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Efficacy and safety of tenecteplase in Indian patients with st-segment elevation myocardial infarction
I Sathyamurthy1, K N Srinivasan, K Jayanthi
1Department of Cardiology, Apollo Hospitals, Chennai. drisapollo@gmail.com
Insights
Tenecteplase is a safe and effective treatment for Indian patients experiencing ST-segment elevation myocardial infarction (STEMI). This study confirms its efficacy, aligning with international findings for STEMI management.
Area of Science:
- Cardiology
- Pharmacology
- Internal Medicine
Background:
- ST-segment elevation myocardial infarction (STEMI) is a critical condition requiring rapid reperfusion therapy.
- Tenecteplase is a fibrin-specific thrombolytic agent used in STEMI management.
Purpose of the Study:
- To evaluate the safety and efficacy of tenecteplase in a cohort of Indian patients with STEMI.
- To compare the outcomes with international data, specifically the ASSENT-2 trial.
Main Methods:
- Prospective data collection from cardiologists/physicians using tenecteplase for STEMI.
- Administration of tenecteplase according to prescribing information with standard adjunctive therapies (clopidogrel, UFH/LMWH).
- Recording of safety and efficacy parameters, including chest pain resolution, ST-segment resolution, and adverse events.
Main Results:
- 507 Indian patients with STEMI were treated with tenecteplase.
- Clinically successful thrombolysis was achieved in 80.67% of patients.
- Low incidence of adverse events: 0.39% intracranial hemorrhage (ICH) attributable to tenecteplase, 2.96% myocardial re-infarction, and 2.36% mortality.
Conclusions:
- Tenecteplase demonstrated favorable safety and efficacy in Indian STEMI patients.
- The results are consistent with the findings of the international ASSENT-2 trial.
- Tenecteplase is a viable therapeutic option for STEMI in the Indian population.
Objective:
To assess the efficacy and safety of tenecteplase in Indian patients with ST-segment elevation MI (STEMI).
Methods:
Cardiologists/physicians who had used tenecteplase for management of STEMI, recorded safety and efficacy parameters from consecutively treated patients. Tenecteplase was administered as per the prescribing information. Adjunctive therapy which included clopidogrel and UFH/LMWH was administered as routinely practiced and indicated by guidelines.
Results:
Five hundred and seven patients (male = 415, females = 92; mean age = 58.28 +/- 12.23 yrs; weight (kg) = 70.12 +/- 11.06) with STEMI were treated with weight-adjusted tenecteplase within median chest pain to drug interval of 120 minutes. Resolution of chest pain within median interval of 45 minutes occurred in 436 patients with median duration required for > or = 50% resolution of ST segment of 75 minutes. Clinically successful thrombolysis was reported in 80.67% patients. Five patients suffered intra-cranial hemorrhage (ICH), of which 3 patients had received Gp IIb/IIIa inhibitors. Incidence of intra-cranial hemorrhage attributable to tenecteplase was 0.39% (2 out of 507 patients). Incidence of myocardial re-infarction was 2.96% (15 out of 507 patients). There were 12 deaths (2.36%). CONCLUSION , This data shows that tenecteplase is safe and effective in Indian patients with STEMI and conforms to the international ASSENT-2 trial data.
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