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


OBJECTIVE
To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK).


METHODS
Double blind, randomized, non-inferiority, multicentric, parallel study.


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 > or = 50% ST segment were used to assess reperfusion.


METHODS
Difference in the groups was assessed by chi-square 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.


CONCLUSIONS
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.
Department of Cardiology K.G.M.C. Hospital, Lucknow, India.
S K
SK
Diwedi
J S
JS
Hiremath
P G
PG
Kerkar
Krishna N
KN
Reddy
C N
CN
Manjunath
S S
SS
Ramesh
S
S
Prabhavati
M
M
Dhobe
Kavita
K
Singh
P
P
Bhusari
Raman
R
Rao
D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D013300:Streptokinase / Q000627:therapeutic use*; D015912:Thrombolytic Therapy; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D013300:Streptokinase