Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial

• Published in: BMJ open 2024-06, Vol.14 (6), p.e079879
• Main Authors: Gao, Daiquan, Chu, Xuehong, Zhang, Yunzhou, Yan, Heli, Niu, Lijian, Jiang, Xuebin, Bao, Shiying, Ji, Xunming, Wu, Chuanjie
• Format: Article
• Language: English
• Subjects: Adult; Aged; Case-Control Studies; Cerebral Hemorrhage - drug therapy; China; Clinical Trial; Contraindications; Edema; Female; Hemorrhage; Hospitals; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Intracerebral Hemorrhage; Ischemia; Male; Medical imaging; Middle Aged; Mortality; Multicenter Studies as Topic; Neurology; Neuroprotective Agents - therapeutic use; Patients; Prospective Studies; Randomized Controlled Trials as Topic; Statins; Stroke; Traumatic brain injury; Variables
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-079879

IntroductionIntracerebral haemorrhage (ICH) is a neurological emergency with high morbidity and mortality, and current treatment is limited. Emerging evidence has reported that statins can exert neuroprotective effects in cerebrovascular diseases. However, most of the published clinical studies are retrospective. Therefore, it is important to conduct a prospective randomised controlled trial to further validate the efficacy and safety of statins in patients with ICH.Methods and analysisThe present study is performed at Xuan Wu Hospital Capital Medical University, Beijing Fengtai You'anmen Hospital and Shunping County Hospital, Hebei Province. The target number of patients is 98. Eligible patients are randomly assigned in a 1:1 ratio to the statins group or the control group. The primary outcome is the perihaemorrhagic oedema to haematoma ratio at 7 days. Secondary outcomes include mortality at 30 days, haematoma resolution rate at 7 days, National Institute of Health stroke scale (NIHSS) score at 7 days or discharge, ordinal distribution of modified Rankin scale (mRS) score at 90 days, the proportion of patients with an mRS score of 0–2 on day 90, the proportion of patients with an mRS score of 0–3 on day 90, absolute haematoma volume changes between initial and 7-day follow-up CT scan, absolute perihaematomal oedema changes between initial and 7-day follow-up CT scan.Ethics and disseminationThe trial has been approved by the ethics committees of Xuan Wu Hospital Capital Medical University, Beijing Fengtai You'anmen Hospital and Shunping County Hospital, Hebei Province. The results will be disseminated in a peer-reviewed journal and in conference reports.Trial registration number NCT04857632.