Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321009
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2006-05-01
Brief Title:
LV Thrombus Pilot Study for Comparing Enoxaparin Vs Warfarin
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 35 months The secondary outcome is cost analysis comparing the two arms
Detailed Description:
Patients with anterior Q-wave MIs and ejection fractions40 will be enrolled within the first 4 days of infarction Patients will be randomized to receive either enoxaparin 1mgkg 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 35 months and cost analysis will be performed
Clinical and safety evaluations 2-D echocardiograms at baseline and at 35 months and cost analysis will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None