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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552747
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : March 10, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Hyperlipidemia Drug: fenofibrate Drug: placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal
Study Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
Drug: fenofibrate
fenofibrate 160 mg capsules qd
Placebo Comparator: 2
placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day
Drug: placebo
capsules placebo

Primary Outcome Measures :
  1. endothelial function [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. HDL particle distribution [ Time Frame: 8 weeks ]
  2. HDL associated antioxidant capacity [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552747

Endocrinology Department National Institute of Cardiology Ignacio Chavez
Mexico City, Mexico, 14080
Sponsors and Collaborators
National Heart Institute, Mexico
Principal Investigator: Carlos Posadas-Romero, MD Principal Investigator
Study Director: Pedro Reyes, MD head bioethics committee

Additional Information:

Responsible Party: Carlos Posadas-Romero MD, National Institute of Cardiology Identifier: NCT00552747     History of Changes
Other Study ID Numbers: fenofibrate
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: May 2008

Keywords provided by National Heart Institute, Mexico:
coronary heart disease
mixed hyperlipidemia

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents