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Warfarin and Antiplatelet Therapy in Chronic Heart Failure

14. juni 2011 opdateret af: US Department of Veterans Affairs

CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1587

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Warfarin Titrated to an INR of 2.5-3.0
Medicin: 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.
Aktiv komparator: 2
Aspirin 182 mg
Medicin: Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
Aktiv komparator: 3
Clopidogrel 75 mg
Medicin: Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

US Department of Veterans Affairs

Samarbejdspartnere

Bristol-Myers Squibb
Sanofi-Synthelabo

Efterforskere

  • Studiestol: Barry M. Massie, MD, VA Medical Center, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 1998

Primær færdiggørelse (Faktiske)

1. juli 2003

Studieafslutning (Faktiske)

1. december 2004

Datoer for studieregistrering

Først indsendt

29. december 2000

Først indsendt, der opfyldte QC-kriterier

30. december 2000

Først opslået (Skøn)

1. januar 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2011

Sidst verificeret

1. juni 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 442

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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