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

Korea University

Status: Withdrawn

Conditions: Atherosclerosis

Treatments: Drug: Ezetrol (Ezetimibe); Drug: Vytorin (Ezetimibe + Simvastatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00926055

R01-2007-000-20546-0

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Control

No Intervention group

Ezetimibe

Active Comparator group

Treatment:

Drug: Ezetrol (Ezetimibe)

Ezetimibe/Simvastatin

Experimental group

Treatment:

Drug: Vytorin (Ezetimibe + Simvastatin)