Warfarin and Antiplatelet Therapy in Chronic Heart Failure
14 juni 2011 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- Open-label Warfarin titrated to an INR of 2.5-3.0;
- Double blind aspirin 162 mg once daily;
- 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.
Studietyp
Interventionell
Inskrivning (Förväntat)
1587
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix, Arizona, Förenta staterna, 85012
- Carl T. Hayden VA Medical Center
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Tucson, Arizona, Förenta staterna, 85723
- Southern Arizona VA Health Care System, Tucson
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Arkansas
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No. Little Rock, Arkansas, Förenta staterna, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
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California
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Downey, California, Förenta staterna, 90242
- Rancho Los Amigos National Rehabilitation Center
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Fresno, California, Förenta staterna, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Förenta staterna, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Förenta staterna, 94304-1290
- VA Palo Alto Health Care System
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San Francisco, California, Förenta staterna, 94121
- VA Medical Center, San Francisco
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Sepulveda, California, Förenta staterna, 91343
- VA Greater Los Angeles HCS, Sepulveda
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Walnut Creek, California, Förenta staterna, 94598
- Cardiovascular Consultants, Walnut Creek
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West Los Angeles, California, Förenta staterna, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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Derby, Connecticut, Förenta staterna, 06418
- Cardiology Associates of Derby, P.C.
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Hartford, Connecticut, Förenta staterna, 06120
- St. Francis Hospital and Medical Center
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West Haven, Connecticut, Förenta staterna, 06516
- VA Connecticut Health Care System (West Haven)
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20422
- VA Medical Center, DC
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Florida
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Atlantis, Florida, Förenta staterna, 33462
- Florida Cardiovascular Research
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Bay Pines, Florida, Förenta staterna, 33708
- VA Medical Center, Bay Pines
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Gainesville, Florida, Förenta staterna, 32608
- North Florida/South Georgia Veterans Health System
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Lakeland, Florida, Förenta staterna, 33805
- Watson Clinic LLP
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Merritt Island, Florida, Förenta staterna, 32952
- Brevard Cardiology
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Miami, Florida, Förenta staterna, 33125
- VA Medical Center, Miami
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Pensacola, Florida, Förenta staterna, 32501
- Cardiology Consultants - Pensacola
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Tamarac, Florida, Förenta staterna, 33321
- University Cardiology Consultants
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Tampa, Florida, Förenta staterna, 33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Augusta, Georgia, Förenta staterna, 30904
- VA Medical Center, Augusta
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Decatur, Georgia, Förenta staterna, 30033
- Atlanta VA Medical and Rehab Center, Decatur
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Jesse Brown VAMC (WestSide Division)
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Hines, Illinois, Förenta staterna, 60141-5000
- Edward Hines, Jr. VA Hospital
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Peoria, Illinois, Förenta staterna, 61603
- Heart Care Midwest
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Indiana
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Jeffersonville, Indiana, Förenta staterna, 47130
- River Cities Cardiology
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71101
- Overton Brooks VA Medical Center, Shreveport
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Massachusetts
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Bedford, Massachusetts, Förenta staterna, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford
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Brockton, Massachusetts, Förenta staterna, 02301
- VA Boston Healthcare System, Brockton Campus
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Springfield, Massachusetts, Förenta staterna, 01104
- Bay State Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48113
- VA Ann Arbor Healthcare System
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Detroit, Michigan, Förenta staterna, 48201
- John D. Dingell VA Medical Center, Detroit
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Trey, Michigan, Förenta staterna, 48095
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- VA Medical Center, Minneapolis
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Mississippi
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Biloxi, Mississippi, Förenta staterna, 39531
- VA Gulf Coast Veterans Health Care System, Biloxi
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Missouri
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Kansas City, Missouri, Förenta staterna, 64128
- VA Medical Center, Kansas City MO
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St Louis, Missouri, Förenta staterna, 63106
- VA Medical Center, St Louis
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68510
- Lincoln Division VA Nebraska Western IA HCS
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Nevada
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Reno, Nevada, Förenta staterna, 89502
- VA Sierra Nevada Health Care System
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New York
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Albany, New York, Förenta staterna, 12208
- VA Stratton Medical Center, Albany
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Buffalo, New York, Förenta staterna, 14215
- VA Western New York Healthcare System at Buffalo
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Flushing, New York, Förenta staterna, 11355
- New York Hospital Medical Center of Queens
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Manhasset, New York, Förenta staterna, 11030
- North Shore University Hospital
