Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease
Intervention: Sinvastatin plus ezetimibe (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
Otavio Mangili, Physician, Principal Investigator, Affiliation: University of Sao Paulo
Overall contact:
Otavio Mangili, Physician, Phone: 554499225115, Email: otaviomangili@yahoo.com.br
Summary
Efects of statin and ezetimibe association on kinetics of artificial chylomicrons in men
with stable coronary heart disease (CHD).
Background:
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.
We 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:
We 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.
Clinical Details
Official title: Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons in Men With Stable Coronary Heart Disease.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Clearance rate of blood artificial chilomicrons after infusion of a radiolabeled artificial chylomicrons emulsion.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Stable coronary heart disease.
Exclusion Criteria:
- Renal and Liver failure
- Hypothyroidism
- Diabetes mellitus
- Neoplasia
- Heart failure.
Locations and Contacts
Otavio Mangili, Physician, Phone: 554499225115, Email: otaviomangili@yahoo.com.br Additional Information
Starting date: June 2007
Ending date: January 2009
Last updated: May 30, 2007
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