Janssen Research & Development, LLC (Janssen) has announced that the phase 3 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, 2018. 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-labelextension trial.
The COMPASS trial evaluated Xarelto 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 2.5 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. “Despite established and effective treatments, incidences of CAD and PAD are rising globally,” said Paul Burton, MD, PhD, FACC, vice president, medical affairs, Janssen. “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 US Food and Drug Administration as quickly as possible.”
CAD affects 16.5 million Americans. PAD affects more than 10 million Americans, and is a powerful risk marker of cardiovascular disease. Globally, screening studies suggest approximately 20 percent of adults older than 55 years have evidence of PAD.
COMPASS is part of the EXPLORER clinical research program for Xarelto. Unmatched by any oral anticoagulant in the NOAC class in its size, scope and ambition, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of Xarelto and its potential role in addressing additional critical medical needs. More than 275,000 people will have participated in the programme by the time of its completion. EXPLORER includes 10 indication-seeking and label expansion studies underway beyond the six approved indications for Xarelto in the United States, with the potential to reach more than 40 million people at risk for blood clots in the years to come.