Effect of Fenofibrate on Endothelial Function and High-Density Lipoproteins (HDL) Physicochemical and Functional Characteristics in Patients With Coronary Heart Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 2007

Last Updated Date

May 12, 2008

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

endothelial function [ Time Frame: 8 weeks ]

Change History

Complete list of historical versions of study NCT00552747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

HDL particle distribution [ Time Frame: 8 weeks ]
HDL associated antioxidant capacity [ Time Frame: 8 weeks ]

Descriptive Information

Brief Title ^ICMJE

Effect of Fenofibrate on Endothelial Function and High-Density Lipoproteins (HDL) Physicochemical and Functional Characteristics in Patients With Coronary Heart Disease

Official Title ^ICMJE

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Coronary Heart Disease
Hyperlipidemia

Intervention ^ICMJE

Drug: fenofibrate
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: fenofibrate
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nacu A Caracas, MD

52-55-5573-2911 ext 1272

nacu77@hotmail.com

Location Countries ^ICMJE

Mexico

Administrative Information

NCT ID ^ICMJE

NCT00552747

Responsible Party

Carlos Posadas-Romero MD, National Institute of Cardiology

Study ID Numbers ^ICMJE

fenofibrate

Study Sponsor ^ICMJE

National Heart Institute, Mexico

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Carlos Posadas-Romero, MD	principal investigator
Study Director:	Pedro Reyes, MD	head bioethics committee

Information Provided By

National Heart Institute, Mexico

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP