The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,803
- 试验地点
- 2
- 主要终点
- Composite outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with atrial fibrillation aged between 19 and 80 years
- •CHA2DS2-VASc score of 1 (male) or 2 (female)
排除标准
- •Significant liver (aspartate transaminase and/or alanine transaminase > 3 times the upper limit of normal or liver cirrhosis classified as Child-Pugh class B or C) or renal disease (serum creatinine ≥ 3.5 mg/dl or creatinine clearance < 30 ml/min)
- •Requiring anticoagulation due to surgery with a mechanical prosthetic valve, moderate-to-severe mitral stenosis, or deep vein thrombosis
- •Significant structural heart disease A. Moderate mitral regurgitation B. Severe valvular regurgitation or stenosis C. Dilated cardiomyopathy D. Hypertrophic cardiomyopathy E. Cardiac amyloidosis
- •Active malignancy
- •Pregnancy or breast-feeding
- •Life expectancy < 1 year
- •Refuse or unable to understand the written informed consent
结局指标
主要结局
Composite outcome
时间窗: 24 months
Composite outcome including stroke/systemic embolism, major bleeding, and cardiovascular death
次要结局
- Hospital admission(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Death(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Systemic embolism(24 months)
- Transient ischemic attack (TIA)(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Clinically Relivant Non-Major Bleeding (CRNMB)(Baseline, 1month, 6 month, 12 month, 18 month, 24 month)
- Stroke(24 months)
- Major bleeding(24 months)
- Cardiovascular Death(24 months)
- Clinically Relevant Non-Major Bleeding (CRNMB)(24 months)
- Death(24 months)
- Transient ischemic attack (TIA)(24 months)
- Myocardial infarction(24 months)
- Hospital admission(24 months)