Study Stopped
Consensus BRAIN-AF Executive Steering Committee to terminate.
Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF
BRAIN-AF
1 other identifier
interventional
1,238
1 country
41
Brief Summary
This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the efficacy and safety of rivaroxaban as compared to standard of care in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF and with low risk of stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Mar 2015
Longer than P75 for phase_3 atrial-fibrillation
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2024
CompletedJune 15, 2025
June 1, 2025
9.2 years
February 26, 2015
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpoint of stroke, TIA and neurocognitive decline. Neurocognitive decline is defined by a decrease in the MoCA score greater than or equal to 2 at any follow-up visit from baseline.
From date of randomization until the date of first documented occurrence of any component of the composite, assessed up to the end of the study
estimated up to 84 months
Secondary Outcomes (4)
Death (total and cardiovascular)
estimated up to 84 months
Composite including stroke/transient ischemic attack (TIA) and systemic embolic events
estimated up to 84 months
Neurocognitive decline
estimated up to 84 months
Hospitalization for cardiovascular (myocardial infarction, heart failure, AF, stroke or unstable angina or other cardiovascular events) or bleeding event
estimated up to 84 months
Other Outcomes (1)
Major clinical bleeding event
estimated up to 84 months
Study Arms (2)
Rivaroxaban
ACTIVE COMPARATORRivaroxaban 15 mg, orally, once daily, preferably at the same time of the day throughout the study.
standard of care
ACTIVE COMPARATORstandard of care
Interventions
Eligibility Criteria
You may qualify if:
- Age at consent ≥30 to ≤62 years;
- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing or any device (i.e. routine 12-lead electrocardiogram, Holter monitor \[continuous ECG recording\] rhythm strip, intracardiac electrogram, or pacemaker or implantable cardiac defibrillator interrogation of at least 30 s, transcutaneous monitoring or other) in the last 2 years;
- Low risk of stroke as defined by the absence of all of the following:
- i. Prior stroke or Transient Ischemic Attack, ii. Hypertension, iii. Diabetes mellitus, iv. Congestive heart failure (New York Heart Association class II or higher at the time of enrolment or a known left ventricular ejection fraction \<35%);
- Signed informed consent
- For entry into the study, none of the following criteria MUST be met
You may not qualify if:
- Known diagnosis of dementia;
- MMSE score \<25;
- Valvular AF \[mechanical heart valve, moderate to severe mitral stenosis (rheumatic or non rheumatic), or hypertrophic cardiomyopathy\];
- Other indication for antiplatelet therapy or anticoagulation;
- History of GI bleeding;
- Conditions associated with an increased risk of bleeding described as follows:
- Major surgery within the previous month;
- Planned surgery or intervention within the next 3 months;
- History of intracranial, intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding;
- Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days;
- Haemorrhagic disorder or bleeding diathesis;
- Fibrinolytic agents within 48 hours of study entry;
- Recent malignancy or radiation therapy (within 6 months from the time of enrolment) and not expected to survive 3 years;
- Reversible cause of AF (e.g. cardiac surgery, pulmonary embolism, untreated hyperthyroidism);
- Absence of recurrence of AF 3 months after AF ablation;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montreal Heart Institutelead
- Canadian Stroke Prevention Intervention Networkcollaborator
- The Montreal Health Innovations Coordinating Center (MHICC)collaborator
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharmacollaborator
- Montreal Heart Institute Foundationcollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- Hewitt Foundationcollaborator
Study Sites (41)
CardiAi Inc.
