LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
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.
|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|
- 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
- What are the associated costs and length of hospital stay after randomized to
- enoxaparin vs. warfarin?
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321009
|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, 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|