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Warfarin and Antiplatelet Therapy in Chronic Heart Failure

2011年6月14日 更新者：US Department of Veterans Affairs

CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)

Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).

研究概览

地位

完全的

条件

干预/治疗

详细说明

Primary Hypothesis: The hypothesis to be tested is whether aspirin, warfarin, and clopidogrel are equally effective in the treatment of patients with symptomatic CHF and reduced ejection fraction.

Secondary Hypothesis: If one therapy proves to be superior with regard to outcomes, what is the cost of this benefit? Can subsets of patients be identified who benefit more from a specific approach to antithrombotic therapy?

Intervention: The three treatment regimens are:

  1. Open-label Warfarin titrated to an INR of 2.5-3.0;
  2. Double blind aspirin 162 mg once daily;
  3. Double blind clopidogrel 75 mg once daily.

Primary Outcomes: Any death (all causes), non-fatal stroke, non-fatal MI.

Study Abstract: Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).

The original target sample size was 4,500 over a 3 year enrollment period with a 2 year follow-up. This sample size yielded 90% power to detect a relative difference of 20% between treatment groups. The sample size was later amended to 1,500 over a 30 month enrollment period with a 12 month follow-up. The reduced sample size yielded 85% to detect a between treatment difference of 30%. This change became effective in March 2002.

This clinical trial enrolled 1,587 patients in 142 medical centers; VA and non-VA centers in the U.S., and medical centers in the United Kingdom and Canada. Patients were randomly and equally allocated to the 3 treatments: warfarin (administered open-label), aspirin and clopidogrel (the latter two administered double-blind). The study was conducted over a 3.5 year period, with a 2.5 year enrollment phase.

Patients with NYHA class II, III, or IV and left ventricular ejection fractions less than or equal to 35% on an ACE inhibitor (unless not tolerated) and a diuretic were entered. The primary end point is the composite of death from any cause, non-fatal MI, and non-fatal stroke. All-cause mortality is the secondary end point.

The WATCH design paper has been published in the Journal of Cardiac Failure. Preliminary results were presented at the meeting of the American College of Cardiology in New Orleans on March 9, 2004. There were no significant differences between the treatment groups for the primary endpoints. The paper with final results is being prepared.

研究类型

介入性

注册 (预期的)

1587

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
      • Calgary、Alberta、加拿大、T2E 7C5
        • Cardiology Consultants
      • Edmonton、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital
      • Edmonton、Alberta、加拿大、T6L 5X8
        • Grey Nuns Com. Hospital and Health Centre
    • British Columbia
      • Campbell River、British Columbia、加拿大、V9W 6X8
        • Alder Medical Centre
      • North Vancouver、British Columbia、加拿大、V7L 2P7
        • North Shore Cardiology Laboratory
      • Surrey、British Columbia、加拿大、V3V 1Z2
        • Surrey Memorial Hospital - Cardiology
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg、Manitoba、加拿大、R3A 1R9
        • Health Sciences Centre - Cardiology Research
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 3A7
        • Queen Elizabeth II HSC
    • Ontario
      • Ajax、Ontario、加拿大、L1S 7K8
        • Ajax and Pickering General Hospital
      • Brampton、Ontario、加拿大、L6V 1B4
        • Bramptom, Research Associates
      • Hamilton、Ontario、加拿大、L8L 2X2
        • Hamilton Health Sciences Corp. - General Div
      • Hamilton、Ontario、加拿大、L8P 3B6
        • St. Joseph's Hospital
      • London、Ontario、加拿大、N6A 5A5
        • London HSC - University Campus
      • Mississauga、Ontario、加拿大、L5M 2N1
        • Credit Valley Hospital Research Associates
      • Niagara Falls、Ontario、加拿大、L2E 7H1
        • Niagara Falls Medical Center
      • Ottawa、Ontario、加拿大、K1Y 4W7
        • Ottawa Heart Institute
      • Rexdale、Ontario、加拿大、M9V 4B8
        • Etobicoke General Hospital
      • Scarborough、Ontario、加拿大、M1S 4V5
        • Cardiology Research Associates
      • Sudbury、Ontario、加拿大、P3E 6B4
        • Neureka Research Inc. Willett Green Millr Cntr
      • Toronto、Ontario、加拿大、M5B 1W8
        • St. Michael's Hospital
      • Toronto、Ontario、加拿大、M5T 2S8
        • Toronto Western Hospital
    • Quebec
      • Longeuil、Quebec、加拿大、J4N 1E1
        • Invascor Clinical Research Inc.
      • Montreal、Quebec、加拿大、H1T 2M4
        • Cardiology Clinic - Maisonneuve-Rosemont
      • Victoriaville、Quebec、加拿大、G6P 6N2
        • Hotel-Dieu D'Artabaska
    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4P 0W5
        • Regina General Hospital
      • Saskatoon、Saskatchewan、加拿大、S7N 0W8
        • Royal University Hospital
      • Saskatoon、Saskatchewan、加拿大、S7K 0Z9
        • St. Paul's Hospital
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • VA Medical Center, Birmingham
    • Arizona
      • Phoenix、Arizona、美国、85012
        • Carl T. Hayden VA Medical Center
      • Tucson、Arizona、美国、85723
        • Southern Arizona VA Health Care System, Tucson
    • Arkansas
      • No. Little Rock、Arkansas、美国、72114-1706
        • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
    • California
      • Downey、California、美国、90242
        • Rancho Los Amigos National Rehabilitation Center
      • Fresno、California、美国、93703
        • VA Central California Health Care System, Fresno
      • Loma Linda、California、美国、92357
        • VA Medical Center, Loma Linda
      • Palo Alto、California、美国、94304-1290
        • VA Palo Alto Health Care System
      • San Francisco、California、美国、94121
        • VA Medical Center, San Francisco
      • Sepulveda、California、美国、91343
        • VA Greater Los Angeles HCS, Sepulveda
      • Walnut Creek、California、美国、94598
        • Cardiovascular Consultants, Walnut Creek
      • West Los Angeles、California、美国、90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Colorado
      • Denver、Colorado、美国、80220
        • VA Eastern Colorado Health Care System, Denver
    • Connecticut
      • Derby、Connecticut、美国、06418
        • Cardiology Associates of Derby, P.C.
      • Hartford、Connecticut、美国、06120
        • St. Francis Hospital and Medical Center
      • West Haven、Connecticut、美国、06516
        • VA Connecticut Health Care System (West Haven)
    • District of Columbia
      • Washington、District of Columbia、美国、20422
        • VA Medical Center, DC
    • Florida
      • Atlantis、Florida、美国、33462
        • Florida Cardiovascular Research
      • Bay Pines、Florida、美国、33708
        • VA Medical Center, Bay Pines
      • Gainesville、Florida、美国、32608
        • North Florida/South Georgia Veterans Health System
      • Lakeland、Florida、美国、33805
        • Watson Clinic LLP
      • Merritt Island、Florida、美国、32952
        • Brevard Cardiology
      • Miami、Florida、美国、33125
        • VA Medical Center, Miami
      • Pensacola、Florida、美国、32501
        • Cardiology Consultants - Pensacola
      • Tamarac、Florida、美国、33321
        • University Cardiology Consultants
      • Tampa、Florida、美国、33612
        • James A. Haley Veterans Hospital, Tampa
    • Georgia
      • Augusta、Georgia、美国、30904
        • VA Medical Center, Augusta
      • Decatur、Georgia、美国、30033
        • Atlanta VA Medical and Rehab Center, Decatur
    • Illinois
      • Chicago、Illinois、美国、60612
        • Jesse Brown VAMC (WestSide Division)
      • Hines、Illinois、美国、60141-5000
        • Edward Hines, Jr. VA Hospital
      • Peoria、Illinois、美国、61603
        • Heart Care Midwest
    • Indiana
      • Jeffersonville、Indiana、美国、47130
        • River Cities Cardiology
    • Louisiana
      • Shreveport、Louisiana、美国、71101
        • Overton Brooks VA Medical Center, Shreveport
    • Massachusetts
      • Bedford、Massachusetts、美国、01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford
      • Brockton、Massachusetts、美国、02301
        • VA Boston Healthcare System, Brockton Campus
      • Springfield、Massachusetts、美国、01104
        • Bay State Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48113
        • VA Ann Arbor Healthcare System
      • Detroit、Michigan、美国、48201
        • John D. Dingell VA Medical Center, Detroit
      • Trey、Michigan、美国、48095
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis、Minnesota、美国、55417
        • VA Medical Center, Minneapolis
    • Mississippi
      • Biloxi、Mississippi、美国、39531
        • VA Gulf Coast Veterans Health Care System, Biloxi
    • Missouri
      • Kansas City、Missouri、美国、64128
        • VA Medical Center, Kansas City MO
      • St Louis、Missouri、美国、63106
        • VA Medical Center, St Louis
    • Nebraska
      • Lincoln、Nebraska、美国、68510
        • Lincoln Division VA Nebraska Western IA HCS
    • Nevada
      • Reno、Nevada、美国、89502
        • VA Sierra Nevada Health Care System
    • New York
      • Albany、New York、美国、12208
        • VA Stratton Medical Center, Albany
      • Buffalo、New York、美国、14215
        • VA Western New York Healthcare System at Buffalo
      • Flushing、New York、美国、11355
        • New York Hospital Medical Center of Queens
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • New York、New York、美国、10010
        • New York Harbor HCS
      • Northport、New York、美国、11768
        • VA Medical Center, Northport
      • Rochester、New York、美国、14642
        • University of Rochester Medical Center
      • Syracuse、New York、美国、13210
        • VA Medical Center, Syracuse
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7075
        • Univ of North Carolina at Chapel Hill
      • Durham、North Carolina、美国、27705
        • VA Medical Center, Durham
      • Hendersonville、North Carolina、美国、28739
        • Margaret Pardee Memorial Hospital
    • North Dakota
      • Fargo、North Dakota、美国、58102
        • VA Medical Center, Fargo
    • Ohio
      • Cincinnati、Ohio、美国、45220
        • VA Medical Center, Cincinnati
      • Cleveland、Ohio、美国、44106
        • VA Medical Center, Cleveland
      • Columbus、Ohio、美国、43203-1278
        • Chalmers P. Wylie VAOPC
      • Dayton、Ohio、美国、45428
        • VA Medical Center, Dayton
    • Oklahoma
      • Muskogee、Oklahoma、美国、74401
        • VA Medical Center, Muskogee
      • Oklahoma City、Oklahoma、美国、73104
        • VA Medical Center, Oklahoma City
    • Oregon
      • Portland、Oregon、美国、97201
        • VA Medical Center, Portland
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • VA Medical Center, Philadelphia
      • Pittsburgh、Pennsylvania、美国、15240
        • VA Pittsburgh Health Care System
    • Rhode Island
      • Providence、Rhode Island、美国、02908
        • VA Medical Center, Providence
    • South Dakota
      • Fort Meade、South Dakota、美国、57741
        • VA Black Hills Health Care System, Fort Meade
    • Tennessee
      • Memphis、Tennessee、美国、38104
        • VA Medical Center, Memphis
      • Nashville、Tennessee、美国、37212-2637
        • VA Medical Center
    • Texas
      • Galveston、Texas、美国、77555-0553
        • University of Texas Medical Branch
      • Houston、Texas、美国、77030
        • Michael E. DeBakey VA Medical Center (152)
      • San Antonio、Texas、美国、78229
        • VA South Texas Health Care System, San Antonio
    • Utah
      • Salt Lake City、Utah、美国、84148
        • VA Salt Lake City Health Care System, Salt Lake City
    • Virginia
      • Richmond、Virginia、美国、23249
        • Hunter Holmes McGuire VA Medical Center
      • South Boston、Virginia、美国、24592
        • DUCCS Research of South Boston
    • West Virginia
      • Huntington、West Virginia、美国、25704
        • VA Medical Center, Huntington
      • Martinsburg、West Virginia、美国、25041
        • VA Medical Center, Martinsburg
    • Wisconsin
      • Madison、Wisconsin、美国、53705
        • Wlliam S. Middleton Memorial Veterans Hospital, Madison
  • 英国
      • Bridlington、英国、YO16 4QP
        • Bridlington and District Hospital
      • Derby、英国、DE1 2QY
        • Derbyshire Royal Infirmary
      • Devon、英国、PL6 8DH
        • Derriford Hospital
      • Glasgow、英国、G12 8QQ
        • Glasgow Western Infirmary
      • London、英国、SE1 7EH
        • St. Thomas' Hospital
      • Wakefield、英国、WF1 4DG
        • Pinderfields General Hospital
    • Antrim
      • Belfast、Antrim、英国、BT12 6BA
        • Royal Victoria Hospital
    • Beds
      • Luton、Beds、英国、LU4 0DZ
        • Luton and Dunstable Hospital
    • Birmingham
      • Selly Oak、Birmingham、英国、B29 6JD
        • Selly Oak Hospital
    • Cheshire
      • Stockport、Cheshire、英国、SK2 7JE
        • Stepping Hills Hospital
    • Cleveland
      • Middlesborough、Cleveland、英国、TS4 3BW
        • South Cleveland Hospital
    • Devon
      • Torbay、Devon、英国、TQ2 7AA
        • Torbay District General
    • Essex
      • Ilford、Essex、英国、IG3 8YB
        • King Geroge Hospital
    • Hull
      • Cottingham、Hull、英国、HU16 5JG
        • Castle Hill Hospital
    • Lancashire
      • Blackpool、Lancashire、英国、FY3 8NR
        • Blackpool Victoria Hospital
    • London
      • Plaistow、London、英国、E13 8SL
        • Newham General Hospital
    • Manchester
      • Wythenshawe、Manchester、英国、M23 9LT
        • Wythenshawe Hospital
    • Middlesex
      • Harrow、Middlesex、英国、HA1 3UJ
        • Northwick Park Hospital and Institue for Medical R
    • North Lincolnshire
      • Scunthorpe、North Lincolnshire、英国、DN15 7BH
        • Scunthorpe General Hospital
    • North Yorkshire
      • York、North Yorkshire、英国、YO3 7HE
        • York District Hospital
    • Renfrewshire
      • Paisley、Renfrewshire、英国、PA2 9PN
        • Royal Alexandra Hospital
    • South Humberside
      • Grimsby、South Humberside、英国、DN33 2BA
        • Princess of Wales Hospital (Grimsby)
    • South Yorkshire
      • Barnsley、South Yorkshire、英国、S75 2EP
        • Barnsley District General
    • Sussex
      • Brighton、Sussex、英国、BN2 1ES
        • Cardiology Research Unit Sussex House
    • West Yorkshire
      • Leeds、West Yorkshire、英国、LS9 7TF
        • St. James' University Hospital
    • West Yorshire
      • Pontefract、West Yorshire、英国、WF8 1PL
        • Pontefract General Infirmary
    • Yorkshire
      • Sheffield、Yorkshire、英国、S5 7AU
        • Northern General 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:

Inclusion Criteria:

  • Patients with NYHA class II, III, or IV and left ventricular ejection fractions less than or equal to 35%, on an ACE inhibitor (unless not tolerated) and on a diuretic.

Exclusion Criteria:

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：1
Warfarin Titrated to an INR of 2.5-3.0
药品：Warfarin titrated to an INR of 2.5-3.0
anticoagulation (administered without blinding) titrated to a target INR of 2.5 to 3.0, monitored by measurements at 6 week intervals after initial titration and stabilization.
有源比较器：2
Aspirin 182 mg
药品：Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
有源比较器：3
Clopidogrel 75 mg
药品：Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

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
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
大体时间：30 months intake; 12-42 months follow-up
The primary safety end point was major bleeding episodes, defined as bleeding episodes leading to death or disability (including loss of neurological or special senses function), requiring surgical intervention, or associated with an acute decline of hemoglobin 2gm/dl or transfusion of >1 U packed red cells or whole blood.
30 months intake; 12-42 months follow-up

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

US Department of Veterans Affairs

合作者

Bristol-Myers Squibb
Sanofi-Synthelabo

调查人员

  • 学习椅：Barry M. Massie, MD、VA Medical Center, San Francisco

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

1998年10月1日

初级完成 (实际的)

2003年7月1日

研究完成 (实际的)

2004年12月1日

研究注册日期

首次提交

2000年12月29日

首先提交符合 QC 标准的

2000年12月30日

首次发布 (估计)

2001年1月1日

研究记录更新

最后更新发布 (估计)

2011年6月16日

上次提交的符合 QC 标准的更新

2011年6月14日

最后验证

2011年6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

  • 442

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.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Cambodia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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