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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Japan Cardiovascular Research Foundation
Suita, Osaka, Japan
RECRUITINGComposite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
Time frame: up to 1.5 years(max 3 years)
Major bleeding events (adapted ISTH standard)
Time frame: up to 1.5 years(max 3 years)
Non-major bleeding events(without Major Bleeding complications)
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
Symptomatic stroke (ischemic or hemorrhagic)
Time frame: up to 1.5 years(max 3 years)
Symptomatic ischemic stroke
Time frame: up to 1.5 years(max 3 years)
Symptomatic hemorrhagic stroke
Time frame: up to 1.5 years(max 3 years)
Systemic embolism
Time frame: up to 1.5 years(max 3 years)
Acute myocardial infarction/unstable angina pectoris
Time frame: up to 1.5 years(max 3 years)
Cardiovascular death
Time frame: up to 1.5 years(max 3 years)
Deep vein thrombosis/pulmonary thromboembolism
Time frame: up to 1.5 years(max 3 years)
Transient ischemic attack
Time frame: up to 1.5 years(max 3 years)
Percutaneous coronary intervention /coronary artery bypass grafting
Time frame: up to 1.5 years(max 3 years)
All cause death
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
Adverse Event excluding hemorrhagic events
Time frame: up to 1.5 years(max 3 years)
Patients adherence related with stroke or systemic embolism
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.