OBJECTIVE Intracranial atherosclerosis is a major cause of ischaemic stroke worldwide. A number of studies have shown the effects of statin treatment on coronary and carotid artery plaques, but there is little evidence on the effects of statin treatment on intracranial atherosclerotic plaques. METHODS The Intensive Statin Treatment in Acute Ischaemic Stroke Patients with Intracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging (STAMINA-MRI) Trial is a single-arm, prospective, observational study monitoring imaging and clinical outcomes of high-dose statin treatment among statin-naive patients with acute ischaemic stroke caused by symptomatic intracranial atherosclerosis. The primary outcome was the change in vascular remodelling and plaque characteristics before and after 6 months (median: 179 days, IQR 163-189 days) of statin treatment measured by high-resolution MRI (HR-MRI). RESULTS A total of 77 patients (mean age: 62.6±13.7 years, 61.0% women) were included in this study. Low-density lipoprotein cholesterol (LDL-C) levels (mg/dL) at initial and follow-up assessments were 125.81±35.69 and 60.95±19.28, respectively. Overall, statin treatment significantly decreased enhancement of plaque volume (mm3, 32.07±39.15 vs 17.06±34.53, p=0.013), the wall area index (7.50±4.28 vs 5.86±4.05, p=0.016) and stenosis degree (%, 76.47±20.23 vs 64.05±21.29, p<0.001), but not the remodelling index (p=0.195). However, 35% patients showed no change or increased enhancement volume and stenosis degree after statin treatment. Higher reduction of LDL-C and longer duration of statin treatment were associated with decreased enhancement volume after statin treatment. CONCLUSIONS High-dose statin treatment effectively stabilised symptomatic intracranial atherosclerotic plaques as documented by HR-MRI. Further study is needed to determine laboratory and genetic factors associated with poor response to statins and alternative therapeutic options, such as proprotein convertase subtilisin-kexin type 9 inhibitors, for these patients. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT02458755.

中文翻译：

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急性缺血性卒中伴颅内动脉粥样硬化的强化他汀类药物治疗：一项高分辨率磁共振成像研究（STAMINA-MRI研究）。

目的颅内动脉粥样硬化是全世界缺血性中风的主要原因。许多研究表明他汀类药物治疗对冠状动脉和颈动脉斑块的影响，但很少有证据表明他汀类药物治疗对颅内动脉粥样硬化斑块的影响。方法对急性缺血性卒中颅内动脉粥样硬化患者进行强化他汀类药物治疗-高分辨率磁共振成像（STAMINA-MRI）试验是一项单臂，前瞻性，观察性研究，监测他汀类药物中大剂量他汀类药物治疗的影像学和临床结局幼稚的急性缺血性中风患者，伴有症状的颅内动脉粥样硬化。主要结局是6个月之前和之后的血管重塑和斑块特征发生变化（中位数：179天，通过高分辨率MRI（HR-MRI）测量他汀类药物治疗的IQR 163-189天）。结果本研究共纳入77例患者（平均年龄：62.6±13.7岁，女性为61.0％）。初始和随访评估中低密度脂蛋白胆固醇（LDL-C）水平（mg / dL）分别为125.81±35.69和60.95±19.28。总体而言，他汀类药物治疗显着降低了斑块体积（mm3，32.07±39.15 vs 17.06±34.53，p = 0.013），壁面积指数（7.50±4.28 vs 5.86±4.05，p = 0.016）和狭窄程度（％，76.47） ±20.23与64.05±21.29，p <0.001），但不包括重塑指数（p = 0.195）。但是，有35％的患者在他汀类药物治疗后未见改变或增强体积和狭窄程度增加。LDL-C的更高降低和他汀类药物治疗时间的延长与他汀类药物治疗后增强量的减少相关。结论高剂量他汀类药物治疗可有效稳定症状性颅内动脉粥样硬化斑块，如HR-MRI所证实。对于这些患者，需要进一步研究以确定与对他汀类药物反应不良和其他治疗选择（例如前蛋白转化酶枯草杆菌蛋白酶-酮类9型抑制剂）相关的实验室和遗传因素。试验注册号ClinicalTrials.gov NCT02458755。例如针对这些患者的前蛋白转化酶枯草杆菌蛋白酶-kexin 9型抑制剂。试验注册号ClinicalTrials.gov NCT02458755。例如针对这些患者的前蛋白转化酶枯草杆菌蛋白酶-kexin 9型抑制剂。试验注册号ClinicalTrials.gov NCT02458755。