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For patients with embolic stroke of undetermined source (ESUS), the optimal antithrombotic regimen to prevent recurrence is unclear. In this double-blind, industry-sponsored, randomized trial, 5400 adults with recent ESUS received the anticoagulant dabigatran (Pradaxa) or aspirin daily. Patients were eligible if they had a nonlacunar ischemic stroke, no extracranial or intracranial stenotic lesion, no atrial fibrillation lasting longer than 6 minutes during at least 20 hours of monitoring, and no intracardiac thrombus.
During median follow-up of 19 months, incidence of recurrent stroke was not significantly different in the dabigatran and aspirin groups (6.6% and 7.7%, respectively). A small excess of major bleeding with dabigatran, compared…