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Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? Clinical research trials and Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction?. Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? clinical trial. Participants frequently get the best healthcare available for their Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction? condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction?



Are Aspirin, Warfarin, and Clopidogrel Equally Effective in the Treatment of Patients With Symptomatic CHF and Reduced Ejection Fraction?

For Condition: Left ventricular ejection fraction less than or equal to 35%,NYHA Class II, III or IV CHF
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Canadian Regional Coordinating Center,UK Regional Coordinating Center,Economic Analysis Lab,Echo Core Lab,Sanofi-Synthelabo,Bristol-Myers Squibb,Dupont Pharmaceuticals
Synopsis: 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).
Details: 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: a. Open-label Warfarin titrated to an INR of 2.5-3.0; b. Double blind aspirin 162 mg once daily; c. Double blind clopidogrel 75 mg once daily. Primary Outcomes: Any of 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). This clinical trial will enroll 1,500 patients in approximately 150-160 medical centers; VA and non-VA centers in the U.S., and medical centers in the United Kingdom and Canada. Patients will be randomly and equally allocated to the 3 treatments: warfarin (administered open-label), aspirin and clopidogrel (the latter two administered double-blind). The study will be 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 will be entered. The primary end point will be the composite of death from any cause, non-fatal MI, and non-fatal stroke. The study has 85% power to detect a 30% difference between treatment groups. All-cause mortality will be the secondary end point. * Value of donated study drugs, Clopidogrel and Aspirin (Sanofi): $10,158,750. ** Value of donated study drug, Warfarin (Dupont): $1,080,000.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 1587

Location and Contact Information:

Vamc - West Los Angeles, Ca
Los Angeles,  California,  90073
United States
 

Torbay District General, Torbay, Uk
Torbay, Devon,  ,  TQ2 7AA
United Kingdom
 

Princess of Wales Hospital (Grimsby)
Grimsby, South Humberside,  ,  DN33 2BA
United Kingdom
 

Heart Care Midwest
Peoria,  Illinois,  61603
United States
 

Hamilton Health Sciences Corp. - General Div
Hamilton,  Ontario,  L8L 2X2
Canada
 

Florida Cardiovascular Research
Atlantis,  Florida,  33462
United States
 

St. Boniface General Hospital
Winnipeg,  Manitoba,  R2H 2A6
Canada
 

Cardiology Associates of Derby, P.C.
Derby,  Connecticut,  06418
United States
 

City Hospital (Birmingham)
Birmingham,  ,  B18 7QH
United Kingdom
 

Ohio State University
Columbus,  Ohio,  43210
United States
 

VAMC - Loma Linda, CA
Loma Linda,  California,  92354
United States
 

VAMC - Providence, RI
Providence,  Rhode Island,  02908
United States
 

Cardiology Assoc. of Gainesville
Gainesville,  Florida,  32601
United States
 

VAMC - Tampa, FL
Tampa,  Florida,  33612
United States
 

Ottawa Heart Institute
Ottawa,  Ontario,  K1Y 4W7
Canada
 

Washington DC VAMC
Washington D.C.,  District of Columbia,  20422
United States
 

University of Alberta Hospital
Edmonton,  Alberta,  T6G 2B7
Canada
 

River Cities Cardiology
Jeffersonville,  Indiana,  47130
United States
 

Northwick Park Hospital and Institue for Medical R
Harrow, Middlesex,  ,  HA1 3UJ
United Kingdom
 

Grey Nuns Com. Hospital and Health Centre
Edmonton,  Alberta,  T6L 5X8
Canada
 

Regina General Hospital
Regina,  Saskatchewan,  S4P 0W5
Canada
 

DUCCS Research of South Boston
South Boston,  Virginia,  24592
United States
 

Bridlington and District Hospital
Bridlington,  ,  YO16 4QP
United Kingdom
 

VAMC Biloxi
Biloxi,  Mississippi,  39531
United States
 

Northern General Hospital
Sheffield, Yorkshire,  ,  S5 7AU
United Kingdom
 

VAMC - Richmond, VA
Richmond,  Virginia,  23249
United States
 

Surrey Memorial Hospital - Cardiology
Surrey,  British Columbia,  V3V 1Z2
Canada
 

VAMC - Reno, NV
Reno,  Nevada,  89520
United States
 

VAMC - San Francisco, CA
San Francisco,  California,  94121
United States
 

Queen Elizabeth II HSC
Halifax,  Nova Scotia,  B3H 3A7
Canada
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0553
United States
 

VAMC - Fargo, ND
Fargo,  North Dakota,  58102
United States
 

VAMC - Houston, TX
Houston,  Texas,  77030
United States
 

Duke University Medical Center
Durham,  North Carolina,  27710-0001
United States
 

