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Warfarin and Antiplatelet Therapy in Chronic Heart Failure
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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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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Bridlington, Verenigd Koninkrijk, YO16 4QP
- Bridlington and District Hospital
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Derby, Verenigd Koninkrijk, DE1 2QY
- Derbyshire Royal Infirmary
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Devon, Verenigd Koninkrijk, PL6 8DH
- Derriford Hospital
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Glasgow, Verenigd Koninkrijk, G12 8QQ
- Glasgow Western Infirmary
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London, Verenigd Koninkrijk, SE1 7EH
- St. Thomas' Hospital
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Wakefield, Verenigd Koninkrijk, WF1 4DG
- Pinderfields General Hospital
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Antrim
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Belfast, Antrim, Verenigd Koninkrijk, BT12 6BA
- Royal Victoria Hospital
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Beds
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Luton, Beds, Verenigd Koninkrijk, LU4 0DZ
- Luton and Dunstable Hospital
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Birmingham
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Selly Oak, Birmingham, Verenigd Koninkrijk, B29 6JD
- Selly Oak Hospital
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Cheshire
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Stockport, Cheshire, Verenigd Koninkrijk, SK2 7JE
- Stepping Hills Hospital
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Cleveland
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Middlesborough, Cleveland, Verenigd Koninkrijk, TS4 3BW
- South Cleveland Hospital
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Devon
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Torbay, Devon, Verenigd Koninkrijk, TQ2 7AA
- Torbay District General
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Essex
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Ilford, Essex, Verenigd Koninkrijk, IG3 8YB
- King Geroge Hospital
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Hull
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Cottingham, Hull, Verenigd Koninkrijk, HU16 5JG
- Castle Hill Hospital
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Lancashire
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Blackpool, Lancashire, Verenigd Koninkrijk, FY3 8NR
- Blackpool Victoria Hospital
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London
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Plaistow, London, Verenigd Koninkrijk, E13 8SL
- Newham General Hospital
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Manchester
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Wythenshawe, Manchester, Verenigd Koninkrijk, M23 9LT
- Wythenshawe Hospital
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Middlesex
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Harrow, Middlesex, Verenigd Koninkrijk, HA1 3UJ
- Northwick Park Hospital and Institue for Medical R
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Verenigd Koninkrijk, DN15 7BH
- Scunthorpe General Hospital
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North Yorkshire
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York, North Yorkshire, Verenigd Koninkrijk, YO3 7HE
- York District Hospital
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Renfrewshire
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Paisley, Renfrewshire, Verenigd Koninkrijk, PA2 9PN
- Royal Alexandra Hospital
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South Humberside
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Grimsby, South Humberside, Verenigd Koninkrijk, DN33 2BA
- Princess of Wales Hospital (Grimsby)
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South Yorkshire
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Barnsley, South Yorkshire, Verenigd Koninkrijk, S75 2EP
- Barnsley District General
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Sussex
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Brighton, Sussex, Verenigd Koninkrijk, BN2 1ES
- Cardiology Research Unit Sussex House
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West Yorkshire
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Leeds, West Yorkshire, Verenigd Koninkrijk, LS9 7TF
- St. James' University Hospital
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West Yorshire
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Pontefract, West Yorshire, Verenigd Koninkrijk, WF8 1PL
- Pontefract General Infirmary
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Yorkshire
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Sheffield, Yorkshire, Verenigd Koninkrijk, S5 7AU
- Northern General Hospital
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85012
- Carl T. Hayden VA Medical Center
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Tucson, Arizona, Verenigde Staten, 85723
- Southern Arizona VA Health Care System, Tucson
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Arkansas
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No. Little Rock, Arkansas, Verenigde Staten, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
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California
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Downey, California, Verenigde Staten, 90242
- Rancho Los Amigos National Rehabilitation Center
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Fresno, California, Verenigde Staten, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Verenigde Staten, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Verenigde Staten, 94304-1290
- VA Palo Alto Health Care System
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San Francisco, California, Verenigde Staten, 94121
- VA Medical Center, San Francisco
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Sepulveda, California, Verenigde Staten, 91343
- VA Greater Los Angeles HCS, Sepulveda
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Walnut Creek, California, Verenigde Staten, 94598
- Cardiovascular Consultants, Walnut Creek
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West Los Angeles, California, Verenigde Staten, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Verenigde Staten, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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Derby, Connecticut, Verenigde Staten, 06418
- Cardiology Associates of Derby, P.C.
