Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: Simvastatin 20mg plus ezetimibe 10mg Drug: ezetimibe Drug: simvastatin 20mg Drug: Simvastatin 80mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
- Cholesteryl Ester Fractional Clearance Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Low Density Lipoprotein [ Time Frame: 12week ] [ Designated as safety issue: No ]
- Triglyceride Fractional Clearance Rate [ Time Frame: 6week ] [ Designated as safety issue: No ]
- Alanine Aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- CPK [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
- Total Cholesterol [ Time Frame: 12 week ] [ Designated as safety issue: No ]
- High Density Lipoprotein [ Time Frame: 12 week ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stable coronary heart disease.
Exclusion Criteria:
- Renal and Liver failure
- Hypothyroidism
- Diabetes mellitus
- Neoplasia
- Heart failure.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Otavio Celeste Mangili, MD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00481351 History of Changes |
| Other Study ID Numbers: | 1068/06 |
| Study First Received: | May 30, 2007 |
| Results First Received: | January 7, 2011 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
artificial chilomicrons kinetics ezetimibe plus statin lipid lowering therapy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Simvastatin Ezetimibe |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013