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New York, New York, Förenta staterna, 10010
- New York Harbor HCS
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Northport, New York, Förenta staterna, 11768
- VA Medical Center, Northport
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Rochester, New York, Förenta staterna, 14642
- University of Rochester Medical Center
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Syracuse, New York, Förenta staterna, 13210
- VA Medical Center, Syracuse
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599-7075
- Univ of North Carolina at Chapel Hill
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Durham, North Carolina, Förenta staterna, 27705
- VA Medical Center, Durham
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Hendersonville, North Carolina, Förenta staterna, 28739
- Margaret Pardee Memorial Hospital
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58102
- VA Medical Center, Fargo
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, Förenta staterna, 44106
- VA Medical Center, Cleveland
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Columbus, Ohio, Förenta staterna, 43203-1278
- Chalmers P. Wylie VAOPC
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Dayton, Ohio, Förenta staterna, 45428
- VA Medical Center, Dayton
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Oklahoma
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Muskogee, Oklahoma, Förenta staterna, 74401
- VA Medical Center, Muskogee
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- VA Medical Center, Oklahoma City
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Oregon
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Portland, Oregon, Förenta staterna, 97201
- VA Medical Center, Portland
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- VA Medical Center, Philadelphia
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Pittsburgh, Pennsylvania, Förenta staterna, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02908
- VA Medical Center, Providence
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South Dakota
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Fort Meade, South Dakota, Förenta staterna, 57741
- VA Black Hills Health Care System, Fort Meade
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- VA Medical Center, Memphis
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Nashville, Tennessee, Förenta staterna, 37212-2637
- VA Medical Center
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Texas
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Galveston, Texas, Förenta staterna, 77555-0553
- University of Texas Medical Branch
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Houston, Texas, Förenta staterna, 77030
- Michael E. DeBakey VA Medical Center (152)
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San Antonio, Texas, Förenta staterna, 78229
- VA South Texas Health Care System, San Antonio
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Utah
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Salt Lake City, Utah, Förenta staterna, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Virginia
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Richmond, Virginia, Förenta staterna, 23249
- Hunter Holmes McGuire VA Medical Center
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South Boston, Virginia, Förenta staterna, 24592
- DUCCS Research of South Boston
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West Virginia
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Huntington, West Virginia, Förenta staterna, 25704
- VA Medical Center, Huntington
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Martinsburg, West Virginia, Förenta staterna, 25041
- VA Medical Center, Martinsburg
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Alberta
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Calgary, Alberta, Kanada, T2E 7C5
- Cardiology Consultants
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Edmonton, Alberta, Kanada, T6G 2B7
- University of Alberta Hospital
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Edmonton, Alberta, Kanada, T6L 5X8
- Grey Nuns Com. Hospital and Health Centre
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British Columbia
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Campbell River, British Columbia, Kanada, V9W 6X8
- Alder Medical Centre
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North Vancouver, British Columbia, Kanada, V7L 2P7
- North Shore Cardiology Laboratory
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Surrey, British Columbia, Kanada, V3V 1Z2
- Surrey Memorial Hospital - Cardiology
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Manitoba
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Winnipeg, Manitoba, Kanada, R2H 2A6
- St. Boniface General Hospital
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Winnipeg, Manitoba, Kanada, R3A 1R9
- Health Sciences Centre - Cardiology Research
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
- Queen Elizabeth II HSC
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Ontario
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Ajax, Ontario, Kanada, L1S 7K8
- Ajax and Pickering General Hospital
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Brampton, Ontario, Kanada, L6V 1B4
- Bramptom, Research Associates
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Hamilton, Ontario, Kanada, L8L 2X2
- Hamilton Health Sciences Corp. - General Div
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Hamilton, Ontario, Kanada, L8P 3B6
- St. Joseph's Hospital
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London, Ontario, Kanada, N6A 5A5
- London HSC - University Campus
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Mississauga, Ontario, Kanada, L5M 2N1
- Credit Valley Hospital Research Associates
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Niagara Falls, Ontario, Kanada, L2E 7H1
- Niagara Falls Medical Center
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Ottawa, Ontario, Kanada, K1Y 4W7
- Ottawa Heart Institute
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Rexdale, Ontario, Kanada, M9V 4B8
- Etobicoke General Hospital
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Scarborough, Ontario, Kanada, M1S 4V5
- Cardiology Research Associates
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Sudbury, Ontario, Kanada, P3E 6B4
- Neureka Research Inc. Willett Green Millr Cntr
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Toronto, Ontario, Kanada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Kanada, M5T 2S8
- Toronto Western Hospital
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Quebec
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Longeuil, Quebec, Kanada, J4N 1E1
- Invascor Clinical Research Inc.
