Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
- Conditions
- Myocardial InfarctionHeart DiseaseStrokeIschemic Heart Disease
- Interventions
- Registration Number
- NCT00041938
- Lead Sponsor
- Columbia University
- Brief Summary
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.
We are now transitioning into the sub-analysis part of the WARCEF patient data.
The study has recently completed data analysis for its Primary Aim. All randomized patients have completed their follow up. All study related procedure as per the protocol has been completed. We are now in the extension phase of the study to obtain more patient data to address further aims of the study. No new procedures are performed and data already in place at the sites will be collected (EKG and echocardiograms).
The aims for this study extension are:
* To assess progression of cardiac dysfunction over time among heart failure patients
* To correlate prognosis with cardiac dysfunction
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2305
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description aspirin aspirin Aspirin: 325 mg per day warfarin Warfarin Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
- Primary Outcome Measures
Name Time Method Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100\*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
- Secondary Outcome Measures
Name Time Method Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death. From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.
Event rate per 100 patient years = 100\*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Trial Locations
- Locations (64)
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Southern Arizona Veterans Affairs Medical Center
🇺🇸Tucson, Arizona, United States
Reno Veterans Affairs Medical Center
🇺🇸Reno, Nevada, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
George Washington University
🇺🇸Washington, District of Columbia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
UMDNJ - New Brunswick
🇺🇸New Brunswick, New Jersey, United States
Center for Neurologic Research
🇨🇦Lethbridge, Alberta, Canada
Veterans Affairs Medical Center
🇺🇸Detroit, Michigan, United States
QE II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Gulf Regional Research, LLC
🇺🇸Metairie, Louisiana, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Concord Hospital
🇺🇸Concord, New Hampshire, United States
Huntington Veterans Affairs Medical Center
🇺🇸Huntington, West Virginia, United States
Five Towns Neuroscience Research
🇺🇸Cedarhurst, New York, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Oklahoma City Veterans Affairs Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Cardiovascular Consultants of South Florida
🇺🇸Tamarac, Florida, United States
Mercy Health Partners
🇺🇸Muskegon, Michigan, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Black Hills Health Care System
🇺🇸Fort Meade, South Dakota, United States
Mayo Clinic Transplant Center
🇺🇸Jacksonville, Florida, United States
Methodist Heart, Lung and Vascular Institute
🇺🇸Peoria, Illinois, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Etobicoke Cardiac Research Centre
🇨🇦Rexdale, Ontario, Canada
Louisville Veterans Affairs Medical Center
🇺🇸Louisville, Kentucky, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Tri-State Medical Group Cardiology
🇺🇸Beaver, Pennsylvania, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Kaleida Health Millard Fillmore Hospital
🇺🇸Buffalo, New York, United States
Northport Veterans Affairs Medical Center
🇺🇸Northport, New York, United States
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Jackson Memorial Hospital/U. of Miami
🇺🇸Miami, Florida, United States
Mercy Research Institute
🇺🇸Miami, Florida, United States
Denver Veterans Affairs Medical Center
🇺🇸Denver, Colorado, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Columbia University, New York Presbyterian Hospital PH 3-342
🇺🇸New York, New York, United States
Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC
🇺🇸Houston, Texas, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Santa Clara Medical Center
🇺🇸Santa Clara, California, United States
West Los Angeles Veterans Affairs Medical Center
🇺🇸West Los Angeles, California, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Albany Medical College
🇺🇸Albany, New York, United States
Sewickley Valley Medical Group, Cardiology
🇺🇸Leetsdale, Pennsylvania, United States
Brooke Army Medical Center MCHE - MDC Cardiology Service
🇺🇸Ft. Sam Houston, Texas, United States
Salem VAMC
🇺🇸Salem, Virginia, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
William S. Middleton Memorial Veterans Hospital
🇺🇸Madison, Wisconsin, United States