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Updated: Jan 21, 2026

Robotic Ablation of Atrial Fibrillation
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Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial

Lena Rivard1, Paul Khairy1, Mario Talajic1

  • 1Department of Medicine, Université de Montréal, Montréal, Québec, Canada.

The Canadian Journal of Cardiology
|August 5, 2019
PubMed

Insights

This study investigated if rivaroxaban reduces stroke and cognitive decline in atrial fibrillation (AF) patients. Results will clarify anticoagulation benefits for AF-related neurocognitive impairment.

Area of Science:

  • Cardiology
  • Neurology
  • Clinical Trials

Background:

  • Growing evidence links atrial fibrillation (AF) to cognitive decline and dementia.
  • Understanding AF's impact on brain health is crucial for preventative strategies.

Purpose of the Study:

  • To determine if rivaroxaban, an oral anticoagulant, reduces the risk of stroke, transient ischemic attack (TIA), or cognitive decline.
  • To evaluate the efficacy of anticoagulation in patients with nonvalvular AF and low stroke risk.

Main Methods:

  • The 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.
  • Patients with nonvalvular AF and low stroke risk were randomized to rivaroxaban (15 mg daily) or standard of care.
  • Exclusion criteria included high bleeding risk.

Main Results:

  • The primary outcome is a composite of stroke, TIA, and cognitive decline (defined as ≥ 3-point decrease in Montreal Cognitive Assessment score).
  • Approximately 3250 patients will be enrolled across 130 sites.
  • The study aims to reach 609 adjudicated primary outcome events.

Conclusions:

  • BRAIN-AF will provide critical data on the effectiveness of rivaroxaban in preventing adverse cerebrovascular and cognitive outcomes in AF patients.
  • Findings will inform clinical guidelines for managing AF to preserve cognitive function.
Abstract

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