Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial

• Published in: 中华医学杂志英文版 Vol. 138; no. 5; pp. 579 - 588
• Main Authors: Li Shengde, Wang Anxin, Shi Lin, Liu Qin, Guo Xiaoling, Liu Kun, Wang Xiaoli, Li Jie, Zhu Jianming, Wu Qiuyi, Yang Qingcheng, Zhuang Xianbo, You Hui, Feng Feng, Luo Yishan, Li Huiling, Ni Jun, Peng Bin
• Format: Journal Article
• Language: Chinese
• Published: Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China%Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China%BrainNow Research Institute, Shenzhen, Guangdong 518000, China%Department of Neurology, The Second People’s Hospital of Yibin, Yibin, Sichuan 644000, China%Department of Neurology, The First Affiliated Hospital of Anhui University of Technology, Huainan, Anhui 232007, China%Department of Neurology, Brain Hospital of Hunan Province (The Second People’s Hospital of Hunan Province), Changsha, Hunan 410007, China%Department of Neurology, Hengshui People’s Hospital, Hengshui, Hebei 053000, China%Department of Neurology, The First People’s Hospital of Yibin, Yibin, Sichuan 644000, China%Department of Neurology, The First People’s Hospital of Changde City, Changde, Hunan 415000, China%Department of Neurology, The First People’s Hospital of Zhangjiagang City, Suzhou, Jiangsu 215600, China%Department of Neurology, The People’s Hospital of Anyang City, Anyang, Henan 455000, China%Department of Neurology, Liaocheng People’s Hospital, Liaocheng, Shandong 252000, China%Department of Radiology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100730, China%Department of Occupational Medicine and Toxicologym, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China 2025
• Subjects: Cerebral infarct; Acute ischemic stroke; Pharmacology; Cerebral edema; Angong Niuhuang Pill
• ISSN: 0366-6999
• DOI: 10.1097/CM9.0000000000003133

Background::Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.Methods::This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.Results::There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score