One hundred ninety patients with acute myocardial infarction (AMI) were treated with recombinant tissue-type plasminogen activator (rt-PA) 2.0 +/- 0.8 hours after the onset of symptoms. Eighty-seven patients were enrolled via mobile intensive care units and 103 through the emergency ward. Patients who were enrolled via the mobile intensive care units were randomized to immediate, prehospital treatment initiation, or to delayed, in-hospital treatment initiation. All 190 patients except 2 underwent delayed coronary angiography and, when indicated, angioplasty at 72 hours after enrollment. Patients treated within 2 hours and those treated 2 to 4 hours after symptom onset had similar preservation of left ventricular function, and similar prevalence of congestive heart failure at discharge. Patients treated within 2 hours of symptom onset had significantly lower short- (0.0 vs 6.3%, p = 0.01) and long-term (1.0 vs 9.5%, p = 0.03) mortality. Prehospital initiation of rt-PA appeared to be safe and feasible and resulted in a 40-minute decrease in the time from symptom onset to treatment initiation.