Assessment of Reperfusion Efficacy of Altelyse Versus Actilyse in Patients with Acute Myocardial Infarction: A Phase 3, Randomized, Double-Blinded, Non-inferiority Clinical Trial

Article

Author: Taati, Reyhaneh ; Solaymani-Dodaran, Masoud ; Asadpour Piranfar, Mohammad ; Sheibani, Mehdi ; Manhoobi, Hootan ; Shahami, Mohammadreza ; Masoumi, Safdar ; Beyranvand, Mohammad Reza ; Shahraz, Saeid ; Mohebbi, Nahid

BACKGROUNDPrimary 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.OBJECTIVEThis 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.METHODSIn 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.RESULTSA 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).CONCLUSIONSAmong patients with STEMI, Altelyse was non-inferior to Actilyse with respect to STR after 90 min.TRIAL REGISTRYTrial Registration Number, Date: IRCT20190729044366N1, 2019-05-25.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	Iran	Arena Life Science	22 Jun 2021

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