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 by Korea University, June 2009

First Received: June 22, 2009 No Changes Posted

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 Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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:

Drug Information available for: Simvastatin Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:

FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight [ Time Frame: baseline, 3 months later ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	August 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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

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
Seoul, Korea, Republic of, 152-050

Sponsors and Collaborators

Korea University

More Information

No publications provided

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

Keywords provided by Korea University:

high risk patients in atherosclerosis

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 18, 2010