Rivaroxaban Trial Meets End Point Ahead of Schedule
An open-label extension trial will also be conducted.
A phase 3 study examining the safety and efficacy of rivaroxaban (Xarelto, Janssen) has ended early based on the recommendation of an independent data monitoring committee, according to a manufacturer's news release.
The Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS; ClinicalTrials.gov identifier: NCT01776424) trial evaluated rivaroxaban therapy for the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction, and stroke, in more than 27,000 patients with either coronary artery disease or peripheral artery disease. The trial reached its prespecified primary end point for superiority well ahead of its estimated March 2018 completion.
Janssen, Bayer, and the Population Health Research Institute will conduct an additional open-label extension trial of rivaroxaban.
According to the press release, complete data analysis will be presented at a yet-to-be-determined medical meeting in 2017.
Phase 3 COMPASS study of Xarelto® (rivaroxaban) stopping early for efficacy; study meets primary endpoint of prevention of major adverse cardiac events in patients with coronary artery disease or peripheral artery disease [news release]. Titusville, NJ: Janssen Pharmaceutical Companies. Published February 8, 2017. Accessed February 14, 2017.