Status:
COMPLETED
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
Lead Sponsor:
Corewell Health East
Collaborating Sponsors:
Rhone-Poulenc Rorer
Conditions:
Coronary Artery Disease
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
NA
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 mo...
Detailed Description
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) s...
Eligibility Criteria
Inclusion
- Age 18 to 80
- Anterior myocardial infarction with:
- Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new
- CK peak\>5 times the upper limit of normal with positive MB bands
- Ejection fraction \<=40% or anterior dyskinesis or documented LV Thrombus
- MI onset \< 7 days from randomization
Exclusion
- Inability to give written informed consent
- Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation
- Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization
- Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin
- Anemia: Baseline Hgb\<=9 gm for women, \<=10 gm for men or platelet count\<100,000
- Renal insufficiency (creatinine \>2.0 mg/dl)
- Serious liver disease as reflected by INR\>1.3
- Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage
- Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants
- Acute pericarditis
- Women of childbearing potential unless pregnancy test negative
- Cardiac or non-cardiac condition with expected survival\< 6 months
- Severe peripheral vascular disease
- Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction
- Allergy to aspirin, heparin or warfarin, pork or pork products
- History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder.
- Current use of warfarin or need for chronic anticoagulation
- Current participation in other trials using investigational drugs or devices
- Prior enrollment in this trial
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00321009
Start Date
March 1 2000
End Date
April 1 2004
Last Update
May 3 2006
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
3
St Joseph's Health Center Dept. of Cardiology
Syracuse, New York, United States, 13203
4
LaBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27403