Warfarin and Antiplatelet Therapy in Chronic Heart Failure
NCT ID: NCT00007683
Last Updated: 2011-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1587 participants
INTERVENTIONAL
1998-10-31
2004-12-31
Brief Summary
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Detailed Description
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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:
1. Open-label Warfarin titrated to an INR of 2.5-3.0;
2. Double blind aspirin 162 mg once daily;
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Warfarin Titrated to an INR of 2.5-3.0
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.
2
Aspirin 182 mg
Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
3
Clopidogrel 75 mg
Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
Interventions
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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.
Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Sanofi-Synthelabo
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Barry M. Massie, MD
Role: STUDY_CHAIR
VA Medical Center, San Francisco
Locations
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VA Medical Center, Birmingham
Birmingham, Alabama, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
VA Central California Health Care System, Fresno
Fresno, California, United States
VA Medical Center, Loma Linda
Loma Linda, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
VA Medical Center, San Francisco
San Francisco, California, United States
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States
Cardiovascular Consultants, Walnut Creek
Walnut Creek, California, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States
Cardiology Associates of Derby, P.C.
Derby, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
VA Medical Center, DC
Washington D.C., District of Columbia, United States
Florida Cardiovascular Research
Atlantis, Florida, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
Watson Clinic LLP
Lakeland, Florida, United States
Brevard Cardiology
Merritt Island, Florida, United States
VA Medical Center, Miami
Miami, Florida, United States
Cardiology Consultants - Pensacola
Pensacola, Florida, United States
University Cardiology Consultants
Tamarac, Florida, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States
VA Medical Center, Augusta
Augusta, Georgia, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
Heart Care Midwest
Peoria, Illinois, United States
River Cities Cardiology
Jeffersonville, Indiana, United States
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States
Bay State Medical Center
Springfield, Massachusetts, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States
William Beaumont Hospital
Trey, Michigan, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
VA Gulf Coast Veterans Health Care System, Biloxi
Biloxi, Mississippi, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States
VA Medical Center, St Louis
St Louis, Missouri, United States
Lincoln Division VA Nebraska Western IA HCS
Lincoln, Nebraska, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
VA Stratton Medical Center, Albany
Albany, New York, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States
New York Hospital Medical Center Of Queens
Flushing, New York, United States
North Shore University Hospital
Manhasset, New York, United States
New York Harbor HCS
New York, New York, United States
VA Medical Center, Northport
Northport, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
VA Medical Center, Syracuse
Syracuse, New York, United States
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
VA Medical Center, Durham
Durham, North Carolina, United States
Margaret Pardee Memorial Hospital
Hendersonville, North Carolina, United States
VA Medical Center, Fargo
Fargo, North Dakota, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States
VA Medical Center, Cleveland
Cleveland, Ohio, United States
Chalmers P. Wylie VAOPC
Columbus, Ohio, United States
VA Medical Center, Dayton
Dayton, Ohio, United States
VA Medical Center, Muskogee
Muskogee, Oklahoma, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States
VA Medical Center, Portland
Portland, Oregon, United States
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
VA Medical Center, Providence
Providence, Rhode Island, United States
VA Black Hills Health Care System, Fort Meade
Fort Meade, South Dakota, United States
VA Medical Center, Memphis
Memphis, Tennessee, United States
VA Medical Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
DUCCS Research of South Boston
South Boston, Virginia, United States
VA Medical Center, Huntington
Huntington, West Virginia, United States
VA Medical Center, Martinsburg
Martinsburg, West Virginia, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States
Cardiology Consultants
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Grey Nuns Com. Hospital and Health Centre
Edmonton, Alberta, Canada
Alder Medical Centre
Campbell River, British Columbia, Canada
North Shore Cardiology Laboratory
North Vancouver, British Columbia, Canada
Surrey Memorial Hospital - Cardiology
Surrey, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Health Sciences Centre - Cardiology Research
Winnipeg, Manitoba, Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
Ajax and Pickering General Hospital
Ajax, Ontario, Canada
Bramptom, Research Associates
Brampton, Ontario, Canada
Neureka Research Inc. Willett Green Millr Cntr
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences Corp. - General Div
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
London HSC - University Campus
London, Ontario, Canada
Credit Valley Hospital Research Associates
Mississauga, Ontario, Canada
Niagara Falls Medical Center
Niagara Falls, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Etobicoke General Hospital
Rexdale, Ontario, Canada
Cardiology Research Associates
Scarborough Village, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Invascor Clinical Research Inc.
Longeuil, Quebec, Canada
Cardiology Clinic - Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hotel-Dieu D'Artabaska
Victoriaville, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Royal Victoria Hospital
Belfast, Antrim, United Kingdom
Luton and Dunstable Hospital
Luton, Beds, United Kingdom
Selly Oak Hospital
Selly Oak, Birmingham, United Kingdom
Bridlington and District Hospital
Bridlington, Bridlington, United Kingdom
Stepping Hills Hospital
Stockport, Cheshire, United Kingdom
South Cleveland Hospital
Middlesbrough, Cleveland, United Kingdom
Derbyshire Royal Infirmary
Derby, Derby, United Kingdom
Derriford Hospital
Devon, Devon, United Kingdom
Torbay District General
Torbay, Devon, United Kingdom
King Geroge Hospital
Ilford, Essex, United Kingdom
Glasgow Western Infirmary
Glasgow, Glasgow, United Kingdom
Castle Hill Hospital
Cottingham, Hull, United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom
St. Thomas' Hospital
London, London, United Kingdom
Newham General Hospital
Plaistow, London, United Kingdom
Wythenshawe Hospital
Wythenshawe, Manchester, United Kingdom
Northwick Park Hospital and Institue for Medical R
Harrow, Middlesex, United Kingdom
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, United Kingdom
York District Hospital
York, North Yorkshire, United Kingdom
Royal Alexandra Hospital
Paisley, Renfrewshire, United Kingdom
Princess of Wales Hospital (Grimsby)
Grimsby, South Humberside, United Kingdom
Barnsley District General
Barnsley, South Yorkshire, United Kingdom
Cardiology Research Unit Sussex House
Brighton, Sussex, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom, United Kingdom
St. James' University Hospital
Leeds, West Yorkshire, United Kingdom
Pontefract General Infirmary
Pontefract, West Yorshire, United Kingdom
Northern General Hospital
Sheffield, Yorkshire, United Kingdom
Countries
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References
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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.
Other Identifiers
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442
Identifier Type: -
Identifier Source: org_study_id
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