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 ante...
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| Series: | Stroke and Vascular Neurology |
| Online Access: | https://svn.bmj.com/content/early/2024/10/02/svn-2024-003318.full |
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| author | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao Tudor G Jovin Xingquan Zhao Zeguang Ren Xiaochuan Huo Wenhuo Chen Yuesong Pan Xiaoxi Yao Bernard Yan Gang Luo Thanh Nguyen Guangxiong Yuan Tingyu Yi Dapeng Sun Hongxin Han |
| author_facet | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao Tudor G Jovin Xingquan Zhao Zeguang Ren Xiaochuan Huo Wenhuo Chen Yuesong Pan Xiaoxi Yao Bernard Yan Gang Luo Thanh Nguyen Guangxiong Yuan Tingyu Yi Dapeng Sun Hongxin Han |
| author_sort | Liping Liu |
| collection | DOAJ |
| description | 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.Trial registration number NCT05624190. |
| format | Article |
| id | doaj-art-02b9c15ef0ae46dcb11d21a9d6942f21 |
| institution | Kabale University |
| issn | 2059-8696 |
| language | English |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Stroke and Vascular Neurology |
| spelling | doaj-art-02b9c15ef0ae46dcb11d21a9d6942f212024-11-30T09:30:09ZengBMJ Publishing GroupStroke and Vascular Neurology2059-869610.1136/svn-2024-003318Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trialLiping Liu0Yongjun Wang1Yilong Wang2Zhongrong Miao3Tudor G Jovin4Xingquan Zhao5Zeguang Ren6Xiaochuan Huo7Wenhuo Chen8Yuesong Pan9Xiaoxi Yao10Bernard Yan11Gang Luo12Thanh Nguyen13Guangxiong Yuan14Tingyu Yi15Dapeng Sun16Hongxin Han17Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaInterventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaCooper Hospital University Medical Center, Camden, New Jersey, USADepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurosurgery, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, ChinaCerebrovascular Disease Department, Neurological Disease Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Fujian Medical University Union Hospital, Fuzhou, Fujian, ChinaChina National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Affiliated Chenzhou Hospital, Southern Medical University (The First People’s Hospital of Chenzhou), The First People`s Hospital of Chenzhou, Chenzhou, ChinaDepartment of Neurology at Melbourne Brain Center, The University of Melbourne Medicine at Royal Melbourne Hospital, Parkville, Victoria, AustraliaInterventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaNeurology, Radiology, Boston Medical Center, Boston, Massachusetts, USADepartment of Emergency, Xiangtan Central Hospital, Xiangtan, ChinaDepartment of Neurology, Zhangzhou Municipal Hospital of Fujian Province and Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, ChinaInterventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Linyi People`s Hospital, Linyi, Shandong, ChinaBackground 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.Trial registration number NCT05624190.https://svn.bmj.com/content/early/2024/10/02/svn-2024-003318.full |
| spellingShingle | Liping Liu Yongjun Wang Yilong Wang Zhongrong Miao Tudor G Jovin Xingquan Zhao Zeguang Ren Xiaochuan Huo Wenhuo Chen Yuesong Pan Xiaoxi Yao Bernard Yan Gang Luo Thanh Nguyen Guangxiong Yuan Tingyu Yi Dapeng Sun Hongxin Han Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial Stroke and Vascular Neurology |
| title | Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial |
| title_full | Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial |
| title_fullStr | Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial |
| title_full_unstemmed | Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial |
| title_short | Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial |
| title_sort | intra arterial tenecteplase after successful endovascular therapy angel tnk protocol of a multicentre open label blinded end point prospective randomised trial |
| url | https://svn.bmj.com/content/early/2024/10/02/svn-2024-003318.full |
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