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

Information source: National Heart Institute, Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Heart Disease; Hyperlipidemia

Intervention: fenofibrate (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Heart Institute, Mexico

Official(s) and/or principal investigator(s):
Carlos Posadas-Romero, MD, Principal Investigator, Affiliation: principal investigator
Pedro Reyes, MD, Study Director, Affiliation: head bioethics committee


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.

Clinical Details

Official title: The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: endothelial function

Secondary outcome:

HDL particle distribution

HDL associated antioxidant capacity

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.


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

Locations and Contacts

Endocrinology Department National Institute of Cardiology Ignacio Chavez, Mexico City 14080, Mexico
Additional Information

Related publications:

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.

Starting date: October 2007
Last updated: March 9, 2011

Page last updated: August 23, 2015

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