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

NCT02633982 | Unknown DMC

• 1 other identifier: GENeRAL/J
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism

  up to 1.5 years(max 3 years)

Secondary Outcomes (17)

• 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)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

5,000

You may qualify if:

• Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners

You may not qualify if:

• Patients are contraindicated for rivaroxaban
• Patients judged as inappropriate for this study by investigators

Sponsors & Collaborators

• Japan Cardiovascular Research Foundation: lead

Study Sites (1)

Japan Cardiovascular Research Foundation

Suita, Osaka, 565-8565, Japan

RECRUITING

Related Publications (1)

• Matsui K, Kusano K, Akao M, Tsuji H, Hiramitsu S, Hatori Y, Odakura H, Ogawa H. Observational study of frailty in older Japanese patients with non-valvular atrial fibrillation receiving anticoagulation therapy. Sci Rep. 2024 Jun 22;14(1):14423. doi: 10.1038/s41598-024-65237-4.

  PMID: 38909144 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Saburo Saito

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 17, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 17, 2015

Record last verified: 2015-11

Locations

JP (1)