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| Name | Class |
|---|---|
| Rhone-Poulenc Rorer | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| What is the incidence of LV mural thrombus with administration of enoxaparin vs. | ||
| warfarin at 3.5 months in patients presenting with anterior wall myocardial | ||
| infarctions. |
| Measure | Description | Time Frame |
|---|---|---|
| What are the associated costs and length of hospital stay after randomized to | ||
| enoxaparin vs. warfarin? |
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Inclusion Criteria:
Age 18 to 80
Anterior myocardial infarction with:
Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus
MI onset < 7 days from randomization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy L Grines, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States | ||
| William Beaumont Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Royal Oak |
| Michigan |
| 48073 |
| United States |
| St Joseph's Health Center Dept. of Cardiology | Syracuse | New York | 13203 | United States |
| LaBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27403 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Cardiovascular Associates Ltd. | Virginia Beach | Virginia | 23454 | United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002241 |
| Carbohydrates |