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

Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926055

Enrollment

Registered

2009-06-23

Start date

2011-09-30

Completion date

Unknown

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

high risk patients in atherosclerosis

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.

Interventions

DRUGEzetrol (Ezetimibe)

Ezetrol - 10 mg once daily for 3 months

DRUGVytorin (Ezetimibe + Simvastatin)

Vytorin - 10/20 mg once daily for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026