Study Design

Study Design:

Patients Enrolled: 3,089
Mean Follow Up: 30 days
Mean Patient Age: >20 years
Female: 20

Patient Populations:

Age >20 years old with nitrate-resistant chest pain lasting for ≥30 minutes, with ST-segment elevation >0.1 mV in two or more frontal plane leads or >0.2 mV in two or more precordial leads, and presentation within six hours after the onset of symptoms

Exclusions:

Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >100 mm Hg on admission or hypertensive retinopathy grade III or IV) or known intracranial, gastrointestinal, clotting, hepatic, pulmonary, renal, urogenital, vascular, or other disorders that could increase the risk of bleeding after thrombolysis. Patients with major trauma or surgical procedures within one month were excluded, as were those with malignancy or known sensitivity to streptokinase or exposure to streptokinase within the past year or streptococcal infection within the past three months.

Primary Endpoints:

Death from any cause at 30 days after the start of study treatment

Secondary Endpoints:

Stroke, reinfarction, and reintervention at 30 days. In-hospital endpoints were bleeding, hypotension, and allergic reactions.

Drug/Procedures Used:

Eligible patients were randomized to receive heparin (5000 IU initial bolus) and saruplase (20 mg initial intravenous [IV] bolus followed by 60 mg IV over the next 60 minutes) or streptokinase (1.5 MU IV over 60 minutes) without the initial heparin bolus.

Concomitant Medications:

Oral or IV aspirin (200-400 mg initially followed by a maintenance dose of ≥75 mg daily thereafter). Thirty minutes after the completion of the initial 60-minute infusions of streptokinase or saruplase, heparin was administered to all patients for ≥24 hours and titrated to achieve a target activated partial thromboplastin time of 1.5-2.5 times the control value.