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

Sponsor:	National Heart Institute, Mexico
Information provided by:	National Heart Institute, Mexico
ClinicalTrials.gov Identifier:	NCT00552747

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 IV

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:

MedlinePlus related topics: Antioxidants Coronary Artery Disease Heart Diseases

Drug Information available for: Procetofen

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:

[No authors listed] Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) Lancet. 1994 Nov 19;344(8934):1383-9.

Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995 Nov 16;333(20):1301-7.

Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9.

Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998 May 27;279(20):1615-22.

Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. Epub 2004 Mar 8. Erratum in: N Engl J Med. 2006 Feb 16;354(7):778.

LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. Epub 2005 Mar 8.

Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation. 1989 Jan;79(1):8-15.

Hokanson JE, Austin MA. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein cholesterol level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk. 1996 Apr;3(2):213-9.

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 February 09, 2012