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Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

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ClinicalTrials.gov Identifier: NCT00481351
Recruitment Status : Completed
First Posted : June 1, 2007
Results First Posted : January 26, 2011
Last Update Posted : January 26, 2011
Information provided by:
University of Sao Paulo

Brief Summary:

Effects of statin and ezetimibe association on kinetics of artificial chylomicrons in men with stable coronary heart disease (CHD).


The rate (kinetics) of chylomicrons removal from circulation have been correlated with the incidence and severity of atherosclerotic lesions; a number of studies demonstrated lower plasmatic clearance of chylomicrons in patients with CHD compared to patients without this condition. It was also demonstrated a correlation among LDL-C levels and removal of chylomicrons remnants by a technique employing artificial chylomicrons.

The investigators also know that higher doses of more potent statins are more effective in chylomicrons removal than lower doses or less potent statins; nevertheless, the effect of the isolated use of statin has not been completely studied up to now.

Study design:

The investigators propose to study 26 outpatients volunteers with chronic CHD, followed at the Heart Institute - INCOR - of the School of Medicine, University of São Paulo.

Following a period of six weeks of washout from any cholesterol reducer, the kinetics of chylomicrons removal by a technique of emulsion of radiolabeled artificial chylomicrons will be evaluated. Lipid fractions, hepatic enzymes and CK will be measured. Initially patients will be randomly allocated to receive simvastatin 20 mg /day (n= 13) or ezetimibe 10 mg/day (n=13) for six weeks. At the end of this period, kinetics of chylomicrons removal and laboratorial measurements will be repeated (Period 1).

In the next period (Period 2) patients will receive simvastatin 20 mg/ ezetimibe 10 mg (n=13) or simvastatin 80 mg (n=13) for additional six weeks; at the end of this period, the evaluations will be repeated (third and last evaluation).

The aim of this study is to further understand chylomicrons metabolism in patients with chronic coronary disease receiving cholesterol reducers at different dosage regimes.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Simvastatin 20mg plus ezetimibe 10mg Drug: ezetimibe Drug: simvastatin 20mg Drug: Simvastatin 80mg Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons in Men With Stable Coronary Heart Disease.
Study Start Date : June 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: group1 ezetimibe
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
Drug: Simvastatin 20mg plus ezetimibe 10mg
simvastatin 20mg plus ezetimibe 10mg once a day for 6 week.
Drug: ezetimibe
ezetimiba 10mg once a day
Active Comparator: group 2 simvastatin
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
Drug: simvastatin 20mg
simvastatin 20mg once a day
Drug: Simvastatin 80mg
simvastatin 20mg for 6week and then simvastatin 80mg for the next 6week.

Primary Outcome Measures :
  1. Cholesteryl Ester Fractional Clearance Rate [ Time Frame: 6 weeks ]
  2. Low Density Lipoprotein [ Time Frame: 12week ]

Secondary Outcome Measures :
  1. Triglyceride Fractional Clearance Rate [ Time Frame: 6week ]
  2. Alanine Aminotransferase [ Time Frame: 12 weeks ]
  3. CPK [ Time Frame: 12 week ]
  4. Total Cholesterol [ Time Frame: 12 week ]
  5. High Density Lipoprotein [ Time Frame: 12 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable coronary heart disease.

Exclusion Criteria:

  • Renal and Liver failure
  • Hypothyroidism
  • Diabetes mellitus
  • Neoplasia
  • Heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481351

Sponsors and Collaborators
University of Sao Paulo
Study Director: Raul D. Santos, Physician University of Sao Paulo
Principal Investigator: Otavio C. Mangili, Physician University of Sao Paulo
Study Chair: Raul C Maranhão, physician University of Sao Paulo
Study Chair: Ana Carolina M Gagliardi, nutritionist University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otavio Celeste Mangili, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00481351     History of Changes
Other Study ID Numbers: 1068/06
First Posted: June 1, 2007    Key Record Dates
Results First Posted: January 26, 2011
Last Update Posted: January 26, 2011
Last Verified: January 2007

Keywords provided by University of Sao Paulo:
artificial chilomicrons kinetics
ezetimibe plus statin
lipid lowering therapy

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors