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Warfarin and Antiplatelet Therapy in Chronic Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Warfarin titrated to an INR of 2.5-3.0
Aspirin
Clopidogrel 75
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring aspirin, clopidogrel, embolic events, Left ventricular ejection fraction less than or eq, NYHA Class II, III or IV CHF, symptomatic CHF, warfarin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • VA Medical Center, Birmingham
  • Carl T. Hayden VA Medical Center
  • Southern Arizona VA Health Care System, Tucson
  • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
  • Rancho Los Amigos National Rehabilitation Center
  • VA Central California Health Care System, Fresno
  • VA Medical Center, Loma Linda
  • VA Palo Alto Health Care System
  • VA Medical Center, San Francisco
  • VA Greater Los Angeles HCS, Sepulveda
  • Cardiovascular Consultants, Walnut Creek
  • VA Greater Los Angeles Healthcare System, West LA
  • VA Eastern Colorado Health Care System, Denver
  • Cardiology Associates of Derby, P.C.
  • St. Francis Hospital and Medical Center
  • VA Connecticut Health Care System (West Haven)
  • VA Medical Center, DC
  • Florida Cardiovascular Research
  • VA Medical Center, Bay Pines
  • North Florida/South Georgia Veterans Health System
  • Watson Clinic LLP
  • Brevard Cardiology
  • VA Medical Center, Miami
  • Cardiology Consultants - Pensacola
  • University Cardiology Consultants
  • James A. Haley Veterans Hospital, Tampa
  • VA Medical Center, Augusta
  • Atlanta VA Medical and Rehab Center, Decatur
  • Jesse Brown VAMC (WestSide Division)
  • Edward Hines, Jr. VA Hospital
  • Heart Care Midwest
  • River Cities Cardiology
  • Overton Brooks VA Medical Center, Shreveport
  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford
  • VA Boston Healthcare System, Brockton Campus
  • Bay State Medical Center
  • VA Ann Arbor Healthcare System
  • John D. Dingell VA Medical Center, Detroit
  • William Beaumont Hospital
  • VA Medical Center, Minneapolis
  • VA Gulf Coast Veterans Health Care System, Biloxi
  • VA Medical Center, Kansas City MO
  • VA Medical Center, St Louis
  • Lincoln Division VA Nebraska Western IA HCS
  • VA Sierra Nevada Health Care System
  • VA Stratton Medical Center, Albany
  • VA Western New York Healthcare System at Buffalo
  • New York Hospital Medical Center Of Queens
  • North Shore University Hospital
  • New York Harbor HCS
  • VA Medical Center, Northport
  • University of Rochester Medical Center
  • VA Medical Center, Syracuse
  • Univ of North Carolina at Chapel Hill
  • VA Medical Center, Durham
  • Margaret Pardee Memorial Hospital
  • VA Medical Center, Fargo
  • VA Medical Center, Cincinnati
  • VA Medical Center, Cleveland
  • Chalmers P. Wylie VAOPC
  • VA Medical Center, Dayton
  • VA Medical Center, Muskogee
  • VA Medical Center, Oklahoma City
  • VA Medical Center, Portland
  • VA Medical Center, Philadelphia
  • VA Pittsburgh Health Care System
  • VA Medical Center, Providence
  • VA Black Hills Health Care System, Fort Meade
  • VA Medical Center, Memphis
  • VA Medical Center
  • University of Texas Medical Branch
  • Michael E. DeBakey VA Medical Center (152)
  • VA South Texas Health Care System, San Antonio
  • VA Salt Lake City Health Care System, Salt Lake City
  • Hunter Holmes McGuire VA Medical Center
  • DUCCS Research of South Boston
  • VA Medical Center, Huntington
  • VA Medical Center, Martinsburg
  • Wlliam S. Middleton Memorial Veterans Hospital, Madison
  • Cardiology Consultants
  • University of Alberta Hospital
  • Grey Nuns Com. Hospital and Health Centre
  • Alder Medical Centre
  • North Shore Cardiology Laboratory
  • Surrey Memorial Hospital - Cardiology
  • St. Boniface General Hospital
  • Health Sciences Centre - Cardiology Research
  • Queen Elizabeth II HSC
  • Ajax and Pickering General Hospital
  • Bramptom, Research Associates
  • Hamilton Health Sciences Corp. - General Div
  • St. Joseph's Hospital
  • London HSC - University Campus
  • Credit Valley Hospital Research Associates
  • Niagara Falls Medical Center
  • Ottawa Heart Institute
  • Etobicoke General Hospital
  • Cardiology Research Associates
  • Neureka Research Inc. Willett Green Millr Cntr
  • St. Michael's Hospital
  • Toronto Western Hospital
  • Invascor Clinical Research Inc.
  • Cardiology Clinic - Maisonneuve-Rosemont
  • Hotel-Dieu D'Artabaska
  • Regina General Hospital
  • St. Paul's Hospital
  • Royal University Hospital
  • Royal Victoria Hospital
  • Luton and Dunstable Hospital
  • Selly Oak Hospital
  • Stepping Hills Hospital
  • South Cleveland Hospital
  • Torbay District General
  • King Geroge Hospital
  • Castle Hill Hospital
  • Blackpool Victoria Hospital
  • Newham General Hospital
  • Wythenshawe Hospital
  • Northwick Park Hospital and Institue for Medical R
  • Scunthorpe General Hospital
  • York District Hospital
  • Royal Alexandra Hospital
  • Princess of Wales Hospital (Grimsby)
  • Barnsley District General
  • Cardiology Research Unit Sussex House
  • St. James' University Hospital
  • Pontefract General Infirmary
  • Northern General Hospital
  • Bridlington and District Hospital
  • Derbyshire Royal Infirmary
  • Derriford Hospital
  • Glasgow Western Infirmary
  • St. Thomas' Hospital
  • Pinderfields General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Warfarin Titrated to an INR of 2.5-3.0

