Intravenous Tenecteplase Prior to Endovascular Treatment for Ischemic Stroke at 4.5 to 24 Hours
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Importance: Whether intravenous tenecteplase prior to endovascular treatment (EVT) for ischemic stroke reduces disability in the late time window is unclear. Objective: To investigate the adverse events and efficacy of tenecteplase prior to EVT in patients 4.5 to 24 hours after ischemic stroke onset due to proximal middle cerebral artery (MCA) occlusion. Design, Setting, and Participants: Multicenter, phase 3, randomized, open-label, blinded end point, superiority trial conducted at 40 centers in China. Adult (≥18 years) patients with acute ischemic stroke 4.5 to 24 hours after last known to be well due to MCA-M1 or proximal M2 occlusion with salvageable brain tissue (ischemic core volume <70 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL) identified on computed tomography-perfusion or magnetic resonance-perfusion-diffusion imaging were enrolled from January 25, 2024, through July 21, 2025, and followed up for 90 days. Final follow-up occurred on October 14, 2025. Interventions: Eligible patients were randomly assigned in a 1:1 ratio to receive intravenous tenecteplase (0.25 mg/kg; maximum dose, 25 mg) before EVT (n = 199) or EVT alone (n = 192). Main Outcomes and Measures: The primary outcome was functional independence, defined as a score of 0 to 2 on the modified Rankin Scale (range, 0-6, with higher scores indicating greater disability) at 90 days. Adverse events outcomes included symptomatic intracranial hemorrhage and death. Results: All of the 391 patients enrolled (median age, 68 years [IQR, 59-75]; 155 [39.6%] females) completed the trial. Functional independence at 90 days occurred in 88 patients (44.2%) in the tenecteplase before EVT group and 83 patients (43.2%) in the EVT alone group (adjusted relative rate, 1.01 [95% CI, 0.83-1.24]; P = .89; risk difference, 0.99% [95% CI, -8.84% to 10.83%]). Mortality within 90 days was 12.7% (25/197) in the tenecteplase before EVT group and 14.2% (27/190) in the EVT alone group. Symptomatic intracranial hemorrhage within 36 hours was 5.1% (10/197) and 2.6% (5/190), respectively. Conclusions and Relevance: In patients presenting to EVT-capable centers 4.5 to 24 hours after stroke onset with proximal MCA occlusion, intravenous tenecteplase before EVT did not improve clinical outcomes vs EVT alone. Trial Registration: ClinicalTrials.gov Identifier: NCT06221371.
Source: JAMA
Authors: Yunyun Xiong, Fengyuan Che, Hao Wang, Manjun Hao, Thanh N. Nguyen, Marc Fisher, Aoming Jin, Zhixin Cao, Ziran Wang, Xiaoxi Yao, Ganghua Feng, Yuelong Xu, Shifeng Guo, Hao Qin, Xianjun Huang, Jianxin Xu, Zhongjun Chen, Jinglin Yuan, Wenshuai Li, Wei Hu, Xueyan Feng, Lixia Zong, Wanxing Ye, Chunmiao Duan, Liyuan Wang, Shuangzhe Wu, Bruce C. V. Campbell, Yongjun Wang, TNK-PLUS Investigators, Chaosheng Li, Haihua Yang, Fanping Kong, Haijun Qiu, Chuyuan Ni, Honggang Wang, Huakun Liu, Jianfeng Chu, Feng Xie, Hongguo Dai, Sujing Zhuang, Ying Liu, Mingchao Ding, Qinglin Dong, Yanxin Wang, Shujun Gao, Sihua Liu, Yutie Zhao, Haicheng Yuan, Cai Zhang, Dongcheng Xu, Lei Mu, Jun Li, Guang Zhang, Huaizhang Shi, Zhenyu Kong, Hongyu Qiao, Min Guan, Jia Yu, Wei Wu, Xiaosong Li, Lihua Wang, Haitao Wang, Bin Zhang, Lei Yang, Liguo Chang, Jiajun Zhuang, Li Zhou, Honghao Man, Xinmin Fu, Shunyuan Guo, Zongjie Shi, Magdy H Selim, Ding Ding, Wenjie Cao, Xiaoquan Xu, Ziqi Xu
Institutions: Capital Medical University, Beijing Tian Tan Hospital, Linyi People's Hospital, Boston Medical Center, Beth Israel Deaconess Medical Center, Chenzhou First People's Hospital, Zaozhuang Municipal Hospital, First Affiliated Hospital of Wannan Medical College, Dalian Municipal Central Hospital, Heze Municipal Hospital, University of Science and Technology of China, The Royal Melbourne Hospital, The University of Melbourne, Florey Institute of Neuroscience and Mental Health
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7160602468