Application of Atorvastatin in the Treatment of Patients With Intracranial Unruptured Aneurysms
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI).
研究概览
简要总结
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin.
详细描述
Unruptured intracranial aneurysms (UIAs) are increasingly detected and often remain clinically asymptomatic for a long time before rupture. However, once the UIAs ruptured, the incidence of mortality rate varies from 30% to 60% within 6 months. Thus, the risk of UIAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making.
Histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of UIAs. Wall enhancement of a saccular aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial saccular aneurysm.
Statins inhibit 3-hydroxy-3-methylglutaryl coenzyme A reductase and are established first-line treatments for hypercholesterolemia. Statins produce a range of pleiotropic effects in addition to inhibition of cholesterol synthesis, especially to reduce inflammation, which may be important in reducing the growth and rupture of UIAs.
In the study, participants known to have UIA that is not planned for treatment and has not yet ruptured, take atorvastatin daily for six months, and have an HRMRI scan before and after to look for the role of atorvastatin in inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 18 or over, male or non-pregnant female;
- •patients have a saccular UIA identified on imaging (CT, MRI or DSA), and the aneurysm ≥3mm;
- •patients with wall enhancement of aneurysm by MRI VWI before treatment;
- •patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.
排除标准
- •Patient with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;
- •Planned treatment of the aneurysm within 6 months;
- •Patient taking the drugs, which might have an anti-inflammatory effect, such as aspirin, statin, immunosuppressive drug, etc.
- •Dyslipidemia or severely impaired liver or renal functions
- •Retreatment of recurrent aneurysm;
- •Pregnant or lactating women;
- •Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
- •Poor compliance patients.
研究组 & 干预措施
Atorvastatin
Atorvastatin tablets, 20mg once a day, for six months.
干预措施: Atorvastatin (Drug)
Placebo
Same color and size coated tablet, 20mg once a day, for six months.
干预措施: Placebos (Drug)
结局指标
主要结局
The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI).
时间窗: 6 months
The change in aneurysm wall enhancement index of at least 20% on MRI vessel wall imaging (VWI) at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.
次要结局
- Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods.(6 months)
- Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods.(6 months)
- Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods.(6 months)
- Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods.(6 months)
- Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods.(6 months)