Efficacy and safety of glibenclamide therapy after intracerebral haemorrhage (GATE-ICH): A multicentre, prospective, randomised, controlled, open-label, blinded-endpoint, phase 2 clinical trial

作者：Jingjing Zhao, Changgeng Song, Deshuai Li, Xiai Yang, Liping Yu, Kangjun Wang, Jun Wu, Xiaofeng Wang, Dongsong Li, Bo Zhang, Binyong Li, Jun Guo, Weikui Feng, Feng Fu, Xinrong Gu, Jian Qian, Jialong Li, Xiangjun Yuan, Qiuwu Liu, Jiang Chen, Xiaochen Wang, Yi Liu, Dong Wei, Ling Wang, L. Shang, Fang Yang, Wen Jiang · 发表于：EClinicalMedicine · 年份：2022 · DOI：10.1016/j.eclinm.2022.101666 · 被引用次数：23 · 研究领域：Intracerebral and Subarachnoid Hemorrhage Research、Acute Ischemic Stroke Management、Traumatic Brain Injury and Neurovascular Disturbances

Background Glibenclamide is a promising agent for treating brain oedema, but whether it improves clinical outcomes in patients with intracerebral haemorrhage (ICH) remains unclear. In this study, we aimed to explore the efficacy and safety of glibenclamide treatment in patients with acute ICH. Methods The Glibenclamide Advantage in Treating Oedema after Intracerebral Haemorrhage (GATE-ICH) study was a randomised controlled phase 2 clinical trial conducted in 26 hospitals in the northwest of China, recruiting patients with acute ganglia ICH no more than 72 h after onset from Dec 12, 2018 to Sept 23, 2020. During the first 7 days after enrolment, patients randomly assigned to the glibenclamide group were given glibenclamide orally (1.25 mg, 3/day) and standard care, while patients randomly assigned to the control group were given standard care alone. The computer-generated randomisation sequence was prepared by a statistician not involved in the rest of the study. Randomisation was computer-generated with a block size of four. The allocation results were unblinded to participants and investigators. The primary outcome was the percentage of patients with poor outcome (defined as modified Rankin Scale [mRS] score of ≥3) at day 90. The trial was registered at ClinicalTrials.gov (NCT03741530). Findings 220 participants were randomised and 200 participants (mean [standard deviation] age, 56 [11] years; sex, 128 [64.0%] male and 72 [36.0%] female) were included in the final analysis,...