RT Journal Article
SR Electronic
T1 Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection: the umbrella phase IIa CHABLIS-T randomised clinical trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 551
OP 559
DO 10.1136/svn-2023-002820
VO 9
IS 5
A1 Cheng, Xin
A1 Hong, Lan
A1 Churilov, Leonid
A1 Lin, Longting
A1 Ling, Yifeng
A1 Zhang, Jin
A1 Yang, Jianhong
A1 Geng, Yu
A1 Wu, Danhong
A1 Liu, Xueyuan
A1 Zhou, Xiaoyu
A1 Zhao, Yuwu
A1 Zhai, Qijin
A1 Zhao, Liandong
A1 Chen, Yangmei
A1 Guo, Ying
A1 Yu, Xiaofei
A1 Gong, Fan
A1 Sui, Yi
A1 Li, Gang
A1 Yang, Lumeng
A1 Gu, Hong-Qiu
A1 Wang, Yilong
A1 Parsons, Mark
A1 Dong, Qiang
A1 
YR 2024
UL http://svn.bmj.com/content/9/5/551.abstract
AB 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 received 0.25 mg/kg (n=43) or 0.32 mg/kg (n=43) tenecteplase, and were available for primary outcome analysis. Fourteen out of 43 patients in the 0.25 mg/kg tenecteplase group and 10 out of 43 patients in the 0.32 mg/kg tenecteplase group reached the primary outcome, providing promise of efficacy and safety for both doses based on Simon’s two-stage design.Discussion Among patients with anterior large/medium vessel occlusion and significant penumbral mismatch presented within 4.5–24 hours from time of last seen well, tenecteplase 0.25 mg/kg and 0.32 mg/kg both provided sufficient promise of efficacy and safety.Trial registration number ClinicalTrials.gov Registry (NCT04086147, https://clinicaltrials.gov/ct2/show/NCT04086147).Data are available upon reasonable request. Readers should contact the corresponding author (at qiang_dong163@163.com) if they wish to enquire about data sharing.