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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: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| 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
| Study ID Numbers: | IND 59673 |
| Study First Received: | May 1, 2006 |
| Last Updated: | May 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00321009 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Myocardial Infarction Left Ventricular Mural Thrombus Low Molecular Weight Heparin |
Enoxaparin Warfarin Echocardiograms |
|
Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Heparin, Low-Molecular-Weight Hematologic Agents Fibrinolytic Agents Arteriosclerosis Necrosis Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases Myocardial Infarction Arterial Occlusive Diseases |
Heart Diseases Anticoagulants Vascular Diseases Cardiovascular Agents Ischemia Warfarin Thrombosis Pharmacologic Actions Enoxaparin Coronary Disease Embolism and Thrombosis Infarction Coronary Artery Disease |