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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00041938 |
Purpose
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 |
|---|---|---|
|
Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction |
Drug: aspirin Drug: Warfarin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial |
| Estimated Enrollment: | 3201 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
aspirin
|
Drug: aspirin
325 mg per day
|
|
Active Comparator: 2
warfarin
|
Drug: Warfarin
INR 2.5-3.0; target INR 2.75
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Show 64 Study Locations| 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 |
More Information
| Responsible Party: | Shunichi Homma, MD, Columbia University, College of Physicians and Surgeons |
| ClinicalTrials.gov Identifier: | NCT00041938 History of Changes |
| Other Study ID Numbers: | AAAC1093, U01NS039143-01, R01NS39154, CRC |
| Study First Received: | July 19, 2002 |
| Last Updated: | August 16, 2011 |
| Health Authority: | United States: Federal Government |
|
heart disease stroke ischemic heart disease myocardial infarction atrial fibrillation |
low ejection fraction cardiac failure aspirin Warfarin anticoagulant |
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Infarction Ischemia Myocardial Infarction Stroke Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Necrosis Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Aspirin Warfarin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |