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

perjantai 29. elokuuta 2014 päivittänyt: 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

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

2305

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: aspirin
Aspirin: 325 mg per day
Lääke: aspirin
325 mg per day
Active Comparator: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Lääke: Warfarin
INR 2.5-3.0; target INR 2.75

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Aikaikkuna: 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.

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Event Rate Per 100 Patient-years for Ischemic Stroke
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Columbia University

Yhteistyökumppanit

National Institute of Neurological Disorders and Stroke (NINDS)

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Tiistai 1. lokakuuta 2002

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. elokuuta 2011

Opintojen valmistuminen (Todellinen)

Tiistai 1. heinäkuuta 2014

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 19. heinäkuuta 2002

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 19. heinäkuuta 2002

Ensimmäinen Lähetetty (Arvio)

Maanantai 22. heinäkuuta 2002

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Perjantai 5. syyskuuta 2014

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 29. elokuuta 2014

Viimeksi vahvistettu

Perjantai 1. elokuuta 2014

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Yhdysvaltain NIH-apuraha/sopimus)
  • R01NS39154

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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