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

29 августа 2014 г. обновлено: 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

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

2305

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: aspirin
Aspirin: 325 mg per day
Лекарство: aspirin
325 mg per day
Активный компаратор: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Лекарство: Warfarin
INR 2.5-3.0; target INR 2.75

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Временное ограничение: 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.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Event Rate Per 100 Patient-years for Ischemic Stroke
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Columbia University

Соавторы

National Institute of Neurological Disorders and Stroke (NINDS)

Следователи

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 октября 2002 г.

Первичное завершение (Действительный)

1 августа 2011 г.

Завершение исследования (Действительный)

1 июля 2014 г.

Даты регистрации исследования

Первый отправленный

19 июля 2002 г.

Впервые представлено, что соответствует критериям контроля качества

19 июля 2002 г.

Первый опубликованный (Оценивать)

22 июля 2002 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

5 сентября 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 августа 2014 г.

Последняя проверка

1 августа 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (Грант/контракт NIH США)
  • R01NS39154

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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