COMPASS: Rivaroxaban superior to aspirin for prevention of CV events in patients with CAD, PAD

Janssen Pharmaceuticals announced that the COMPASS trial of rivaroxaban for prevention of major adverse CV events in patients with CAD or peripheral artery disease was stopped early due to superiority being demonstrated.

In the phase 3 trial, 27,402 patients with CAD or PAD from more than 600 sites in more than 30 countries were randomly assigned rivaroxaban (Xarelto, Janssen Pharmaceuticals) 2.5 mg twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone or aspirin 100 mg once daily alone, according to a press release from Janssen.

According to the release, the trial’s data safety and monitoring board decided to stop the study after the primary endpoint of major adverse CV events, defined as CV death, MI or stroke, reached its prespecified criteria for superiority.

The sponsors of the trial, Janssen, Bayer and the Population Health Research Institute, decided to offer rivaroxaban to all participants in an open-label extension trial, according to the release.

“Despite established and effective treatments, incidences of CAD and PAD are growing globally,” Paul Burton, MD, PhD, FACC, Janssen’s vice president of medical affairs, said in the release. “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 [FDA] as quickly as possible.”

The researchers expect to present a full analysis of the data at a medical meeting in 2017, according to the release.

Disclosure: Burton is an employee of Janssen Pharmaceuticals.