Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)
Heart Disease, Stroke, Ischemic Heart Disease
About this trial
This is an interventional prevention trial for Heart Disease focused on measuring heart disease, stroke, ischemic heart disease, myocardial infarction, atrial fibrillation, low ejection fraction, cardiac failure, aspirin, Warfarin, anticoagulant
Eligibility 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.
Sites / Locations
- Southern Arizona Veterans Affairs Medical Center
- University of Arizona Health Sciences Center
- Santa Clara Medical Center
- West Los Angeles Veterans Affairs Medical Center
- Denver Health Medical Center
- Denver Veterans Affairs Medical Center
- George Washington University
- Mayo Clinic Transplant Center
- Melbourne Internal Medicine Associates
- Jackson Memorial Hospital/U. of Miami
- Mercy Research Institute
- Cardiovascular Consultants of South Florida
- Morehouse School of Medicine
- Northeast Georgia Heart Center
- University of Illinois at Chicago
- Methodist Heart, Lung and Vascular Institute
- University of Kentucky
- Louisville Veterans Affairs Medical Center
- University of Louisville
- Gulf Regional Research, LLC
- LSU Health Sciences Center
- Lahey Clinic
- Veterans Affairs Medical Center
- Mercy Health Partners
- Reno Veterans Affairs Medical Center
- Concord Hospital
- UMDNJ - New Brunswick
- University of Medicine and Dentistry of New Jersey
- Albany Medical College
- Buffalo General Hospital
- Kaleida Health Millard Fillmore Hospital
- Five Towns Neuroscience Research
- Long Island Jewish Medical Center
- Columbia University, New York Presbyterian Hospital PH 3-342
- Columbia University Medical Center
- Mount Sinai Medical Center
- Northport Veterans Affairs Medical Center
- University of Rochester Medical Center
- University of North Carolina at Chapel Hill
- MetroHealth Medical Center
- Oklahoma City Veterans Affairs Medical Center
- Lehigh Valley Hospital
- Tri-State Medical Group Cardiology
- Sewickley Valley Medical Group, Cardiology
- Albert Einstein Medical Center
- Hospital of the University of Pennsylvania
- Penn Presbyterian Medical Center
- Temple University Hospital
- Black Hills Health Care System
- Brooke Army Medical Center MCHE - MDC Cardiology Service
- Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC
- Salem VAMC
- Huntington Veterans Affairs Medical Center
- William S. Middleton Memorial Veterans Hospital
- Center for Neurologic Research
- St. Boniface General Hospital
- Saint John Regional Hospital
- QE II Health Sciences Centre
- London Health Sciences Centre
- Ottawa Heart Institute
- Etobicoke Cardiac Research Centre
- St. Michael's Hospital
- Montreal General Hospital
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
aspirin
warfarin
Aspirin: 325 mg per day
Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75