Clinical Trial: LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 S

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: William Beaumont Hospitals

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • What are the associated costs and length of hospital stay after randomized to
  • enoxaparin vs. warfarin?


Original Secondary Outcome: Same as current

Information By: William Beaumont Hospitals

Dates:
Date Received: May 1, 2006
Date Started: March 2000
Date Completion: April 2004
Last Updated: May 1, 2006
Last Verified: May 2006