GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence

Study Overview
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Brief Summary
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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.

Official Title
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Registry Study on the Effectiveness of Rivaroxaban in Patients With Non-valvular Atrial Fibrillation Managed by General Practitioners(GENERAL Study)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners Exclusion Criteria: Patients are contraindicated for rivaroxaban Patients judged as inappropriate for this study by investigators

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism |  | up to 1.5 years(max 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding events (adapted ISTH standard) |  | up to 1.5 years(max 3 years) | 
| Non-major bleeding events(without Major Bleeding complications) |  | 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 ischemic stroke |  | up to 1.5 years(max 3 years) | 
| Symptomatic hemorrhagic stroke |  | up to 1.5 years(max 3 years) | 
| Systemic embolism |  | up to 1.5 years(max 3 years) | 
| Acute myocardial infarction/unstable angina pectoris |  | up to 1.5 years(max 3 years) | 
| Cardiovascular death |  | up to 1.5 years(max 3 years) | 
| Deep vein thrombosis/pulmonary thromboembolism |  | up to 1.5 years(max 3 years) | 
| Transient ischemic attack |  | up to 1.5 years(max 3 years) | 
| Percutaneous coronary intervention /coronary artery bypass grafting |  | up to 1.5 years(max 3 years) | 
| All cause death |  | 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) | 
| 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) | 
| 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) |