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

29. srpna 2014 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

2305

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: aspirin
Aspirin: 325 mg per day
Lék: aspirin
325 mg per day
Aktivní komparátor: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Lék: Warfarin
INR 2.5-3.0; target INR 2.75

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event Rate Per 100 Patient-years for Ischemic Stroke
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Columbia University

Spolupracovníci

National Institute of Neurological Disorders and Stroke (NINDS)

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2002

Primární dokončení (Aktuální)

1. srpna 2011

Dokončení studie (Aktuální)

1. července 2014

Termíny zápisu do studia

První předloženo

19. července 2002

První předloženo, které splnilo kritéria kontroly kvality

19. července 2002

První zveřejněno (Odhad)

22. července 2002

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

5. září 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. srpna 2014

Naposledy ověřeno

1. srpna 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Grant/smlouva NIH USA)
  • R01NS39154

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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