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

Can J Cardiol. 2019 Aug;35(8):1069-1077. doi: 10.1016/j.cjca.2019.04.022. Epub 2019 May 7.

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.

Trial registration: ClinicalTrials.gov NCT02387229.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / drug therapy
  • Blood Coagulation / drug effects
  • Brain Ischemia* / etiology
  • Brain Ischemia* / prevention & control
  • Cognitive Dysfunction* / diagnosis
  • Cognitive Dysfunction* / etiology
  • Cognitive Dysfunction* / prevention & control
  • Double-Blind Method
  • Drug Monitoring / methods
  • Factor Xa Inhibitors / administration & dosage
  • Factor Xa Inhibitors / adverse effects
  • Female
  • Humans
  • Male
  • Mental Status and Dementia Tests
  • Middle Aged
  • Outcome Assessment, Health Care
  • Rivaroxaban* / administration & dosage
  • Rivaroxaban* / adverse effects
  • Stroke* / etiology
  • Stroke* / prevention & control

Substances

  • Factor Xa Inhibitors
  • Rivaroxaban

Associated data

  • ClinicalTrials.gov/NCT02387229