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| Sponsor: | William Beaumont Hospitals |
|---|---|
| Collaborator: |
Rhone-Poulenc Rorer |
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00321009 |
Purpose
To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Acute Myocardial Infarction |
Drug: Enoxaparin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Randomized Trial Comparing Enoxaparin to Warfarin for the Prevention of LV Thrombus Formation After Anterior Wall Myocardial Infarction: A 60 Patient Pilot Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | April 2004 |
Patients with anterior Q-wave MIs and ejection fractions<=40% will be enrolled within the first 4 days of infarction. Patients will be randomized to receive either enoxaparin 1mg/kg (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral warfarin for 3 months.
Clinical and safety evaluations, 2-D echocardiograms at baseline and at 3.5 months and cost analysis will be performed.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Anterior myocardial infarction with:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New York | |
| St Joseph's Health Center Dept. of Cardiology | |
| Syracuse, New York, United States, 13203 | |
| United States, North Carolina | |
| LaBauer Cardiovascular Research Foundation | |
| Greensboro, North Carolina, United States, 27403 | |
| United States, Pennsylvania | |
| Doylestown Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| United States, Virginia | |
| Cardiovascular Associates Ltd. | |
| Virginia Beach, Virginia, United States, 23454 | |
| Principal Investigator: | Cindy L Grines, MD | William Beaumont Hospitals |
More Information
| ClinicalTrials.gov Identifier: | NCT00321009 History of Changes |
| Other Study ID Numbers: | IND 59673 |
| Study First Received: | May 1, 2006 |
| Last Updated: | May 1, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Myocardial Infarction Left Ventricular Mural Thrombus Low Molecular Weight Heparin |
Enoxaparin Warfarin Echocardiograms |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Thrombosis Anterior Wall Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes |
Necrosis Embolism and Thrombosis Heparin, Low-Molecular-Weight Warfarin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |