Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: 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 administration
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Labelled/Unlabelled and Serious/Non- Serious] reported during the study Timepoint: 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity, outcome of Adverse Events of Special Interest Internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or sites of recent surgical intervention. Cholesterol Embolization Cardiac Arrhythmias Timepoint: 90 minutes;Thromboembolic episodes. ?Proportion of patients with Clinically Evident Successful Thrombolysis (Defined as significant relief in chest pain and resolution of the ST-segment elevation on the ECG or =50% resolution of elevated ST segmentTimepoint: 90 min, 24, 48, 30 days, 60 days and 90 days ;Mortality rateTimepoint: 30 days, 60 days and 90 days and 180 days;Immunogenicity assessment at BaselineTimepoint: 30 days, 90 days or end of the study, if earlier | — |
Countries
India
Contacts
Public ContactDr Subhadeep Sinha MD
Hetero Labs Limited
Outcome results
None listed