Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
Effects 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2007
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
June 1, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
January 26, 2011
CompletedJanuary 26, 2011
January 1, 2007
2.6 years
May 30, 2007
January 7, 2011
January 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cholesteryl Ester Fractional Clearance Rate
6 weeks
Low Density Lipoprotein
12week
Secondary Outcomes (5)
Triglyceride Fractional Clearance Rate
6week
Alanine Aminotransferase
12 weeks
CPK
12 week
Total Cholesterol
12 week
High Density Lipoprotein
12 week
Study Arms (2)
group1 ezetimibe
EXPERIMENTAL6 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.
group 2 simvastatin
ACTIVE COMPARATOR6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
Interventions
simvastatin 20mg plus ezetimibe 10mg once a day for 6 week.
simvastatin 20mg for 6week and then simvastatin 80mg for the next 6week.
Eligibility Criteria
You may qualify if:
- Stable coronary heart disease.
You may not qualify if:
- Renal and Liver failure
- Hypothyroidism
- Diabetes mellitus
- Neoplasia
- Heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Mangili OC, Moron Gagliardi AC, Mangili LC, Mesquita CH, Machado Cesar LA, Tanaka A, Schaefer EJ, Maranhao RC, Santos RD. Favorable effects of ezetimibe alone or in association with simvastatin on the removal from plasma of chylomicrons in coronary heart disease subjects. Atherosclerosis. 2014 Mar;233(1):319-25. doi: 10.1016/j.atherosclerosis.2013.12.008. Epub 2014 Jan 17.
PMID: 24503114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Otavio Celeste Mangili, MD
- Organization
- Universidade de São Paulo
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 30, 2007
First Posted
June 1, 2007
Study Start
June 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 26, 2011
Results First Posted
January 26, 2011
Record last verified: 2007-01