Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF): Methods and Design.
Administration, Oral
Adult
Atrial Fibrillation
/ complications
Blood Coagulation
/ drug effects
Brain Ischemia
/ etiology
Cognitive Dysfunction
/ diagnosis
Double-Blind Method
Drug Monitoring
/ methods
Factor Xa Inhibitors
/ administration & dosage
Female
Humans
Male
Mental Status and Dementia Tests
Middle Aged
Outcome Assessment, Health Care
Rivaroxaban
/ administration & dosage
Stroke
/ etiology
Journal
The Canadian journal of cardiology
ISSN: 1916-7075
Titre abrégé: Can J Cardiol
Pays: England
ID NLM: 8510280
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
18
03
2019
revised:
26
04
2019
accepted:
26
04
2019
entrez:
5
8
2019
pubmed:
5
8
2019
medline:
14
4
2020
Statut:
ppublish
Résumé
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.
Sections du résumé
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.
Identifiants
pubmed: 31376908
pii: S0828-282X(19)30295-8
doi: 10.1016/j.cjca.2019.04.022
pii:
doi:
Substances chimiques
Factor Xa Inhibitors
0
Rivaroxaban
9NDF7JZ4M3
Banques de données
ClinicalTrials.gov
['NCT02387229']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1069-1077Informations de copyright
Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.