Department of Neurology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Department of Radiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Clin Neurol Neurosurg. 2024 Oct;245:108507. doi: 10.1016/j.clineuro.2024.108507. Epub 2024 Aug 15.
Intracranial atherosclerotic stenosis (ICAS) is one of the most common causes of stroke worldwide and confers a high risk of stroke recurrence, despite aggressive medical therapy. Asymptomatic ICAS (aICAS) is a frequent finding on neuroimaging, and it's an independent risk factor for future stroke. Alirocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and effectively lower low-density lipoprotein cholesterol levels. We hypothesize that extra alirocumab in addition to statin therapy (EAST) could stabilize intracranial plaques in patients with aICAS.
In this prospective, randomized, open-label, blinded end-point study, we will use high-resolution vessel-wall magnetic resonance imaging (HR-vwMRI) to evaluate the efficacy and safety of alirocumab in patients with asymptomatic ICAS. Eighty patients with aICAS (50 %-99 %) caused by unstable plaques will be assigned to the arm of alirocumab plus statin therapy, or the arm of statin therapy in a 1:1 ratio. Patients will undergo HR-vwMRI at recruitment and after 6 months. The primary outcome is changes in plaque features evaluated by HR-vwMRI after 6 months' treatment. This trial is being conducted at the first affiliated hospital of Nanjing medical university, China.
The study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University. Written informed consents will be obtained from all participants. Study results will be published as peer-reviewed articles.
ClinicalTrials.gov, Identifier: NCT06080256.
颅内动脉粥样硬化性狭窄（ICAS）是全球范围内最常见的中风原因之一，尽管进行了积极的药物治疗，但中风复发的风险仍然很高。无症状性颅内动脉粥样硬化（aICAS）在神经影像学上是一种常见的发现，是未来中风的独立危险因素。阿利西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（PCSK9），有效降低低密度脂蛋白胆固醇水平。我们假设，在他汀类药物治疗的基础上加用阿利西尤单抗（EAST）可以稳定 aICAS 患者的颅内斑块。
在这项前瞻性、随机、开放标签、盲终点研究中，我们将使用高分辨率血管壁磁共振成像（HR-vwMRI）来评估阿利西尤单抗在无症状性 ICAS 患者中的疗效和安全性。将 80 例由不稳定斑块引起的 aICAS（50%~99%）患者按照 1:1 的比例随机分配至阿利西尤单抗联合他汀类药物治疗组或他汀类药物治疗组。患者在招募时和 6 个月后进行 HR-vwMRI 检查。主要终点是 6 个月治疗后 HR-vwMRI 评估的斑块特征变化。该试验在中国南京医科大学第一附属医院进行。
该研究已获得南京医科大学第一附属医院伦理委员会的批准。将从所有参与者处获得书面知情同意书。研究结果将以同行评议的文章形式发表。
ClinicalTrials.gov，标识符：NCT06080256。
