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

Not Applicable

Withdrawn

• Conditions: Atherosclerosis
• Interventions: Drug: Vytorin (Ezetimibe + Simvastatin); Drug: Ezetrol (Ezetimibe)

• Registration Number: NCT00926055
• Lead Sponsor: Korea University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Status Verified: 2010-06
• Study Start: 2011-09
• Primary Completion: 2012-09
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe/Simvastatin	Vytorin (Ezetimibe + Simvastatin)	-
Ezetimibe	Ezetrol (Ezetimibe)	-

Primary Outcome Measures

Name	Time	Method
The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups	3 months later

Trial Locations

Locations (1)

Korea University Guro; 🇰🇷 Seoul, Korea, Republic of