- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00007683
Warfarin and Antiplatelet Therapy in Chronic Heart Failure
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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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, Royaume-Uni, YO16 4QP
- Bridlington and District Hospital
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Derby, Royaume-Uni, DE1 2QY
- Derbyshire Royal Infirmary
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Devon, Royaume-Uni, PL6 8DH
- Derriford Hospital
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Glasgow, Royaume-Uni, G12 8QQ
- Glasgow Western Infirmary
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London, Royaume-Uni, SE1 7EH
- St. Thomas' Hospital
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Wakefield, Royaume-Uni, WF1 4DG
- Pinderfields General Hospital
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Antrim
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Belfast, Antrim, Royaume-Uni, BT12 6BA
- Royal Victoria Hospital
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Beds
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Luton, Beds, Royaume-Uni, LU4 0DZ
- Luton and Dunstable Hospital
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Birmingham
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Selly Oak, Birmingham, Royaume-Uni, B29 6JD
- Selly Oak Hospital
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Cheshire
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Stockport, Cheshire, Royaume-Uni, SK2 7JE
- Stepping Hills Hospital
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Cleveland
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Middlesborough, Cleveland, Royaume-Uni, TS4 3BW
- South Cleveland Hospital
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Devon
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Torbay, Devon, Royaume-Uni, TQ2 7AA
- Torbay District General
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Essex
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Ilford, Essex, Royaume-Uni, IG3 8YB
- King Geroge Hospital
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Hull
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Cottingham, Hull, Royaume-Uni, HU16 5JG
- Castle Hill Hospital
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Lancashire
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Blackpool, Lancashire, Royaume-Uni, FY3 8NR
- Blackpool Victoria Hospital
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London
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Plaistow, London, Royaume-Uni, E13 8SL
- Newham General Hospital
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Manchester
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Wythenshawe, Manchester, Royaume-Uni, M23 9LT
- Wythenshawe Hospital
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Middlesex
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Harrow, Middlesex, Royaume-Uni, HA1 3UJ
- Northwick Park Hospital and Institue for Medical R
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North Lincolnshire
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Scunthorpe, North Lincolnshire, Royaume-Uni, DN15 7BH
- Scunthorpe General Hospital
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North Yorkshire
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York, North Yorkshire, Royaume-Uni, YO3 7HE
- York District Hospital
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Renfrewshire
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Paisley, Renfrewshire, Royaume-Uni, PA2 9PN
- Royal Alexandra Hospital
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South Humberside
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Grimsby, South Humberside, Royaume-Uni, DN33 2BA
- Princess of Wales Hospital (Grimsby)
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South Yorkshire
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Barnsley, South Yorkshire, Royaume-Uni, S75 2EP
- Barnsley District General
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Sussex
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Brighton, Sussex, Royaume-Uni, BN2 1ES
- Cardiology Research Unit Sussex House
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West Yorkshire
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Leeds, West Yorkshire, Royaume-Uni, LS9 7TF
- St. James' University Hospital
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West Yorshire
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Pontefract, West Yorshire, Royaume-Uni, WF8 1PL
- Pontefract General Infirmary
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Yorkshire
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Sheffield, Yorkshire, Royaume-Uni, S5 7AU
- Northern General Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix, Arizona, États-Unis, 85012
- Carl T. Hayden VA Medical Center
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Tucson, Arizona, États-Unis, 85723
- Southern Arizona VA Health Care System, Tucson
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Arkansas
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No. Little Rock, Arkansas, États-Unis, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
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California
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Downey, California, États-Unis, 90242
- Rancho Los Amigos National Rehabilitation Center
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Fresno, California, États-Unis, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, États-Unis, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, États-Unis, 94304-1290
- VA Palo Alto Health Care System
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San Francisco, California, États-Unis, 94121
- VA Medical Center, San Francisco
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Sepulveda, California, États-Unis, 91343
- VA Greater Los Angeles HCS, Sepulveda
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Walnut Creek, California, États-Unis, 94598
- Cardiovascular Consultants, Walnut Creek
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West Los Angeles, California, États-Unis, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, États-Unis, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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Derby, Connecticut, États-Unis, 06418
- Cardiology Associates of Derby, P.C.
