NCT00431145Unknown2 期
Influence of Combined Therapy of Niacin and Statins on Stem Cell Mobilization and Inflammatory Parameters in Patients Suffering From Coronary Artery Disease - Randomized Clinical Study -
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- numbers of EPCs and inflammatory markers
研究概览
简要总结
Aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of EPCs and other stem cell populations and adiponectin as well as hsCRP levels in patients with CAD.
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
- None
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 at least 18 years old, male or female
- •Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)
- •LDL > 100 mg/dl
- •HDL < 50 mg/dl
- •Triglycerides < 400 mg/dl
- •No Nicotine abuse for at least 3 months
- •Statin-therapy for more than 4 weeks
- •Give a written informed consent
- •Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
排除标准
- •Women of childbearing potential, pregnancy or being lactating
- •Current participation in another clinical trial
- •Have other severe concurrent illness (e.g., active infection, malignancy)
- •Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.
- •Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST)
- •Suffer from myopathy, active peptic disease or arterial bleeding
- •Have a known hypersensitivity against niacin or statins
- •Are actually treated with any of itraconazole, ketoconazole, HIV-Protease-Inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.
- •Actual therapy with ezetimibe
- •Diabetes mellitus Type I
结局指标
主要结局
numbers of EPCs and inflammatory markers
adiponectin
hsCRP
each after 8 weeks
次要结局
- each after 4 and 8 weeks
- carotid artery distensibility
- carotid artery plaque composition
- each after 8 weeks
- optionally 1 year follow-up
- numbers of EPCs,
- inflammatory markers
- adiponectin
- hsCRP
- each after 4 weeks
- number and type of progenitor cells
- dendritic cells
- cytokines
- lipoproteins in peripheral blood
- vascular function
研究者
研究点 (2)
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