Phase III COMPASS trial of Xarelto (rivaroxaban) for the prevention of major adverse cardiac events stopped early- Janssen

Janssen Research & Development announced that the Phase III COMPASS trial, evaluating the efficacy and safety of Xarelto (rivaroxaban) for the prevention of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or with peripheral artery disease (PAD), is stopping earlier than planned.

This decision is based on the recommendation of the study's independent Data Monitoring Committee (DMC), as the primary MACE endpoint has reached its pre-specified criteria for superiority. The estimated study completion date for the COMPASS trial had been March, 2018i. Given the magnitude of effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the COMPASS clinical trial, will offer rivaroxaban to study participants in an open-label extension trial.

The COMPASS trial enrolled 27,402 patients from more than 600 sites across 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. A complete analysis of the data from the COMPASS trial is expected to be presented at a medical meeting in 2017.