Clinical trial NCT00552747: Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease
Official title: The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Hyperlipidemia
Keywords: fenofibrate
coronary heart disease
mixed hyperlipidemia
Lead sponsor: National Heart Institute, Mexico
Sponsor class: OTHER_GOV
First posted: 2007-11-02
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: endothelial function
timeFrame: 8 weeks
Secondary outcomes:
measure: HDL particle distribution
timeFrame: 8 weeks
measure: HDL associated antioxidant capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Endocrinology Department National Institute of Cardiology Ignacio Chavez
Study officials:
affiliation: Principal Investigator
name: Carlos Posadas-Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: head bioethics committee
name: Pedro Reyes, MD
role: STUDY_DIRECTOR
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