Study to assess the Safety and efficacy of Hetero tenecteplase in the treatment of Myocardial infarction.

Phase 4

Conditions: Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site

Recruitment & Eligibility

Inclusion Criteria

1. Adult male and female of 18 years or above

2. Patients and 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. Patients with Suspected Myocardial Infarction with Persistent ST

Elevation and/or Recent Left Bundle Branch Block (LBBB) within 6

Hours after the Onset of Acute Myocardial Infarction (AMI) Symptoms

4. Women of childbearing potential must agree to get pregnancy test done

at the time of enrolment and it should be negative.

Exclusion Criteria

1. Patients contraindicated or with history/evidence of hypersensitivity to

thrombolytics or any of the components of formulation.

2. Patients with history/ active internal active bleeding or hemorrhagic

3. Patients with history of cerebrovascular accident

4. History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or intra spinal surgery or trauma within the past 2

months

5. Uncontrolled hypertension (systolic BP LTN 180 mmHg or diastolic BP GRTN 110 mmHg).

6. Where, in the opinion of the investigator, participation in this study will

not be in the best interest of the subject, or any other circumstances that

prevent the subject from participating in the study safely.

7. If the patient participated in any clinical trials or clinical usage

involving Tenecteplase, Alteplase or other anti-thrombolytic drugs prior

to one year of enrolment.

Primary Outcome Measures

Name	Time	Method
Incidence, severity, outcome, duration, action taken, and causality of <br/ ><br>individual adverse events [Labelled/Unlabelled and Serious/Non- <br/ ><br>Serious] reported during the study <br/ ><br>Timepoint: 180 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Immunogenicity assessment at BaselineTimepoint: 30 days, 90 days or end of the study, if earlier;Incidence, severity, outcome of Adverse Events of Special Interest <br/ ><br>Internal bleeding, involving intracranial and retroperitoneal sites, or the <br/ ><br>gastrointestinal, genitourinary, or respiratory tracts. <br/ ><br>Superficial or surface bleeding, observed mainly at vascular puncture and access <br/ ><br>sites (e.g., venous cutdowns, arterial punctures) or sites of recent surgical <br/ ><br>intervention. <br/ ><br>Cholesterol Embolization <br/ ><br>Cardiac Arrhythmias <br/ ><br>Timepoint: 90 minutes;Mortality rateTimepoint: 30 days, 60 days and 90 days and 180 days;Thromboembolic episodes. <br/ ><br>?Proportion of patients with Clinically Evident Successful Thrombolysis (Defined as <br/ ><br>significant relief in chest pain and resolution of the ST-segment elevation on the ECG <br/ ><br>or =50% resolution of elevated ST segmentTimepoint: 90 min, 24, 48, 30 days, 60 days and 90 days <br/ ><br>