Clinical trial NCT02633982: GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence
Official title: Registry Study on the Effectiveness of Rivaroxaban in Patients With Non-valvular Atrial Fibrillation Managed by General Practitioners(GENERAL Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Japan Cardiovascular Research Foundation
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5,000

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
timeFrame: up to 1.5 years(max 3 years)
Secondary outcomes:
measure: Major bleeding events (adapted ISTH standard)
timeFrame: up to 1.5 years(max 3 years)
measure: Non-major bleeding events(without Major Bleeding complications)
timeFrame: up to 1.5 years(max 3 years)
measure: Composite of symptomatic stroke(ischemic or hemorrhagic),systemic embolism,myocardial infarction/unstable angina pectoris and cardiovascular death
timeFrame: up to 1.5 years(max 3 years)
measure: Symptomatic stroke (ischemic or hemorrhagic)
timeFrame: up to 1.5 years(max 3 years)
measure: Symptomatic ischemic stroke
timeFrame: up to 1.5 years(max 3 years)
measure: Symptomatic hemorrhagic stroke
timeFrame: up to 1.5 years(max 3 years)
measure: Systemic embolism
timeFrame: up to 1.5 years(max 3 years)
measure: Acute myocardial infarction/unstable angina pectoris
timeFrame: up to 1.5 years(max 3 years)
measure: Cardiovascular death
timeFrame: up to 1.5 years(max 3 years)
measure: Deep vein thrombosis/pulmonary thromboembolism
timeFrame: up to 1.5 years(max 3 years)
measure: Transient ischemic attack
timeFrame: up to 1.5 years(max 3 years)
measure: Percutaneous coronary intervention /coronary artery bypass grafting
timeFrame: up to 1.5 years(max 3 years)
measure: All cause death
timeFrame: up to 1.5 years(max 3 years)
measure: 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
timeFrame: up to 1.5 years(max 3 years)
measure: Adverse Event excluding hemorrhagic events
timeFrame: up to 1.5 years(max 3 years)
measure: Patients adherence related with stroke or systemic embolism
timeFrame: up to 1.5 years(max 3 years)
measure: Correlation with CHADS2 score or other risk factors and outcome events in Japanese patients who administered Rivaroxaban
timeFrame: up to 1.5 years(max 3 years)
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Japan Cardiovascular Research Foundation
state: Osaka
Study officials:
References: