Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial

Abstract

BACKGROUND: Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology.The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK).AIM: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK).SETTINGS AND DESIGN: Double blind, randomized, non-inferiority, multicentric, parallel study.MATERIALS AND METHODS: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V 1 -V 6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK.CK Peaking and decrease of >50% ST segment were used to assess reperfusion.STATISTICAL ANALYSIS: Difference in the groups was assessed by chisquare or paired t test as required.Probability value <0.05 was considered significant with 95% confidence interval.RESULTS: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable.Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively.Commonly seen adverse events were fever in 7 (8.5%),hypotension in 3 (3.6%),nausea in 2 (2.4%) patients.Minor bleeding were seen in 4 (4.8%) of patients.CONCLUSION: Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.