LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

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.

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