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Early Tirofiban Infusion after Intravenous Thrombolysis for Stroke

作者:Chunrong Tao, Tianlong Liu, Tao Cui, Jie Liu, Zongliang Li, Youquan Ren, Xingli Zhao, Fuyou Xie, Jianqiao Li, Hao Wang, Ling Huang, Jianjun Li, Jianshang Wen, Jianzhong Zeng, J. Y. Zhu, Liang Li, Dajun Li, Xuefeng Hu, Biao Huang, Jing Wang, Chi Zhang, Bin Ye, Yubao Hou, Yanlin Gan, Hong Sun, Fei Guan, Ya Shao, Zongtao Liu, Zhongwen Ou, Shikai Fan, Yao Wang, Hongjiang Zhai, Chunhua Ni, Hao Wang, Chenggang Zhang, Yan Zhao, Guoping Wang, Yuyou Zhu, Rui Li, Jun Sun, Haiying Hu, Jiangping Cui, Li Wang, Chao Zhang, Jianlong Song, Xiaozhong Jing, Anmo Wang, Jinjing Wang, Pengfei Xu, Adnan I. Qureshi, Thanh N. Nguyen, Raul G. Nogueira, Jeffrey L. Saver, Wei Hu · 发表于:New England Journal of Medicine · 年份:2025 · DOI:10.1056/nejmoa2503678 · 被引用次数:55 · 研究领域:Acute Ischemic Stroke Management、Intracerebral and Subarachnoid Hemorrhage Research、Antiplatelet Therapy and Cardiovascular Diseases

BACKGROUND: Intravenous thrombolysis remains a standard treatment for acute ischemic stroke within 4.5 hours after onset. Vascular reocclusion may occur after intravenous thrombolysis and may be preventable with an antiplatelet agent within the first 24 hours after thrombolysis. Tirofiban, a platelet glycoprotein IIb-IIIa receptor antagonist, has reduced macrovascular reocclusion in experimental models. METHODS: In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted at 38 centers in China, we assigned patients with acute ischemic noncardioembolic stroke who presented within 4.5 hours after stroke onset and who were not eligible for thrombectomy to receive a 24-hour intravenous infusion of tirofiban or placebo within 60 minutes after intravenous thrombolysis. The primary efficacy outcome was an excellent functional outcome, defined as a score of 0 to 1 on the modified Rankin scale, at 90 days. The safety outcomes were symptomatic intracranial hemorrhage within 36 hours and death at 90 days. RESULTS: A total of 414 patients were assigned to receive tirofiban and 418 to receive placebo. Thrombolytic agents included alteplase (in 75% of the patients) and tenecteplase (in 25%). At 90 days, a score of 0 to 1 on the modified Rankin scale was reported in a higher percentage of patients in the tirofiban group than in the placebo group (65.9% vs. 54.9%; risk ratio, 1.20; 95% confidence interval, 1.07 to 1.34; P = 0.001). Symptomatic intracranial hemo...