Emory Univ. School of Med., Atlanta, Ga
Atlanta,  Georgia,  30303
United States
 

University Cardiology Consultants
Tamarac,  Florida,  33321
United States
 

Newham General Hospital
Plaistow, London,  ,  E13 8SL
United Kingdom
 

St. Michael's Hospital
Toronto,  Ontario,  M5B 1W8
Canada
 

Etobicoke General Hospital
Rexdale,  Ontario,  M9V 4B8
Canada
 

Cardiology Clinic - Maisonneuve-Rosemont
Montreal,  Quebec,  H1T 2M4
Canada
 

VAMC - Memphis, TN
Memphis,  Tennessee,  38104
United States
 

VAMC - Martinsburg WV
Martinsburg,  West Virginia,  25401
United States
 

Neureka Research Inc. Willett Green Millr Cntr
Sudbury,  Ontario,  P3E 6B4
Canada
 

Luton and Dunstable Hospital
Luton, Beds,  ,  LU4 0DZ
United Kingdom
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

VAMC - West Roxbury, MA
West Roxbury,  Massachusetts,  02132
United States
 

Pinderfields General Hospital
Wakefield,  ,  WF1 4DG
United Kingdom
 

VAMC - Fresno, CA
Fresno,  California,  93703
United States
 

VAMC - Miami, FL
Miami,  Florida,  33125
United States
 

Rancho Los Amigos National Rehabilitation Center
Downey,  California,  90242
United States
 

VAMC - Durham, NC
Durham,  North Carolina,  27705
United States
 

Invascor Clinical Research Inc.
Longueuil,  Quebec,  J4N 1E1
Canada
 

King Geroge Hospital
Ilford, Essex,  ,  IG3 8YB
United Kingdom
 

Derbyshire Royal Infirmary
Derby,  ,  DE1 2QY
United Kingdom
 

Barnsley District General
Barnsley, S.Yorkshire,  ,  S75 2EP
United Kingdom
 

York District Hospital
York, North Yorkshire,  ,  YO3 7HE
United Kingdom
 

VAMC - Muskogee, OK
Muskogee,  Oklahoma,  74401
United States
 

VAMC - Ann Arbor, MI
Ann Arbor,  Michigan,  48105
United States
 

VAMC - Syracuse, NY
Syracuse,  New York,  13210
United States
 

VAMC - Minneapolis, MN
Minneapolis,  Minnesota,  55417
United States
 

VAMC - Phoenix, AZ
Phoenix,  Arizona,  85012
United States
 

VAMC - Bay Pines, FL
Bay Pines,  Florida,  33744
United States
 

Cardiac Centers of Louisiana, L.L.C.
Shreveport,  Louisiana,  71103
United States
 

William Beaumont Hospital
Troy,  Michigan,  48095
United States
 

Royal University Hospital
Saskatoon,  Saskatchewan,  S7N 0W8
Canada
 

Blackpool Victoria Hospital
Blackpool, Lancashire,  ,  FY3 8NR
United Kingdom
 

Watson Clinic LLP
Lakeland,  Florida,  33805
United States
 

VAMC - West Haven, CT
West Haven,  Connecticut,  06516
United States
 

Cardiology Consultants
Calgary,  Alberta,  T2E 7C5
Canada
 

New York Hospital Medical Center of Queens
Flushing,  New York,  11355
United States
 

St. Paul's Hospital
Saskatoon,  Saskatchewan,  S7K 0Z9
Canada
 

Bay State Medical Center
Springfield,  Massachusetts,  01104
United States
 

Northwestern University
Chicago,  Illinois,  60611-2450
United States
 

Derriford Hosptial
Devon,  ,  PL6 8DH
United Kingdom
 

Augusta Cardiology Clinic, PC
Augusta,  Georgia,  30901
United States
 

Buffalo General Hospital
Buffalo,  New York,  14203
United States
 

Alder Medical Centre
Campbell River,  British Columbia,  V9W 6X8
Canada
 

Royal Victoria Hospital
Belfast, Co. Antrim, N.Ireland,  ,  BT12 6BA
United Kingdom
 

VAMC - Kansas City, MO
Kansas City,  Missouri,  64128
United States
 

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Castle Hill Hospital
Cottingham, Hull,  ,  HU16 5JG
United Kingdom
 

Cardiology Consultants - Pensacola
Pensacola,  Florida,  32501
United States
 

Margaret Pardee Memorial Hospital
Hendersonville,  North Carolina,  28739
United States
 

Credit Valley Hospital Research Associates
Mississauga,  Ontario,  L5M 2N1
Canada
 

VAMC - Huntington, WV
Huntington,  West Virginia,  25704
United States
 

Univ of North Carolina at Chapel Hill
Chapel Hill,  North Carolina,  27599-7075
United States
 

VAMC - San Antonio, TX
San Antonio,  Texas,  78229
United States
 

VAMC Palo Alto
Palo Alto,  California,  94304
United States
 

Nashville VAMC
Nashville,  Tennessee,  37212-2637
United States
 

VAMC - Salt Lake City, UT
Salt Lake City,  Utah,  84148
United States
 

Royal Alexandra Hospital
Paisley, Renfrewshire, Scotland,  ,  PA2 9PN
United Kingdom
 