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Hartford, Connecticut, Verenigde Staten, 06120
- St. Francis Hospital and Medical Center
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West Haven, Connecticut, Verenigde Staten, 06516
- VA Connecticut Health Care System (West Haven)
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20422
- VA Medical Center, DC
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Florida
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Atlantis, Florida, Verenigde Staten, 33462
- Florida Cardiovascular Research
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Bay Pines, Florida, Verenigde Staten, 33708
- VA Medical Center, Bay Pines
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Gainesville, Florida, Verenigde Staten, 32608
- North Florida/South Georgia Veterans Health System
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Lakeland, Florida, Verenigde Staten, 33805
- Watson Clinic LLP
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Merritt Island, Florida, Verenigde Staten, 32952
- Brevard Cardiology
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Miami, Florida, Verenigde Staten, 33125
- VA Medical Center, Miami
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Pensacola, Florida, Verenigde Staten, 32501
- Cardiology Consultants - Pensacola
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Tamarac, Florida, Verenigde Staten, 33321
- University Cardiology Consultants
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Tampa, Florida, Verenigde Staten, 33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Augusta, Georgia, Verenigde Staten, 30904
- VA Medical Center, Augusta
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Decatur, Georgia, Verenigde Staten, 30033
- Atlanta VA Medical and Rehab Center, Decatur
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Jesse Brown VAMC (WestSide Division)
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Hines, Illinois, Verenigde Staten, 60141-5000
- Edward Hines, Jr. VA Hospital
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Peoria, Illinois, Verenigde Staten, 61603
- Heart Care Midwest
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Indiana
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Jeffersonville, Indiana, Verenigde Staten, 47130
- River Cities Cardiology
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Louisiana
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Shreveport, Louisiana, Verenigde Staten, 71101
- Overton Brooks VA Medical Center, Shreveport
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Massachusetts
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Bedford, Massachusetts, Verenigde Staten, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford
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Brockton, Massachusetts, Verenigde Staten, 02301
- VA Boston Healthcare System, Brockton Campus
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Springfield, Massachusetts, Verenigde Staten, 01104
- Bay State Medical Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48113
- VA Ann Arbor Healthcare System
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Detroit, Michigan, Verenigde Staten, 48201
- John D. Dingell VA Medical Center, Detroit
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Trey, Michigan, Verenigde Staten, 48095
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55417
- VA Medical Center, Minneapolis
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Mississippi
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Biloxi, Mississippi, Verenigde Staten, 39531
- VA Gulf Coast Veterans Health Care System, Biloxi
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64128
- VA Medical Center, Kansas City MO
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St Louis, Missouri, Verenigde Staten, 63106
- VA Medical Center, St Louis
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68510
- Lincoln Division VA Nebraska Western IA HCS
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
- VA Sierra Nevada Health Care System
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New York
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Albany, New York, Verenigde Staten, 12208
- VA Stratton Medical Center, Albany
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Buffalo, New York, Verenigde Staten, 14215
- VA Western New York Healthcare System at Buffalo
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Flushing, New York, Verenigde Staten, 11355
- New York Hospital Medical Center of Queens
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Manhasset, New York, Verenigde Staten, 11030
- North Shore University Hospital
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New York, New York, Verenigde Staten, 10010
- New York Harbor HCS
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Northport, New York, Verenigde Staten, 11768
- VA Medical Center, Northport
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester Medical Center
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Syracuse, New York, Verenigde Staten, 13210
- VA Medical Center, Syracuse
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7075
- Univ of North Carolina at Chapel Hill
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Durham, North Carolina, Verenigde Staten, 27705
- VA Medical Center, Durham
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Hendersonville, North Carolina, Verenigde Staten, 28739
- Margaret Pardee Memorial Hospital
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North Dakota
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Fargo, North Dakota, Verenigde Staten, 58102
- VA Medical Center, Fargo
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, Verenigde Staten, 44106
- VA Medical Center, Cleveland
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Columbus, Ohio, Verenigde Staten, 43203-1278
- Chalmers P. Wylie VAOPC
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Dayton, Ohio, Verenigde Staten, 45428
- VA Medical Center, Dayton
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Oklahoma
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Muskogee, Oklahoma, Verenigde Staten, 74401
- VA Medical Center, Muskogee
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- VA Medical Center, Oklahoma City
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Oregon
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Portland, Oregon, Verenigde Staten, 97201
- VA Medical Center, Portland
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- VA Medical Center, Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02908
- VA Medical Center, Providence
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South Dakota
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Fort Meade, South Dakota, Verenigde Staten, 57741
- VA Black Hills Health Care System, Fort Meade
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38104
- VA Medical Center, Memphis
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Nashville, Tennessee, Verenigde Staten, 37212-2637
- VA Medical Center
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Texas
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Galveston, Texas, Verenigde Staten, 77555-0553
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030
- Michael E. DeBakey VA Medical Center (152)
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San Antonio, Texas, Verenigde Staten, 78229
- VA South Texas Health Care System, San Antonio
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Virginia
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Richmond, Virginia, Verenigde Staten, 23249
- Hunter Holmes McGuire VA Medical Center
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South Boston, Virginia, Verenigde Staten, 24592
- DUCCS Research of South Boston
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West Virginia
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Huntington, West Virginia, Verenigde Staten, 25704
- VA Medical Center, Huntington
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Martinsburg, West Virginia, Verenigde Staten, 25041
- VA Medical Center, Martinsburg
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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.
|
Actieve vergelijker: 2
Aspirin 182 mg
|
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
|
Actieve vergelijker: 3
Clopidogrel 75 mg
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(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Barry M. Massie, MD, VA Medical Center, San Francisco
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hartziekten
- Hart-en vaatziekten
- Hartfalen
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Fibrinolytische middelen
- Fibrine modulerende middelen
- Bloedplaatjesaggregatieremmers
- Cyclo-oxygenaseremmers
- Antipyretica
- Purinerge P2Y-receptorantagonisten
- Purinerge P2-receptorantagonisten
- Purinerge antagonisten
- Purinerge middelen
- Anticoagulantia
- Aspirine
- Clopidogrel
- Warfarine
Andere studie-ID-nummers
- 442
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