Janssen announced that the Phase 3 trial, COMPASS, is stopping earlier than planned based on the recommendation of the study’s Independent Data Monitoring Committee (DMC), as the primary major adverse cardiovascular events (MACE) endpoint has reached its pre-specified criteria for superiority.
The COMPASS trial (n=27,402) evaluated the efficacy and safety of Xarelto (rivaroxaban) for the prevention of MACE, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or with peripheral artery disease (PAD). Patients were randomized to either rivaroxaban 2.5mg twice daily + aspirin 100mg once daily, rivaroxaban 5mg twice daily alone, or aspirin 100mg once daily alone.
The trial was anticipated to complete in March 2018 but due to the extent of its effect, rivaroxaban will be offered to study patients in an open-label extension trial. The full analysis of data will be presented at a medical conference in 2017.
Xarelto, a Factor Xa inhibitor, is indicated to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem; to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again; and 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 call (800) 526-7736 or visit Xarelto.com.