Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection: the umbrella phase IIa CHABLIS-T randomised clinical trial

作者：Xin Cheng, Lan Hong, Leonid Churilov, Longting Lin, Yifeng Ling, Jin Zhang, Jianhong Yang, Yu Geng, Danhong Wu, Xueyuan Liu, Xiaoyu Zhou, Yuwu Zhao, Qijin Zhai, Liandong Zhao, Yangmei Chen, Ying Guo, Xiaofei Yu, Fan Gong, Yi Sui, Gang Li, Lumeng Yang, Hongqiu Gu, Yilong Wang, Mark Parsons, Qiang Dong · 发表于：Stroke and Vascular Neurology · 年份：2024 · DOI：10.1136/svn-2023-002820 · 被引用次数：21 · 研究领域：Acute Ischemic Stroke Management、S100 Proteins and Annexins、Blood Coagulation and Thrombosis Mechanisms

BACKGROUND: The performance of intravenous tenecteplase in patients who had an acute ischaemic stroke with large/medium vessel occlusion or severe stenosis in an extended time window remains unknown. We investigated the promise of efficacy and safety of different doses of tenecteplase manufactured in China, in patients who had an acute ischaemic stroke with large/medium vessel occlusion beyond 4.5-hour time window. METHODS: The CHinese Acute tissue-Based imaging selection for Lysis In Stroke-Tenecteplase was an investigator-initiated, umbrella phase IIa, open-label, blinded-endpoint, Simon's two-stage randomised clinical trial in 13 centres across mainland China. Participants who had salvageable brain tissue on automated perfusion imaging and presented within 4.5-24 hours from time of last seen well were randomised to receive 0.25 mg/kg tenecteplase or 0.32 mg/kg tenecteplase, both with a bolus infusion over 5-10 s. The primary outcome was proportion of patients with promise of efficacy and safety defined as reaching major reperfusion without symptomatic intracranial haemorrhage at 24-48 hours after thrombolysis. Assessors were blinded to treatment allocation. All participants who received tenecteplase were included in the analysis. RESULTS: A total of 86 patients who had an acute ischaemic stroke identified with anterior large/medium vessel occlusion or severe stenosis were included in this study from November 2019 to December 2021. All of the 86 patients enrolled either rec...