The primary endpoint will be the time to occurrence of major or clinically relevant non-major bleeding. The secondary endpoints will be the time to occurrence of any bleeding (including major, clinically relevant non-major, and minimal) and the time to occurrence of death, ischemic or nonischemic stroke, MI, or other systemic embolism.