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

• Conditions: Atrial Fibrillation

• Registration Number: NCT02633982
• Lead Sponsor: Japan Cardiovascular Research Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-11
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Study First Posted: 2015-12-17
• Last Update Posted: 2015-12-17
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism	up to 1.5 years(max 3 years)

Secondary Outcome Measures

Name	Time	Method
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)
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)
Cardiovascular death	up to 1.5 years(max 3 years)

Trial Locations

Locations (1)

Japan Cardiovascular Research Foundation; 🇯🇵 Suita, Osaka, Japan