Horizon scanning: Phase II study of betrixaban vs. warfarin in patients with atrial fibrillation (Explore-Xa)

Source: Eur Heart J Area: News Betrixaban is an investigational once daily oral factor Xa inhibitor mostly excreted unchanged in the bile and with low (17%) renal excretion. The phase II study assessed its safety and tolerability at three different doses compared with warfarin in 508 patients with AF and more than one risk factor for stroke.   The patients had mean CHADS2 score of 2.2 and 87% had previously received vitamin K antagonist therapy. They were randomised to betrixaban 40, 60, or 80 mg once daily (n= 127 each dose) or unblinded warfarin, adjusted to an INR of 2.0-3.0 (n= 127). The primary outcome was major or clinically relevant non-major bleeding.   After a mean follow-up of 147 days:   . The time in therapeutic range on warfarin was 63.4%.   . There were 1, 5, 5, and 7 patients with a primary outcome on betrixaban 40, 60, 80 mg daily, or warfarin, respectively.   . The rate of the primary outcome was lowest on betrixaban 40 mg ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news