The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- endothelial function
研究概览
简要总结
Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions by regulating the expression con key proteins that participate in vascular inflammation, plaque stability and thrombosis.
Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small, dense LDL particles. The use of this drug has resulted in improvement of vascular function measured by endothelial function. Our hypotheses state that fenofibrate will improve: endothelial function, improve HDL antioxidant capacity and size distribution towards a predominance of small HDL particles.
详细描述
Patients with stable coronary heart disease, with LDL-C levels at goal will be invited to participate in this randomized, double blind study to receive either placebo or fenofibrate in addition to their statin therapy.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 18-60 years of age
- •Stable coronary heart disease (no cardiovascular event 3 months prior to enrollment)
- •Stable lipid-modifying drug therapy (previous 2 months)
- •Low-dose statin therapy with LDL-C at goal (< 100 mg/dl)
- •Triglyceride levels 151-500 mg/dl
- •HDL-C levels <40 mg/dl
排除标准
- •Diabetes mellitus
- •Uncontrolled hypertension Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
- •Subjects with renal (serum creatinine >1.5 times the upper limit of normal (ULN)), hepatobiliary (cholelithiasis, biliary cirrhosis, AST and/or ALT >2x ULN) or active thyroid disease (TSH >1.5x ULN or <0.05 uUI/ml)
- •Hypersensitivity to fenofibrate or to any other component of its formula
- •History of photoallergic reaction or phototoxicity to fenofibrate or ketoprofen
研究组 & 干预措施
1
fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
干预措施: fenofibrate (Drug)
2
placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day
干预措施: placebo (Drug)
结局指标
主要结局
endothelial function
时间窗: 8 weeks
次要结局
- HDL particle distribution(8 weeks)
- HDL associated antioxidant capacity(8 weeks)