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

Primary Purpose

Coronary Heart Disease, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
fenofibrate
placebo
Sponsored by
National Heart Institute, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring fenofibrate, coronary heart disease, mixed hyperlipidemia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology Department National Institute of Cardiology Ignacio Chavez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day

placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day

Outcomes

Primary Outcome Measures

endothelial function

Secondary Outcome Measures

HDL particle distribution
HDL associated antioxidant capacity

Full Information

First Posted
November 1, 2007
Last Updated
March 9, 2011
Sponsor
National Heart Institute, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00552747
Brief Title
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease
Official Title
The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart Institute, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Hyperlipidemia
Keywords
fenofibrate, coronary heart disease, mixed hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Intervention Description
fenofibrate 160 mg capsules qd
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsules placebo
Primary Outcome Measure Information:
Title
endothelial function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
HDL particle distribution
Time Frame
8 weeks
Title
HDL associated antioxidant capacity
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Posadas-Romero, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Reyes, MD
Organizational Affiliation
head bioethics committee
Official's Role
Study Director
Facility Information:
Facility Name
Endocrinology Department National Institute of Cardiology Ignacio Chavez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
7968073
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.
Results Reference
background
PubMed Identifier
7566020
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. doi: 10.1056/NEJM199511163332001.
Results Reference
background
PubMed Identifier
8801446
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. doi: 10.1056/NEJM199610033351401.
Results Reference
background
PubMed Identifier
9613910
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. doi: 10.1001/jama.279.20.1615.
Results Reference
background
PubMed Identifier
15007110
Citation
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. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8. Erratum In: N Engl J Med. 2006 Feb 16;354(7):778.
Results Reference
background
PubMed Identifier
15755765
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. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.
Results Reference
background
PubMed Identifier
2642759
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. doi: 10.1161/01.cir.79.1.8.
Results Reference
background
PubMed Identifier
8836866
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.
Results Reference
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Links:
URL
http://www.cardiologia.org.mx
Description
National Institute of Cardiology Mexico City MEXICO

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

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