BRAIN-AF
(2026)Objective
To determine whether rivaroxaban prevents cognitive decline in AF patients with CHA₂DS₂-VASc 0–1 who do not otherwise require anticoagulation
Study Summary
• Rivaroxaban did not prevent cognitive decline in low-risk AF patients (CHA₂DS₂-VASc 0–1).
• The trial was stopped early for futility after 3.7 years, with no difference in the primary composite cognitive outcome.
• The trial was stopped early for futility after 3.7 years, with no difference in the primary composite cognitive outcome.
Intervention
Rivaroxaban 15 mg daily vs matching placebo
Inclusion Criteria
AF with CHA₂DS₂-VASc 0 (men) or 1 (women), no indication for anticoagulation
Study Design
Arms: Array
Patients per Arm: 611 rivaroxaban, 624 placebo
Outcome
Primary composite (≥2-point MoCA drop, dementia, or stroke): 20.7% vs 20.0% (HR 1.10, 95% CI 0.86–1.40, P=0.46). No difference in any secondary endpoint. Major bleeding 0.09% vs 0.21%/yr (NS).