Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in AF (BRAIN-AF): Methods and design

Abstract Background Compelling evidence showing a link between AF and cognitive decline and dementia are accumulating. Methods BRAIN-AF is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with non-valvular AF and a low risk of stroke. Patients with a high risk of bleeding will be excluded from the study. Participants will be randomized to receive either rivaroxaban (15 mg daily) or standard of care (placebo in patients without vascular disease or ASA 100 mg daily in patients with vascular disease). The primary outcome is the composite of stroke, transient ischemic attack, (TIA) and cognitive decline (defined by a decrease in the MoCA score ≥3 at any follow-up visit after baseline). Approximately 3,250 patients will be enrolled in about 130 clinical sites until 609 adjudicated primary outcome events have occurred. Conclusion BRAIN-AF will determine whether oral anticoagulation therapy with rivaroxaban compared with standard of care reduces the risk of stroke, TIA or cognitive decline in patients with non-valvular AF and a low risk of stroke.