Aspirin 182 mg

Clopidogrel 75 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2000
Last Updated
June 14, 2011
Sponsor
US Department of Veterans Affairs
Collaborators
Sanofi-Synthelabo, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00007683
Brief Title
Warfarin and Antiplatelet Therapy in Chronic Heart Failure
Official Title
CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Sanofi-Synthelabo, Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
aspirin, clopidogrel, embolic events, Left ventricular ejection fraction less than or eq, NYHA Class II, III or IV CHF, symptomatic CHF, warfarin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1587 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Warfarin Titrated to an INR of 2.5-3.0
Arm Title
2
Arm Type
Active Comparator
Arm Description
Aspirin 182 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Clopidogrel 75 mg
Intervention Type
Drug
Intervention Name(s)
Warfarin titrated to an INR of 2.5-3.0
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75
Intervention Description
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)
Primary Outcome Measure Information:
Title
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Description
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.
Time Frame
30 months intake; 12-42 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry M. Massie, MD
Organizational Affiliation
VA Medical Center, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
VA Medical Center, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Carl T. Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Southern Arizona VA Health Care System, Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
VA Central California Health Care System, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
VA Medical Center, Loma Linda
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA Medical Center, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
VA Greater Los Angeles HCS, Sepulveda
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
Cardiovascular Consultants, Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Eastern Colorado Health Care System, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Cardiology Associates of Derby, P.C.
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06120
Country
United States
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
VA Medical Center, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Florida Cardiovascular Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
VA Medical Center, Bay Pines
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Watson Clinic LLP
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Brevard Cardiology
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
VA Medical Center, Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Cardiology Consultants - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
University Cardiology Consultants
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
James A. Haley Veterans Hospital, Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VA Medical Center, Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Jesse Brown VAMC (WestSide Division)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States
Facility Name
Heart Care Midwest
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
River Cities Cardiology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Overton Brooks VA Medical Center, Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
VA Boston Healthcare System, Brockton Campus
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Bay State Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48113
Country
United States
Facility Name
John D. Dingell VA Medical Center, Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
William Beaumont Hospital
City
Trey
State/Province
Michigan
ZIP/Postal Code
48095
Country
United States
Facility Name
VA Medical Center, Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
VA Gulf Coast Veterans Health Care System, Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
VA Medical Center, Kansas City MO
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
VA Medical Center, St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Lincoln Division VA Nebraska Western IA HCS
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
VA Stratton Medical Center, Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
VA Western New York Healthcare System at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
New York Hospital Medical Center Of Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York Harbor HCS
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
VA Medical Center, Northport
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
VA Medical Center, Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Univ of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7075
Country
United States
Facility Name
VA Medical Center, Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Margaret Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28739
Country
United States
Facility Name
VA Medical Center, Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
VA Medical Center, Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Chalmers P. Wylie VAOPC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203-1278
Country
United States
Facility Name
VA Medical Center, Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
VA Medical Center, Muskogee
City
Muskogee
State/Province
Oklahoma
ZIP/Postal Code
74401
Country
United States
Facility Name
VA Medical Center, Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
VA Medical Center, Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
VA Medical Center, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
VA Pittsburgh Health Care System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
