February 9, 2017 — Janssen Research & Development LLC (Janssen) announced that the Phase 3 COMPASS trial is stopping earlier than planned. The trial was 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). The decision to stop the trial 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-label extension 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.
Xarelto is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how Xarelto and warfarin compare in reducing the risk of stroke.
Xarelto is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
It can also be prescribed to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
For more information: www.janssen.com