Phase III COMPASS study with Bayer's rivaroxaban (Xarelto®) shows overwhelming efficacy and meets primary endpoint early

Bayer AG and its cooperation partner Janssen Research & Development, LLC have announced that the Phase III trial COMPASS evaluating the efficacy and safety of rivaroxaban (Xarelto®) for the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) has met its primary endpoint ahead of time. Following a planned interim analysis conducted by the independent Data Monitoring Committee (DMC), the DMC recommended to stop the trial early as the primary MACE endpoint has reached its prespecified criteria for superiority. Owing to the magnitude of effect and the confirmation of the existing safety profile of rivaroxaban, Bayer, Janssen and the Population Health Research Institute (PHRI) will offer rivaroxaban to study participants in an open-label extension trial. The COMPASS study is the largest clinical study of rivaroxaban to date.