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Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
This study is currently recruiting participants.
Verified by Columbia University, March 2009
First Received: July 19, 2002   Last Updated: May 27, 2009   History of Changes
Sponsor: Columbia University
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00041938
  Purpose

The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.


Condition Intervention Phase
Heart Disease
Stroke
Ischemic Heart Disease
Myocardial Infarction
Drug: aspirin
Drug: Warfarin
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Comparison of aspirin and warfarin to determine if either is superior for preventing the combined endpoint of all-cause mortality and stroke in patients with left ventricular ejection fraction <35%. [ Time Frame: 1 to 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3201
Study Start Date: October 2002
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
aspirin
Drug: aspirin
325 mg per day
2: Active Comparator
warfarin
Drug: Warfarin
INR 2.5-3.0; target INR 2.75

Detailed Description:

Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac (heart) failure and patients with low ejection fraction (EF). EF is the proportion of left ventricular volume emptied during systole. It reliably measures left ventricular systolic function.

With the rapidly increasing numbers of elderly patients with heart failure, this study has important public health implications. The study will determine which of two commonly used treatments Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
  • Modified Rankin score <=4.
  • Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
  • Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
  • Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
  • Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
  • Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.

Exclusion Criteria

  • The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
  • Cyanotic congenital heart disease, Eisenmenger's syndrome.
  • Decompensated heart failure.
  • Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
  • A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
  • Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
  • Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
  • Comorbid conditions that may limit survival to less than five years.
  • Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
  • Enrollment in another study that would conflict with WARCEF.
  • Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
  • Person under 18 years of age.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041938

