LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
|Study Design:||Allocation: Randomized
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|