- Question
- Can low-dose rivaroxaban anticoagulation prevent cognitive decline, stroke and TIA in patients with atrial fibrillation (AF) at low thromboembolic risk?
- Design
- Multicenter, double-blind, placebo-controlled trial with 1:1 randomization. A total of 1235 of the intended 1424 participants (919 men and 316 women) were enrolled, and the trial was stopped for futility after a planned interim analysis; median follow-up was 3.7 years.
- Population
- Patients with AF and low thromboembolic risk, with a CHA2DS2-VASc score of 0 or 1 (excluding female sex).
- Intervention
- Rivaroxaban 15 mg once daily.
- Control
- Placebo.
- Primary outcome
- Composite of cognitive decline (drop of ≥ 2 points on the Montreal Cognitive Assessment), stroke, or transient ischemic attack with motor deficit or aphasia.
- Results
- The primary outcome occurred in 256 participants (20.7%), with an annual rate of 7.0% with rivaroxaban versus 6.4% with placebo (HR 1.10; 95% CI 0.86-1.40; P = 0.46). Conditional power analysis estimated a 1.2% probability of reaching a significant effect had the trial continued to the planned 410 events.
- Safety
- Major bleeding occurred in two patients on rivaroxaban (0.09% per year) and in five on placebo (0.21% per year).
- Conclusion
- Despite a high incidence of cognitive decline in AF patients at low stroke risk, low-dose rivaroxaban showed no benefit and the trial was stopped for futility.
- Why it matters
- It provides randomized evidence against using low-dose anticoagulation to prevent cognitive decline in AF patients at low thromboembolic risk, a strategy suggested by observational studies.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026