Warfarin and Antiplatelet Therapy in Chronic Heart Failure
14. juni 2011 oppdatert 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
1587
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2E 7C5
- Cardiology Consultants
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Edmonton, Alberta, Canada, T6L 5X8
- Grey Nuns Com. Hospital and Health Centre
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British Columbia
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Campbell River, British Columbia, Canada, V9W 6X8
- Alder Medical Centre
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North Vancouver, British Columbia, Canada, V7L 2P7
- North Shore Cardiology Laboratory
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Surrey, British Columbia, Canada, V3V 1Z2
- Surrey Memorial Hospital - Cardiology
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Centre - Cardiology Research
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Queen Elizabeth II HSC
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- Ajax and Pickering General Hospital
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Brampton, Ontario, Canada, L6V 1B4
- Bramptom, Research Associates
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences Corp. - General Div
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Hamilton, Ontario, Canada, L8P 3B6
- St. Joseph's Hospital
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London, Ontario, Canada, N6A 5A5
- London HSC - University Campus
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital Research Associates
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Niagara Falls, Ontario, Canada, L2E 7H1
- Niagara Falls Medical Center
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Ottawa, Ontario, Canada, K1Y 4W7
- Ottawa Heart Institute
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Rexdale, Ontario, Canada, M9V 4B8
- Etobicoke General Hospital
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Scarborough, Ontario, Canada, M1S 4V5
- Cardiology Research Associates
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Sudbury, Ontario, Canada, P3E 6B4
- Neureka Research Inc. Willett Green Millr Cntr
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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Quebec
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Longeuil, Quebec, Canada, J4N 1E1
- Invascor Clinical Research Inc.
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Montreal, Quebec, Canada, H1T 2M4
- Cardiology Clinic - Maisonneuve-Rosemont
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Victoriaville, Quebec, Canada, G6P 6N2
- Hotel-Dieu D'Artabaska
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Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
- Regina General Hospital
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
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Saskatoon, Saskatchewan, Canada, S7K 0Z9
- St. Paul's Hospital
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix, Arizona, Forente stater, 85012
- Carl T. Hayden VA Medical Center
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Tucson, Arizona, Forente stater, 85723
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Arkansas
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No. Little Rock, Arkansas, Forente stater, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
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California
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Downey, California, Forente stater, 90242
- Rancho Los Amigos National Rehabilitation Center
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Fresno, California, Forente stater, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Forente stater, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Forente stater, 94304-1290
- VA Palo Alto Health Care System
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San Francisco, California, Forente stater, 94121
- VA Medical Center, San Francisco
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Sepulveda, California, Forente stater, 91343
- VA Greater Los Angeles HCS, Sepulveda
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Walnut Creek, California, Forente stater, 94598
- Cardiovascular Consultants, Walnut Creek
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West Los Angeles, California, Forente stater, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Forente stater, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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Derby, Connecticut, Forente stater, 06418
- Cardiology Associates of Derby, P.C.
