Alteplase for Acute Ischemic Stroke at 4.5 to 24 Hours

作者：Ying Zhou, Yaode He, Bruce Campbell, David S. Liebeskind, C. Z. Yuan, Hui Chen, Yanxing Zhang, Tingyu Yi, Zhongyu Luo, Zuowen Zhang, Changcai Meng, Jianhua Cheng, Hezhong Ouyang, Jin Hu, Fei Wang, Sheng Zhang, Qi Fang, Haitao Hu, Xuting Zhang, Yi Chen, Wansi Zhong, Maarten G. Lansberg, Shenqiang Yan, Min Lou, HOPE investigators, Huan Tang, Wanli Zhang, Siyan Chen, Zhenghao Shi, Yang Gao, Yuhua Zhu, Zhimin Wang, Lin Qing, Lin Zhang, Xiaoling Zhang, Shuxia Qian, Jun Luo, Dajun Li, Kui Lu, Jing Ding, Bing Zhang, Xingxing Hu, Gang Li, Weinv Fan, Da Li, Yongxing Su, David Wang, Kun Chen, Yaxian Wang, Guomin Xie, Songbin He, Fujian Chen, Jiansheng Yang, Chenghua Xu, Tinghuan Wang, Xinchun Jin, Jingjing Fu · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2025.12063 · 被引用次数：51 · 研究领域：Acute Ischemic Stroke Management、Intracerebral and Subarachnoid Hemorrhage Research、Stroke Rehabilitation and Recovery

Importance: The safety and efficacy of intravenous thrombolytics beyond 4.5 hours after ischemic stroke onset remain inadequately studied. Objective: To evaluate the safety and efficacy of intravenous alteplase administered 4.5 to 24 hours after stroke onset in patients with salvageable brain tissue, regardless of the presence of large vessel occlusion. Design, Setting, and Participants: This randomized, open-label, blinded end-point trial was conducted at 26 stroke centers across China. A total of 372 patients with acute ischemic stroke and salvageable brain tissue identified by perfusion imaging were enrolled between June 21, 2021, and June 30, 2024 (final follow-up October 2, 2024). Eligibility criteria included stroke onset (or the midpoint between last known well and symptom recognition if onset was unknown) of 4.5 to 24 hours prior to presentation, and no initial plan for endovascular thrombectomy. Data were analyzed from December 2024 to February 2025. Interventions: Patients were randomly assigned (1:1) using a minimization algorithm to receive intravenous alteplase (0.9 mg/kg; maximum dose, 90 mg; n = 186) or standard medical treatment (n = 186). Main Outcomes and Measures: The primary efficacy outcome was functional independence, defined as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage within 36 hours and all-cause mortality within 90 days. Results: Among 372 patients who were enrolled (median [IQR] ...