{"title":"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。","authors":"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","doi":"10.1177/23969873241286983","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>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.</p><p><strong>Aim: </strong>To explore the safety and efficacy of intra-arterial tenecteplase after successful endovascular thrombectomy in patients with LVO stroke.</p><p><strong>Sample size: </strong>To randomize 498 participants 1:1 to receive intra-arterial tenecteplase or no intra-arterial adjunctive thrombolysis therapy.</p><p><strong>Methods and design: </strong>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.</p><p><strong>Outcomes: </strong>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.</p><p><strong>Discussion: </strong>The POST-TNK trial will evaluate the efficacy and safety of intra-arterial tenecteplase in patients with LVO stroke and excellent to complete reperfusion.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":null,"pages":null},"PeriodicalIF":5.8000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adjunctive intra-arterial tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke (POST-TNK): Study rationale and design.\",\"authors\":\"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\",\"doi\":\"10.1177/23969873241286983\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Rationale: </strong>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.</p><p><strong>Aim: </strong>To explore the safety and efficacy of intra-arterial tenecteplase after successful endovascular thrombectomy in patients with LVO stroke.</p><p><strong>Sample size: </strong>To randomize 498 participants 1:1 to receive intra-arterial tenecteplase or no intra-arterial adjunctive thrombolysis therapy.</p><p><strong>Methods and design: </strong>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.</p><p><strong>Outcomes: </strong>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.</p><p><strong>Discussion: </strong>The POST-TNK trial will evaluate the efficacy and safety of intra-arterial tenecteplase in patients with LVO stroke and excellent to complete reperfusion.</p>\",\"PeriodicalId\":46821,\"journal\":{\"name\":\"European Stroke Journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.8000,\"publicationDate\":\"2024-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Stroke Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/23969873241286983\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Stroke Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/23969873241286983","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.