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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-01-31

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.

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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.

Conditions

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Coronary Heart Disease Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day

Group Type ACTIVE_COMPARATOR

fenofibrate

Intervention Type DRUG

fenofibrate 160 mg capsules qd

2

placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsules placebo

Interventions

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fenofibrate

fenofibrate 160 mg capsules qd

Intervention Type DRUG

placebo

capsules placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No