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Hartford, Connecticut, Forente stater, 06120
- St. Francis Hospital and Medical Center
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West Haven, Connecticut, Forente stater, 06516
- VA Connecticut Health Care System (West Haven)
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District of Columbia
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Washington, District of Columbia, Forente stater, 20422
- VA Medical Center, DC
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Florida
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Atlantis, Florida, Forente stater, 33462
- Florida Cardiovascular Research
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Bay Pines, Florida, Forente stater, 33708
- VA Medical Center, Bay Pines
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Gainesville, Florida, Forente stater, 32608
- North Florida/South Georgia Veterans Health System
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Lakeland, Florida, Forente stater, 33805
- Watson Clinic LLP
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Merritt Island, Florida, Forente stater, 32952
- Brevard Cardiology
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Miami, Florida, Forente stater, 33125
- VA Medical Center, Miami
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Pensacola, Florida, Forente stater, 32501
- Cardiology Consultants - Pensacola
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Tamarac, Florida, Forente stater, 33321
- University Cardiology Consultants
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Tampa, Florida, Forente stater, 33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Augusta, Georgia, Forente stater, 30904
- VA Medical Center, Augusta
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Decatur, Georgia, Forente stater, 30033
- Atlanta VA Medical and Rehab Center, Decatur
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Jesse Brown VAMC (WestSide Division)
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Hines, Illinois, Forente stater, 60141-5000
- Edward Hines, Jr. VA Hospital
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Peoria, Illinois, Forente stater, 61603
- Heart Care Midwest
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Indiana
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Jeffersonville, Indiana, Forente stater, 47130
- River Cities Cardiology
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Louisiana
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Shreveport, Louisiana, Forente stater, 71101
- Overton Brooks VA Medical Center, Shreveport
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Massachusetts
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Bedford, Massachusetts, Forente stater, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford
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Brockton, Massachusetts, Forente stater, 02301
- VA Boston Healthcare System, Brockton Campus
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Springfield, Massachusetts, Forente stater, 01104
- Bay State Medical Center
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Michigan
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Ann Arbor, Michigan, Forente stater, 48113
- VA Ann Arbor Healthcare System
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Detroit, Michigan, Forente stater, 48201
- John D. Dingell VA Medical Center, Detroit
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Trey, Michigan, Forente stater, 48095
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- VA Medical Center, Minneapolis
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Mississippi
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Biloxi, Mississippi, Forente stater, 39531
- VA Gulf Coast Veterans Health Care System, Biloxi
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Missouri
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Kansas City, Missouri, Forente stater, 64128
- VA Medical Center, Kansas City MO
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St Louis, Missouri, Forente stater, 63106
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Nebraska
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Lincoln, Nebraska, Forente stater, 68510
- Lincoln Division VA Nebraska Western IA HCS
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Nevada
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Reno, Nevada, Forente stater, 89502
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New York
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Albany, New York, Forente stater, 12208
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Buffalo, New York, Forente stater, 14215
- VA Western New York Healthcare System at Buffalo
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Flushing, New York, Forente stater, 11355
- New York Hospital Medical Center of Queens
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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New York, New York, Forente stater, 10010
- New York Harbor HCS
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Northport, New York, Forente stater, 11768
- VA Medical Center, Northport
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
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Syracuse, New York, Forente stater, 13210
- VA Medical Center, Syracuse
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7075
- Univ of North Carolina at Chapel Hill
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Durham, North Carolina, Forente stater, 27705
- VA Medical Center, Durham
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Hendersonville, North Carolina, Forente stater, 28739
- Margaret Pardee Memorial Hospital
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North Dakota
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Fargo, North Dakota, Forente stater, 58102
- VA Medical Center, Fargo
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Ohio
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Cincinnati, Ohio, Forente stater, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, Forente stater, 44106
- VA Medical Center, Cleveland
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Columbus, Ohio, Forente stater, 43203-1278
- Chalmers P. Wylie VAOPC
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Dayton, Ohio, Forente stater, 45428
- VA Medical Center, Dayton
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Oklahoma
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Muskogee, Oklahoma, Forente stater, 74401
- VA Medical Center, Muskogee
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Oklahoma City, Oklahoma, Forente stater, 73104
- VA Medical Center, Oklahoma City
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Oregon
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Portland, Oregon, Forente stater, 97201
- VA Medical Center, Portland
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- VA Medical Center, Philadelphia
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Pittsburgh, Pennsylvania, Forente stater, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Forente stater, 02908
- VA Medical Center, Providence
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South Dakota
