• Yunyun Xiong, CampbellBruce C VBCVFrom the Department of Neurology (Y. Xiong, Y.J., L. Zong, M.H., Z.C., Liyuan Wang, S.W., Z.L., X.Z., Y.W.), the China National Clinical Research Center for Neurologic Diseases (Y. Xiong, X.M., A.J., Y.J., Y.P., C.D., W.Y., H.L., Y.W.), Lee H Schwamm, Xia Meng, Aoming Jin, Mark W Parsons, Marc Fisher, Yong Jiang, Fengyuan Che, Lihua Wang, Li Zhou, Hongguo Dai, Xintong Liu, Yuesong Pan, Chunmiao Duan, Yuming Xu, Anding Xu, Lixia Zong, Zefeng Tan, Wanxing Ye, Hao Wang, Ziran Wang, Manjun Hao, Zhixin Cao, Liyuan Wang, Shuangzhe Wu, Hao Li, Zixiao Li, Xingquan Zhao, Yongjun Wang, and TRACE-III Investigators.
• From the Department of Neurology (Y. Xiong, Y.J., L. Zong, M.H., Z.C., Liyuan Wang, S.W., Z.L., X.Z., Y.W.), the China National Clinical Research Center for Neurologic Diseases (Y. Xiong, X.M., A.J., Y.J., Y.P., C.D., W.Y., H.L., Y.W.), and the Advanced Innovation Center for Human Brain Protection (Y.W.), the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, and the Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences (Y.W.), Beijing, the Department of Neurology, Linyi People's Hospital, Linyi (F.C., H.W., Z.W.), the Department of Neurology, Second Affiliated Hospital of Harbin Medical University, Harbin (Lihua Wang), the Department of Neurology, Weifang People's Hospital, Weifang (L. Zhou), the Department of Emergency Medicine, Linfen Central Hospital, Linfen (H.D.), the Department of Neurology, Guangdong Second Provincial General Hospital, Guangzhou (X.L.), the Department of Neurology, First Affiliated Hospital of Zhengzhou University, the National Health Commission Key Laboratory of Prevention and Treatment of Cerebrovascular Disease, Zhengzhou (Y. Xu), the Department of Neurology, First Affiliated Hospital of Jinan University, Guangzhou (A.X.), and the Department of Neurology, First People's Hospital of Foshan, Foshan (Z.T.) - all in China; the Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC (B.C.V.C), and the Department of Neurology, University of New South Wales South Western Sydney Clinical School, Liverpool (M.W.P.) - both in Australia; Yale New Haven Health System, Yale School of Medicine, New Haven, CT (L.H.S.); and the Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (M.F.).
• N. Engl. J. Med. 2024 Jul 18; 391 (3): 203212203-212.

BackgroundTenecteplase is an effective thrombolytic agent for eligible patients with stroke who are treated within 4.5 hours after the onset of stroke. However, data regarding the effectiveness of tenecteplase beyond 4.5 hours are limited.MethodsIn a trial conducted in China, we randomly assigned patients with large-vessel occlusion of the middle cerebral artery or internal carotid artery who had salvageable brain tissue as identified on perfusion imaging and who did not have access to endovascular thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 4.5 to 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome was the absence of disability, which was defined as a score of 0 or 1 on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability), at day 90. The key safety outcomes were symptomatic intracranial hemorrhage and death.ResultsA total of 516 patients were enrolled; 264 were randomly assigned to receive tenecteplase and 252 to receive standard medical treatment. Less than 2% of the patients (4 in the tenecteplase group and 5 in the standard-treatment group) underwent rescue endovascular thrombectomy. Treatment with tenecteplase resulted in a higher percentage of patients with a modified Rankin scale score of 0 or 1 at 90 days than standard medical treatment (33.0% vs. 24.2%; relative rate, 1.37; 95% confidence interval, 1.04 to 1.81; P = 0.03). Mortality at 90 days was 13.3% with tenecteplase and 13.1% with standard medical treatment, and the incidence of symptomatic intracranial hemorrhage within 36 hours after treatment was 3.0% and 0.8%, respectively.ConclusionsIn this trial involving Chinese patients with ischemic stroke due to large-vessel occlusion, most of whom did not undergo endovascular thrombectomy, treatment with tenecteplase administered 4.5 to 24 hours after stroke onset resulted in less disability and similar survival as compared with standard medical treatment, and the incidence of symptomatic intracranial hemorrhage appeared to be higher. (Funded by the National Natural Science Foundation of China and others; TRACE-III ClinicalTrials.gov number, NCT05141305.).Copyright © 2024 Massachusetts Medical Society.

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