Gao Gan, Wang Qian-Nan, Hao Fang-Bin, Wang Xiao-Peng, Liu Si-Meng, Wang Min-Jie, Han Cong, Bao Xiang-Yang, Duan Lian
Chinese PLA Medical School, Beijing, China.
Department of Neurosurgery, Chinese PLA General Hospital, Beijing, China.
Front Neurol. 2023 Jun 1;14:1169253. doi: 10.3389/fneur.2023.1169253. eCollection 2023.
The aim of this large, prospective, double-blind randomized controlled trial is to investigate the effect of atorvastatin on the formation of collateral blood vessels in patients after encephaloduroarteriosynangiosis (EDAS) and to provide a theoretical basis for clinical drug intervention. Specifically, we will determine whether atorvastatin has an effect on the development of collateral vascularization and on cerebral blood perfusion after revasculoplasty in patients with moyamoya disease (MMD).
Overall, 180 patients with moyamoya disease will be recruited and randomly assigned to the atorvastatin treatment group or the placebo control group in a 1:1 ratio. Before revascularization surgery, magnetic resonance imaging (MRI) scanning and digital subangiography (DSA) examination will be routinely performed on the enrolled patients. All patients will receive intervention via EDAS. According to the randomization results, patients in the experimental group will be treated with atorvastatin (20 mg/day, once a day, for 8 weeks) and patients in the control group will be treated with placebo (20 mg/day, once a day, for 8 weeks). All participants will return to the hospital for MRI scan and DSA examination 6 months after EDAS surgery. The primary outcome of this trial will be the difference in the formation of collateral blood vessels revealed by DSA examination at 6 months after EDAS surgery between the two groups. The secondary outcome will be an improvement in the dynamic susceptibility contrast sequence cerebral perfusion on MRI at 6 months after EDAS, compared to the preoperative baseline.
This study was approved by the Ethics Committee of the First Medical Center of the PLA General Hospital. All participates will voluntary provide written informed consent before participating in the trial.
ClinicalTrials.gov, ChiCTR2200064976.
这项大型、前瞻性、双盲随机对照试验的目的是研究阿托伐他汀对脑硬脑膜动脉血管融通术（EDAS）后患者侧支血管形成的影响，并为临床药物干预提供理论依据。具体而言，我们将确定阿托伐他汀对烟雾病（MMD）患者血管重建术后侧支血管形成及脑血流灌注是否有影响。
总共将招募180例烟雾病患者，并按1:1的比例随机分配至阿托伐他汀治疗组或安慰剂对照组。在血管重建手术前，将对入组患者常规进行磁共振成像（MRI）扫描和数字减影血管造影（DSA）检查。所有患者均通过EDAS接受干预。根据随机化结果，试验组患者将接受阿托伐他汀治疗（20毫克/天，每日一次，共8周），对照组患者将接受安慰剂治疗（20毫克/天，每日一次，共8周）。所有参与者将在EDAS手术后6个月返回医院进行MRI扫描和DSA检查。本试验的主要结局将是两组在EDAS手术后6个月时DSA检查显示的侧支血管形成差异。次要结局将是与术前基线相比，EDAS术后6个月时MRI上动态磁敏感对比序列脑灌注的改善情况。
本研究已获得中国人民解放军总医院第一医学中心伦理委员会的批准。所有参与者在参加试验前将自愿提供书面知情同意书。
ClinicalTrials.gov，ChiCTR2200064976。
