Atrial FibrillationGENeRALNCT02633982
GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence
An observational study of Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 5,000 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2015to Oct 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5,000
Who may be able to join
- Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners
Who cannot join
- Patients are contraindicated for rivaroxaban
- Patients judged as inappropriate for this study by investigators
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Japan Cardiovascular Research Foundation
Suita, Osaka, 565-8565
Hisao Ogawa, +81-6-6833-5012 ext. 2231, ogawah@ncvc.go.jp
Hisao Ogawa, M.D.
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
Measured: up to 1.5 years(max 3 years)
Secondary outcomes (17)
Major bleeding events (adapted ISTH standard)
Measured: up to 1.5 years(max 3 years)
Non-major bleeding events(without Major Bleeding complications)
Measured: 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
Measured: up to 1.5 years(max 3 years)
Symptomatic stroke (ischemic or hemorrhagic)
Measured: up to 1.5 years(max 3 years)
Symptomatic ischemic stroke
Measured: up to 1.5 years(max 3 years)
Symptomatic hemorrhagic stroke
Measured: up to 1.5 years(max 3 years)
Systemic embolism
Measured: up to 1.5 years(max 3 years)
Acute myocardial infarction/unstable angina pectoris
Measured: up to 1.5 years(max 3 years)
Cardiovascular death
Measured: up to 1.5 years(max 3 years)
Deep vein thrombosis/pulmonary thromboembolism
Measured: up to 1.5 years(max 3 years)
Transient ischemic attack
Measured: up to 1.5 years(max 3 years)
Percutaneous coronary intervention /coronary artery bypass grafting
Measured: up to 1.5 years(max 3 years)
All cause death
Measured: 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
Measured: up to 1.5 years(max 3 years)
Adverse Event excluding hemorrhagic events
Measured: up to 1.5 years(max 3 years)
Patients adherence related with stroke or systemic embolism
Measured: 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
Measured: up to 1.5 years(max 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Japan Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633982
- Sponsor's protocol ID
- GENeRAL/J
- Acronym
- GENeRAL
- Status last verified
- Nov 2015
- First submitted
- 9 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38909144
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on the Effectiveness of Rivaroxaban in Patients With Non-valvular Atrial Fibrillation Managed by General Practitioners(GENERAL Study)
- ClinicalTrials.gov ID
- NCT02633982
- Acronym / sponsor ID
- GENeRAL / GENeRAL/J
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Japan Cardiovascular Research FoundationUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5,000
Key inclusion criteria (1 listed)
- Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners
Key exclusion criteria (2 listed)
- Patients are contraindicated for rivaroxaban
- Patients judged as inappropriate for this study by investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
Time frame: up to 1.5 years(max 3 years)
17 secondary outcomes
Major bleeding events (adapted ISTH standard)
Time frame: up to 1.5 years(max 3 years)
Non-major bleeding events(without Major Bleeding complications)
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
Symptomatic stroke (ischemic or hemorrhagic)
Time frame: up to 1.5 years(max 3 years)
Symptomatic ischemic stroke
Time frame: up to 1.5 years(max 3 years)
Symptomatic hemorrhagic stroke
Time frame: up to 1.5 years(max 3 years)
Systemic embolism
Time frame: up to 1.5 years(max 3 years)
Acute myocardial infarction/unstable angina pectoris
Time frame: up to 1.5 years(max 3 years)
Cardiovascular death
Time frame: up to 1.5 years(max 3 years)
Deep vein thrombosis/pulmonary thromboembolism
Time frame: up to 1.5 years(max 3 years)
Transient ischemic attack
Time frame: up to 1.5 years(max 3 years)
Percutaneous coronary intervention /coronary artery bypass grafting
Time frame: up to 1.5 years(max 3 years)
All cause death
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
Adverse Event excluding hemorrhagic events
Time frame: up to 1.5 years(max 3 years)
Patients adherence related with stroke or systemic embolism
Time frame: 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
Time frame: up to 1.5 years(max 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Derived from this study: PubMed 38909144Matsui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saburo Saito (+81-6-6872-0010, general@jcvrf.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism (time frame: up to 1.5 years(max 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.