Rivaroxaban for stroke prevention after embolic stroke of undetermined source

The NAVIGATE ESUS clinical trial was designed to evaluate rivaroxaban for the prevention of recurrent stroke in patients who have suffered embolic stroke of undetermined source. The multinational sample population included about 7,200 participants whose ischemic stroke was without arterial stenosis, lacune, or an identified cardioembolic source.

The NAVIGATE ESUS clinical trial was designed to evaluate rivaroxaban for the prevention of recurrent stroke in patients who have suffered embolic stroke of undetermined source. The multinational sample population included about 7,200 participants whose ischemic stroke was without arterial stenosis, lacune, or an identified cardioembolic source. After randomization, 3,609 participants received oral rivaroxaban and 3,604 received aspirin. The primary efficacy endpoint was first recurrence of ischemic or hemorrhagic stroke or systemic embolism, which affected 5.1% of the rivaroxaban group and 4.8% of the aspirin group. Recurrent ischemic stroke occurred at about the same rate in both cohorts. The main safety outcome, meanwhile, was incidence of major bleeding—which occurred in 1.8% of patients taking rivaroxaban and 0.7% of aspirin-takers. Based on the Phase III study findings, which demonstrate that rivaroxaban is no better than aspirin in preventing recurrent stroke and is correlated with a higher risk of bleeding, researchers halted the trial early.