- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00007683
Warfarin and Antiplatelet Therapy in Chronic Heart Failure
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
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Alberta
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Calgary, Alberta, Kanada, T2E 7C5
- Cardiology Consultants
-
Edmonton, Alberta, Kanada, T6G 2B7
- University of Alberta Hospital
-
Edmonton, Alberta, Kanada, T6L 5X8
- Grey Nuns Com. Hospital and Health Centre
-
-
British Columbia
-
Campbell River, British Columbia, Kanada, V9W 6X8
- Alder Medical Centre
-
North Vancouver, British Columbia, Kanada, V7L 2P7
- North Shore Cardiology Laboratory
-
Surrey, British Columbia, Kanada, V3V 1Z2
- Surrey Memorial Hospital - Cardiology
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R2H 2A6
- St. Boniface General Hospital
-
Winnipeg, Manitoba, Kanada, R3A 1R9
- Health Sciences Centre - Cardiology Research
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 3A7
- Queen Elizabeth II HSC
-
-
Ontario
-
Ajax, Ontario, Kanada, L1S 7K8
- Ajax and Pickering General Hospital
-
Brampton, Ontario, Kanada, L6V 1B4
- Bramptom, Research Associates
-
Hamilton, Ontario, Kanada, L8L 2X2
- Hamilton Health Sciences Corp. - General Div
-
Hamilton, Ontario, Kanada, L8P 3B6
- St. Joseph's Hospital
-
London, Ontario, Kanada, N6A 5A5
- London HSC - University Campus
-
Mississauga, Ontario, Kanada, L5M 2N1
- Credit Valley Hospital Research Associates
-
Niagara Falls, Ontario, Kanada, L2E 7H1
- Niagara Falls Medical Center
-
Ottawa, Ontario, Kanada, K1Y 4W7
- Ottawa Heart Institute
-
Rexdale, Ontario, Kanada, M9V 4B8
- Etobicoke General Hospital
-
Scarborough, Ontario, Kanada, M1S 4V5
- Cardiology Research Associates
-
Sudbury, Ontario, Kanada, P3E 6B4
- Neureka Research Inc. Willett Green Millr Cntr
-
Toronto, Ontario, Kanada, M5B 1W8
- St. Michael's Hospital
-
Toronto, Ontario, Kanada, M5T 2S8
- Toronto Western Hospital
-
-
Quebec
-
Longeuil, Quebec, Kanada, J4N 1E1
- Invascor Clinical Research Inc.
-
Montreal, Quebec, Kanada, H1T 2M4
- Cardiology Clinic - Maisonneuve-Rosemont
-
Victoriaville, Quebec, Kanada, G6P 6N2
- Hotel-Dieu D'Artabaska
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4P 0W5
- Regina General Hospital
-
Saskatoon, Saskatchewan, Kanada, S7N 0W8
- Royal University Hospital
-
Saskatoon, Saskatchewan, Kanada, S7K 0Z9
- St. Paul's Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, Stany Zjednoczone, 35233
- VA Medical Center, Birmingham
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85012
- Carl T. Hayden VA Medical Center
-
Tucson, Arizona, Stany Zjednoczone, 85723
- Southern Arizona VA Health Care System, Tucson
-
-
Arkansas
-
No. Little Rock, Arkansas, Stany Zjednoczone, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
-
-
California
-
Downey, California, Stany Zjednoczone, 90242
- Rancho Los Amigos National Rehabilitation Center
-
Fresno, California, Stany Zjednoczone, 93703
- VA Central California Health Care System, Fresno
-
Loma Linda, California, Stany Zjednoczone, 92357
- VA Medical Center, Loma Linda
-
Palo Alto, California, Stany Zjednoczone, 94304-1290
- VA Palo Alto Health Care System
-
San Francisco, California, Stany Zjednoczone, 94121
- VA Medical Center, San Francisco
-
Sepulveda, California, Stany Zjednoczone, 91343
- VA Greater Los Angeles HCS, Sepulveda
-
Walnut Creek, California, Stany Zjednoczone, 94598
- Cardiovascular Consultants, Walnut Creek
-
West Los Angeles, California, Stany Zjednoczone, 90073
- VA Greater Los Angeles Healthcare System, West LA
-
-
Colorado
-
Denver, Colorado, Stany Zjednoczone, 80220
- VA Eastern Colorado Health Care System, Denver
-
-
Connecticut
-
Derby, Connecticut, Stany Zjednoczone, 06418
- Cardiology Associates of Derby, P.C.
