大血管闭塞性卒中患者血管内血栓切除术成功后辅助动脉内替尼采普酶(POST-TNK):研究原理与设计。

IF 5.8 3区 医学 Q1 CLINICAL NEUROLOGY
Jiacheng Huang, Changwei Guo, Jie Yang, Xiaolei Shi, Chang Liu, Jiaxing Song, Fengli Li, Weilin Kong, Shitao Fan, Zhouzhou Peng, Shihai Yang, Jinfu Ma, Xu Xu, Linyu Li, Zhixi Wang, Nizhen Yu, Wenzhe Sun, Chengsong Yue, Xiang Liu, Dahong Yang, Cheng Huang, Duolao Wang, Raul G Nogueira, Thanh N Nguyen, Jeffrey L Saver, Yangmei Chen, Wenjie Zi
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引用次数: 0

摘要

理由:辅助动脉内阿替普酶已被证明可改善成功接受血管内血栓切除术的大血管闭塞(LVO)卒中患者的临床预后。特奈替普酶以其增强的纤维蛋白特异性和延长的活性持续时间而著称,如果作为动脉内辅助疗法使用,有可能改善再灌注成功后中风患者的预后。目的:探讨在 LVO 中风患者血管内血栓切除术成功后使用动脉内特奈替普酶的安全性和有效性:方法与设计:由研究者发起的一项前瞻性研究:一项由研究者发起的前瞻性、随机、开放标签、盲端点多中心临床试验。符合条件的前循环低密度脂蛋白血栓性脑卒中患者在症状发生后24小时内(最后一次已知良好的时间)出现症状,且血管内溶栓治疗的再灌注效果极佳(扩大的脑梗死溶栓治疗(eTICI)评分2c-3),计划对其进行随机分组:主要结果是90天后无残疾(改良Rankin量表,mRS为0-1)。主要安全性结果为90天内的死亡率和48小时内的无症状颅内出血:POST-TNK试验将评估动脉内替尼采普酶对低密度脂蛋白血症卒中患者的疗效和安全性,以及完全再灌注的效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adjunctive intra-arterial tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke (POST-TNK): Study rationale and design.

Rationale: Adjunct intra-arterial alteplase has been shown to potentially improve clinical outcomes in patients with large vessel occlusion (LVO) stroke who have undergone successful endovascular thrombectomy. Tenecteplase, known for its enhanced fibrin specificity and extended activity duration, could potentially enhance outcomes in stroke patients after successful reperfusion when used as an adjunct intra-arterial therapy.

Aim: To explore the safety and efficacy of intra-arterial tenecteplase after successful endovascular thrombectomy in patients with LVO stroke.

Sample size: To randomize 498 participants 1:1 to receive intra-arterial tenecteplase or no intra-arterial adjunctive thrombolysis therapy.

Methods and design: An investigator-initiated, prospective, randomized, open-label, blind-endpoint multicenter clinical trial. Eligible patients with anterior circulation LVO stroke presenting within 24 h from symptom onset (time last known well) and excellent to complete reperfusion (expanded Thrombolysis In Cerebral Infarction (eTICI) scale 2c-3) at endovascular thrombectomy are planned to be randomized.

Outcomes: The primary outcome is freedom from disability (modified Rankin Scale, mRS, of 0-1) at 90 days. The primary safety outcomes are mortality through 90 days and symptomatic intracranial hemorrhage within 48 h.

Discussion: The POST-TNK trial will evaluate the efficacy and safety of intra-arterial tenecteplase in patients with LVO stroke and excellent to complete reperfusion.

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来源期刊
CiteScore
7.50
自引率
6.60%
发文量
102
期刊介绍: Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.
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