NCT00926055

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

March 18, 2015

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

June 22, 2009

Last Update Submit

March 17, 2015

Conditions

Atherosclerosis

Keywords

high risk patients in atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Control

NO INTERVENTION

Ezetimibe

ACTIVE COMPARATOR
Drug: Ezetrol (Ezetimibe)

Ezetimibe/Simvastatin

EXPERIMENTAL
Drug: Vytorin (Ezetimibe + Simvastatin)

Interventions

Ezetrol (Ezetimibe)DRUG

Ezetrol - 10 mg once daily for 3 months

Ezetimibe
Vytorin (Ezetimibe + Simvastatin)DRUG

Vytorin - 10/20 mg once daily for 3 months

Ezetimibe/Simvastatin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hsCRP \> 2 mg/L and LDL cholesterol \> 130 mm/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro

Seoul, 152-050, South Korea

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

EzetimibeEzetimibe, Simvastatin Drug CombinationSimvastatin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Last Updated

March 18, 2015

Record last verified: 2010-06

Locations

KR(1)