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

14. desember 2015 oppdatert av: Japan Cardiovascular Research Foundation

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.

Studieoversikt

Status

Ukjent

Forhold

Atrieflimmer

Studietype

Observasjonsmessig

Registrering (Forventet)

5000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Japan
- Osaka
  - Suita, Osaka, Japan, 565-8565
    - Rekruttering
    - Japan Cardiovascular Research Foundation
    - Ta kontakt med:
      
      Hisao Ogawa
      
      Telefonnummer: 2231 +81-6-6833-5012
      
      E-post: ogawah@ncvc.go.jp
    - Hovedetterforsker:
      
      Hisao Ogawa, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

5,000

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)

Sekundære resultatmål

Resultatmål	Tidsramme
Major bleeding events (adapted ISTH standard) Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Non-major bleeding events(without Major Bleeding complications) Tidsramme: 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 Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic stroke (ischemic or hemorrhagic) Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic ischemic stroke Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic hemorrhagic stroke Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Systemic embolism Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Acute myocardial infarction/unstable angina pectoris Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Cardiovascular death Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Deep vein thrombosis/pulmonary thromboembolism Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Transient ischemic attack Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Percutaneous coronary intervention /coronary artery bypass grafting Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
All cause death Tidsramme: up to 1.5 years(max 3 years)	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 Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Adverse Event excluding hemorrhagic events Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Patients adherence related with stroke or systemic embolism Tidsramme: up to 1.5 years(max 3 years)	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 Tidsramme: up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Japan Cardiovascular Research Foundation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2015

Primær fullføring (Forventet)

1. oktober 2018

Studiet fullført (Forventet)