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

Phase 3

Completed

Conditions: Myocardial Infarction
Heart Disease
Stroke
Ischemic Heart Disease

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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.

Locations (64): Southern Arizona Veterans Affairs Medical Center
🇺🇸
Tucson, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
Santa Clara Medical Center
🇺🇸
Santa Clara, California, United States
West Los Angeles Veterans Affairs Medical Center
🇺🇸
West Los Angeles, California, United States
Denver Health Medical Center
🇺🇸
Denver, Colorado, United States
Denver Veterans Affairs Medical Center
🇺🇸
Denver, Colorado, United States
George Washington University
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Washington, District of Columbia, United States
Mayo Clinic Transplant Center
🇺🇸
Jacksonville, Florida, United States
Melbourne Internal Medicine Associates
🇺🇸
Melbourne, Florida, United States
Jackson Memorial Hospital/U. of Miami
🇺🇸
Miami, Florida, United States
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Southern Arizona Veterans Affairs Medical Center
🇺🇸Tucson, Arizona, United States