Heart rhythm O2 · 2025
Efficacy and safety of direct oral anticoagulants for intermediate stroke risk in patients with atrial fibrillation (SINGLE-AF): Study design and protocol.
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Kim Daehoon, Lee Young Soo, Shim Jaemin, Park Junbeom, Park Jin-Kyu, Oh Il-Young, Kang Ki-Woon, Choi Eue-Keun, Park Kyoung-Min, Park Hyoung-Seob, Yu Hee Tae, Kim Tae-Hoon, Uhm Jae-Sun, Pak Hui-Nam, Joung Boyoung
Аннотация
BACKGROUND: The optimal antithrombotic strategy for patients with atrial fibrillation (AF) with intermediate stroke risk (CHA2DS2-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: The Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants for Intermediate Stroke Risk in Patients With Atrial Fibrillation trial is an investigator-initiated, multicenter, open-label, superiority, randomized trial with blinded outcome assessment, enrolling 1800 patients with AF who have 1 nongender stroke risk factor, as indicated by their CHA2DS2-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.
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: The Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants for Intermediate Stroke Risk in Patients With Atrial Fibrillation trial is an investigator-initiated, multicenter, open-label, superiority, randomized trial with blinded outcome assessment, enrolling 1800 patients with AF who have 1 nongender stroke risk factor, as indicated by their CHA2DS2-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.