Study Design

Study Design:

Patients Screened: 2,807
Patients Enrolled: 205
Mean Follow Up: One year
Mean Patient Age: 40-70
Female: 0

Patient Populations:

Men aged 40-70 years admitted to a coronary care unit with ongoing chest pain or anginal chest pain during the preceding 48 hours. The chest pain had to be associated with new or previously unknown ST depression ≥0.1 mV or T-wave inversion >0.1 mV in at least two adjacent leads on the ECG.

Exclusions:

Women, increased risk of bleeding, contraindication to thrombolysis, acute QWMI, previous QWMI, previous bypass graft, other heart disease, hemodynamic instability, severe noncardiac disease, hypersensitivity to aspirin or heparin, administrative difficulties, pericarditis, pulmonary embolism, or VOC mitrale

Primary Endpoints:

Occurrence of death, MI, urgent coronary revascularization, or indication for urgent revascularization. Urgent revascularization was defined as revascularization because of refractory angina. Indication for revascularization was defined as signs of myocardial ischemia and three-vessel disease, left main stenosis, or proximal left anterior descending stenosis as part of two-vessel disease.

Secondary Endpoints:

Coronary lesions at coronary angiography one month after inclusion, signs of myocardial ischemia during either of two exercise tests, or symptoms of angina during follow-up

Drug/Procedures Used:

Patients were randomized to IV infusion of rTPA (n=105) or placebo (n=100). The total dose of rTPA was 1 mg/kg body weight with a maximal dose of 100 mg. Half the dose was infused over the first hour and the other half over the following three hours. Patients without chest pain at rest and without new ECG changes for two consecutive days underwent stress testing prior to discharge and between 30 and 45 days after enrollment.

Concomitant Medications:

All patients were treated with oral aspirin, 225 mg initially, then 75 mg daily thereafter. All patients received heparin, 5000 IU, as an initial bolus immediately before trial drug infusion.

After randomization, heparin was infused at 1000 IU/h over 36-48 hours. Thereafter, heparin was given as subcutaneous injections of 10,000 IU twice daily for four days.

All patients without contraindications were treated with oral metoprolol and, if needed, with nitrates and calcium channel blockers (specific numbers of patients not reported).