Lena Rivard1, Paul Khairy2, Mario Talajic2, Jean-Claude Tardif2, Stanley Nattel2, Louis Bherer2, Sandra Black3, Jeffrey Healey4, Sylvain Lanthier2, Jason Andrade5, Fadi Massoud2, Isabelle Nault6, Marie-Claude Guertin7, Paul Dorian8, Simon Kouz7, Vidal Essebag9, Kenneth A Ellenbogen10, George Wyse11, Normand Racine2, Laurent Macle2, Blandine Mondesert2, Katia Dyrda2, Rafik Tadros2, Peter Guerra2, Bernard Thibault2, Julia Cadrin-Tourigny2, Marc Dubuc2, Jean-Francois Roux12, Helene Mayrand13, Isabelle Greiss2, Denis Roy2. 1. Department of Medicine, Université de Montréal, Montréal, Québec, Canada. Electronic address: lena.rivard@umontreal.ca. 2. Department of Medicine, Université de Montréal, Montréal, Québec, Canada. 3. Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. 4. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 5. University of British Columbia, Vancouver, British Columbia, Canada. 6. Institut Universitaire de Cardiologie et Pneumologie de Québec, Québec City, Québec, Canada. 7. Montreal Health Innovations Coordinating Center, Montréal, Québec, Canada. 8. Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 9. McGill University Health Centre, Hôpital Sacré Coeur de Montréal, Montréal, Québec, Canada. 10. Division of Cardiology, Virginia Commonwealth University, Richmond, Virginia, USA. 11. Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada. 12. Cardiology Service, Department of Medicine, Faculty of Medicine and Health Sciences, Sherbrooke University, Sherbrooke, Québec, Canada. 13. Hôpital de la Cité-de-la-Santé, Laval, Québec, Canada.
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 oracetylsalicylic 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.
RCT Entities:
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.