重新开放：在因大血管闭塞导致的急性缺血性中风血管内治疗期间，生物类似药替奈普酶（TNK）与组织型纤溶酶原激活剂（TPA）的随机试验

RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions.

作者信息

Bhatia Rohit, Srivastava Mv Padma, Fatima Saman, Sarkar Risha, Longkumer Imnameren, Gaikwad Shailesh, Devaranjan Leve S Joseph, Garg Ajay, Durai Pandian Jeyaraj, Khurana Dheeraj, Sylaja P N, Jain Shweta, Arora Deepti, Dhasan Aneesh, Aaron Sanjith, Miraclin Angel T, Vijaya Pamidimukkala, Rajendran Srijithesh P, Roy Jayanta, Ray Biman Kanti, Nambiar Vivek, Alapatt Paul J, Sharma Meenakshi

机构信息

Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.

Department of Neuroimaging and Interventional Neuroradiology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

BMJ Neurol Open. 2024 Mar 15;6(1):e000531. doi: 10.1136/bmjno-2023-000531. eCollection 2024.

DOI:10.1136/bmjno-2023-000531

PMID:38501129

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10946358/

Abstract

RATIONALE

Rapid and timely treatment with intravenous thrombolysis and endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS) and large vessel occlusion (LVO) significantly improves patient outcomes. Bridging therapy is the current standard of care in these patients. However, an incompletely answered question is whether one thrombolytic agent is better than another during bridging therapy.

AIM

The current study aims to understand if one thrombolytic agent is superior to the other during bridging therapy in the treatment of AIS and LVO.

SAMPLE SIZE ESTIMATES

Using 80% power and an alpha error of 5 %, presuming a 10% drop out rate, a total of 372 patients will be recruited for the study.

METHODS AND DESIGN

This study is a prospective, randomised, multicentre, open-label trial with blinded outcome analysis design.

STUDY OUTCOMES

The include proportion of patients who will be independent at 3 months (modified Rankin score (mRS) ≤2 as good outcome) and proportion of patients who achieve recanalisation modified thrombolysis in cerebral infarction grade 2b/3 at first angiography run at the end of EVT. include proportion of patients with early neurological improvement, rate of symptomatic intracerebral haemorrhage (ICH), rate of any ICH, rate of any systemic major or minor bleeding and duration of hospital stay. include any intracranial bleeding or symptomatic ICH.

DISCUSSION

This trial is envisioned to confirm the theoretical advantages and increase the strength and quality of evidence for use of tenecteplase (TNK) in practice. Also, it will help to generate data on the efficacy and safety of biosimilar TNK.

TRIAL REGISTRATION NUMBER

CTRI/2022/01/039473.

摘要

理论依据

急性缺血性卒中（AIS）合并大血管闭塞（LVO）患者通过静脉溶栓和血管内治疗（EVT）进行快速及时的治疗可显著改善患者预后。桥接治疗是这些患者当前的标准治疗方案。然而，一个尚未完全解答的问题是，在桥接治疗期间，一种溶栓药物是否优于另一种。

目的

本研究旨在了解在AIS和LVO治疗的桥接治疗期间，一种溶栓药物是否优于另一种。

样本量估计

使用80%的检验效能和5%的α错误率，假定脱落率为10%，本研究将总共招募372例患者。

方法与设计

本研究是一项前瞻性、随机、多中心、开放标签试验，采用盲法结局分析设计。

研究结局

主要结局包括3个月时能够独立的患者比例（改良Rankin量表评分（mRS）≤2为良好结局）以及在EVT结束时首次血管造影时达到脑梗死溶栓改良分级2b/3再通的患者比例。次要结局包括早期神经功能改善的患者比例、症状性颅内出血（ICH）发生率、任何ICH发生率、任何全身性严重或轻微出血发生率以及住院时间。安全性结局包括任何颅内出血或症状性ICH。