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Hartford, Connecticut, États-Unis, 06120
- St. Francis Hospital and Medical Center
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West Haven, Connecticut, États-Unis, 06516
- VA Connecticut Health Care System (West Haven)
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District of Columbia
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Washington, District of Columbia, États-Unis, 20422
- VA Medical Center, DC
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Florida
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Atlantis, Florida, États-Unis, 33462
- Florida Cardiovascular Research
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Bay Pines, Florida, États-Unis, 33708
- VA Medical Center, Bay Pines
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Gainesville, Florida, États-Unis, 32608
- North Florida/South Georgia Veterans Health System
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Lakeland, Florida, États-Unis, 33805
- Watson Clinic LLP
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Merritt Island, Florida, États-Unis, 32952
- Brevard Cardiology
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Miami, Florida, États-Unis, 33125
- VA Medical Center, Miami
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Pensacola, Florida, États-Unis, 32501
- Cardiology Consultants - Pensacola
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Tamarac, Florida, États-Unis, 33321
- University Cardiology Consultants
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Tampa, Florida, États-Unis, 33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Augusta, Georgia, États-Unis, 30904
- VA Medical Center, Augusta
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Decatur, Georgia, États-Unis, 30033
- Atlanta VA Medical and Rehab Center, Decatur
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Jesse Brown VAMC (WestSide Division)
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Hines, Illinois, États-Unis, 60141-5000
- Edward Hines, Jr. VA Hospital
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Peoria, Illinois, États-Unis, 61603
- Heart Care Midwest
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Indiana
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Jeffersonville, Indiana, États-Unis, 47130
- River Cities Cardiology
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Louisiana
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Shreveport, Louisiana, États-Unis, 71101
- Overton Brooks VA Medical Center, Shreveport
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Massachusetts
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Bedford, Massachusetts, États-Unis, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford
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Brockton, Massachusetts, États-Unis, 02301
- VA Boston Healthcare System, Brockton Campus
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Springfield, Massachusetts, États-Unis, 01104
- Bay State Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48113
- VA Ann Arbor Healthcare System
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Detroit, Michigan, États-Unis, 48201
- John D. Dingell VA Medical Center, Detroit
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Trey, Michigan, États-Unis, 48095
- William Beaumont Hospital
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55417
- VA Medical Center, Minneapolis
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Mississippi
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Biloxi, Mississippi, États-Unis, 39531
- VA Gulf Coast Veterans Health Care System, Biloxi
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- VA Medical Center, Kansas City MO
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St Louis, Missouri, États-Unis, 63106
- VA Medical Center, St Louis
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Nebraska
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Lincoln, Nebraska, États-Unis, 68510
- Lincoln Division VA Nebraska Western IA HCS
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Nevada
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Reno, Nevada, États-Unis, 89502
- VA Sierra Nevada Health Care System
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New York
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Albany, New York, États-Unis, 12208
- VA Stratton Medical Center, Albany
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Buffalo, New York, États-Unis, 14215
- VA Western New York Healthcare System at Buffalo
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Flushing, New York, États-Unis, 11355
- New York Hospital Medical Center of Queens
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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New York, New York, États-Unis, 10010
- New York Harbor HCS
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Northport, New York, États-Unis, 11768
- VA Medical Center, Northport
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Rochester, New York, États-Unis, 14642
- University of Rochester Medical Center
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Syracuse, New York, États-Unis, 13210
- VA Medical Center, Syracuse
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7075
- Univ of North Carolina at Chapel Hill
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Durham, North Carolina, États-Unis, 27705
- VA Medical Center, Durham
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Hendersonville, North Carolina, États-Unis, 28739
- Margaret Pardee Memorial Hospital
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North Dakota
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Fargo, North Dakota, États-Unis, 58102
- VA Medical Center, Fargo
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Ohio
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Cincinnati, Ohio, États-Unis, 45220
- VA Medical Center, Cincinnati
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Cleveland, Ohio, États-Unis, 44106
- VA Medical Center, Cleveland
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Columbus, Ohio, États-Unis, 43203-1278
- Chalmers P. Wylie VAOPC
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Dayton, Ohio, États-Unis, 45428
- VA Medical Center, Dayton
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Oklahoma
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Muskogee, Oklahoma, États-Unis, 74401
- VA Medical Center, Muskogee
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Oklahoma City, Oklahoma, États-Unis, 73104
- VA Medical Center, Oklahoma City
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Oregon
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Portland, Oregon, États-Unis, 97201
- VA Medical Center, Portland
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- VA Medical Center, Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, États-Unis, 02908
- VA Medical Center, Providence
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South Dakota
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Fort Meade, South Dakota, États-Unis, 57741
- VA Black Hills Health Care System, Fort Meade
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Tennessee
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Memphis, Tennessee, États-Unis, 38104
- VA Medical Center, Memphis
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Nashville, Tennessee, États-Unis, 37212-2637
- VA Medical Center
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Texas
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Galveston, Texas, États-Unis, 77555-0553
- University of Texas Medical Branch
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Houston, Texas, États-Unis, 77030
- Michael E. DeBakey VA Medical Center (152)
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San Antonio, Texas, États-Unis, 78229
- VA South Texas Health Care System, San Antonio
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Utah
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Salt Lake City, Utah, États-Unis, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Virginia
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Richmond, Virginia, États-Unis, 23249
- Hunter Holmes McGuire VA Medical Center
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South Boston, Virginia, États-Unis, 24592
- DUCCS Research of South Boston
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West Virginia
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Huntington, West Virginia, États-Unis, 25704
- VA Medical Center, Huntington
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Martinsburg, West Virginia, États-Unis, 25041
- VA Medical Center, Martinsburg
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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.
|
Comparateur actif: 2
Aspirin 182 mg
|
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
|
Comparateur actif: 3
Clopidogrel 75 mg
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(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Barry M. Massie, MD, VA Medical Center, San Francisco
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies cardiaques
- Maladies cardiovasculaires
- Insuffisance cardiaque
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires non stéroïdiens
- Analgésiques, non narcotiques
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Inhibiteurs de l'agrégation plaquettaire
- Inhibiteurs de la cyclooxygénase
- Antipyrétiques
- Antagonistes des récepteurs purinergiques P2Y
- Antagonistes des récepteurs purinergiques P2
- Antagonistes purinergiques
- Agents purinergiques
- Anticoagulants
- Aspirine
- Clopidogrel
- Warfarine
Autres numéros d'identification d'étude
- 442
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