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

Atrial Fibrillation Clinical Trial

— GENeRAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633982
• Other study ID #: GENeRAL/J
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2015
• Last updated: December 14, 2015
• Start date: September 2015
• Est. completion date: October 2018

Study information

• Verified date: November 2015
• Source: Japan Cardiovascular Research Foundation
• Contact: Saburo Saito
• Phone: +81-6-6872-0010
• Email: general[@]jcvrf.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Japan	Japan Cardiovascular Research Foundation	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Cardiovascular Research Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism		up to 1.5 years(max 3 years)	Yes
Secondary	Major bleeding events (adapted ISTH standard)		up to 1.5 years(max 3 years)	Yes
Secondary	Non-major bleeding events(without Major Bleeding complications)		up to 1.5 years(max 3 years)	Yes
Secondary	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)	Yes
Secondary	Symptomatic stroke (ischemic or hemorrhagic)		up to 1.5 years(max 3 years)	Yes
Secondary	Symptomatic ischemic stroke		up to 1.5 years(max 3 years)	Yes
Secondary	Symptomatic hemorrhagic stroke		up to 1.5 years(max 3 years)	Yes
Secondary	Systemic embolism		up to 1.5 years(max 3 years)	Yes
Secondary	Acute myocardial infarction/unstable angina pectoris		up to 1.5 years(max 3 years)	Yes
Secondary	Cardiovascular death		up to 1.5 years(max 3 years)	Yes
Secondary	Deep vein thrombosis/pulmonary thromboembolism		up to 1.5 years(max 3 years)	Yes
Secondary	Transient ischemic attack		up to 1.5 years(max 3 years)	Yes
Secondary	Percutaneous coronary intervention /coronary artery bypass grafting		up to 1.5 years(max 3 years)	Yes
Secondary	All cause death		up to 1.5 years(max 3 years)	Yes
Secondary	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)	Yes
Secondary	Adverse Event excluding hemorrhagic events		up to 1.5 years(max 3 years)	Yes
Secondary	Patients adherence related with stroke or systemic embolism		up to 1.5 years(max 3 years)	No
Secondary	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)	No