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

• Sponsor: Korea University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00926055
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: Ezetrol (Ezetimibe); Drug: Vytorin (Ezetimibe + Simvastatin)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Sep 1, 2011
• Anticipated Primary Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro	Seoul		Korea, Republic of	152-050

Sponsors and Collaborators

• Korea University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00926055
• Other Study ID Numbers: R01-2007-000-20546-0
• First Posted: Jun 23, 2009
• Last Update Posted: Mar 18, 2015
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: high risk patients in atherosclerosis
• Additional relevant MeSH terms: Atherosclerosis; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination

Study Results

No Results Posted as of Mar 18, 2015