A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
研究概览
简要总结
The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ages 30 to 80
- •Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening
排除标准
- •Participant has human immunodeficiency virus (HIV), Hepatitis B or C
- •Participant uses illegal drugs
- •Participant has Type I diabetes
- •Participant has a history of claustrophobia
研究组 & 干预措施
10 mg Atorvastatin
10 mg atorvastatin + placebo
干预措施: atorvastatin (Drug)
10 mg Atorvastatin
10 mg atorvastatin + placebo
干预措施: placebo (Drug)
80 mg Atorvastatin
80 mg atorvastatin + placebo
干预措施: atorvastatin (Drug)
80 mg Atorvastatin
80 mg atorvastatin + placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
时间窗: Baseline and Week 12
Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.
次要结局
- Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants(Baseline and Week 12)