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Canadian Journal of Cardiology

Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF): Methods and Design

      Abstract

      Background

      Compelling evidence showing a link between atrial fibrillation (AF) and cognitive decline and dementia is accumulating.

      Methods

      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).

      Results

      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.

      Conclusions

      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.

      Résumé

      Contexte

      Les données probantes montrant l’existence d’un lien entre la fibrillation auriculaire (FA) et le déclin cognitif et la démence sont de plus en plus nombreuses.

      Méthodologie

      L’étude BRAIN-AF (Blinded Randomized trial of Anticoagulation to prevent Ischemic stroke and Neurocognitive impairment in Atrial Fibrillation) est une étude prospective multicentrique à double insu et à répartition aléatoire menée auprès de patients présentant une FA non valvulaire et un faible risque d’accident vasculaire cérébral (AVC). Les patients présentant un risque élevé d’hémorragie seront exclus de l’étude. Les participants seront répartis aléatoirement pour recevoir soit du rivaroxaban (à raison de 15 mg par jour), soit un traitement de référence (placebo chez les patients ne présentant pas de maladie vasculaire et acide acétylsalicylique à 100 mg par jour chez les patients présentant une maladie vasculaire).

      Résultats

      Le paramètre principal regroupe l’AVC, l’ischémie cérébrale transitoire et le déclin cognitif (défini par une baisse ≥ 3 du score à l’échelle MoCa [Montreal Cognitive Assessment, Évaluation cognitive de Montréal] à n’importe quelle visite de suivi après le début de l’étude). Environ 3 250 patients seront recrutés dans quelque 130 centres, et l’étude se poursuivra jusqu’à ce que 609 événements confirmés correspondant au paramètre principal soient survenus.

      Conclusions

      L’étude BRAIN-AF vise à comparer l’efficacité du traitement anticoagulant à prise orale par le rivaroxaban et du traitement de référence à l’égard de la réduction du risque d’AVC, d’ischémie cérébrale transitoire et de déclin cognitif chez les patients présentant une FA non valvulaire et un faible risque d’AVC.
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