Xiaochuan Huo, Gang Luo, Dapeng Sun, Thanh Nguyen, Mohamad Abdalkader, Wenhuo Chen, Xiaoxi Yao, Guangxiong Yuan, Tingyu Yi, Hongxin Han, Yuesong Pan, Tudor G Jovin, David S Liebeskind, Liping Liu, Xingquan Zhao, Zeguang Ren, Yilong Wang, Yongjun Wang, Bernard Yan, Zhongrong Miao
{"title":"血管内治疗成功后的动脉内替尼西普酶（ANGEL-TNK）：一项多中心、开放标签、终点盲法、前瞻性、随机试验的方案。","authors":"Xiaochuan Huo, Gang Luo, Dapeng Sun, Thanh Nguyen, Mohamad Abdalkader, Wenhuo Chen, Xiaoxi Yao, Guangxiong Yuan, Tingyu Yi, Hongxin Han, Yuesong Pan, Tudor G Jovin, David S Liebeskind, Liping Liu, Xingquan Zhao, Zeguang Ren, Yilong Wang, Yongjun Wang, Bernard Yan, Zhongrong Miao","doi":"10.1136/svn-2024-003318","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Despite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.</p><p><strong>Methods: </strong>ANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.</p><p><strong>Results: </strong>The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0-1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0-2, mRS 0-3, all-cause mortality and any intracranial haemorrhage.</p><p><strong>Conclusion: </strong>In patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.</p><p><strong>Trial registration number: </strong>NCT05624190.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial.\",\"authors\":\"Xiaochuan Huo, Gang Luo, Dapeng Sun, Thanh Nguyen, Mohamad Abdalkader, Wenhuo Chen, Xiaoxi Yao, Guangxiong Yuan, Tingyu Yi, Hongxin Han, Yuesong Pan, Tudor G Jovin, David S Liebeskind, Liping Liu, Xingquan Zhao, Zeguang Ren, Yilong Wang, Yongjun Wang, Bernard Yan, Zhongrong Miao\",\"doi\":\"10.1136/svn-2024-003318\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Despite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.</p><p><strong>Methods: </strong>ANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.</p><p><strong>Results: </strong>The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0-1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0-2, mRS 0-3, all-cause mortality and any intracranial haemorrhage.</p><p><strong>Conclusion: </strong>In patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.</p><p><strong>Trial registration number: </strong>NCT05624190.</p>\",\"PeriodicalId\":48733,\"journal\":{\"name\":\"Journal of Investigative Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Investigative Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/svn-2024-003318\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Investigative Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/svn-2024-003318","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial.
Background: Despite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.
Methods: ANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.
Results: The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0-1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0-2, mRS 0-3, all-cause mortality and any intracranial haemorrhage.
Conclusion: In patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.
期刊介绍：
Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research.
JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.
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