Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Information source: Korea University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis
Intervention: Ezetrol (Ezetimibe) (Drug); Vytorin (Ezetimibe + Simvastatin) (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Korea University Overall contact:
Hye Jin Yoo, MD. PhD, Phone: 82-2-2626-3045, Email: deisy21@medimail.co.kr
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.
Clinical Details
Official title: Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- hsCRP > 2 mg/L or 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 and Contacts
Hye Jin Yoo, MD. PhD, Phone: 82-2-2626-3045, Email: deisy21@medimail.co.kr
Korea University Guro, Seoul 152-050, Korea, Republic of
Additional Information
Starting date: August 2009
Last updated: June 22, 2009
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