Rivaroxaban trial stopped early due to positive results in coronary artery disease patients

Janssen announced on Feb. 8 that it had stopped a phase 3 trial early after the study reached its pre-specified criteria for superiority.

The COMPASS trial evaluated the safety and efficacy of rivaroxaban (Xarelto) to prevent major adverse cardiac events in patients with coronary artery disease or peripheral artery disease.

Janssen said that the study’s independent data monitoring committee recommended stopping the trial early. The company expected to complete the study in March 2018.

The FDA approved rivaroxaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, to treat deep vein thrombosis, pulmonary embolism and to reduce the risk of recurrence of deep vein thrombosis and pulmonary embolism.

In October, the FDA concluded that rivaroxaban was a safe and effective alternative to warfarin for patients with atrial fibrillation. The agency’s announced came three months after Alere voluntarily recalled devices that were used to monitor warfarin in a pivotal phase 3 trial that supported rivaroxaban’s approval in 2011.

The COMPASS trial enrolled 27,402 patients with coronary artery disease or peripheral artery disease. The patients were randomized to receive 2.5 mg of rivaroxaban twice daily plus 100 mg of aspirin once daily, five mg of rivaroxaban twice daily or 100 mg of aspirin once daily.

Janssen said that the trial met its primary endpoint of preventing major adverse cardiac events such as cardiovascular death, MI and stroke. Researchers will now offer rivaroxaban to all participants as part of an open-label extension trial.

Full results of the study are expected to be presented later this year at a medical meeting, according to Janssen.