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Warfarin and Antiplatelet Therapy in Chronic Heart Failure

14 giugno 2011 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1587

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Regno Unito
      • Bridlington, Regno Unito, YO16 4QP
        • Bridlington and District Hospital
      • Derby, Regno Unito, DE1 2QY
        • Derbyshire Royal Infirmary
      • Devon, Regno Unito, PL6 8DH
        • Derriford Hospital
      • Glasgow, Regno Unito, G12 8QQ
        • Glasgow Western Infirmary
      • London, Regno Unito, SE1 7EH
        • St. Thomas' Hospital
      • Wakefield, Regno Unito, WF1 4DG
        • Pinderfields General Hospital
    • Antrim
      • Belfast, Antrim, Regno Unito, BT12 6BA
        • Royal Victoria Hospital
    • Beds
      • Luton, Beds, Regno Unito, LU4 0DZ
        • Luton and Dunstable Hospital
    • Birmingham
      • Selly Oak, Birmingham, Regno Unito, B29 6JD
        • Selly Oak Hospital
    • Cheshire
      • Stockport, Cheshire, Regno Unito, SK2 7JE
        • Stepping Hills Hospital
    • Cleveland
      • Middlesborough, Cleveland, Regno Unito, TS4 3BW
        • South Cleveland Hospital
    • Devon
      • Torbay, Devon, Regno Unito, TQ2 7AA
        • Torbay District General
    • Essex
      • Ilford, Essex, Regno Unito, IG3 8YB
        • King Geroge Hospital
    • Hull
      • Cottingham, Hull, Regno Unito, HU16 5JG
        • Castle Hill Hospital
    • Lancashire
      • Blackpool, Lancashire, Regno Unito, FY3 8NR
        • Blackpool Victoria Hospital
    • London
      • Plaistow, London, Regno Unito, E13 8SL
        • Newham General Hospital
    • Manchester
      • Wythenshawe, Manchester, Regno Unito, M23 9LT
        • Wythenshawe Hospital
    • Middlesex
      • Harrow, Middlesex, Regno Unito, HA1 3UJ
        • Northwick Park Hospital and Institue for Medical R
    • North Lincolnshire
      • Scunthorpe, North Lincolnshire, Regno Unito, DN15 7BH
        • Scunthorpe General Hospital
    • North Yorkshire
      • York, North Yorkshire, Regno Unito, YO3 7HE
        • York District Hospital
    • Renfrewshire
      • Paisley, Renfrewshire, Regno Unito, PA2 9PN
        • Royal Alexandra Hospital
    • South Humberside
      • Grimsby, South Humberside, Regno Unito, DN33 2BA
        • Princess of Wales Hospital (Grimsby)
    • South Yorkshire
      • Barnsley, South Yorkshire, Regno Unito, S75 2EP
        • Barnsley District General
    • Sussex
      • Brighton, Sussex, Regno Unito, BN2 1ES
        • Cardiology Research Unit Sussex House
    • West Yorkshire
      • Leeds, West Yorkshire, Regno Unito, LS9 7TF
        • St. James' University hospital
    • West Yorshire
      • Pontefract, West Yorshire, Regno Unito, WF8 1PL
        • Pontefract General Infirmary
    • Yorkshire
      • Sheffield, Yorkshire, Regno Unito, S5 7AU
        • Northern General Hospital
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • VA Medical Center, Birmingham
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85012
        • Carl T. Hayden VA Medical Center
      • Tucson, Arizona, Stati Uniti, 85723
        • Southern Arizona VA Health Care System, Tucson
    • Arkansas
      • No. Little Rock, Arkansas, Stati Uniti, 72114-1706
        • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
    • California
      • Downey, California, Stati Uniti, 90242
        • Rancho Los Amigos National Rehabilitation Center
      • Fresno, California, Stati Uniti, 93703
        • VA Central California Health Care System, Fresno
      • Loma Linda, California, Stati Uniti, 92357
        • VA Medical Center, Loma Linda
      • Palo Alto, California, Stati Uniti, 94304-1290
        • VA Palo Alto Health Care System
      • San Francisco, California, Stati Uniti, 94121
        • VA Medical Center, San Francisco
      • Sepulveda, California, Stati Uniti, 91343
        • VA Greater Los Angeles HCS, Sepulveda
      • Walnut Creek, California, Stati Uniti, 94598
