LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT00321009

Collaborator

Rhone-Poulenc Rorer (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Acute Myocardial Infarction	Drug: Enoxaparin	N/A

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) 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2000

Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

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. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
6	Cardiovascular Associates Ltd.	Virginia Beach	Virginia	United States	23454