Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal

Conditions
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Coronary Heart Disease, Hyperlipidemia

Intervention / Treatment
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* Drug: fenofibrate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day | Drug: fenofibrate<br>* fenofibrate 160 mg capsules qd<br>|
| Placebo Comparator: 2<br>placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day | Drug: placebo<br>* capsules placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL particle distribution |  | 8 weeks | 
| HDL associated antioxidant capacity |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fenofibrate, coronary heart disease, mixed hyperlipidemia