-
Hartford, Connecticut, Stany Zjednoczone, 06120
- St. Francis Hospital and Medical Center
-
West Haven, Connecticut, Stany Zjednoczone, 06516
- VA Connecticut Health Care System (West Haven)
-
-
District of Columbia
-
Washington, District of Columbia, Stany Zjednoczone, 20422
- VA Medical Center, DC
-
-
Florida
-
Atlantis, Florida, Stany Zjednoczone, 33462
- Florida Cardiovascular Research
-
Bay Pines, Florida, Stany Zjednoczone, 33708
- VA Medical Center, Bay Pines
-
Gainesville, Florida, Stany Zjednoczone, 32608
- North Florida/South Georgia Veterans Health System
-
Lakeland, Florida, Stany Zjednoczone, 33805
- Watson Clinic LLP
-
Merritt Island, Florida, Stany Zjednoczone, 32952
- Brevard Cardiology
-
Miami, Florida, Stany Zjednoczone, 33125
- VA Medical Center, Miami
-
Pensacola, Florida, Stany Zjednoczone, 32501
- Cardiology Consultants - Pensacola
-
Tamarac, Florida, Stany Zjednoczone, 33321
- University Cardiology Consultants
-
Tampa, Florida, Stany Zjednoczone, 33612
- James A. Haley Veterans Hospital, Tampa
-
-
Georgia
-
Augusta, Georgia, Stany Zjednoczone, 30904
- VA Medical Center, Augusta
-
Decatur, Georgia, Stany Zjednoczone, 30033
- Atlanta VA Medical and Rehab Center, Decatur
-
-
Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60612
- Jesse Brown VAMC (WestSide Division)
-
Hines, Illinois, Stany Zjednoczone, 60141-5000
- Edward Hines, Jr. VA Hospital
-
Peoria, Illinois, Stany Zjednoczone, 61603
- Heart Care Midwest
-
-
Indiana
-
Jeffersonville, Indiana, Stany Zjednoczone, 47130
- River Cities Cardiology
-
-
Louisiana
-
Shreveport, Louisiana, Stany Zjednoczone, 71101
- Overton Brooks VA Medical Center, Shreveport
-
-
Massachusetts
-
Bedford, Massachusetts, Stany Zjednoczone, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford
-
Brockton, Massachusetts, Stany Zjednoczone, 02301
- VA Boston Healthcare System, Brockton Campus
-
Springfield, Massachusetts, Stany Zjednoczone, 01104
- Bay State Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Stany Zjednoczone, 48113
- VA Ann Arbor Healthcare System
-
Detroit, Michigan, Stany Zjednoczone, 48201
- John D. Dingell VA Medical Center, Detroit
-
Trey, Michigan, Stany Zjednoczone, 48095
- William Beaumont Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, Stany Zjednoczone, 55417
- VA Medical Center, Minneapolis
-
-
Mississippi
-
Biloxi, Mississippi, Stany Zjednoczone, 39531
- VA Gulf Coast Veterans Health Care System, Biloxi
-
-
Missouri
-
Kansas City, Missouri, Stany Zjednoczone, 64128
- VA Medical Center, Kansas City MO
-
St Louis, Missouri, Stany Zjednoczone, 63106
- VA Medical Center, St Louis
-
-
Nebraska
-
Lincoln, Nebraska, Stany Zjednoczone, 68510
- Lincoln Division VA Nebraska Western IA HCS
-
-
Nevada
-
Reno, Nevada, Stany Zjednoczone, 89502
- VA Sierra Nevada Health Care System
-
-
New York
-
Albany, New York, Stany Zjednoczone, 12208
- VA Stratton Medical Center, Albany
-
Buffalo, New York, Stany Zjednoczone, 14215
- VA Western New York Healthcare System at Buffalo
-
Flushing, New York, Stany Zjednoczone, 11355
- New York Hospital Medical Center of Queens
-
Manhasset, New York, Stany Zjednoczone, 11030
- North Shore University Hospital
-
New York, New York, Stany Zjednoczone, 10010
- New York Harbor HCS
-
