Rivaroxaban non-inferior to warfarin in ROCKET

Bayer AG (Xetra:BAY) and Johnson & Johnson (NYSE:JNJ) said oral rivaroxaban was non-inferior to warfarin on the primary efficacy endpoint of the incidence of stroke and non-CNS systemic embolism in the Phase III ROCKET AF trial to prevent stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF) (2.12% vs. 2.42%; p<0.001 for non-inferiority). In the per protocol population (n=14,143), the direct Factor Xa inhibitor was superior to warfarin on the primary efficacy endpoint (1.7% vs. 2.15%; p=0.015). On the primary safety endpoint, the composite rates of major and non-major clinically relevant bleeding events were similar between rivaroxaban and warfarin in the per protocol population. Rates of major bleeding were also similar between treatment groups. The double-blind, international trial included 14,171 evaluable patients. ...