Scholarlink

Background <p>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.</p> Objective <p>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<sup>®</sup> (Boehringer Ingelheim, GERMANY) in patients with STEMI.</p> Methods <p>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.</p> Results <p>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 −&#xa0;45.89 ± 32.92% and −&#xa0;37.11 ± 35.28% in the Altelyse and Actilyse groups, respectively (the mean difference [95% confidence interval]: −&#xa0;8.77 [−&#xa0;19.92, 2.36]; <i>p</i>-value for non-inferiority: 0.0004).</p> Conclusions <p>Among patients with STEMI, Altelyse was non-inferior to Actilyse with respect to STR after 90 min.</p> Trial Registry <p>Trial Registration Number, Date: IRCT20190729044366N1, 2019-05-25.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 发表日期：

    2025年1月28日

查看全文
  • Mohammad Reza Beyranvand,
  • Mohammad Asadpour Piranfar,
  • Masoud Solaymani-Dodaran,
  • Nahid Mohebbi,
  • Reyhaneh Taati,
  • Mehdi Sheibani,
  • Mohammadreza Shahami,
  • Safdar Masoumi,
  • Saeid Shahraz,
  • Hootan Manhoobi

摘要

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.