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

29 augustus 2014 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

2305

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: aspirin
Aspirin: 325 mg per day
Geneesmiddel: aspirin
325 mg per day
Actieve vergelijker: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Geneesmiddel: Warfarin
INR 2.5-3.0; target INR 2.75

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event Rate Per 100 Patient-years for Ischemic Stroke
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Columbia University

Medewerkers

National Institute of Neurological Disorders and Stroke (NINDS)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2002

Primaire voltooiing (Werkelijk)

1 augustus 2011

Studie voltooiing (Werkelijk)

1 juli 2014

Studieregistratiedata

Eerst ingediend

19 juli 2002

Eerst ingediend dat voldeed aan de QC-criteria

19 juli 2002

Eerst geplaatst (Schatting)

22 juli 2002

Updates van studierecords

Laatste update geplaatst (Schatting)

5 september 2014

Laatste update ingediend die voldeed aan QC-criteria

29 augustus 2014

Laatst geverifieerd

1 augustus 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Subsidie/contract van de Amerikaanse NIH)
  • R01NS39154

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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