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Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation (EXPAND)

21. mai 2014 oppdatert av: Hiroaki Shimokawa, MD, PhD, Tohoku University

Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice

The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.

Studieoversikt

Status

Ukjent

Forhold

Ikke-valvulær atrieflimmer

Studietype

Observasjonsmessig

Registrering (Forventet)

7000

Kontakter og plasseringer

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

Studiesteder

Japan
- Miyagi
  - Sendai, Miyagi, Japan, 980-6574
    - Rekruttering
    - Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
    - Ta kontakt med:
      
      Koji Fukuda, MD, PhD
      
      Telefonnummer: +81-22-717-7153
      
      E-post: fukuda@cardio.med.tohoku.ac.jp
    - Hovedetterforsker:
      
      Hiroaki Shimokawa, MD, PhD

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

Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)

Beskrivelse

Inclusion Criteria:

Patients who meet all the criteria below

Patients aged over 20 years
Patients diagnosed with non-valvular atrial fibrillation
Patients who are treated or will be treated with rivaroxaban
Patients from whom written informed consent has been obtained

Exclusion Criteria:

Patients who meet any of the criteria below

The following patients in whom rivaroxaban is contraindicated for use
Patients with a history of allergies to the ingredients contained in this drug
Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
Patients having renal failure (creatinine clearance: <15 mL/min)
Women who are or are likely to be pregnant
Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Non-valvular atrial fibrillation Patients diagnosed with non-valvular atrial fibrillation Patients who are treated or will be treated with rivaroxaban

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism Tidsramme: up to March/2016	Primary efficacy endpoint	up to March/2016
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification) Tidsramme: up to March/2016	Primary safety endpoint	up to March/2016

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Symptomatic ischemic stroke Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Symptomatic hemorrhagic stroke Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Systemic embolism Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Acute myocardial infarction/unstable angina pectoris Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Cardiovascular death Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Deep vein thrombosis/pulmonary thromboembolism Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Transient ischemic attack Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Interventional/surgical treatment Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
All-cause death Tidsramme: up to March/2016	Secondary efficacy endpoints	up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events) Tidsramme: up to March/2016	Secondary safety endpoint	up to March/2016

Samarbeidspartnere og etterforskere

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

Sponsor

Tohoku University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

EXPAND study home page

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. november 2012

Primær fullføring (Forventet)

1. juni 2016

Datoer for studieregistrering

Først innsendt

12. mai 2014

Først innsendt som oppfylte QC-kriteriene

21. mai 2014

Først lagt ut (Anslag)

26. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)