BRAIN-AF
Trial question
What is the role of rivaroxaban in preventing AIS and neurocognitive impairment in patients with AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 1235
1235 patients (321 female, 914 male).
Inclusion criteria: adult patients aged 30-62 years with AF.
Key exclusion criteria: prior stroke or TIA; hypertension; diabetes; congestive HF; increased risk of bleeding; reversible cause of AF; dementia; CKD.
Interventions
N=611 rivaroxaban (at an oral dose of 15 mg daily).
N=624 placebo (matching placebo).
Primary outcome
Cognitive decline, stroke, or transient ischemic attack per year
7%
6.4%
7.0 %
5.3 %
3.5 %
1.8 %
0.0 %
Rivaroxaban
Placebo
No significant
difference ↔
No significant difference in cognitive decline, stroke, or TIA per year (7% vs. 6.4%; HR 1.1, 95% CI 0.86 to 1.4).
Secondary outcomes
No significant difference in major bleeding (0.3% vs. 0.8%; ARD -0.5, 95% CI -1.38 to 0.38).
Conclusion
In adult patients aged 30-62 years with AF, rivaroxaban was not superior to placebo with respect to cognitive decline, stroke, or TIA per year.
Reference
Lena Rivard, et al. Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF (BRAIN-AF). American Heart Association. 2024 Nov 16.
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