LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Condition(s) targeted: Coronary Artery Disease; Acute Myocardial Infarction

Intervention: Enoxaparin (Drug)

Phase: N/A

Status: Completed

Sponsored by: William Beaumont Hospitals

Official(s) and/or principal investigator(s):
Cindy L Grines, MD, Principal Investigator, Affiliation: William Beaumont Hospital

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.

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 design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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.

Secondary outcome:

What are the associated costs and length of hospital stay after randomized to

enoxaparin vs. warfarin?

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 to 80

- Anterior myocardial infarction with:

1. Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new

2. 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

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

St Joseph's Health Center Dept. of Cardiology, Syracuse, New York 13203, United States

LaBauer Cardiovascular Research Foundation, Greensboro, North Carolina 27403, United States

Doylestown Hospital, Doylestown, Pennsylvania 18901, United States

Cardiovascular Associates Ltd., Virginia Beach, Virginia 23454, United States

Starting date: March 2000
Ending date: April 2004
Last updated: May 1, 2006