Study Design

Study Design:

Patients Enrolled: 1,208
Mean Follow Up: 30 days
Mean Patient Age: 30-92
Female: 24

Patient Populations:

Patients aged 18-75 years with a time interval between symptom onset and start of therapy of <6 hours and an ST-segment elevation ≥0.2 mV in at least two precordial leads or ST-segment elevation ≥0.1 mV in at least two limb leads were eligible.

Exclusions:

Contraindications to thrombolysis, streptokinase therapy during the last year, heparin therapy within two hours before study medications, and known renal insufficiency (serum creatinine >2.0 mg/dl or 1.77 mmol/l)

Primary Endpoints:

The primary endpoint was TIMI 3 flow in the infarct-related artery 90 minutes after start of study medication.

Secondary Endpoints:

The combined and individual incidences of death, nonfatal stroke, nonfatal reinfarction, rescue PTCA, or refractory angina pectoris within 30 days after randomization; the individual incidences of hemorrhagic and nonhemorrhagic strokes; the proportion of patients with complete resolution of ST-segment elevation at 90 and 180 minutes; and one-year mortality

Drug/Procedures Used:

Eligible patients were randomized to receive either an IV bolus of lepirudin (0.2 mg/kg body weight) or placebo prior to streptokinase (1.5 million units IV given over six minutes). Subsequently, patients in the lepirudin arm received subcutaneous injections (0.5 mg/kg) every 12 hours and those in the heparin arm received subcutaneous injections of 12,500 IE every 12 hours. Both groups had dosing adjusted to a target activated partial thromboplastin time of two times normal for 5-7 days.

Concomitant Medications:

A loading dose of 300 mg aspirin followed by 100-200 mg daily thereafter