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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02633982

Acronym

GENeRAL

Enrollment

5000

Registered

2015-12-17

Start date

2015-09-30

Completion date

2018-10-31

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)
Major bleeding events (adapted ISTH standard)	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)
Deep vein thrombosis/pulmonary thromboembolism	up to 1.5 years(max 3 years)

Countries

Japan

Contacts

Primary ContactSaburo Saito

general@jcvrf.jp+81-6-6872-0010

Outcome results