Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration

作者：Xuting Zhang, Wansi Zhong, Rui Xue, Haidi Jin, Xiaoxian Gong, Yuhui Huang, Fujian Chen, Mozi Chen, Li‐Qun Gu, Yebo Ge, Xiaodong Ma, Bifeng Zhong, Mengjie Wang, Haitao Hu, Zhicai Chen, Shenqiang Yan, Yi Chen, Xin Wang, Xiaoling Zhang, Dongjuan Xu, Yuping He, Minfang Lou, Aiju Wang, Xiong Zhang, Li Ma, Xiaodong Lü, Jianer Wang, Qiong Lou, Ping’an Qian, Guomin Xie, Xiaofen Zhu, Songbin He, Jin Hu, Xiongjie Wen, Yan Liu, Yanwen Wang, Jingjing Fu, Weinv Fan, David S. Liebeskind, Changzheng Yuan, Min Lou · 发表于：JAMA Neurology · 年份：2024 · DOI：10.1001/jamaneurol.2023.5093 · 被引用次数：56 · 研究领域：Acute Ischemic Stroke Management、Intracerebral and Subarachnoid Hemorrhage Research、S100 Proteins and Annexins

Importance: The effect of argatroban in patients with acute ischemic stroke (AIS) and early neurological deterioration (END) is unknown. Objective: To assess the efficacy of argatroban for END in AIS. Design, Setting, and Participants: This open-label, blinded-end point, randomized clinical trial was conducted from April 4, 2020, through July 31, 2022. The date of final follow-up was October 31, 2022. This was a multicenter trial. Eligible patients were adults with AIS who experienced END, which was defined as an increase of 2 or more points on the National Institutes of Health Stroke Scale within 48 hours from symptom onset. Patients who withdrew consent, experienced duplicate randomization, or were lost to follow-up were excluded from the study. Interventions: Patients were randomly assigned to the argatroban group and control group within 48 hours of symptom onset. Both groups received standard therapy based on guidelines, including oral mono or dual antiplatelet therapy. The argatroban group received intravenous argatroban for 7 days (continuous infusion at a dose of 60 mg per day for 2 days, followed by 20 mg per day for 5 days) in addition to standard therapy. Main Outcome and Measure: The primary end point was good functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 3. Results: A total of 628 patients (mean [SD] age, 65 [11.9] years; 400 male [63.7%]) were included in this study (argatroban group, 314 [50%] and control group, 314 [50%]). Of ...