Warfarin and Antiplatelet Therapy in Chronic Heart Failure
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
1 other identifier
interventional
1,587
3 countries
134
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Oct 1998
Longer than P75 for phase_3 heart-failure
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 29, 2000
CompletedFirst Posted
Study publicly available on registry
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedJune 16, 2011
June 1, 2011
4.8 years
December 29, 2000
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
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
Study Arms (3)
1
ACTIVE COMPARATORWarfarin Titrated to an INR of 2.5-3.0
2
ACTIVE COMPARATORAspirin 182 mg
3
ACTIVE COMPARATORClopidogrel 75 mg
Interventions
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.
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Sanofi-Synthelabocollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (134)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
VA Central California Health Care System, Fresno
Fresno, California, 93703, United States
VA Medical Center, Loma Linda
Loma Linda, California, 92357, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343, United States
Cardiovascular Consultants, Walnut Creek
Walnut Creek, California, 94598, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220, United States
Cardiology Associates of Derby, P.C.
Derby, Connecticut, 06418, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06120, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516, United States
VA Medical Center, DC
Washington D.C., District of Columbia, 20422, United States
Florida Cardiovascular Research
Atlantis, Florida, 33462, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
Watson Clinic LLP
Lakeland, Florida, 33805, United States
Brevard Cardiology
Merritt Island, Florida, 32952, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
Cardiology Consultants - Pensacola
Pensacola, Florida, 32501, United States
University Cardiology Consultants
Tamarac, Florida, 33321, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Medical Center, Augusta
Augusta, Georgia, 30904, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
Heart Care Midwest
Peoria, Illinois, 61603, United States
River Cities Cardiology
Jeffersonville, Indiana, 47130, United States
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, 71101, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, 01730, United States
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301, United States
Bay State Medical Center
Springfield, Massachusetts, 01104, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201, United States
William Beaumont Hospital
Trey, Michigan, 48095, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
VA Gulf Coast Veterans Health Care System, Biloxi
Biloxi, Mississippi, 39531, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
VA Medical Center, St Louis
St Louis, Missouri, 63106, United States
Lincoln Division VA Nebraska Western IA HCS
Lincoln, Nebraska, 68510, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
VA Stratton Medical Center, Albany
Albany, New York, 12208, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215, United States
New York Hospital Medical Center Of Queens
Flushing, New York, 11355, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York Harbor HCS
New York, New York, 10010, United States
VA Medical Center, Northport
Northport, New York, 11768, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
VA Medical Center, Syracuse
Syracuse, New York, 13210, United States
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7075, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
Margaret Pardee Memorial Hospital
Hendersonville, North Carolina, 28739, United States
VA Medical Center, Fargo
Fargo, North Dakota, 58102, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220, United States
VA Medical Center, Cleveland
Cleveland, Ohio, 44106, United States
Chalmers P. Wylie VAOPC
Columbus, Ohio, 43203-1278, United States
VA Medical Center, Dayton
Dayton, Ohio, 45428, United States
VA Medical Center, Muskogee
Muskogee, Oklahoma, 74401, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
VA Medical Center, Providence
Providence, Rhode Island, 02908, United States
VA Black Hills Health Care System, Fort Meade
Fort Meade, South Dakota, 57741, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA Medical Center
Nashville, Tennessee, 37212-2637, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0553, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
DUCCS Research of South Boston
South Boston, Virginia, 24592, United States
VA Medical Center, Huntington
Huntington, West Virginia, 25704, United States
VA Medical Center, Martinsburg
Martinsburg, West Virginia, 25041, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
Cardiology Consultants
Calgary, Alberta, T2E 7C5, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Com. Hospital and Health Centre
Edmonton, Alberta, T6L 5X8, Canada
Alder Medical Centre
Campbell River, British Columbia, V9W 6X8, Canada
North Shore Cardiology Laboratory
North Vancouver, British Columbia, V7L 2P7, Canada
Surrey Memorial Hospital - Cardiology
Surrey, British Columbia, V3V 1Z2, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Health Sciences Centre - Cardiology Research
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3A7, Canada
Ajax and Pickering General Hospital
Ajax, Ontario, L1S 7K8, Canada
Bramptom, Research Associates
Brampton, Ontario, L6V 1B4, Canada
Neureka Research Inc. Willett Green Millr Cntr
Greater Sudbury, Ontario, P3E 6B4, Canada
Hamilton Health Sciences Corp. - General Div
Hamilton, Ontario, L8L 2X2, Canada
St. Joseph's Hospital
Hamilton, Ontario, L8P 3B6, Canada
London HSC - University Campus
London, Ontario, N6A 5A5, Canada
Credit Valley Hospital Research Associates
Mississauga, Ontario, L5M 2N1, Canada
Niagara Falls Medical Center
Niagara Falls, Ontario, L2E 7H1, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Etobicoke General Hospital
Rexdale, Ontario, M9V 4B8, Canada
Cardiology Research Associates
Scarborough Village, Ontario, M1S 4V5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Invascor Clinical Research Inc.