Contacts
Contact: Vilma Mejia (212) 342-6058

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States
Contact: Denise Bruck     520-626-1933     dbruck@email.arizona.edu    
Principal Investigator: Vince Sorrell            
Southern Arizona Veterans Affairs Medical Center Recruiting
Tucson, Arizona, United States
Contact: Sherry Daugherty     520-792-1450     Sherry.Daugherty@va.gov    
Principal Investigator: Steven Goldman            
United States, California
Santa Clara Medical Center Recruiting
Santa Clara, California, United States
Contact: Patricia Lockyer     408-851-3826     patricia.lockyer@kp.org    
Principal Investigator: Erna Nishime            
West Los Angeles Veterans Affairs Medical Center Recruiting
West Los Angeles, California, United States
Contact: Janet Johnson     310-478-3711     Janet.Johnson8@va.gov    
Principal Investigator: Alberta Warner            
United States, Colorado
Denver Veterans Affairs Medical Center Recruiting
Denver, Colorado, United States
Contact: Barbara Watson     303-399-8020     barbara.watson2@med.va.gov    
Principal Investigator: Brack Hattler            
Denver Health Medical Center Recruiting
Denver, Colorado, United States
Contact: Matthew Applegate     303-436-7431     matthew.applegate@dhha.org    
Principal Investigator: Richard Hughes            
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Donna Embersit     202-741-2798     dembersit@mfa.gwu.edu    
Principal Investigator: Richard Katz, MD            
United States, Florida
Mayo Clinic Transplant Center Recruiting
Jacksonville, Florida, United States
Contact: Pamela Oldano     904-956-3270     oldano.pamela@mayo.edu    
Principal Investigator: Daniel Yip            
Mercy Research Institute Recruiting
Miami, Florida, United States
Contact: Adriana Silva     305-854-4400 ext 2495     ASilva@mercymiami.org    
Principal Investigator: Javier Jimenez            
Cardiovascular Consultants of South Florida Recruiting
Tamarac, Florida, United States
Contact: Miriam Johnson     954-721-6680     mjohnson@cardiologyfl.com    
Principal Investigator: Ricky Schneider            
Melbourne Internal Medicine Associates Recruiting
Melbourne, Florida, United States
Contact: Carole Vasile     321-725-4500     Carole.Vasile@mima.com    
Principal Investigator: Bhuvaneswari Dandapani            
Jackson Memorial Hospital/U. of Miami Recruiting
Miami, Florida, United States
Contact: Maria del Carmen Lichtenberger     305-243-1386     mlichtenberger@med.miami.edu    
Principal Investigator: Gustavo Ortiz, MD            
United States, Georgia
Morehouse School of Medicine Recruiting
Atlanta, Georgia, United States
Contact: Patricia Jackson     404-752-1067     pjackson@msm.edu    
Principal Investigator: Elizabeth Ofili            
Northeast Georgia Heart Center Recruiting
Gainesville, Georgia, United States
Contact: Gina Nesbit     678-989-5003     research@ngheartcenter.com    
Principal Investigator: Brenda Hott, MD            
United States, Illinois
Methodist Heart, Lung and Vascular Institute Recruiting
Peoria, Illinois, United States
Contact: Tracy Rennie     309-672-4808     tlrennie@mmci.org    
Principal Investigator: Alexander Alder            
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States
Contact: Karen Whited     312-996-0572     kwhited@uic.edu    
Principal Investigator: Thomas Stamos            
United States, Kentucky
Louisville Veterans Affairs Medical Center Recruiting
Louisville, Kentucky, United States
Contact: Rita Longaker     502-587-4430     heartres@aol.com    
Principal Investigator: Marcus Stoddard            
University of Louisville Recruiting
Louisville, Kentucky, United States
Contact: Rita Longaker     502-587-4430     heartres@aol.com    
Principal Investigator: Marcus Stoddard            
University of Kentucky Recruiting
Lexington, Kentucky, United States
Contact: Debra Taylor     859-257-5560     DTAYL2@email.uky.edu    
Principal Investigator: L.Creed Pettigrew            
United States, Louisiana
Gulf Regional Research, LLC Recruiting
Metairie, Louisiana, United States
Contact: Louise Roffidal     504-220-6275     tgiles4@cox.net    
Principal Investigator: Thomas Giles            
LSU Health Sciences Center Recruiting
Shreveport, Louisiana, United States
Contact: Pat Jinkins     318-813-1481     pjinki@lsuhsc.edu    
Principal Investigator: Roger Kelley            
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States
Contact: Junius Beebe     781-744-5601     Junius.O.Beebe@lahey.org    
Principal Investigator: Matthew Tilem            
United States, Michigan
Veterans Affairs Medical Center Recruiting
Detroit, Michigan, United States
Contact: Elizabeth Jones     313-576-3277     elizabeth.jones3@va.gov    
Principal Investigator: Preeti Ramappa            
Mercy Health Partners Recruiting
Muskegon, Michigan, United States
Contact: Kathleen Thomas     231-672-3941     thomask@trinity-health.org    
Principal Investigator: Mark Meengs, MD            
United States, Nevada
Reno Veterans Affairs Medical Center Recruiting
Reno, Nevada, United States
Contact: Anne Baker     775-328-1830     anne.baker@med.va.gov    
Principal Investigator: William Graettinger            
United States, New Hampshire
Concord Hospital Recruiting
Concord, New Hampshire, United States
Contact: Mary Macklin     603-227-7000     mmacklin@crhc.org    
Principal Investigator: Kenneth Deloge, MD            
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States
Contact: Tina Occhiuto     973-972-4708     occhiutm@umdnj.edu    
Principal Investigator: Christine Gerula            
UMDNJ - New Brunswick Recruiting
New Brunswick, New Jersey, United States
Contact: Laurie Casazza     732-235-8694     casazzla@umdnj.edu    
Principal Investigator: Sebastian Palmeri            
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States
Contact: Vicki Conary-Rocco     585-273-4956     Vicki_Rocco@urmc.rochester.edu    
Principal Investigator: John Bisognano            
Buffalo General Hospital Recruiting
Buffalo, New York, United States
Contact: Mary Bonora     716-859-4641     mbonora@kaleidahealth.org    
Principal Investigator: Susan Graham            
Mount Sinai Medical Center Recruiting
New York, New York, United States
Contact: Arlene Travis     212-241-6121     Arlene.Travis@mssm.edu    
Principal Investigator: Bruce Darrow            
Columbia University, New York Presbyterian Hospital PH 3-342 Recruiting
New York, New York, United States, 10032
Contact: Vilma Mejia     212-342-6058        
Principal Investigator: Shunichi Homma, M.D.            
Kaleida Health Millard Fillmore Hospital Recruiting
Buffalo, New York, United States
Contact: Karol Rejman     716-887-4048     KRejman@kaleidahealth.org    
Principal Investigator: Michael Wilson            
Northport Veterans Affairs Medical Center Recruiting
Northport, New York, United States
Contact: Diana Mauceri     631-261-4400     dianagrace.mauceri@va.gov    
Principal Investigator: George Mallis            
