ASPIRE Summary

ASPIRE  is a randomized, double-blinded, phase 3 clinical trial designed to test the efficacy and safety of apixaban, compared with aspirin, in patients with a recent intracerebral hemorrhage (ICH) and high-risk non-valvular atrial fibrillation (AF). Seven hundred patients will be recruited at sites coordinated through the NIH/NINDS StrokeNet. Participants will be followed for outcomes over a median of 24 months (12 months minimum, 36 months maximum). Efficacy outcomes are stroke or death (primary) and change in modified Rankin Scale score (secondary). Tertiary outcomes include change in cognition and quality of life, major hemorrhage, myocardial infarction, venous thromboembolism, systemic embolism, and individual components of the primary outcome.