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

NCT ID: NCT02633982

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Cardiovascular Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Japan Cardiovascular Research Foundation

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Saburo Saito

Role: CONTACT

Phone: +81-6-6872-0010

Email: [email protected]

Facility Contacts

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Hisao Ogawa

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38909144 (View on PubMed)

Other Identifiers

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GENeRAL/J

Identifier Type: -

Identifier Source: org_study_id