Department of Medicine, Université de Montréal, Montréal, Québec, Canada.
Department of Medicine, Université de Montréal, Montréal, Québec, Canada.
Can J Cardiol. 2019 Aug;35(8):1069-1077. doi: 10.1016/j.cjca.2019.04.022. Epub 2019 May 7.
Compelling evidence showing a link between atrial fibrillation (AF) and cognitive decline and dementia is accumulating.
Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF) is a prospective, multicentric, double-blind, randomized-controlled trial, recruiting patients with nonvalvular 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 acetylsalicylic acid 100 mg daily in patients with vascular disease).
The primary outcome is the composite of stroke, transient ischemic attack, and cognitive decline (defined by a decrease in the Montreal Cognitive Assessment score ≥ 3 at any follow-up visit after baseline). Approximately 3250 patients will be enrolled in approximately 130 clinical sites until 609 adjudicated primary outcome events have occurred.
BRAIN-AF determines whether oral anticoagulation therapy with rivaroxaban compared with standard of care reduces the risk of stroke, transient ischemic attack, or cognitive decline in patients with nonvalvular AF and a low risk of stroke.
越来越多的证据表明心房颤动（AF）与认知能力下降和痴呆之间存在关联。
抗凝预防心房颤动缺血性卒中和神经认知障碍的盲法随机试验（BRAIN-AF）是一项前瞻性、多中心、双盲、随机对照试验，招募非瓣膜性心房颤动且卒中风险低的患者。有高出血风险的患者将被排除在研究之外。参与者将被随机分配接受利伐沙班（每日 15 毫克）或标准治疗（无血管疾病的患者给予安慰剂，有血管疾病的患者给予乙酰水杨酸 100 毫克/日）。
主要结局是卒中、短暂性脑缺血发作和认知能力下降的复合结局（定义为基线后任何随访访视时蒙特利尔认知评估评分下降≥3）。大约 3250 名患者将在大约 130 个临床中心入组，直到 609 例经裁决的主要结局事件发生。
BRAIN-AF 旨在确定与标准治疗相比，口服抗凝治疗利伐沙班是否可降低非瓣膜性心房颤动且卒中风险低的患者发生卒中、短暂性脑缺血发作或认知能力下降的风险。
