Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Hetero-Tenecteplase: Single dose of Hetero-Tenecteplase on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase). Tenecteplase is for intravenous administra
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients of age 18-65 years (both inclusive) 2. Patient willing to provide written informed consent. Consent from Legally Acceptable Representative (LAR), if patient is not in the condition to give consent. However, when the patient is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study 3. Patient presenting with chest pain and/or symptoms of Acute Myocardial Infarction with ST elevation in at least 2 or more contiguous leads (12 Lead ECG) with the following: a. ST elevation of =0.25 mV in men AND/OR b. ST elevation of =0.1 mV in other contiguous chest leads or limb leads 4. Patient presenting with AMI within 6 hours of occurrence of symptoms 5. Female patient of childbearing potential must agree to get pregnancy test done at the time of enrolment and it should be negative.
Exclusion criteria
Exclusion criteria: 1. Patient with new onset Left Bundle Branch Block (LBBB) 2. Patient with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation including gentamicin 3. Patient planned for primary percutaneous coronary intervention (PCI). 4. Patient receiving oral anticoagulant treatments with INR >1.3 5. Patient with history of prolonged cardiopulmonary resuscitation ( >2 minutes) within the past 2 weeks 6. Patient with history/ active internal bleeding disorder within 6 months 7. Patient with history of recent gastrointestinal or genitourinary bleeding (within the past 10 days) 8. Patient with known hemorrhagic diathesis 9. Patient with known history of hemorrhagic stroke or stroke of unknown origin 10. Patient with history of ischemic stroke or transient ischemic attack in the preceding 6 months 11. Patient with history of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or spinal surgery 12. Patient of known arterial/venous malformations 13. Patient with history of trauma to the head or cranium within 6 months 14. Patient with history of major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI). 15. Patient of uncontrolled hypertension of systolic BP >160 mm of Hg and diastolic BP >110 mm of Hg 16. Patient administered Tenecteplase in the last 14 days prior to screening. 17. Patient administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hours prior to screening. 18. Patient with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction. 19. Patient with high risk as per TIMI risk scoring. 20. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of TIMI grade 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related arteryTimepoint: At 90 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% resolution of elevated ST segmentTimepoint: At day 7, 14 and 30 or EOS if its earlier;All cause 30 day mortality rateTimepoint: Day 30;Change in cardiac enzymes levelTimepoint: At hours 24 and 48;Changes in left ventricular ejection fraction assessed by 2D-EchocardiographyTimepoint: At day 7, 14 and 30 or EOS if its earlier;Events of myocardial re-infarction(s)Timepoint: At day 7, 14 and 30 or EOS if its earlier;Events of ventricular tachyarrhythmiasTimepoint: At day 7, 14 and 30 or EOS if its earlier;Immunogenicity assessmentTimepoint: At baseline and day 30 or EOS, if its earlier;Pharmacokinetic parameters comparisons of Cmax, AUC0-t and AUC0-infTimepoint: After Single Dose Administration;Treatment emergent adverse events (clinical and laboratory)Timepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Drugs Limited
Outcome results
None listed