Study Design

Study Design:

Patients Enrolled: 20,479
Mean Follow Up: 30 days

Patient Populations:

Male or nonpregnant female over 18 years old presenting within 6 hours of the onset of ischemic symptoms of STEMI (0.1 mV in two or more limb leads or 0.2 mV in two or more contiguous precordial leads or left bundle branch block), scheduled to undergo fibrinolysis

Exclusions:

Patients who were ineligible to receive thrombolytics were excluded. Other exclusions: serum creatine >2.5 (men) or creatine >2.0 (women), recent/current exposure to low molecular weight heparin or glycoprotein IIb/IIIa inhibitors, international normalized ratio >1.5.

Primary Endpoints:

All-cause mortality or nonfatal recurrent MI through 30 days

Secondary Endpoints:

Composite of all-cause mortality, nonfatal reinfarction, or recurrent myocardial ischemia leading to urgent revascularization in the first 30 days

Drug/Procedures Used:

Patients were randomized in a double-blind, double-dummy manner to enoxaparin or UFH. The choice of thrombolytic was determined by the treating physician. UFH or placebo was given as an intravenous (IV) bolus of 60 U/kg followed by a continuous infusion at 12 U/kg/h, adjusting the rate to maintain an activated partial thromboplastin time of 1.5-2.0 times normal. Enoxaparin was administered as a 30 mg IV bolus followed by 1 mg/kg subcutaneous (SC) injections every 12 hours. For patients 75 years and older or with impaired renal function (creatinine clearance <30 ml/min), IV bolus was omitted and 0.75 mg/kg SC injections were used. The subcutaneous enoxaparin regimen was continued until hospital discharge or for a maximum of 8 days.