Registry Study on the Effectiveness of Rivaroxaban in Patients With Non-valvular Atrial Fibrillation Managed by General Practitioners(GENERAL Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
研究概览
简要总结
In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering this,warfarin is a drug which puts a great burden on patients and medical providers.
With the population aging, the number of non-valvular atrial fibrillation patients is increasing, and a necessity that not only specialist but also general practitioners. Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti- coagulant effect soon after administration. It hardly reacts with foods or other drugs and therefore does not require regular monitoring. GENERAL study is to investigate the effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients when it is prescribed by general practioners in real life settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners
排除标准
- •Patients are contraindicated for rivaroxaban
- •Patients judged as inappropriate for this study by investigators
结局指标
主要结局
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
时间窗: up to 1.5 years(max 3 years)
次要结局
- All cause death(up to 1.5 years(max 3 years))
- Symptomatic ischemic stroke(up to 1.5 years(max 3 years))
- Major bleeding events (adapted ISTH standard)(up to 1.5 years(max 3 years))
- Composite of symptomatic stroke(ischemic or hemorrhagic),systemic embolism,myocardial infarction/unstable angina pectoris and cardiovascular death(up to 1.5 years(max 3 years))
- Symptomatic stroke (ischemic or hemorrhagic)(up to 1.5 years(max 3 years))
- Symptomatic hemorrhagic stroke(up to 1.5 years(max 3 years))
- Correlation with CHADS2 score or other risk factors and outcome events in Japanese patients who administered Rivaroxaban(up to 1.5 years(max 3 years))
- Non-major bleeding events(without Major Bleeding complications)(up to 1.5 years(max 3 years))
- Systemic embolism(up to 1.5 years(max 3 years))
- Cardiovascular death(up to 1.5 years(max 3 years))
- Transient ischemic attack(up to 1.5 years(max 3 years))
- Acute myocardial infarction/unstable angina pectoris(up to 1.5 years(max 3 years))
- Percutaneous coronary intervention /coronary artery bypass grafting(up to 1.5 years(max 3 years))
- Deep vein thrombosis/pulmonary thromboembolism(up to 1.5 years(max 3 years))
- Adverse Event excluding hemorrhagic events(up to 1.5 years(max 3 years))
- Patients adherence related with stroke or systemic embolism(up to 1.5 years(max 3 years))
- Comparison of primary outcome (composite of symptomatic stroke(ischemic/hemorrhagic) and systemic embolism) rate and Major Bleeding complications (adapted ISTH standard)rate between EXPAND study and FUSHIMI AF registry(up to 1.5 years(max 3 years))