Phase 3 cardiac trial stopped early after meeting primary endpoint

The Phase 3 COMPASS study of rivaroxaban (Xarelto) has been stopped early after meeting its primary endpoint of preventing major adverse cardiac events in patients with coronary artery disease or peripheral artery disease, pharmaceuticals Bayer and Janssen have announced.

The COMPASS trial was evaluating the efficacy and safety of 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). The decision to stop early was 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 original end date for the study had been March 2018. Following the success of the trial Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the COMPASS clinical trial, will now offer rivaroxaban to study participants in an open-label extension trial.

The COMPASS trial evaluated rivaroxaban in patients with CAD or PAD. It 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 2.5mg twice daily in addition to aspirin 100mg once daily, rivaroxaban 5mg twice daily alone, or aspirin 100mg once daily alone.

A complete analysis of the data from the COMPASS trial is expected to be presented at a medical meeting in 2017.

Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen, said: “Despite established and effective treatments, incidences of CAD and PAD are rising globally. 

“We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the U.S. Food and Drug Administration as quickly as possible.”