        • Cardiovascular Consultants, Walnut Creek
      • West Los Angeles, California, Stati Uniti, 90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Colorado
      • Denver, Colorado, Stati Uniti, 80220
        • VA Eastern Colorado Health Care System, Denver
    • Connecticut
      • Derby, Connecticut, Stati Uniti, 06418
        • Cardiology Associates of Derby, P.C.
      • Hartford, Connecticut, Stati Uniti, 06120
        • St. Francis Hospital and Medical Center
      • West Haven, Connecticut, Stati Uniti, 06516
        • VA Connecticut Health Care System (West Haven)
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20422
        • VA Medical Center, DC
    • Florida
      • Atlantis, Florida, Stati Uniti, 33462
        • Florida Cardiovascular Research
      • Bay Pines, Florida, Stati Uniti, 33708
        • VA Medical Center, Bay Pines
      • Gainesville, Florida, Stati Uniti, 32608
        • North Florida/South Georgia Veterans Health System
      • Lakeland, Florida, Stati Uniti, 33805
        • Watson Clinic LLP
      • Merritt Island, Florida, Stati Uniti, 32952
        • Brevard Cardiology
      • Miami, Florida, Stati Uniti, 33125
        • VA Medical Center, Miami
      • Pensacola, Florida, Stati Uniti, 32501
        • Cardiology Consultants - Pensacola
      • Tamarac, Florida, Stati Uniti, 33321
        • University Cardiology Consultants
      • Tampa, Florida, Stati Uniti, 33612
        • James A. Haley Veterans Hospital, Tampa
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30904
        • VA Medical Center, Augusta
      • Decatur, Georgia, Stati Uniti, 30033
        • Atlanta VA Medical and Rehab Center, Decatur
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Jesse Brown VAMC (WestSide Division)
      • Hines, Illinois, Stati Uniti, 60141-5000
        • Edward Hines, Jr. VA Hospital
      • Peoria, Illinois, Stati Uniti, 61603
        • Heart Care Midwest
    • Indiana
      • Jeffersonville, Indiana, Stati Uniti, 47130
        • River Cities Cardiology
    • Louisiana
      • Shreveport, Louisiana, Stati Uniti, 71101
        • Overton Brooks VA Medical Center, Shreveport
    • Massachusetts
      • Bedford, Massachusetts, Stati Uniti, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford
      • Brockton, Massachusetts, Stati Uniti, 02301
        • VA Boston Healthcare System, Brockton Campus
      • Springfield, Massachusetts, Stati Uniti, 01104
        • Bay State Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48113
        • VA Ann Arbor Healthcare System
      • Detroit, Michigan, Stati Uniti, 48201
        • John D. Dingell VA Medical Center, Detroit
      • Trey, Michigan, Stati Uniti, 48095
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55417
        • VA Medical Center, Minneapolis
    • Mississippi
      • Biloxi, Mississippi, Stati Uniti, 39531
        • VA Gulf Coast Veterans Health Care System, Biloxi
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64128
        • VA Medical Center, Kansas City MO
      • St Louis, Missouri, Stati Uniti, 63106
        • VA Medical Center, St Louis
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68510
        • Lincoln Division VA Nebraska Western IA HCS
    • Nevada
      • Reno, Nevada, Stati Uniti, 89502
        • VA Sierra Nevada Health Care System
    • New York
      • Albany, New York, Stati Uniti, 12208
        • VA Stratton Medical Center, Albany
      • Buffalo, New York, Stati Uniti, 14215
        • VA Western New York Healthcare System at Buffalo
      • Flushing, New York, Stati Uniti, 11355
        • New York Hospital Medical Center of Queens
      • Manhasset, New York, Stati Uniti, 11030
        • North Shore University Hospital
      • New York, New York, Stati Uniti, 10010
        • New York Harbor HCS
      • Northport, New York, Stati Uniti, 11768
        • VA Medical Center, Northport
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, Stati Uniti, 13210
