Background: Primary percutaneous coronary intervention (PPCI) and fibrinolytic or thrombolytic therapy are common treatments for ST-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention is more effective than thrombolytic therapy, but fibrinolytic therapy is still a preferable option for patients with limited access to healthcare. Alteplase is a tissue plasminogen activator (tPA) used to treat acute myocardial infarction, acute ischemic stroke, and pulmonary embolism.
Objective: This study aims to compare the efficacy and safety of Altelyse (bio-similar Alteplase, Arena Life Science Company, Tehran, IRAN) versus the brand name Actilyse® (Boehringer Ingelheim, GERMANY) in patients with STEMI.
Methods: In this phase 3, double-blind, randomized trial, we assigned patients with STEMI to receive Altelyse or Actilyse, an intravenous bolus of 15 mg followed by an infusion of 0.75 mg/kg over 30 min (with a maximum dose of 50 mg) and continued with 0.50 mg/kg over 60 min (with a maximum dose of 35 mg). The primary endpoint was total ST-segment resolution (STR) in all leads with ST-segment elevations after 90 min of receiving fibrinolytic therapy.
Results: A total of 153 STEMI patients received Actilyse (79 patients) or Altelyse (74 patients). The mean total STR in all leads with ST elevation after 90 min was - 45.89 ± 32.92% and - 37.11 ± 35.28% in the Altelyse and Actilyse groups, respectively (the mean difference [95% confidence interval]: - 8.77 [- 19.92, 2.36]; p-value for non-inferiority: 0.0004).
Conclusions: Among patients with STEMI, Altelyse was non-inferior to Actilyse with respect to STR after 90 min.
Trial registry: Trial Registration Number, Date: IRCT20190729044366N1, 2019-05-25.
This study compares two treatments for heart attack patients, highlighting the effectiveness of Altelyse, a local manufacturer of Alteplase, versus Actilyse®, the brand name. Both therapies function by dissolving blood clots, which are the primary cause of heart attacks, to restore blood flow to the heart. The findings indicated that Altelyse was equally as effective as Actilyse in dissolving blood clots. Both therapies demonstrated similar efficacy in dissolving the blood clots and had comparable side effects, with only slight differences in minor bleeding occurrences. This research supports Altelyse as a viable treatment for heart attack patients, showing its equivalence to the globally acknowledged Actilyse.
© 2025. The Author(s), under exclusive licence to Springer Nature Switzerland AG.