Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

Korea University

Overview

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore, in this study the investigators intend to compare the effect of ezetimibe monotherapy or ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Atherosclerosis

Interventions

Ezetrol (Ezetimibe)DRUG

Ezetrol - 10 mg once daily for 3 months

Vytorin (Ezetimibe + Simvastatin)DRUG

Vytorin - 10/20 mg once daily for 3 months

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * hsCRP \> 2 mg/L and LDL cholesterol \> 130 mm/dL Exclusion Criteria: * history of cardiovascular disease * diabetes * uncontrolled hypertension * active infection * previous anti-hyperlipidemic agents within 6 months * previous steroid or anti-inflammatory agents within 6 months * liver disease * renal disease

Locations (1)

Korea University Guro

Seoul, South Korea

Outcomes

Primary Outcomes

The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups

Time frame: 3 months later

Data from ClinicalTrials.gov

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