Bayer AG: Phase III ROCKET AF Study of Rivaroxaban meets its primary efficacy endpoint with Comparable Safety vs. Warfarin

Leverkusen, Germany,--

Bayer today announced the preliminary results of the pivotal Phase III ROCKET AF study of rivaroxaban, the full details of which will be presented at the Late Breaker Session on November 15, 2010, [10:45 am – 10:55 am CST], at the Scientific Sessions of the American Heart Association (AHA) in Chicago, USA.

The primary objective of the study was to establish the non-inferiority of 20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal impairment at screening) compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS systemic embolism. The primary efficacy endpoint was a composite of all-cause stroke and non-CNS systemic embolism. The primary safety endpoint was the composite of major and non-major clinically relevant bleeding events.

Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted warfarin. The rates of the composite of major and non-major clinically relevant bleeding were comparable.

ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) was an event-driven, prospective, randomized, double-blind Phase III study in which more than 14,000 patients have been enrolled from more than 1,100 centers across 45 countries worldwide. The study was led by the Duke Clinical Research Institute, Durham, North Carolina, USA, and an international academic executive committee.