VA Medical Center, Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
VA Black Hills Health Care System, Fort Meade
City
Fort Meade
State/Province
South Dakota
ZIP/Postal Code
57741
Country
United States
Facility Name
VA Medical Center, Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0553
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VA South Texas Health Care System, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
DUCCS Research of South Boston
City
South Boston
State/Province
Virginia
ZIP/Postal Code
24592
Country
United States
Facility Name
VA Medical Center, Huntington
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25704
Country
United States
Facility Name
VA Medical Center, Martinsburg
City
Martinsburg
State/Province
West Virginia
ZIP/Postal Code
25041
Country
United States
Facility Name
Wlliam S. Middleton Memorial Veterans Hospital, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Cardiology Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 7C5
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Com. Hospital and Health Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Alder Medical Centre
City
Campbell River
State/Province
British Columbia
ZIP/Postal Code
V9W 6X8
Country
Canada
Facility Name
North Shore Cardiology Laboratory
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2P7
Country
Canada
Facility Name
Surrey Memorial Hospital - Cardiology
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Health Sciences Centre - Cardiology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II HSC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Ajax and Pickering General Hospital
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Bramptom, Research Associates
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6V 1B4
Country
Canada
Facility Name
Hamilton Health Sciences Corp. - General Div
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3B6
Country
Canada
Facility Name
London HSC - University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Credit Valley Hospital Research Associates
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Niagara Falls Medical Center
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H1
Country
Canada
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Etobicoke General Hospital
City
Rexdale
State/Province
Ontario
ZIP/Postal Code
M9V 4B8
Country
Canada
Facility Name
Cardiology Research Associates
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S 4V5
Country
Canada
Facility Name
Neureka Research Inc. Willett Green Millr Cntr
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 6B4
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Invascor Clinical Research Inc.
City
Longeuil
State/Province
Quebec
ZIP/Postal Code
J4N 1E1
Country
Canada
Facility Name
Cardiology Clinic - Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hotel-Dieu D'Artabaska
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6N2
Country
Canada
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
St. Paul's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0Z9
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Royal Victoria Hospital
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Luton and Dunstable Hospital
City
Luton
State/Province
Beds
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Selly Oak Hospital
City
Selly Oak
State/Province
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Stepping Hills Hospital
City
Stockport
State/Province
Cheshire
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
South Cleveland Hospital
City
Middlesborough
State/Province
Cleveland
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Torbay District General
City
Torbay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
King Geroge Hospital
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
Hull
ZIP/Postal Code
HU16 5JG
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Newham General Hospital
City
Plaistow
State/Province
London
ZIP/Postal Code
E13 8SL
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Northwick Park Hospital and Institue for Medical R
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
North Lincolnshire
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
York District Hospital
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO3 7HE
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
State/Province
Renfrewshire
ZIP/Postal Code
PA2 9PN
Country
United Kingdom
Facility Name
Princess of Wales Hospital (Grimsby)
City
Grimsby
State/Province
South Humberside
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
Barnsley District General
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Cardiology Research Unit Sussex House
City
Brighton
State/Province
Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
St. James' University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract
State/Province
West Yorshire
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Bridlington and District Hospital
City
Bridlington
ZIP/Postal Code
YO16 4QP
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Derriford Hospital
City
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Glasgow Western Infirmary
City
Glasgow
ZIP/Postal Code
G12 8QQ
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Pinderfields General Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15101020
Citation
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.
Results Reference
background
PubMed Identifier
19289640
Citation
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.
Results Reference
result
PubMed Identifier
19944357
Citation
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.
Results Reference
result

Learn more about this trial

Warfarin and Antiplatelet Therapy in Chronic Heart Failure

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