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).

BACKGROUND

Non-vitamin K antagonist anticoagulant (NOAC) is considered the first-line treatment for atrial fibrillation (AF) patients to reduce the risk of stroke, especially in the elderly. However, robust clinical evidence is lacking regarding the appropriateness of low-dose NOAC.

DESIGN

The SAFE-AF trial is an investigator-initiated, multicenter, open-label, randomized controlled, blind endpoint evaluation, non-inferiority designed trial comparing the efficacy and safety of low-dose rivaroxaban with standard-dose rivaroxaban in patients aged ≥70 years with AF. Participants (N = 4,374) will be randomized 1:1 to receive either standard-dose rivaroxaban (20 mg once daily) or low-dose rivaroxaban (15 mg once daily). The primary efficacy endpoint is the composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolic events (SEE). The primary safety endpoint is the composite endpoint of major bleeding events and clinically relevant non-major bleeding events.

CONCLUSIONS

The SAFE-AF trial is intended to provide valid evidence concerning low-dose rivaroxaban for anticoagulant therapy in older patients with AF.

TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06108414.