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

This study has been completed.
Sponsor:
Information provided by:
National Heart Institute, Mexico
ClinicalTrials.gov Identifier:
NCT00552747
First received: November 1, 2007
Last updated: March 9, 2011
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Heart Disease
Hyperlipidemia
 Drug: fenofibrate
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

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

Further study details as provided by National Heart Institute, Mexico:

Primary Outcome Measures:
  • endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDL particle distribution [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • HDL associated antioxidant capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: fenofibrate
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
Other Name: placebo

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552747

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

Publications:

Responsible Party: Carlos Posadas-Romero MD, National Institute of Cardiology
ClinicalTrials.gov Identifier: NCT00552747     History of Changes
Other Study ID Numbers: fenofibrate
Study First Received: November 1, 2007
Last Updated: March 9, 2011
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hyperlipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013