Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Capital Medical University, Beijing, People's Republic of China.
Department of Interventional Neuroradiology, Beijing TianTan Hospital, Capital Medical University, Beijing, People's Republic of China.
BMJ Open. 2022 Apr 28;12(4):e059616. doi: 10.1136/bmjopen-2021-059616.
Vertebrobasilar dissecting aneurysms (VBDAs) are associated with serious complications and a poor prognosis. It is believed that inflammation of the aneurysm wall may be the main cause of rupture or deterioration. Atorvastatin has been shown to inhibit inflammation and may be a suitable drug candidate. Here, we report a clinical research study protocol to investigate whether atorvastatin inhibits inflammation of the aneurysm wall, as measured by signal index enhancement.
We have designed a single-centre, randomised, double-blind, blank-controlled clinical trial. 40 patients with non-ruptured VBDAs with enhancement aneurysm walls will be enrolled in Beijing Tiantan Hospital. Eligible patients will be randomly divided into two treatment groups, at a ratio of 1:1, to receive atorvastatin 20 mg orally for 6 months or no treatment. The primary assessment outcome will be the change in aneurysm wall enhancement, as measured by the signal index during the 6-month treatment period. The secondary assessment outcomes will be the aneurysm morphology (intramural haematoma, dissection valve and false lumen) and changes in the concentrations of inflammatory factors, including C reactive protein, tumour necrosis factor-α, interleukin (IL)-1β and IL-6.
The protocol has been approved by the medical ethics committee of the Beijing Tiantan Hospital at which the work will be conducted (Approval No. KY 2019-024-02). Written informed consent will be obtained from all participants. Findings from the study will be submitted for publication in a peer-reviewed journal.
NCT04943783.
椎基底动脉夹层动脉瘤（VBDAs）与严重并发症和预后不良有关。据信，动脉瘤壁的炎症可能是破裂或恶化的主要原因。阿托伐他汀已被证明能抑制炎症，可能是一种合适的候选药物。在这里，我们报告了一项临床研究方案，以研究阿托伐他汀是否能抑制通过信号指数增强测量的动脉瘤壁炎症。
我们设计了一项单中心、随机、双盲、空白对照的临床试验。将在北京天坛医院招募 40 名患有增强型壁非破裂 VBDAs 的患者。符合条件的患者将以 1:1 的比例随机分为两组，分别接受阿托伐他汀 20mg 口服治疗 6 个月或不治疗。主要评估结果将是 6 个月治疗期间动脉瘤壁增强的变化，用信号指数来衡量。次要评估结果将是动脉瘤形态（壁内血肿、夹层瓣和假腔）和炎症因子浓度的变化，包括 C 反应蛋白、肿瘤坏死因子-α、白细胞介素（IL）-1β 和 IL-6。
该方案已获得北京天坛医院医学伦理委员会的批准（批准号 KY 2019-024-02）。将从所有参与者那里获得书面知情同意。研究结果将提交给同行评议的期刊发表。
NCT04943783。
