Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial

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.