Adjunctive intra-arterial tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke (POST-TNK): Study rationale and design

作者：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, Zhi‐Xi 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 · 发表于：European Stroke Journal · 年份：2024 · DOI：10.1177/23969873241286983 · 被引用次数：7 · 研究领域：Acute Ischemic Stroke Management、Intracerebral and Subarachnoid Hemorrhage Research、Blood Coagulation and Thrombosis Mechanisms

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 reperfu...