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

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

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 Overview

• Status: Unknown
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-8565
      • Recruiting
      • Japan Cardiovascular Research Foundation
      • Contact: Hisao Ogawa; Phone Number: 2231 +81-6-6833-5012; Email: ogawah@ncvc.go.jp
      • Principal Investigator: Hisao Ogawa, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

5,000

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Japan Cardiovascular Research Foundation

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GENeRAL/J