Calgary, Alberta, Canada
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Office of Dr. TunZan Maung, MD
Abbotsford, British Columbia, V5Z 1M9, Canada
North Shore Heart Center
North Vancouver, British Columbia, Canada
Vancouver General Hospital/UBC
Vancouver, British Columbia, Canada
Cardio 1
Winnipeg, Manitoba, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Dr. Georges-L - Dumont University Hospital Center
Moncton, New Brunswick, Canada
QEll Health Sciences Center-Halifax Infirmary
Halifax, Nova Scotia, Canada
Western University - London Health Sciences Centre
London, Onatrio, Canada
PACE (Partners in Advanced Cardiac Evaluation)
Newmarket, Onatrio, Canada
Oakville Cardiovascular Research LP
Oakville, Onatrio, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada
Vizel Cardiac Research
Cambridge, Ontario, Canada
Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
Cardiology Clinic
Kitchener, Ontario, Canada
St. Mary's general Hospital
Kitchener, Ontario, Canada
One Heart Care
Mississauga, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Viacar Recherche Clinique Inc.
Brossard, Quebec, Canada
CIUSSS du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska (Hopital de Granby)
Granby, Quebec, Canada
CISSSMC-Hopital Charles-Lemoyne
Greenfield Park, Quebec, Canada
Viacar Recherche Clinique Inc.
Greenfield Park, Quebec, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada
Clinique Cardiologie de Levis
Lévis, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, H1T1C8, Canada
CHUM
Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CISSS BSL-Hopital de Rimouski
Rimouski, Quebec, Canada
CISSS des Laurentides-Unite de recherche clinique
Saint-Jérôme, Quebec, Canada
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
CISSS de Lanaudiere-Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada
CIUSSS MCQ CHAUR- Centre Hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, Canada
CHU de Quebec-Universite Laval/Hotel Dieu de Quebec
Québec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Canada
Related Publications (2)
Rivard L, Khairy P, Talajic M, Tardif JC, Healey JS, Black SE, Andrade JG, Field TS, Nault I, Bherer L, Massoud F, Nattel S, Lanthier S, Racine N, Roux JF, Greiss I, Macle L, Guerra PG, Tadros R, Mayrand H, Gosselin G, Conen D, Bocti C, Chayer C, Deschaintre Y, Sandhu RK, Manlucu J, Khaykin Y, Verma A, Mondesert B, Dyrda K, Cadrin-Tourigny J, Thibault B, Raymond-Paquin A, Aguilar M, Brouillette J, Roussin A, Robillard A, Tremblay-Gravel M, David LP, Cossette M, Parkash R, Guertin MC, Roy D; BRAIN-AF investigators; Pandey AS, Pichette F, Barrero M, Kus T, Lemieux A, Gaudreault V, Marzban P, Wong J, Sit PL, Laflamme D, Fowlis R, Quadros K, Kapoor A, Jolly US, Wilton S, Azzari FA, Dorian P, Deslongchamps F, Pesant Y, Vizel S, Maung T, Heffernan M, Nery P, Curnew G, Bourgeois S, Essebag V, Kouz S, Cormier L, Vyselaar J, Chehayeb R, Khoo C, Gupta A, Bessoudo R, Bhargava R, Sandrin F, Schram G, St-Maurice F, Tsui W, Liang W. Anticoagulation to prevent ischemic stroke and neurocognitive impairment in atrial fibrillation: the BRAIN-AF randomized clinical trial. Nat Med. 2026 Jan 7. doi: 10.1038/s41591-025-04101-y. Online ahead of print.
PMID: 41501492DERIVEDRivard L, Khairy P, Talajic M, Tardif JC, Nattel S, Bherer L, Black S, Healey J, Lanthier S, Andrade J, Massoud F, Nault I, Guertin MC, Dorian P, Kouz S, Essebag V, Ellenbogen KA, Wyse G, Racine N, Macle L, Mondesert B, Dyrda K, Tadros R, Guerra P, Thibault B, Cadrin-Tourigny J, Dubuc M, Roux JF, Mayrand H, Greiss I, Roy D. 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.
PMID: 31376908DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lena Rivard, MD
Montreal Heart Institute
- STUDY DIRECTOR
Sophie Tanguay, M.Sc.
Montreal health Innovations Coordinating Centre
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 12, 2015
Study Start
March 1, 2015
Primary Completion
May 18, 2024
Study Completion
May 18, 2024
Last Updated
June 15, 2025
Record last verified: 2025-06