715-6 lnternational Joint Efficacy Comparison of Thrombolytics (INJECT): Reteplase vs Streptokinase in Acute Myocardial Infarction

Abstract

Reteplase (r-PA) is a non-glycosylated recombinant plasminogen activator containing the kringle-2 and protease domains but lacking the finger, epidermal growth factor and kringle-1 domains. It has a longer half-life than native t-PA and the 20 MU dose administered as two 10 MU boluses separated by 30 minutes has been shown to achieve a 90 minute patency rate of 85%. The objective of the INJECT trial was to compare the efficacy and safety of this r-PA regimen with standard regimen Streptokinase (1.5 MU over 60 minutes) in patients with acute myocardial infarction receiving treatment within 12 hours of symptom onset. A double-blind. double-dummy design was employed and standard inclusion/exclusion criteria for thrombolysis applied. The primary endpoint was 35 day survival. Target recruitment was 6000 patients, this number providing good power to determine the clinical benefit of r-PA. Total recruitment was achieved over one year to September 1994. 211 Coronary Care Units in 9 countries participated. This paper will present for the first time the results of INJECT and thus provide a detailed characterisation of the efficacy and safety (including mortality) of Reteplase, a second generation direct plasminogen activator.