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. maj 2014 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
7000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Miyagi
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Sendai, Miyagi, Japan, 980-6574
- Rekruttering
- Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
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Kontakt:
- Koji Fukuda, MD, PhD
- Telefonnummer: +81-22-717-7153
- E-mail: fukuda@cardio.med.tohoku.ac.jp
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Ledende efterforsker:
- Hiroaki Shimokawa, MD, PhD
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Non-valvular atrial fibrillation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2012
Primær færdiggørelse (Forventet)
1. juni 2016
Datoer for studieregistrering
Først indsendt
12. maj 2014
Først indsendt, der opfyldte QC-kriterier
21. maj 2014
Først opslået (Skøn)
26. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EXPAND study
- UMIN000009376 (Anden identifikator: UMIN)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .