Study Design

Study Design:

Patients Enrolled: 412
Mean Follow Up: 35 days
Mean Patient Age: not reported
Female: 25
Mean Ejection Fraction: The ejection fraction at day 2-3 was as follows: heparin, 60.7±1.3; low dose hirulog, 58.1±1.4; high-dose hirulog 60.7±1.3 (p=0.11 for heparin vs all hirulog patients).

Patient Populations:

Presentation within 12 hours of the onset of symptoms. Infarction with 1 mm of ST-segment elevation in 2 limb leads and/or leads V4 through V6 of a 12-lead ECG or 2 mm of ST-segment elevation in 2 contiguous precordial V1 through V3 leads.

Exclusions:

Previous administration of streptokinase. History of systemic, gastrointestinal, or genitourinary bleeding within 3 months. History of cerebrovascular disease including stroke or transient ischemic attack within 6 months. History of intracranial neoplasm, arteriovenous malformation, or aneurysm. Severe trauma or major surgery within the previous 3 months. Puncture of noncompressible vessels within the previous 10 days. Traumatic cardiopulmonary resuscitation within the previous month. Severe and uncontrolled hypertension. Cardiogenic shock.

Primary Endpoints:

Complete patency (TIMI grade 3 flow) at 90-120 minutes.

Secondary Endpoints:

Complete patency (TIMI grade 3 flow) at 2-3 days. Left ventricular function, global ejection fraction, end-systolic volume, and regional wall motion at 2 to 3 days in patients without a prior history of myocardial infarction. Incidence of death, stroke, reinfarction and cardiogenic shock at 35 days after treatment.

Drug/Procedures Used:

Patients received 150-325 mg aspirin after admission and continued daily thereafter. Streptokinase (1.5 million U) was administered over 30-60 minutes. Patients were randomized to either heparin (5000 U bolus + infusion of 1000 U/h for those <80 kgs and 1200 U/h for those >=80 kg for up to 60 hours); or low dose hirulog (0.125 mg/kg IV bolus + infusion of 0.25 mg/kg/h for 12 hours followed by 0.125 mg/kg/h for up to 60 hours); or high dose hirulog (0.25 mg/kg IV bolus + infusion of 0.5 mg/kg/h for 12 hours followed by 0.25 mg/kg/h for up to 60 hours). Patients underwent angiography at 90-120 minutes and again at 2-3 days after thrombolytic administration.