Conditions: Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction
Keywords: heart disease stroke ischemic heart disease myocardial infarction atrial fibrillation low ejection fraction cardiac failure aspirin Warfarin anticoagulant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2305
Healthy volunteers: no

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.

Arms:
arm 1: Aspirin: 325 mg per day arm 2: Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75

Interventions: intervention 1: aspirin intervention 2: Warfarin
Intervention descriptions: intervention 1: 325 mg per day intervention 2: INR 2.5-3.0; target INR 2.75

Protocol document: