A Trial Using Double-Bolus THR-100 Versus Streptokinase (THR-100)
Acute Myocardial Infarction
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring THR 100
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged 30 to < 75 years inclusive.
- Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible.
- Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms.
- Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test.
- Written informed consent should be sought from the patient prior to inclusion in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent.
- NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity.
Exclusion Criteria:
- Previous administration of staphylokinase.
- Active bleeding or known hemorrhagic diathesis.
- Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation.
- Major surgery or trauma within the past 3 months.
- Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization.
- Current treatment with vitamin K antagonists resulting with an INR > 1.5.
- Anticipated difficulty with vascular access.
- Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock.
- Patients who have participated in an investigational drug study within the past 30 days.
- Pregnancy or lactation, parturition within the previous 30 days.
- Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial
- Patients known to have a history of or life limiting malignant disease or HIV.
- Significant hepatic or renal dysfunction or any other condition which, in the opinion of the Investigator, makes the patient unsuitable for study entry.
- Previous participation in this trial
Sites / Locations
- Sri Jayadeva Institute of Cardiology.
- Narayana Hrudayalaya
- Lotus Super speciality Hospita
- Institute of Post Graduate Medical Education and Research (IPGMER)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Test - THR-100
Streptokinase
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)
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.