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States
Contact: Rosario Gonzaga-Camfield     718-470-7367     rcamfiel@lij.edu    
Principal Investigator: Richard Libman            
Columbia University Medical Center Recruiting
New York, New York, United States
Contact: Andre Gabriel     212-305-9282     apg2120@columbia.edu    
Principal Investigator: Carlos Rodriguez, MD            
Five Towns Neuroscience Research Recruiting
Cedarhurst, New York, United States
Contact: Cheryl Casale     516-239-1800     ccasale@ftniresearch.com    
Principal Investigator: David Steiner            
Albany Medical College Recruiting
Albany, New York, United States
Contact: Carolyn Voulgaridis     518-262-6693     voulgaC@mail.amc.edu    
Principal Investigator: Edward Philbin, MD            
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States
Contact: Carl Schuler     919-843-4597     carl_schuler@med.unc.edu    
Principal Investigator: Patricia Chang            
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States
Contact: Scott Bailey     216-778-7476     sbailey@metrohealth.org    
Principal Investigator: Joseph Hanna            
United States, Oklahoma
Oklahoma City Veterans Affairs Medical Center Recruiting
Oklahoma City, Oklahoma, United States
Contact: John Turner     405-270-0501     john-turner@ouhsc.edu    
Principal Investigator: Udho Thadani            
United States, Pennsylvania
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States
Contact: Susanne Donovan     856-261-6605     Susanne.donovan@uphs.upenn.edu    
Principal Investigator: Brian Drachman            
Sewickley Valley Medical Group, Cardiology Recruiting
Leetsdale, Pennsylvania, United States
Contact: Jessica Hobbs-Williams     724-728-3302     jhobbs@hvhs.org    
Principal Investigator: Michael Malkowski            
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States
Contact: Jennie Wong     215-707-5340     Jennie.Wong@tuhs.temple.edu    
Principal Investigator: Lazaros Nikolaidis            
Tri-State Medical Group Cardiology Recruiting
Beaver, Pennsylvania, United States
Contact: Jessica Hobbs-Williams     724-728-3302     jhobbs@hvhs.org    
Principal Investigator: Michael Malkowski, MD            
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States
Contact: Rohini Bhole     215-456-3894     bholeroh@einstein.edu    
Principal Investigator: Jonathan Dissin            
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Kimberly Craig     215-662-6900     craigk@uphs.upenn.edu    
Principal Investigator: Thomas Cappola            
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States
Contact: Susan Nabhan     610-402-9340     susan.nabhan@lvh.com    
Principal Investigator: Ronald Freudenberger            
United States, South Dakota
Black Hills Health Care System Recruiting
Fort Meade, South Dakota, United States
Contact: Barbara McGinnis     605-720-7375     Barbara.McGinnis@va.gov    
Principal Investigator: Lana Fischer, MD            
United States, Texas
Brooke Army Medical Center MCHE - MDC Cardiology Service Recruiting
Ft. Sam Houston, Texas, United States
Contact: Dorette Pearce Moore     210-916-4417     dorette.pearcemoore@amedd.army.mil    
Principal Investigator: Ahmad Slim            
Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC Recruiting
Houston, Texas, United States
Contact: Gilberto DeFreitas     713-794-7759     gdefreit@bcm.tmc.edu    
Principal Investigator: Biyhem Bozkurt            
United States, Virginia
Salem VAMC Recruiting
Salem, Virginia, United States
Contact: Tracy Ochalek     540-982-2463     tracy.ochalek@med.va.gov    
Principal Investigator: Nabil Jarmukli            
United States, West Virginia
Huntington Veterans Affairs Medical Center Recruiting
Huntington, West Virginia, United States
Contact: Sandra Shaw     304-429-6755     sandra.shaw@va.gov    
Principal Investigator: Joseph Pellecchia            
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital Recruiting
Madison, Wisconsin, United States
Contact: Lou Ellen Williams     608-256-1901     LouEllen.Williams@med.va.gov    
Principal Investigator: Peter Kosolcharoen            
Canada, Alberta
Center for Neurologic Research Recruiting
Lethbridge, Alberta, Canada
Contact: Carolyn Walker     4033294828     c-nr@shaw.ca    
Principal Investigator: Toni Winder            
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada
Contact: Rachel Gerstein     2042372793     rgerstein@sbgh.mb.ca    
Principal Investigator: Shelley Zieroth            
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada
Contact: Ann McNulty     5066486441     mcnan@reg2.health.nb.ca    
Principal Investigator: Richard Bessoudo            
Canada, Nova Scotia
QE II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Margo MacFarlane     902-4732728     margo.macfarlane@cdha.nshealth.ca    
Principal Investigator: Miroslaw Rajda            
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Sandra Felix     416-864-6060     felixs@smh.toronto.on.ca    
Principal Investigator: Gordon Moe            
Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: JoAnn Donaldson     6137614296     jdonaldson@ottawaheart.ca    
Principal Investigator: Haissam Haddad            
Etobicoke Cardiac Research Centre Recruiting
Rexdale, Ontario, Canada
Contact: Bev Donnelly     416-7478560     etobicokecardiology@bellnet.ca    
Principal Investigator: Toan To            
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Julie Smith     5196858500     JulieK.Smith@lhsc.on.ca    
Principal Investigator: Malcolm Arnold            
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Barbara St. Jacques     514-934-1934     barbara.stjacques@muhc.mcgill.ca    
Principal Investigator: Thao Huynh            
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Helene Brown     5143763330     helene.brown@icm-mhi.org    
Principal Investigator: Anique Ducharme            
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Shunichi Homma, M.D. Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine
Principal Investigator: Seamus Thompson, PhD Statistical PI: Clinical Professor of Biostatistics and Neurology
  More Information

No publications provided

Responsible Party: Columbia University, College of Physicians and Surgeons ( Shunichi Homma, MD )
Study ID Numbers: U01NS43975-01, U01NS39143-01, R01NS39154, CRC
Study First Received: July 19, 2002
Last Updated: May 27, 2009
ClinicalTrials.gov Identifier: NCT00041938     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
heart disease
stroke
ischemic heart disease
myocardial infarction
atrial fibrillation
low ejection fraction
cardiac failure
aspirin
Warfarin
anticoagulant

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Aspirin
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Myocardial Infarction
Anticoagulants
Heart Diseases
Cyclooxygenase Inhibitors
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Warfarin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009