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Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)

29. august 2014 oppdatert av: Shunichi Homma, Columbia University

The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.

We are now transitioning into the sub-analysis part of the WARCEF patient data.

The study has recently completed data analysis for its Primary Aim. All randomized patients have completed their follow up. All study related procedure as per the protocol has been completed. We are now in the extension phase of the study to obtain more patient data to address further aims of the study. No new procedures are performed and data already in place at the sites will be collected (EKG and echocardiograms).

The aims for this study extension are:

  • To assess progression of cardiac dysfunction over time among heart failure patients
  • To correlate prognosis with cardiac dysfunction

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac (heart) failure and patients with low ejection fraction (EF). EF is the proportion of left ventricular volume emptied during systole. It reliably measures left ventricular systolic function.

With the rapidly increasing numbers of elderly patients with heart failure, this study has important public health implications. The study will determine which of two commonly used treatments Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction.

Studietype

Intervensjonell

Registrering (Faktiske)

2305

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Alberta
      • Lethbridge, Alberta, Canada
        • Center for Neurologic Research
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface General Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Saint John Regional Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QE II Health Sciences Centre
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Heart Institute
      • Rexdale, Ontario, Canada
        • Etobicoke Cardiac Research Centre
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
      • Montreal, Quebec, Canada
        • Montreal General Hospital
  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater
        • University of Arizona Health Sciences Center
      • Tucson, Arizona, Forente stater
        • Southern Arizona Veterans Affairs Medical Center
    • California
      • Santa Clara, California, Forente stater
        • Santa Clara Medical Center
      • West Los Angeles, California, Forente stater
        • West Los Angeles Veterans Affairs Medical Center
    • Colorado
      • Denver, Colorado, Forente stater
        • Denver Health Medical Center
      • Denver, Colorado, Forente stater
        • Denver Veterans Affairs Medical Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20037
        • George Washington University
    • Florida
      • Jacksonville, Florida, Forente stater
        • Mayo Clinic Transplant Center
      • Melbourne, Florida, Forente stater
        • Melbourne Internal Medicine Associates
      • Miami, Florida, Forente stater
        • Jackson Memorial Hospital/U. of Miami
      • Miami, Florida, Forente stater
        • Mercy Research Institute
      • Tamarac, Florida, Forente stater
        • Cardiovascular Consultants of South Florida
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Morehouse School of Medicine
      • Gainesville, Georgia, Forente stater
        • Northeast Georgia Heart Center
    • Illinois
      • Chicago, Illinois, Forente stater
        • University of Illinois at Chicago
      • Peoria, Illinois, Forente stater
        • Methodist Heart, Lung and Vascular Institute
    • Kentucky
      • Lexington, Kentucky, Forente stater
        • University of Kentucky
      • Louisville, Kentucky, Forente stater
        • University of Louisville
      • Louisville, Kentucky, Forente stater
        • Louisville Veterans Affairs Medical Center
    • Louisiana
      • Metairie, Louisiana, Forente stater
        • Gulf Regional Research, LLC
      • Shreveport, Louisiana, Forente stater
        • LSU Health Sciences Center
    • Massachusetts
      • Burlington, Massachusetts, Forente stater
        • Lahey Clinic
    • Michigan
      • Detroit, Michigan, Forente stater
        • Veterans Affairs Medical Center
      • Muskegon, Michigan, Forente stater
        • Mercy Health Partners
    • Nevada
      • Reno, Nevada, Forente stater
        • Reno Veterans Affairs Medical Center
    • New Hampshire
      • Concord, New Hampshire, Forente stater
        • Concord Hospital
    • New Jersey
      • New Brunswick, New Jersey, Forente stater
        • UMDNJ - New Brunswick
      • Newark, New Jersey, Forente stater
        • University of Medicine and Dentistry of New Jersey
    • New York
      • Albany, New York, Forente stater
        • Albany Medical College
      • Buffalo, New York, Forente stater
        • Buffalo General Hospital
      • Buffalo, New York, Forente stater
        • Kaleida Health Millard Fillmore Hospital
      • Cedarhurst, New York, Forente stater
        • Five Towns Neuroscience Research
      • New Hyde Park, New York, Forente stater
        • Long Island Jewish Medical Center
      • New York, New York, Forente stater
        • Columbia University Medical Center
      • New York, New York, Forente stater
        • Mount Sinai Medical Center
      • New York, New York, Forente stater, 10032
        • Columbia University, New York Presbyterian Hospital PH 3-342
      • Northport, New York, Forente stater
        • Northport Veterans Affairs Medical Center
      • Rochester, New York, Forente stater
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, Forente stater
        • MetroHealth Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
        • Oklahoma City Veterans Affairs Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater
        • LeHigh Valley Hospital
      • Beaver, Pennsylvania, Forente stater
        • Tri-State Medical Group Cardiology
      • Leetsdale, Pennsylvania, Forente stater
        • Sewickley Valley Medical Group, Cardiology
      • Philadelphia, Pennsylvania, Forente stater
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Forente stater
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, Forente stater
        • Penn Presbyterian Medical Center
    • South Dakota
      • Fort Meade, South Dakota, Forente stater
        • Black Hills Health Care System
    • Texas
      • Ft. Sam Houston, Texas, Forente stater
        • Brooke Army Medical Center MCHE - MDC Cardiology Service
      • Houston, Texas, Forente stater
        • Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC
    • Virginia
      • Salem, Virginia, Forente stater
        • Salem Vamc
    • West Virginia
      • Huntington, West Virginia, Forente stater
        • Huntington Veterans Affairs Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forente stater
        • William S. Middleton Memorial Veterans Hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  • Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
  • Modified Rankin score <=4.
  • Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
  • Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
  • Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
  • Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
  • Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.

