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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Osaka
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Suita, Osaka, Giappone, 565-8565
- Reclutamento
- Japan Cardiovascular Research Foundation
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Contatto:
- Hisao Ogawa
- Numero di telefono: 2231 +81-6-6833-5012
- Email: ogawah@ncvc.go.jp
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Investigatore principale:
- Hisao Ogawa, M.D.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Major bleeding events (adapted ISTH standard)
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Non-major bleeding events(without Major Bleeding complications)
Lasso di tempo: up to 1.5 years(max 3 years)
|
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
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Symptomatic stroke (ischemic or hemorrhagic)
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Symptomatic ischemic stroke
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Symptomatic hemorrhagic stroke
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Systemic embolism
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
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Acute myocardial infarction/unstable angina pectoris
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Cardiovascular death
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Deep vein thrombosis/pulmonary thromboembolism
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
|
Transient ischemic attack
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
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Percutaneous coronary intervention /coronary artery bypass grafting
Lasso di tempo: up to 1.5 years(max 3 years)
|
up to 1.5 years(max 3 years)
|
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All cause death
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
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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
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
|
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Adverse Event excluding hemorrhagic events
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
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Patients adherence related with stroke or systemic embolism
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
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Correlation with CHADS2 score or other risk factors and outcome events in Japanese patients who administered Rivaroxaban
Lasso di tempo: up to 1.5 years(max 3 years)
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up to 1.5 years(max 3 years)
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GENeRAL/J
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