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

National Heart Institute, Mexico

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia; Coronary Heart Disease

Treatments: Drug: placebo; Drug: fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00552747

fenofibrate

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: fenofibrate

2

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo