Beyranvand Mohammad Reza, Asadpour Piranfar Mohammad, Solaymani-Dodaran Masoud, Mohebbi Nahid, Taati Reyhaneh, Sheibani Mehdi, Shahami Mohammadreza, Masoumi Safdar, Shahraz Saeid, Manhoobi Hootan
Department of Cardiology, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Epidemiology, Faculty of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Clin Drug Investig. 2025 Feb;45(2):101-110. doi: 10.1007/s40261-025-01420-3. Epub 2025 Jan 28.
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.
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.
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.
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).
Among patients with STEMI, Altelyse was non-inferior to Actilyse with respect to STR after 90 min.
Trial Registration Number, Date: IRCT20190729044366N1, 2019-05-25.
直接经皮冠状动脉介入治疗（PPCI）和纤维蛋白溶解或溶栓治疗是ST段抬高型心肌梗死（STEMI）的常见治疗方法。直接经皮冠状动脉介入治疗比溶栓治疗更有效，但对于医疗服务可及性有限的患者，溶栓治疗仍是更可取的选择。阿替普酶是一种用于治疗急性心肌梗死、急性缺血性中风和肺栓塞的组织纤溶酶原激活剂（tPA）。
本研究旨在比较Altelyse（生物类似药阿替普酶，伊朗德黑兰Arena生命科学公司）与品牌药爱通立（德国勃林格殷格翰公司）在STEMI患者中的疗效和安全性。
在这项3期双盲随机试验中，我们将STEMI患者分配接受Altelyse或爱通立治疗，静脉推注15mg，随后在30分钟内输注0.75mg/kg（最大剂量50mg），并在60分钟内继续输注0.50mg/kg（最大剂量35mg）。主要终点是接受溶栓治疗90分钟后所有ST段抬高导联的总ST段回落（STR）。
共有153例STEMI患者接受了爱通立（79例患者）或Altelyse（74例患者）治疗。Altelyse组和爱通立组在90分钟后所有ST段抬高导联的平均总STR分别为-45.89±32.92%和-37.11±35.28%（平均差值[95%置信区间]：-8.77[-19.92，2.36]；非劣效性p值：0.0004）。
在STEMI患者中，Altelyse在90分钟后的STR方面不劣于爱通立。
试验注册号、日期：IRCT20190729044366N1，2019年5月25日。
