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

29 agosto 2014 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

2305

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: aspirin
Aspirin: 325 mg per day
Droga: aspirin
325 mg per day
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Event Rate Per 100 Patient-years for Ischemic Stroke
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Columbia University

Collaboratori

National Institute of Neurological Disorders and Stroke (NINDS)

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2002

Completamento primario (Effettivo)

1 agosto 2011

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

19 luglio 2002

Primo inviato che soddisfa i criteri di controllo qualità

19 luglio 2002

Primo Inserito (Stima)

22 luglio 2002

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 settembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 agosto 2014

Ultimo verificato

1 agosto 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Sovvenzione/contratto NIH degli Stati Uniti)
  • R01NS39154

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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