Primary Endpoint Met Early in COMPASS Study of Xarelto for CAD and PAD Patient

February 8, 2017—Bayer AG and its partner Janssen Research & Development, LLC announced that the phase 3 COMPASS trial has met its primary endpoint ahead of schedule. COMPASS is evaluating the efficacy and safety of rivaroxaban (Xarelto) for the prevention of major adverse cardiac events (MACEs) including cardiovascular death, myocardial infarction, and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD). A complete data analysis from this study is expected to be presented at an upcoming meeting in 2017. Rivaroxaban is a non-vitamin K antagonist oral anticoagulant.

According to Bayer, the COMPASS trial was conducted in collaboration with the Population Health Research Institute (PHRI) and has enrolled 27,402 patients at more than 600 sites in more than 30 countries worldwide. In the study, patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.

After a planned interim analysis was 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. Because of the magnitude of effect and the confirmation of the existing safety profile of rivaroxaban, Bayer, Janssen, and the PHRI will offer rivaroxaban to study participants in an open-label extension trial, advised the company.