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

This study is not yet open for participant recruitment.

Verified June 2010 by Korea University

First Received on June 22, 2009. Last Updated on June 23, 2011 History of Changes

Sponsor:	Korea University
Information provided by:	Korea University
ClinicalTrials.gov Identifier:	NCT00926055

Purpose

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.

Condition	Intervention
Atherosclerosis	Drug: Ezetrol (Ezetimibe) Drug: Vytorin (Ezetimibe + Simvastatin)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:

The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups [ Time Frame: 3 months later ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2011
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control
Active Comparator: Ezetimibe	Drug: Ezetrol (Ezetimibe) Ezetrol - 10 mg once daily for 3 months
Experimental: Ezetimibe/Simvastatin	Drug: Vytorin (Ezetimibe + Simvastatin) Vytorin - 10/20 mg once daily for 3 months

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926055

Contacts

Contact: Hye Jin Yoo, MD. PhD

82-2-2626-3045

deisy21@medimail.co.kr

Locations

Korea, Republic of
Korea University Guro	Not yet recruiting
Seoul, Korea, Republic of, 152-050
Principal Investigator: Kyung Mook Choi, MD
Sub-Investigator: Hye Jin Yoo, MD
Sub-Investigator: Seung Eun Kim, MD

Sponsors and Collaborators

Korea University

More Information

No publications provided

Responsible Party:	Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier:	NCT00926055 History of Changes
Other Study ID Numbers:	R01-2007-000-20546-0
Study First Received:	June 22, 2009
Last Updated:	June 23, 2011
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Korea University:

high risk patients in atherosclerosis

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012