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

29 août 2014 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

2305

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: aspirin
Aspirin: 325 mg per day
Médicament: aspirin
325 mg per day
Comparateur actif: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Médicament: Warfarin
INR 2.5-3.0; target INR 2.75

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Event Rate Per 100 Patient-years for Ischemic Stroke
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Columbia University

Collaborateurs

National Institute of Neurological Disorders and Stroke (NINDS)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2002

Achèvement primaire (Réel)

1 août 2011

Achèvement de l'étude (Réel)

1 juillet 2014

Dates d'inscription aux études

Première soumission

19 juillet 2002

Première soumission répondant aux critères de contrôle qualité

19 juillet 2002

Première publication (Estimation)

22 juillet 2002

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 septembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 août 2014

Dernière vérification

1 août 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Subvention/contrat des NIH des États-Unis)
  • R01NS39154

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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