Zhang Xiao, Zhao Jingjing, Sun Zhongqing, Wei Dong, Yao Li, Li Weiwang, Zhu Hao, Liu Wen, Zhang Huiping, Yuan Xiangjun, Ma Xingshun, Meng Junpeng, Wang Bin, Jia Yi, Qin Na, Jiang Wen
Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, China.
Department of Neurology, Xi'an XD Group Hospital, Xi'an, China.
BMJ Open. 2024 Dec 20;14(12):e093443. doi: 10.1136/bmjopen-2024-093443.
Despite the implementation of mechanical thrombectomy, acute ischaemic stroke with large vessel occlusion (AIS-LVO) remains a significant health concern, characterised by substantial morbidity and mortality. Our trial aims to evaluate the efficacy and safety of minocycline in reducing infarct volume and improving functional outcomes in patients undergoing mechanical thrombectomy for anterior circulation AIS-LVO.
The MIST-A trial is a prospective, randomised, open-label, blinded-endpoint trial to be conducted across 12 medical centres. The study will enrol 180 adult patients who have experienced an anterior circulation AIS-LVO and have undergone mechanical thrombectomy. These patients will be randomly divided into two groups: one receiving minocycline in addition to standard care and the other receiving only standard care. The primary efficacy outcome is the change in infarct volume as measured by MRI, from baseline to day 5. The secondary efficacy outcomes include the incidence of intracerebral haemorrhage occurring within 24 hours and the clinical scores between the baseline and follow-up assessments. The primary outcome will be assessed using a mixed-effects model to determine the association between treatment and outcomes.
The study is approved by the Ethics Committee of Xijing Hospital (XJLL-KY20222186) and is registered at ClinicalTrials.gov (NCT05487417). This trial is estimated to end in the first quarter of 2025 and study findings are expected to be published in scientific journals that undergo peer review and also to be showcased at scientific conferences.
NCT05487417.
尽管实施了机械取栓术,但伴有大血管闭塞的急性缺血性卒中(AIS-LVO)仍然是一个重大的健康问题,具有较高的发病率和死亡率。我们的试验旨在评估米诺环素在接受前循环AIS-LVO机械取栓术的患者中减少梗死体积和改善功能结局的疗效和安全性。
MIST-A试验是一项前瞻性、随机、开放标签、盲终点试验,将在12个医学中心进行。该研究将招募180名经历过前循环AIS-LVO并接受了机械取栓术的成年患者。这些患者将被随机分为两组:一组在标准治疗的基础上接受米诺环素治疗,另一组仅接受标准治疗。主要疗效结局是通过MRI测量的从基线到第5天梗死体积的变化。次要疗效结局包括24小时内发生脑出血的发生率以及基线和随访评估之间的临床评分。将使用混合效应模型评估主要结局,以确定治疗与结局之间的关联。
该研究已获得西京医院伦理委员会(XJLL-KY20222186)的批准,并在ClinicalTrials.gov(NCT05487417)上注册。该试验预计于2025年第一季度结束,研究结果预计将发表在经过同行评审的科学期刊上,并在科学会议上展示。
NCT05487417。