Journal Article

Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial

Miao, Zhongrong, Liebeskind, David S, Luo, Gang, Sun, Dapeng, Abdalkader, Mohamad, Yi, Tingyu, Liu, Liping, Han, Hongxin, Yan, Bernard, Nguyen, Thanh, Yuan, Guangxiong, Zhao, Xingquan, Wang, Yilong, Pan, Yuesong, Yao, Xiaoxi, Ren, Zeguang, Jovin, Tudor G, Huo, Xiaochuan, Wang, Yongjun, Chen, Wenhuo

2025

Overview

BackgroundDespite 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.MethodsANGEL-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.ResultsThe 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.ConclusionIn 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.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Anticoagulants / Blood pressure / Carotid arteries / Clinical outcomes / Disability Evaluation / Endovascular Procedures - adverse effects / Endovascular Procedures - mortality / Female / Fibrinolytic Agents - administration & dosage / Fibrinolytic Agents - adverse effects / Functional Status / Hospitals / Humans / Hypotheses / Intracranial Hemorrhages - chemically induced / Ischemic Stroke - diagnosis / Ischemic Stroke - mortality / Ischemic Stroke - physiopathology / Ischemic Stroke - therapy / Male / Medical imaging / Multicenter Studies as Topic / Neurology / Neurosurgery / Patient safety / Prospective Studies / Protocol / Randomized Controlled Trials as Topic / Recovery of Function / Stroke / Tenecteplase - administration & dosage / Tenecteplase - adverse effects / Thrombectomy / Thrombectomy - adverse effects / Thrombectomy - mortality / Thrombolysis / Thrombolytic drugs / Thrombolytic Therapy - adverse effects / Thrombolytic Therapy - mortality / Time Factors / Treatment Outcome / Veins & arteries