Janssen Research & Development and Bayer announced the Phase III NAVIGATE ESUS study, evaluating the efficacy and safety of XARELTO (rivaroxaban) for the secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source (ESUS), is stopping early for futility, according to a press release.
This decision is based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as the trial showed comparable efficacy between rivaroxaban and the standard of care, aspirin, and little chance of rivaroxaban showing an overall benefit versus aspirin if the study were to be completed. While bleeding rates were very low overall and within the expected range, an increase in bleeding was observed in the rivaroxaban arm compared to aspirin.
“XARELTO is a highly effective anticoagulant for patients at risk for stroke from atrial fibrillation, as well as for the prevention and treatment of clots in a variety of approved indications,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. “Results from ROCKET AF and emerging real-world data continue to show the positive benefit of XARELTO in preventing cardiovascular events, including stroke.”