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

Phase 4

Completed

• Conditions: Coronary Heart Disease; Hyperlipidemia
• Interventions: Drug: fenofibrate; Drug: placebo

• Registration Number: NCT00552747
• Lead Sponsor: National Heart Institute, Mexico

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Status Verified: 2008-05
• Primary Completion: 2010-03
• Study Completion: 2011-01
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fenofibrate	fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
2	placebo	placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day

Primary Outcome Measures

Name	Time	Method
endothelial function	8 weeks

Secondary Outcome Measures

Name	Time	Method
HDL particle distribution	8 weeks
HDL associated antioxidant capacity	8 weeks

Trial Locations

Locations (1)

Endocrinology Department National Institute of Cardiology Ignacio Chavez; 🇲🇽 Mexico City, Mexico