Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin

Summary

Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.

Timeline

Start

2008-10

Primary completion

2009-08

Completion

2009-11

Outcome

Met primary endpoint

registry Betrixaban 40 mg vs Warfarin; p = 0.035; Hazard Ratio (HR) 0.14 (95% CI 0.017 to 1.14); Log Rank NCT00742859 ↗

Drugs

Indications