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Montreal, Quebec, Kanada, H1T 2M4
- Cardiology Clinic - Maisonneuve-Rosemont
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Victoriaville, Quebec, Kanada, G6P 6N2
- Hotel-Dieu D'Artabaska
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4P 0W5
- Regina General Hospital
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Saskatoon, Saskatchewan, Kanada, S7N 0W8
- Royal University Hospital
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Saskatoon, Saskatchewan, Kanada, S7K 0Z9
- St. Paul's Hospital
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Bridlington, Storbritannien, YO16 4QP
- Bridlington and District Hospital
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Derby, Storbritannien, DE1 2QY
- Derbyshire Royal Infirmary
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Devon, Storbritannien, PL6 8DH
- Derriford Hospital
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Glasgow, Storbritannien, G12 8QQ
- Glasgow Western Infirmary
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London, Storbritannien, SE1 7EH
- St. Thomas' Hospital
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Wakefield, Storbritannien, WF1 4DG
- Pinderfields General Hospital
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Antrim
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Belfast, Antrim, Storbritannien, BT12 6BA
- Royal Victoria Hospital
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Beds
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Luton, Beds, Storbritannien, LU4 0DZ
- Luton and Dunstable Hospital
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Birmingham
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Selly Oak, Birmingham, Storbritannien, B29 6JD
- Selly Oak Hospital
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Cheshire
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Stockport, Cheshire, Storbritannien, SK2 7JE
- Stepping Hills Hospital
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Cleveland
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Middlesborough, Cleveland, Storbritannien, TS4 3BW
- South Cleveland Hospital
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Devon
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Torbay, Devon, Storbritannien, TQ2 7AA
- Torbay District General
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Essex
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Ilford, Essex, Storbritannien, IG3 8YB
- King Geroge Hospital
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Hull
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Cottingham, Hull, Storbritannien, HU16 5JG
- Castle Hill Hospital
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Lancashire
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Blackpool, Lancashire, Storbritannien, FY3 8NR
- Blackpool Victoria Hospital
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London
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Plaistow, London, Storbritannien, E13 8SL
- Newham General Hospital
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Manchester
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Wythenshawe, Manchester, Storbritannien, M23 9LT
- Wythenshawe Hospital
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Middlesex
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Harrow, Middlesex, Storbritannien, HA1 3UJ
- Northwick Park Hospital and Institue for Medical R
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Storbritannien, DN15 7BH
- Scunthorpe General Hospital
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North Yorkshire
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York, North Yorkshire, Storbritannien, YO3 7HE
- York District Hospital
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Renfrewshire
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Paisley, Renfrewshire, Storbritannien, PA2 9PN
- Royal Alexandra Hospital
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South Humberside
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Grimsby, South Humberside, Storbritannien, DN33 2BA
- Princess of Wales Hospital (Grimsby)
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South Yorkshire
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Barnsley, South Yorkshire, Storbritannien, S75 2EP
- Barnsley District General
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Sussex
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Brighton, Sussex, Storbritannien, BN2 1ES
- Cardiology Research Unit Sussex House
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West Yorkshire
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Leeds, West Yorkshire, Storbritannien, LS9 7TF
- St. James' University hospital
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West Yorshire
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Pontefract, West Yorshire, Storbritannien, WF8 1PL
- Pontefract General Infirmary
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Yorkshire
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Sheffield, Yorkshire, Storbritannien, S5 7AU
- Northern General Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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:
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1
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.
|
|
Aktiv komparator: 2
Aspirin 182 mg
|
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
|
|
Aktiv komparator: 3
Clopidogrel 75 mg
|
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Barry M. Massie, MD, VA Medical Center, San Francisco
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Massie BM, Krol WF, Ammon SE, Armstrong PW, Cleland JG, Collins JF, Ezekowitz M, Jafri SM, O'Connor CM, Packer M, Schulman KA, Teo K, Warren S. The Warfarin and Antiplatelet Therapy in Heart Failure trial (WATCH): rationale, design, and baseline patient characteristics. J Card Fail. 2004 Apr;10(2):101-12. doi: 10.1016/j.cardfail.2004.02.006.
- Massie BM, Collins JF, Ammon SE, Armstrong PW, Cleland JG, Ezekowitz M, Jafri SM, Krol WF, O'Connor CM, Schulman KA, Teo K, Warren SR; WATCH Trial Investigators. Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial. Circulation. 2009 Mar 31;119(12):1616-24. doi: 10.1161/CIRCULATIONAHA.108.801753. Epub 2009 Mar 16.
- Patterson ME, Grant WC, Glickman SW, Massie BM, Ammon SE, Armstrong PW, Cleland JG, Collins JF, Teo KK, Schulman KA, Reed SD. Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation. J Card Fail. 2009 Dec;15(10):819-27. doi: 10.1016/j.cardfail.2009.07.004. Epub 2009 Aug 21.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 1998
Primärt slutförande (Faktisk)
1 juli 2003
Avslutad studie (Faktisk)
1 december 2004
Studieregistreringsdatum
Först inskickad
29 december 2000
Först inskickad som uppfyllde QC-kriterierna
30 december 2000
Första postat (Uppskatta)
1 januari 2001
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 juni 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juni 2011
Senast verifierad
1 juni 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Hjärtsvikt
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Fibrinolytiska medel
- Fibrinmodulerande medel
- Trombocytaggregationshämmare
- Cyklooxygenashämmare
- Antipyretika
- Purinerga P2Y-receptorantagonister
- Purinerga P2-receptorantagonister
- Purinerga antagonister
- Purinerga medel
- Antikoagulantia
- Aspirin
- Clopidogrel
- Warfarin
Andra studie-ID-nummer
- 442
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .