- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552747
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease
The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Mexico City, Mexico, 14080
- Endocrinology Department National Institute of Cardiology Ignacio Chavez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
|
fenofibrate 160 mg capsules qd
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Placebo Comparator: 2
placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day
|
capsules placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endothelial function
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HDL particle distribution
Time Frame: 8 weeks
|
8 weeks
|
HDL associated antioxidant capacity
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Posadas-Romero, MD, Principal Investigator
- Study Director: Pedro Reyes, MD, head bioethics committee
Publications and helpful links
General 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. doi: 10.1056/NEJM199511163332001.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Hypolipidemic Agents
- Lipid Regulating Agents
- Fenofibrate
Other Study ID Numbers
- fenofibrate
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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