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Fort Meade, South Dakota, Forente stater, 57741
- VA Black Hills Health Care System, Fort Meade
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Tennessee
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Memphis, Tennessee, Forente stater, 38104
- VA Medical Center, Memphis
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Nashville, Tennessee, Forente stater, 37212-2637
- VA Medical Center
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Texas
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Galveston, Texas, Forente stater, 77555-0553
- University of Texas Medical Branch
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Houston, Texas, Forente stater, 77030
- Michael E. DeBakey VA Medical Center (152)
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San Antonio, Texas, Forente stater, 78229
- VA South Texas Health Care System, San Antonio
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Utah
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Salt Lake City, Utah, Forente stater, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Virginia
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Richmond, Virginia, Forente stater, 23249
- Hunter Holmes McGuire VA Medical Center
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South Boston, Virginia, Forente stater, 24592
- DUCCS Research of South Boston
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West Virginia
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Huntington, West Virginia, Forente stater, 25704
- VA Medical Center, Huntington
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Martinsburg, West Virginia, Forente stater, 25041
- VA Medical Center, Martinsburg
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Bridlington, Storbritannia, YO16 4QP
- Bridlington and District Hospital
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Derby, Storbritannia, DE1 2QY
- Derbyshire Royal Infirmary
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Devon, Storbritannia, PL6 8DH
- Derriford Hospital
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Glasgow, Storbritannia, G12 8QQ
- Glasgow Western Infirmary
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London, Storbritannia, SE1 7EH
- St. Thomas' Hospital
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Wakefield, Storbritannia, WF1 4DG
- Pinderfields General Hospital
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Antrim
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Belfast, Antrim, Storbritannia, BT12 6BA
- Royal Victoria Hospital
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Beds
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Luton, Beds, Storbritannia, LU4 0DZ
- Luton and Dunstable Hospital
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Birmingham
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Selly Oak, Birmingham, Storbritannia, B29 6JD
- Selly Oak Hospital
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Cheshire
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Stockport, Cheshire, Storbritannia, SK2 7JE
- Stepping Hills Hospital
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Cleveland
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Middlesborough, Cleveland, Storbritannia, TS4 3BW
- South Cleveland Hospital
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Devon
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Torbay, Devon, Storbritannia, TQ2 7AA
- Torbay District General
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Essex
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Ilford, Essex, Storbritannia, IG3 8YB
- King Geroge Hospital
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Hull
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Cottingham, Hull, Storbritannia, HU16 5JG
- Castle Hill Hospital
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Lancashire
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Blackpool, Lancashire, Storbritannia, FY3 8NR
- Blackpool Victoria Hospital
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London
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Plaistow, London, Storbritannia, E13 8SL
- Newham General Hospital
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Manchester
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Wythenshawe, Manchester, Storbritannia, M23 9LT
- Wythenshawe Hospital
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Middlesex
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Harrow, Middlesex, Storbritannia, HA1 3UJ
- Northwick Park Hospital and Institue for Medical R
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Storbritannia, DN15 7BH
- Scunthorpe General Hospital
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North Yorkshire
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York, North Yorkshire, Storbritannia, YO3 7HE
- York District Hospital
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Renfrewshire
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Paisley, Renfrewshire, Storbritannia, PA2 9PN
- Royal Alexandra Hospital
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South Humberside
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Grimsby, South Humberside, Storbritannia, DN33 2BA
- Princess of Wales Hospital (Grimsby)
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South Yorkshire
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Barnsley, South Yorkshire, Storbritannia, S75 2EP
- Barnsley District General
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Sussex
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Brighton, Sussex, Storbritannia, BN2 1ES
- Cardiology Research Unit Sussex House
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West Yorkshire
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Leeds, West Yorkshire, Storbritannia, LS9 7TF
- St. James' University hospital
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West Yorshire
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Pontefract, West Yorshire, Storbritannia, WF8 1PL
- Pontefract General Infirmary
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Yorkshire
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Sheffield, Yorkshire, Storbritannia, S5 7AU
- Northern General Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Barry M. Massie, MD, VA Medical Center, San Francisco
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 1998
Primær fullføring (Faktiske)
1. juli 2003
Studiet fullført (Faktiske)
1. desember 2004
Datoer for studieregistrering
Først innsendt
29. desember 2000
Først innsendt som oppfylte QC-kriteriene
30. desember 2000
Først lagt ut (Anslag)
1. januar 2001
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juni 2011
Sist bekreftet
1. juni 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Hjertefeil
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodplateaggregasjonshemmere
- Syklooksygenase-hemmere
- Antipyretika
- Purinergiske P2Y-reseptorantagonister
- Purinergiske P2-reseptorantagonister
- Purinergiske antagonister
- Purinergiske midler
- Antikoagulanter
- Aspirin
- Klopidogrel
- Warfarin
Andre studie-ID-numre
- 442
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .