A Trial Using Double-Bolus THR-100 Versus Streptokinase (THR-100)
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|ClinicalTrials.gov Identifier: NCT01305226|
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : February 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: THR-100 Drug: Streptokinase||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase III Parallel, Randomised Controlled Trial Using Double-bolus Recombinant Staphylokinase (THR-100) vs Streptokinase in Patients With Acute Myocardial Infarction|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Test - THR-100
120 subjects are to be recruited into the trial, with patients randomized in a 1:1 allocation ratio to THR-100 and Streptokinase 60 subjects are to be recruited into Test arm, and administered 15 mg double-bolus (15mg/15ml), separated by 30 minutes (total 30 mg)
THR-100: 15 mg double-bolus (15mg/15ml), separated by 30 minutes (total 30 mg)
Other Name: Staphylokinase
Active Comparator: Streptokinase
120 subjects are to be recruited into the trial, with patients randomized in a 1:1 allocation ratio to THR-100 and Streptokinase Streptokinase: Standard regimen (1.5 million IU) is made up in 150 ml of physiological saline or glucose solution and administered intravenously over a period of 60 minutes.
Streptokinase: Standard regimen (1.5 million IU) is made up in 150 ml of physiological saline or glucose solution and administered intravenously over a period of 60 minutes.
Other Name: Streptase
- To demonstrate efficacy of THR100 as compared with streptokinase by assessment of 12-lead Electrocardiogram, specific cardiac Enzymes levels, pain relief and TIMI-90. (Non-Inferiority study) [ Time Frame: up to 4 weeks ]12-lead Electrocardiogram, ≥50% resolution of ST segment in single ECG lead of maximum deviation present at 90 minutes and 24 hours after start of thrombolytic therapy.
- To evaluate the safety profile of THR-100 in comparison with Streptokinase [ Time Frame: up to 4 weeks ]Assessment of net clinical benefit, defined as reduced mortality, non-fatal stroke, clinically-evident intracranial hemorrhage, or recurrent myocardial infarction at thirty (30) days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305226
|Sri Jayadeva Institute of Cardiology.|
|Bangalore, Karnataka, India, 560 069|
|Bangalore, Karnataka, India, 560 099|
|Lotus Super speciality Hospita|
|Agra, Uttar Pradesh, India, 282 002|
|Institute of Post Graduate Medical Education and Research (IPGMER)|
|Kolkatta, West Bengal, India, 700 020|
|Study Director:||Dr.A Singh, MBBS, MD||Bharat Biotech Int. Ltd.|