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.

• Authors: Lena Rivard, Paul Khairy, Mario Talajic, Jean-Claude Tardif, Stanley Nattel, Louis Bherer, Sandra Black, Jeffrey Healey, Sylvain Lanthier, Jason Andrade, Fadi Massoud, Isabelle Nault, Marie-Claude Guertin, Paul Dorian, Simon Kouz, Vidal Essebag, Kenneth A Ellenbogen, George Wyse, Normand Racine, Laurent Macle, Blandine Mondesert, Katia Dyrda, Rafik Tadros, Peter Guerra, Bernard Thibault, Julia Cadrin-Tourigny, Marc Dubuc, Jean-Francois Roux, Helene Mayrand, Isabelle Greiss, Denis Roy
• Journal: The Canadian journal of cardiology (Can J Cardiol) Vol. 35 Issue 8 Pg. 1069-1077 (08 2019) ISSN: 1916-7075 [Electronic] England
• PMID: 31376908 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Chemical References

• Factor Xa Inhibitors
• Rivaroxaban

Topics

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