At a glance
ClinicalIndex Comparison Record- ✓Cardiac ejection fraction ≤35% by radionuclide ventriculography, left ventriculography, quantitative echocardiography, or wall motion index ≤1.2, measured within 3 months of enrollment and ≥3 months after MI, coronary bypass, or PTCA (≥1 month after pacemaker insertion).
- ✓Modified Rankin score ≤4.
- ✓Current use of ACE inhibitor; if intolerant, angiotensin II receptor blocker or hydralazine/nitrates required.
- ✓Ability to follow outpatient protocol with monthly blood tests and clinic visits every 4 months.
- ✕Chronic or paroxysmal atrial fibrillation, mechanical valve, endocarditis, intracardiac thrombus, or valvular vegetation.
- ✕Cyanotic congenital heart disease or Eisenmenger's syndrome.
- ✕Decompensated heart failure.
- ✕Cardiac surgery, angioplasty, or MI within 3 months prior to randomization.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
In Brief
A Phase 3 clinical trial evaluating aspirin and Warfarin for Heart Disease and 3 related conditions. Completed, enrolled 2,305 participants across 64 sites in 2 countries.
Detailed 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
Study Details
Timeline
Interventions
325 mg per day
INR 2.5-3.0; target INR 2.75