Dai Jiaqi, Zhao Haobo, Chen Xinyu, Nie Ping, Gong Jie, Wang Min, Zhang Kezhong, Wang Zhaolu, Lu Hua
Department of Neurology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Front Neurol. 2025 May 9;16:1520356. doi: 10.3389/fneur.2025.1520356. eCollection 2025.
There is a high risk of stroke occurrence and recurrence in patients with intracranial atherosclerotic stenosis (ICAS) despite aggressive medical therapy. Evolocumab is a monoclonal antibody which can inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) and effectively reduce the level of low-density lipoprotein cholesterol. We hypothesize that evolocumab added to statin therapy (EAST) can stabilize intracranial plaques in patients with symptomatic ICAS.
This is a prospective, randomized, open-label, blinded end-point study, which will assess the efficacy and safety of evolocumab in patients with symptomatic ICAS. Eighty patients who suffer a stroke/transient ischemic attack (TIA) caused by ICAS recently will be randomly allocated in a 1:1 ratio to the evolocumab plus statin treatment group or the statin treatment group. High resolution vessel wall magnetic resonance imaging (HR-vwMRI) will be performed at recruitment and after 6 months and 12 months. The primary outcome is changes in plaque characteristics assessed by HR-vwMRI at 6th month and 12th month after treatment. Cognitive and neurological function will also be evaluated at recruitment and follow-up. This trial is being conducted at the first affiliated hospital of Nanjing medical university, China.
All participants will sign written informed consents. Peer-reviewed articles will be published to disseminate study outcomes.
ClinicalTrials.gov, identifier: NCT05741086.
尽管进行了积极的药物治疗，但颅内动脉粥样硬化狭窄（ICAS）患者发生中风和复发的风险仍然很高。依洛尤单抗是一种单克隆抗体，可抑制前蛋白转化酶枯草溶菌素9型（PCSK9）并有效降低低密度脂蛋白胆固醇水平。我们假设在他汀类药物治疗基础上加用依洛尤单抗（EAST）可稳定有症状ICAS患者的颅内斑块。
这是一项前瞻性、随机、开放标签、盲终点研究，将评估依洛尤单抗对有症状ICAS患者的疗效和安全性。近期因ICAS导致中风/短暂性脑缺血发作（TIA）的80名患者将按1:1的比例随机分配至依洛尤单抗加他汀类药物治疗组或他汀类药物治疗组。在入组时、6个月和12个月后进行高分辨率血管壁磁共振成像（HR-vwMRI）检查。主要结局是治疗后第6个月和第12个月通过HR-vwMRI评估的斑块特征变化。在入组和随访时还将评估认知和神经功能。本试验在中国南京医科大学第一附属医院进行。
所有参与者将签署书面知情同意书。将发表经过同行评审的文章以传播研究结果。
ClinicalTrials.gov，标识符：NCT05741086。