Brevard Cardiology
Merritt Island,  Florida,  32952
United States
 

VAMC - Denver, CO
Denver,  Colorado,  80220
United States
 

St. Thomas' Hospital
London,  ,  SE1 7EH
United Kingdom
 

Mercy Cardiology Clinic, Inc.
St. Louis,  Missouri,  63141
United States
 

VAMC - Little Rock, AR
Little Rock,  Arkansas,  72205
United States
 

Heart Center of Los Angeles, Los Angeles, Ca
Los Angeles,  California,  90048
United States
 

Toronto Western Hospital
Toronto,  Ontario,  M5T 2S8
Canada
 

Wythenshawe Hospital
Wythenshawe, Manchester,  ,  M23 9LT
United Kingdom
 

Cleveland Clinic Foundation
Cleveland,  Ohio,  44195
United States
 

Stepping Hills Hospital
Stockport, Cheshire,  ,  SK2 7JE
United Kingdom
 

London HSC - University Campus
London,  Ontario,  N6A 5A5
Canada
 

VAMC - Birmingham, AL
Birmingham,  Alabama,  35233
United States
 

Columbia University
New York City,  New York,  10032
United States
 

University Hospitals of Cleveland
Cleveland,  Ohio,  44106-5038
United States
 

Lds Hospital Cardiology
Salt Lake City,  Utah,  84143
United States
 

North Shore Cardiology Laboratory
North Vancouver,  British Columbia,  V7L 2P7
Canada
 

Bedford Hospital
Bedford,  ,  MK42 9DJ
United Kingdom
 

VAMC - Oklahoma City, OK
Oklahoma City,  Oklahoma,  73104
United States
 

Vamc - Black Hills, Ft Meade Sd
Fort Meade,  South Dakota,  57741
United States
 

Washington University
St. Louis,  Missouri,  63110
United States
 

Pontefract General Infirmary
Pontefract, W. Yorkshire,  ,  WF8 1PL
United Kingdom
 

Loma Linda University Medical Center
Loma Linda,  California,  92354
United States
 

VAMC - Cincinnati
Cincinnati,  Ohio,  45220
United States
 

Vamc - Cleveland, Oh
Cleveland,  Ohio,  44106
United States
 

VAMC - Albany, NY
Albany,  New York,  12208
United States
 

Cardiovascular Consultants, Walnut Creek, Ca
Walnut Creek,  California,  94598
United States
 

VAMC - Madison, WI
Madison,  Wisconsin,  53705
United States
 

St. James' University Hospital
Leeds, W. Yorkshire,  ,  LS9 7TF
United Kingdom
 

Cardiology Research Associates
Scarborough,  Ontario,  M1S 4V5
Canada
 

VAMC - Tucson, AZ
Tucson,  Arizona,  85723
United States
 

St. Joseph's Hospital
Hamilton,  Ontario,  L8P 3B6
Canada
 

Cardiology Research Unit Sussex House
Brighton, Sussex,  ,  BN2 1ES
United Kingdom
 

Niagara Falls Medical Center
Niagara Falls,  Ontario,  L2E 7H1
Canada
 

Nebraska Heart Institute
Lincoln,  Nebraska,  68506
United States
 

Hotel-Dieu D'Artabaska, Quebec, Qu
Victoriaville,  Quebec,  G6P 6N2
Canada
 

VAMC - Hines, IL
Hines,  Illinois,  60141
United States
 

St. Francis Hospital and Medical Center
Hartford,  Connecticut,  06120
United States
 

VAMC - Portland, OR
Portland,  Oregon,  97201
United States
 

Ajax and Pickering General Hospital
Ajax,  Ontario,  L1S 7K8
Canada
 

Bramptom, Research Associates
Brampton,  Ontario,  L6V 1B4
Canada
 

Glasgow Western Infirmary, Glasgow, Uk
Glasgow,  ,  G12 8QQ
United Kingdom
 

Albert Einstein Med Center-PA Cardiology Group
Philadelphia,  Pennsylvania,  19141
United States
 

VAMC - Pittsburgh, PA
Pittsburgh,  Pennsylvania,  15240
United States
 

VAMC - Northport, NY
Northport,  New York,  11768
United States
 

Hospital of the University of PA
Philadelphia,  Pennsylvania,  19104
United States
 

VAMC - Dayton, OH
Dayton,  Ohio,  45428
United States
 

Health Sciences Centre - Cardiology Research
Winnipeg,  Manitoba,  R3A 1R9
Canada
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

South Cleveland Hospital
Middlesborough, Cleveland,  ,  TS4 3BW
United Kingdom
 

Selly Oak Hospital
Selly Oak, Birmingham,  ,  B29 6JD
United Kingdom
 

MetroHealth Medical Center
Cleveland,  Ohio,  44109-1998
United States
 

Scunthorpe General Hospital
Scunthorpe, N. Lincolnshire,  ,  DN15 7BH
United Kingdom
 


Additional Information:
Study ID Numbers:
  442; 
Study Start Date: October 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007683

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