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Sponsors and Collaborators: |
Columbia University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00041938 |
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.
Condition | Intervention | Phase |
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Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction |
Drug: aspirin Drug: Warfarin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial |
Estimated Enrollment: | 3201 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
aspirin
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Drug: aspirin
325 mg per day
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2: Active Comparator
warfarin
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Drug: Warfarin
INR 2.5-3.0; target INR 2.75
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Vilma Mejia | (212) 342-6058 |
Principal Investigator: | Shunichi Homma, M.D. | Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine |
Principal Investigator: | Seamus Thompson, PhD | Statistical PI: Clinical Professor of Biostatistics and Neurology |
Responsible Party: | Columbia University, College of Physicians and Surgeons ( Shunichi Homma, MD ) |
Study ID Numbers: | U01NS43975-01, U01NS39143-01, R01NS39154, CRC |
Study First Received: | July 19, 2002 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041938 |
Health Authority: | United States: Federal Government |
heart disease stroke ischemic heart disease myocardial infarction atrial fibrillation |
low ejection fraction cardiac failure aspirin Warfarin anticoagulant |
Heart Failure Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Central Nervous System Diseases Warfarin |
Ischemia Brain Diseases Cerebrovascular Disorders Necrosis Aspirin Atrial Fibrillation Infarction Myocardial Infarction |
Anti-Inflammatory Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |