LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

William Beaumont Hospitals

Status

Completed

Conditions

Coronary Artery Disease

Acute Myocardial Infarction

Treatments

Drug: Enoxaparin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00321009

IND 59673

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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