RE-OPEN:在大血管闭塞导致的急性缺血性中风的血管内治疗中,生物类似物 TNK 与 TPA 的随机试验

IF 2.1 Q3 CLINICAL NEUROLOGY BMJ Neurology Open Pub Date : 2024-03-01 DOI:10.1136/bmjno-2023-000531
Rohit Bhatia, MV Padma Srivastava, Saman Fatima, Risha Sarkar, Imnameren Longkumer, Shailesh Gaikwad, Leve S Joseph Devaranjan, Ajay Garg, Jeyaraj Durai Pandian, Dheeraj Khurana, PN Sylaja, Shweta Jain, Deepti Arora, Aneesh Dhasan, Sanjith Aaron, Angel T Miraclin, Pamidimukkala Vijaya, Srijithesh P Rajendran, Jayanta Roy, Biman Kanti Ray, Vivek Nambiar, Paul J Alapatt, Meenakshi Sharma
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引用次数: 0

摘要

理由 对急性缺血性卒中(AIS)和大血管闭塞(LVO)患者进行快速及时的静脉溶栓和血管内治疗(EVT)可显著改善患者的预后。桥接疗法是目前治疗这类患者的标准疗法。然而,在桥接疗法中,一种溶栓药物是否优于另一种溶栓药物,这个问题尚未得到完全解答。本研究旨在了解在治疗 AIS 和 LVO 的桥接疗法中,一种溶栓药物是否优于另一种溶栓药物。样本量估计 以80%的功率和5%的α误差,假定10%的退出率,本研究将招募372名患者。方法和设计 本研究是一项前瞻性、随机、多中心、开放标签试验,采用盲法结果分析设计。研究结果 主要结果包括:3个月时能独立生活的患者比例(改良Rankin评分(mRS)≤2为良好结果)和在EVT结束时首次血管造影达到再通改良脑梗塞溶栓2b/3级的患者比例。次要结果包括早期神经功能改善的患者比例、无症状性脑内出血(ICH)发生率、任何 ICH 发生率、任何全身性大出血或小出血发生率以及住院时间。安全性结果包括任何颅内出血或症状性 ICH。讨论 该试验旨在证实替奈普酶(TNK)的理论优势,并提高其在实际应用中的证据力度和质量。此外,该试验还有助于获得生物仿制药 TNK 的疗效和安全性数据。试验注册号:CTRI/2022/01/039473。
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RE-OPEN: Randomised trial of biosimilar TNK versus TPA during endovascular therapy for acute ischaemic stroke due to large vessel occlusions
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 primary outcomes 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. Secondary outcomes 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. Safety outcomes 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.
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来源期刊
BMJ Neurology Open
BMJ Neurology Open Medicine-Neurology (clinical)
CiteScore
3.20
自引率
3.70%
发文量
46
审稿时长
13 weeks
期刊最新文献
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