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The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)

Sponsor: Yonsei University

Summary

Atrial fibrillation (AF) increases the risk of stroke, and oral anticoagulation is strongly recommended for patients at high thromboembolic risk. However, for patients with intermediate stroke risk, defined as a CHA₂DS₂-VASc score of 1 in men or 2 in women, randomized evidence supporting anticoagulation remains limited. The SINGLE-AF trial is an investigator-initiated, multicenter, open-label, adjudicator-masked, superiority randomized trial conducted in South Korea. Eligible patients with AF and intermediate stroke risk are randomly assigned in a 1:1 ratio to receive direct oral anticoagulant (DOAC) therapy or no anticoagulant therapy. Patients assigned to anticoagulation receive a direct oral anticoagulant, primarily apixaban or rivaroxaban. Patients assigned to no anticoagulant therapy do not receive routine oral anticoagulation, although temporary anticoagulation is permitted around rhythm-control procedures when clinically indicated. The primary objective of this trial is to determine whether DOAC therapy reduces the risk of adverse clinical events compared with no anticoagulant therapy. The primary end point is a composite of stroke, systemic embolism, major bleeding, or cardiovascular death at 24 months after randomization.

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