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

2014年8月29日 更新者：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

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

2305

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：aspirin
Aspirin: 325 mg per day
药品：aspirin
325 mg per day
有源比较器：warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
药品：Warfarin
INR 2.5-3.0; target INR 2.75

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
大体时间：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.

其他结果措施

结果测量
措施说明
大体时间
Event Rate Per 100 Patient-years for Ischemic Stroke
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

合作者

National Institute of Neurological Disorders and Stroke (NINDS)

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年10月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2002年7月19日

首先提交符合 QC 标准的

2002年7月19日

首次发布 (估计)

2002年7月22日

研究记录更新

最后更新发布 (估计)

2014年9月5日

上次提交的符合 QC 标准的更新

2014年8月29日

最后验证

2014年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AAAC1093
  • CRC (NINDS)
  • U01NS039143-01 (美国 NIH 拨款/合同)
  • R01NS39154

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

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