Arrhythmias & electrophysiology
Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF)
Study context
- Population
- Patients aged ≥70 years with atrial fibrillation (AF)planned, randomised 1:1
- Participants
- 4,374 patients
- Planned comparison
- Low-dose vs standard-dose rivaroxaban
- Primary endpoint
- Composite of CV death, MI, stroke and systemic embolic events (efficacy); composite of major and clinically relevant non-major bleeding (safety)
Methodological detailsinvestigator-initiated, multicentre, open-label, blind endpoint evaluation, non-inferiority
- Investigator-initiated
- Multicentre
- Open-label
- Blind endpoint evaluation
- Non-inferiority
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF). Am Heart J. Published 15 July 2025. doi:10.
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