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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552747
• Other study ID #: fenofibrate
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2007
• Last updated: March 9, 2011
• Start date: October 2007
• Est. completion date: January 2011

Study information

• Verified date: May 2008
• Source: National Heart Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Myocardial Ischemia

Intervention

Drug:
• fenofibrate
fenofibrate 160 mg capsules qd
• placebo
capsules placebo

Locations

Country	Name	City	State
Mexico	Endocrinology Department National Institute of Cardiology Ignacio Chavez	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Institute, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function		8 weeks	No
Secondary	HDL particle distribution		8 weeks	No
Secondary	HDL associated antioxidant capacity		8 weeks	No

External Links

•   National Institute of Cardiology Mexico City MEXICO