The post marketing clinical research on drug Tenecteplase in patients with ST segment elevation myocardial infarction or left bundle branch block
- Conditions
- Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
- Registration Number
- CTRI/2020/07/026356
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. ST-segment elevation >= 0.1 mV in two or more limb leads or > 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new onset left bundle-branch block.
2. Patients presenting with AMI within 6 hours of onset of symptoms.
3. Women of childbearing potential should have a negative pregnancy test and be taking adequate birth control measures.
4. 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.
1. Known history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient)
2. Use of Abciximab or other marketed GPIIb/IIIa antagonists within the preceding 24 hours
3.Significant bleeding disorder either at present or within the past 6 months
4. Patients on oral anticoagulant treatment
5. Internal active bleeding or known history of hemorrhagic diathesis
6. Hypertension with systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg during current admission prior to enrolment
7. Cardiogenic shock (Systolic BP < 60 mm Hg)
8. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)
9. Recent trauma to the head or cranium within 1 year
10. Prolonged cardiopulmonary resuscitation ( > 2 minutes) within the past 2 weeks
11. Patients with acute pericarditis and/or subacute bacterial endocarditis
12. Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
13. Patients with arterial aneurysm or known arterial/venous malformation, active peptic ulceration, acute pancreatitis, neoplasm with increased bleeding risk, or dementia
14. Known history of haemorrhagic stroke or stroke of unknown origin
15. Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months
16. Pregnancy or lactation, or parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test.
17. Known participation in another investigative drug study or investigative device protocol within the previous 3 months
18. Any other condition which investigator feels would pose a significant hazard to patient if tenecteplase is administered.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events occurring during the studyTimepoint: Incidence of treatment emergent adverse events occurring during the study
- Secondary Outcome Measures
Name Time Method Thirty-day mortality, defined as death at or before 30 days after enrollment <br/ ><br>-â??Net clinical benefitâ?? defined as the absence of mortality and non-fatal stroke at 30 days <br/ ><br>-Incidence of stroke <br/ ><br>-Rates of bleeding events (serious and non-serious, Major and Minor events <br/ ><br>-Rates of bleeding events (serious and non-serious, Major and Minor events)Timepoint: 30 days;Thirty-day mortality, defined as death at or before 30 days after enrollment <br/ ><br>-â??Net clinical benefitâ?? defined as the absence of mortality and non-fatal stroke at 30 days <br/ ><br>-Incidence of stroke <br/ ><br>-Rates of bleeding events (serious and non-serious, Major and Minor events <br/ ><br>-Rates of bleeding events (serious and non-serious, Major and Minor events)Timepoint: 30 days