Efficacy and safety of direct oral anticoagulants for intermediate stroke risk in patients with atrial fibrillation (SINGLE-AF): Study design and protocol

Background: -VASc score of 1 [in males] and 2 [in females]) is uncertain. Although current guidelines provide class IIa recommendations for oral anticoagulant (OAC) treatment in the population, no randomized trials have addressed this therapeutic question. Objective: This study aimed to conduct a randomized clinical trial evaluating the safety and efficacy of OAC therapy compared with no OAC therapy in patients with AF at intermediate stroke risk. Methods: -VASc score scoring 1 (in males) and 2 (in females). Eligible patients will be randomized to receive either OAC therapy with direct OACs (apixaban or rivaroxaban) or no OAC therapy. Results: The primary endpoint is a composite of stroke, systemic embolism, major bleeding as defined by the International Society on Thrombosis and Hemostasis criteria, and cardiovascular death, assessed at 2 years after randomization. We hypothesized that OAC therapy would be superior to no OAC therapy for the net composite outcome among patients with AF. Conclusion: The Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants for Intermediate Stroke Risk in Patients With Atrial Fibrillation trial will evaluate the efficacy and safety of OAC therapy vs no OAC in patients with AF with a single nongender stroke risk factor, aiming to provide evidence to guide anticoagulation strategies in those with intermediate stroke risk.