Northport, New York, Stany Zjednoczone, 11768
- VA Medical Center, Northport
-
Rochester, New York, Stany Zjednoczone, 14642
- University of Rochester Medical Center
-
Syracuse, New York, Stany Zjednoczone, 13210
- VA Medical Center, Syracuse
-
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North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7075
- Univ of North Carolina at Chapel Hill
-
Durham, North Carolina, Stany Zjednoczone, 27705
- VA Medical Center, Durham
-
Hendersonville, North Carolina, Stany Zjednoczone, 28739
- Margaret Pardee Memorial Hospital
-
-
North Dakota
-
Fargo, North Dakota, Stany Zjednoczone, 58102
- VA Medical Center, Fargo
-
-
Ohio
-
Cincinnati, Ohio, Stany Zjednoczone, 45220
- VA Medical Center, Cincinnati
-
Cleveland, Ohio, Stany Zjednoczone, 44106
- VA Medical Center, Cleveland
-
Columbus, Ohio, Stany Zjednoczone, 43203-1278
- Chalmers P. Wylie VAOPC
-
Dayton, Ohio, Stany Zjednoczone, 45428
- VA Medical Center, Dayton
-
-
Oklahoma
-
Muskogee, Oklahoma, Stany Zjednoczone, 74401
- VA Medical Center, Muskogee
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- VA Medical Center, Oklahoma City
-
-
Oregon
-
Portland, Oregon, Stany Zjednoczone, 97201
- VA Medical Center, Portland
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- VA Medical Center, Philadelphia
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15240
- VA Pittsburgh Health Care System
-
-
Rhode Island
-
Providence, Rhode Island, Stany Zjednoczone, 02908
- VA Medical Center, Providence
-
-
South Dakota
-
Fort Meade, South Dakota, Stany Zjednoczone, 57741
- VA Black Hills Health Care System, Fort Meade
-
-
Tennessee
-
Memphis, Tennessee, Stany Zjednoczone, 38104
- VA Medical Center, Memphis
-
Nashville, Tennessee, Stany Zjednoczone, 37212-2637
- VA Medical Center
-
-
Texas
-
Galveston, Texas, Stany Zjednoczone, 77555-0553
- University of Texas Medical Branch
-
Houston, Texas, Stany Zjednoczone, 77030
- Michael E. DeBakey VA Medical Center (152)
-
San Antonio, Texas, Stany Zjednoczone, 78229
- VA South Texas Health Care System, San Antonio
-
-
Utah
-
Salt Lake City, Utah, Stany Zjednoczone, 84148
- VA Salt Lake City Health Care System, Salt Lake City
-
-
Virginia
-
Richmond, Virginia, Stany Zjednoczone, 23249
- Hunter Holmes McGuire VA Medical Center
-
South Boston, Virginia, Stany Zjednoczone, 24592
- DUCCS Research of South Boston
-
-
West Virginia
-
Huntington, West Virginia, Stany Zjednoczone, 25704
- VA Medical Center, Huntington
-
Martinsburg, West Virginia, Stany Zjednoczone, 25041
- VA Medical Center, Martinsburg
-
-
Wisconsin
-
Madison, Wisconsin, Stany Zjednoczone, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
-
-
-
-
-
Bridlington, Zjednoczone Królestwo, YO16 4QP
- Bridlington and District Hospital
-
Derby, Zjednoczone Królestwo, DE1 2QY
- Derbyshire Royal Infirmary
-
Devon, Zjednoczone Królestwo, PL6 8DH
- Derriford Hospital
-
Glasgow, Zjednoczone Królestwo, G12 8QQ
- Glasgow Western Infirmary
-
London, Zjednoczone Królestwo, SE1 7EH
- St. Thomas' Hospital
-
Wakefield, Zjednoczone Królestwo, WF1 4DG
- Pinderfields General Hospital
-
-
Antrim
-
Belfast, Antrim, Zjednoczone Królestwo, BT12 6BA
- Royal Victoria Hospital
-
-
Beds
-
Luton, Beds, Zjednoczone Królestwo, LU4 0DZ
