BRAIN-AF

Treating the Heart-Helping the Brain.

Study Progression Status Number of Sites Number of Patients Enrolled
Planning/Start Up Target: 50 Target: 500 for pilot
studies-brain-af-brain-af

Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder afflicting 0.4% of the general population. The prevalence of AF is increasing, even after adjusting for age. Growing evidence suggests that the rate of cognitive impairment and dementia is magnified in patients with AF, independently of clinical stroke. Importantly, the strongest association between AF and dementia has been observed in patients

Patients deemed at low risk of stroke (i.e., without: congestive heart failure, hypertension, age ›75 years, diabetes, and prior stroke or transient ischemic attack) constitute a large subset (20-25%) of the AF population for whom aspirin is generally recommended.

With C-SPIN, our team proposes to challenge standard paradigms in testing the hypothesis that a pharmacological intervention, i.e., anticoagulation, may delay neurocognitive decline and reduce the probability that an individual will ever develop dementia:

  • The primary hypothesis of the BRAIN-AF study is that anticoagulation with low dose rivaroxaban in patients with non-valvular atrial fibrillation and a low stroke risk will reduce the combined endpoint consisting of stroke or cognitive impairment when compared to aspirin.
  • A total of 6,396 patients (age 18 to 64 years) from across Canada and key international sites will be enrolled and randomized 1:1 (i.e., 3,198 per treatment arm) to rivaroxaban 15 mg

BRAIN-AF – ClinicalTrials.gov

Investigators:

Lena Rivard, M.D,
Denis Roy, M.D.
Mario Talajic, M.D.
Dominique Johnson, M.D.

Countries Participating:

  • Canada