Clinical Research Studies

Site for Survivors of intracerebral hemorrhage (ICH) who have atrial fibrillation/flutter (AF) are at high risk for subsequent ischemic stroke. Although randomized clinical trials have established the of anticoagulant therapy for preventing ischemic stroke in patients with AF,1 these trials did not enroll ICH patients because of concern that a potential increase in risk for recurrent hemorrhagic strokes would offset any benefit. As a result, American Heart Association/American Stroke Association guidelines equivocate on whether to use anticoagulants in patients with AF after ICH2 and only a minority of these patients are currently offered this therapy.3,4 The Anticoagulation for Stroke Prevention and Recovery after ICH (ASPIRE) study is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score = 2). A total of 700 patients, age 18 years or older, with a first-ever ICH 14-120 days before entry will be randomized in a 1:1 ratio to receive apixaban (5 mg tablets twice daily, or 2.5 mg tablets twice daily for patients meeting standard dose-adjustment requirements) or aspirin (81 mg tablet once daily). Participants will be followed for study outcomes for a median of 24 months (minimum 12 months, maximum 36 months). The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Tertiary efficacy and safety outcomes include change in cognition and quality of life, major hemorrhage, myocardial infarction, and individual components of the primary outcome. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.