- Luton and Dunstable Hospital
-
-
Birmingham
-
Selly Oak, Birmingham, Zjednoczone Królestwo, B29 6JD
- Selly Oak Hospital
-
-
Cheshire
-
Stockport, Cheshire, Zjednoczone Królestwo, SK2 7JE
- Stepping Hills Hospital
-
-
Cleveland
-
Middlesborough, Cleveland, Zjednoczone Królestwo, TS4 3BW
- South Cleveland Hospital
-
-
Devon
-
Torbay, Devon, Zjednoczone Królestwo, TQ2 7AA
- Torbay District General
-
-
Essex
-
Ilford, Essex, Zjednoczone Królestwo, IG3 8YB
- King Geroge Hospital
-
-
Hull
-
Cottingham, Hull, Zjednoczone Królestwo, HU16 5JG
- Castle Hill Hospital
-
-
Lancashire
-
Blackpool, Lancashire, Zjednoczone Królestwo, FY3 8NR
- Blackpool Victoria Hospital
-
-
London
-
Plaistow, London, Zjednoczone Królestwo, E13 8SL
- Newham General Hospital
-
-
Manchester
-
Wythenshawe, Manchester, Zjednoczone Królestwo, M23 9LT
- Wythenshawe Hospital
-
-
Middlesex
-
Harrow, Middlesex, Zjednoczone Królestwo, HA1 3UJ
- Northwick Park Hospital and Institue for Medical R
-
-
North Lincolnshire
-
Scunthorpe, North Lincolnshire, Zjednoczone Królestwo, DN15 7BH
- Scunthorpe General Hospital
-
-
North Yorkshire
-
York, North Yorkshire, Zjednoczone Królestwo, YO3 7HE
- York District Hospital
-
-
Renfrewshire
-
Paisley, Renfrewshire, Zjednoczone Królestwo, PA2 9PN
- Royal Alexandra Hospital
-
-
South Humberside
-
Grimsby, South Humberside, Zjednoczone Królestwo, DN33 2BA
- Princess of Wales Hospital (Grimsby)
-
-
South Yorkshire
-
Barnsley, South Yorkshire, Zjednoczone Królestwo, S75 2EP
- Barnsley District General
-
-
Sussex
-
Brighton, Sussex, Zjednoczone Królestwo, BN2 1ES
- Cardiology Research Unit Sussex House
-
-
West Yorkshire
-
Leeds, West Yorkshire, Zjednoczone Królestwo, LS9 7TF
- St. James' University hospital
-
-
West Yorshire
-
Pontefract, West Yorshire, Zjednoczone Królestwo, WF8 1PL
- Pontefract General Infirmary
-
-
Yorkshire
-
Sheffield, Yorkshire, Zjednoczone Królestwo, S5 7AU
- Northern General Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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.
|
|
Aktywny komparator: 2
Aspirin 182 mg
|
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
|
|
Aktywny komparator: 3
Clopidogrel 75 mg
|
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Ramy czasowe: 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
|
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Barry M. Massie, MD, VA Medical Center, San Francisco
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby serca
- Choroby układu krążenia
- Niewydolność serca
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenty obwodowego układu nerwowego
- Inhibitory enzymów
- Środki przeciwbólowe
- Agenci systemu sensorycznego
- Środki przeciwzapalne, niesteroidowe
- Środki przeciwbólowe, nie narkotyczne
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Środki fibrynolityczne
- Środki modulujące fibrynę
- Inhibitory agregacji płytek krwi
- Inhibitory cyklooksygenazy
- Leki przeciwgorączkowe
- Antagoniści receptora purynergicznego P2Y
- Antagoniści receptora purynergicznego P2
- Antagonistów purynergicznych
- Środki purynergiczne
- Antykoagulanty
- Aspiryna
- Klopidogrel
- Warfaryna
Inne numery identyfikacyjne badania
- 442
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .