이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Warfarin and Antiplatelet Therapy in Chronic Heart Failure

2011년 6월 14일 업데이트: 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).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

1587

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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:

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 1
Warfarin Titrated to an INR of 2.5-3.0
의약품: 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.
활성 비교기: 2
Aspirin 182 mg
의약품: Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
활성 비교기: 3
Clopidogrel 75 mg
의약품: Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

US Department of Veterans Affairs

협력자

Bristol-Myers Squibb
Sanofi-Synthelabo

수사관

  • 연구 의자: Barry M. Massie, MD, VA Medical Center, San Francisco

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

1998년 10월 1일

기본 완료 (실제)

2003년 7월 1일

연구 완료 (실제)

2004년 12월 1일

연구 등록 날짜

최초 제출

2000년 12월 29일

QC 기준을 충족하는 최초 제출

2000년 12월 30일

처음 게시됨 (추정)

2001년 1월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 6월 14일

마지막으로 확인됨

2011년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 442

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Panama

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다