Exclusion Criteria

  • The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
  • Cyanotic congenital heart disease, Eisenmenger's syndrome.
  • Decompensated heart failure.
  • Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
  • A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
  • Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
  • Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
  • Comorbid conditions that may limit survival to less than five years.
  • Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
  • Enrollment in another study that would conflict with WARCEF.
  • Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
  • Person under 18 years of age.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: aspirin
Aspirin: 325 mg per day
Legemiddel: aspirin
325 mg per day
Aktiv komparator: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Legemiddel: Warfarin
INR 2.5-3.0; target INR 2.75

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Tidsramme: From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years
The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Tidsramme: From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.

The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.

Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Event Rate Per 100 Patient-years for Ischemic Stroke
Tidsramme: From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient-years for Intracerebral Hemorrhage
Tidsramme: From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient-years for Death
Tidsramme: From date of randomization to date of death component of primary composite outcome, up to 6 years
Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of death component of primary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome
Tidsramme: From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.
Tidsramme: From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome
Tidsramme: From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome
Tidsramme: From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome
Tidsramme: From date of randomization to date of death component of secondary composite outcome, up to 6 years
Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization to date of death component of secondary composite outcome, up to 6 years
Rate Per 100 Patient Years of Major Hemorrhage
Tidsramme: From date of randomization until end of scheduled follow-up, up to 6 years
Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
From date of randomization until end of scheduled follow-up, up to 6 years
Rate Per 100 Patient-years of Minor Hemorrhage.
Tidsramme: From date of randomization until the end of scheduled follow-up, up to 6 years
Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
From date of randomization until the end of scheduled follow-up, up to 6 years

Samarbeidspartnere og etterforskere

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

Sponsor

Columbia University

Samarbeidspartnere

National Institute of Neurological Disorders and Stroke (NINDS)

Etterforskere

  • Hovedetterforsker: Shunichi Homma, M.D., Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine
  • Hovedetterforsker: Seamus Thompson, PhD, Statistical PI: Clinical Professor of Biostatistics and Neurology

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.

Generelle publikasjoner

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. oktober 2002

Primær fullføring (Faktiske)

1. august 2011

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

19. juli 2002

Først innsendt som oppfylte QC-kriteriene

19. juli 2002

Først lagt ut (Anslag)

22. juli 2002

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2014

Sist bekreftet

1. august 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (U.S. NIH-stipend/kontrakt)
  • R01NS39154

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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