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

29 de agosto de 2014 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2305

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: aspirin
Aspirin: 325 mg per day
Droga: aspirin
325 mg per day
Comparador activo: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Droga: Warfarin
INR 2.5-3.0; target INR 2.75

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Event Rate Per 100 Patient-years for Ischemic Stroke
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Columbia University

Colaboradores

National Institute of Neurological Disorders and Stroke (NINDS)

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2002

Finalización primaria (Actual)

1 de agosto de 2011

Finalización del estudio (Actual)

1 de julio de 2014

Fechas de registro del estudio

Enviado por primera vez

19 de julio de 2002

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2002

Publicado por primera vez (Estimar)

22 de julio de 2002

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de septiembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

29 de agosto de 2014

Última verificación

1 de agosto de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Subvención/contrato del NIH de EE. UU.)
  • R01NS39154

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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