NCT02003638已完成不适用
A 12-WEEK STUDY EVALUATING THE EFFECTS OF NIACIN ON VASCULAR HEALTH ASSESSED BY FLUORODEOXYGLUCOSE-PET/CT AND CIRCULATING ENDOTHELIAL PROGENITOR CELLS AND MICROPARTICLES
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
研究概览
简要总结
This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
- •Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period
排除标准
- •Anxiety or claustrophobia prohibiting imaging
- •History of allergy to intravenous contrast, iodine, or shellfish
- •Renal insufficiency
- •History of allergy or severe intolerance to niacin
- •History of diabetes mellitus or elevated fasting glucose
- •Moderate to severe gout
- •Peptic ulcer disease
- •Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
- •Heart failure or unstable angina pectoris
- •Use of daily non-statin lipid-altering therapy prior to the initiation of study medication
研究组 & 干预措施
Niacin
Experimental
Niacin titrated up to 6 grams taken orally every day for 12 weeks
干预措施: Niacin (Drug)
Placebo
Placebo Comparator
Placebo taken orally every day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Emil deGoma
Assistant Professor of Medicine
University of Pennsylvania
研究点 (1)
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