        • VA Medical Center, Syracuse
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7075
        • Univ of North Carolina at Chapel Hill
      • Durham, North Carolina, Stati Uniti, 27705
        • VA Medical Center, Durham
      • Hendersonville, North Carolina, Stati Uniti, 28739
        • Margaret Pardee Memorial Hospital
    • North Dakota
      • Fargo, North Dakota, Stati Uniti, 58102
        • VA Medical Center, Fargo
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45220
        • VA Medical Center, Cincinnati
      • Cleveland, Ohio, Stati Uniti, 44106
        • VA Medical Center, Cleveland
      • Columbus, Ohio, Stati Uniti, 43203-1278
        • Chalmers P. Wylie VAOPC
      • Dayton, Ohio, Stati Uniti, 45428
        • VA Medical Center, Dayton
    • Oklahoma
      • Muskogee, Oklahoma, Stati Uniti, 74401
        • VA Medical Center, Muskogee
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • VA Medical Center, Oklahoma City
    • Oregon
      • Portland, Oregon, Stati Uniti, 97201
        • VA Medical Center, Portland
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • VA Medical Center, Philadelphia
      • Pittsburgh, Pennsylvania, Stati Uniti, 15240
        • VA Pittsburgh Health Care System
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02908
        • VA Medical Center, Providence
    • South Dakota
      • Fort Meade, South Dakota, Stati Uniti, 57741
        • VA Black Hills Health Care System, Fort Meade
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38104
        • VA Medical Center, Memphis
      • Nashville, Tennessee, Stati Uniti, 37212-2637
        • VA Medical Center
    • Texas
      • Galveston, Texas, Stati Uniti, 77555-0553
        • University of Texas Medical Branch
      • Houston, Texas, Stati Uniti, 77030
        • Michael E. DeBakey VA Medical Center (152)
      • San Antonio, Texas, Stati Uniti, 78229
        • VA South Texas Health Care System, San Antonio
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84148
        • VA Salt Lake City Health Care System, Salt Lake City
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23249
        • Hunter Holmes McGuire VA Medical Center
      • South Boston, Virginia, Stati Uniti, 24592
        • DUCCS Research of South Boston
    • West Virginia
      • Huntington, West Virginia, Stati Uniti, 25704
        • VA Medical Center, Huntington
      • Martinsburg, West Virginia, Stati Uniti, 25041
        • VA Medical Center, Martinsburg
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53705
        • Wlliam S. Middleton Memorial Veterans Hospital, Madison

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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:

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Warfarin Titrated to an INR of 2.5-3.0
Droga: 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.
Comparatore attivo: 2
Aspirin 182 mg
Droga: Aspirin
an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.
Comparatore attivo: 3
Clopidogrel 75 mg
Droga: Clopidogrel 75
(an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

US Department of Veterans Affairs

Collaboratori

Bristol-Myers Squibb
Sanofi-Synthelabo

Investigatori

  • Cattedra di studio: Barry M. Massie, MD, VA Medical Center, San Francisco

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 1998

Completamento primario (Effettivo)

1 luglio 2003

Completamento dello studio (Effettivo)

1 dicembre 2004

Date di iscrizione allo studio

Primo inviato

29 dicembre 2000

Primo inviato che soddisfa i criteri di controllo qualità

30 dicembre 2000

Primo Inserito (Stima)

1 gennaio 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 giugno 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 giugno 2011

Ultimo verificato

1 giugno 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 442

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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