Longeuil, Quebec, J4N 1E1, Canada
Cardiology Clinic - Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hotel-Dieu D'Artabaska
Victoriaville, Quebec, G6P 6N2, Canada
Regina General Hospital
Regina, Saskatchewan, S4P 0W5, Canada
St. Paul's Hospital
Saskatoon, Saskatchewan, S7K 0Z9, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Royal Victoria Hospital
Belfast, Antrim, BT12 6BA, United Kingdom
Luton and Dunstable Hospital
Luton, Beds, LU4 0DZ, United Kingdom
Selly Oak Hospital
Selly Oak, Birmingham, B29 6JD, United Kingdom
Bridlington and District Hospital
Bridlington, Bridlington, YO16 4QP, United Kingdom
Stepping Hills Hospital
Stockport, Cheshire, SK2 7JE, United Kingdom
South Cleveland Hospital
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Derbyshire Royal Infirmary
Derby, Derby, DE1 2QY, United Kingdom
Derriford Hospital
Devon, Devon, PL6 8DH, United Kingdom
Torbay District General
Torbay, Devon, TQ2 7AA, United Kingdom
King Geroge Hospital
Ilford, Essex, IG3 8YB, United Kingdom
Glasgow Western Infirmary
Glasgow, Glasgow, G12 8QQ, United Kingdom
Castle Hill Hospital
Cottingham, Hull, HU16 5JG, United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR, United Kingdom
St. Thomas' Hospital
London, London, SE1 7EH, United Kingdom
Newham General Hospital
Plaistow, London, E13 8SL, United Kingdom
Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT, United Kingdom
Northwick Park Hospital and Institue for Medical R
Harrow, Middlesex, HA1 3UJ, United Kingdom
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom
York District Hospital
York, North Yorkshire, YO3 7HE, United Kingdom
Royal Alexandra Hospital
Paisley, Renfrewshire, PA2 9PN, United Kingdom
Princess of Wales Hospital (Grimsby)
Grimsby, South Humberside, DN33 2BA, United Kingdom
Barnsley District General
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Cardiology Research Unit Sussex House
Brighton, Sussex, BN2 1ES, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom, WF1 4DG, United Kingdom
St. James' University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Pontefract General Infirmary
Pontefract, West Yorshire, WF8 1PL, United Kingdom
Northern General Hospital
Sheffield, Yorkshire, S5 7AU, United Kingdom
Related Publications (3)
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.
PMID: 15101020BACKGROUNDMassie 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.
PMID: 19289640RESULTPatterson 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.
PMID: 19944357RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Barry M. Massie, MD
VA Medical Center, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
December 29, 2000
First Posted
January 1, 2001
Study Start
October 1, 1998
Primary Completion
July 1, 2003
Study Completion
December 1, 2004
Last Updated
June 16, 2011
Record last verified: 2011-06