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NCT Number: NCT00552747

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

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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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Dyslipidemias Genetic Diseases, Inborn Heart Diseases Hyperlipidemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Endocrinology Department National Institute of Cardiology Ignacio Chavez

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

fenofibrate 160 mg capsules qd

Placebo

Drug

capsules placebo

Primary outcomes

  1. endothelial function

    Time frame: 8 weeks

Secondary outcomes

  1. HDL particle distribution

    Time frame: 8 weeks

  2. HDL associated antioxidant capacity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

National Heart Institute, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 2, 2007
Registry last updated
Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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