Huo Xiaochuan, Luo Gang, Sun Dapeng, Nguyen Thanh, Abdalkader Mohamad, Chen Wenhuo, Yao Xiaoxi, Yuan Guangxiong, Yi Tingyu, Han Hongxin, Pan Yuesong, Jovin Tudor G, Liebeskind David S, Liu Liping, Zhao Xingquan, Ren Zeguang, Wang Yilong, Wang Yongjun, Yan Bernard, Miao Zhongrong
Cerebrovascular Disease Department, Neurological Disease Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Stroke Vasc Neurol. 2024 Nov 21. doi: 10.1136/svn-2024-003318.
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.
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.
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.
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.
NCT05624190.
尽管大血管闭塞（LVO）性卒中患者在进行取栓术后成功实现了再灌注，但仍有多达一半的患者在3个月随访时出现依赖或死亡。本研究的目的是证明在前循环LVO患者中，给予辅助动脉内（IA）替奈普酶的安全性和有效性，这些患者已实现定义为脑梗死溶栓分级（eTICI）2b50至3级的成功再灌注。
ANGEL-TNK是一项多中心、开放标签、评估者盲法终点、前瞻性随机对照试验，将招募多达256名患者。符合前循环LVO卒中纳入标准且成功再灌注的患者将按1:1的比例随机接受IA替奈普酶或最佳药物治疗。
主要终点是90天良好预后，定义为改良Rankin量表（mRS）0-1分。主要安全终点是随机分组后48小时内出现症状性颅内出血。次要终点包括90天序贯mRS、mRS 0-2、mRS 0-3、全因死亡率和任何颅内出血。
在前循环LVO卒中患者中，ANGEL-TNK试验将明确在成功的取栓再灌注后给予辅助IA替奈普酶是否能改善患者预后。
NCT05624190。
