Anti-inflammatory Effect of Atorvastatin in Atherosclerotic Plaques Assessed by FDG-PET Imaging

Phase 4

• Conditions: Atherosclerosis; Inflammation
• Interventions: Drug: Atorvastatin; Behavioral: Lifestyle counseling

• Registration Number: NCT00920101
• Lead Sponsor: National Defense Medical College, Japan

Brief Summary

The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12
• Primary Completion: 2013-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects with accumulation of FDG-PET in carotid artery or aorta

Exclusion Criteria

• LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
• subjects currently taking HMG CoA-reductase (Statins) or fibrates
• symptomatic coronary artery diseases
• symptomatic cerebrovascular diseases
• subjects suffered from myocardial infarction or stroke within 6 months
• subjects underwent percutaneous vascular interventions or vascular operations within 6 months
• diabetic patients with poor glycemic control (HbA1c>8.5)
• hypertensive patients with poor blood pressure control
• subjects with neoplasms
• subjects with systemic inflammatory diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	-
Lifestyle counseling	Lifestyle counseling	Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques	Baseline and 3 months after intervention

Secondary Outcome Measures

Name	Time	Method
Flow-mediated vasodilation of brachial artery determined by ultrasonography	Baseline and 3 months after intervention
Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1	Baseline and 3 months after intervention
Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine	Baseline and 3 months after intervention
Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography	Baseline and 3 months after intervention
Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides	Baseline and 3 months after intervention

Trial Locations

Locations (1)

National Defense medical College; 🇯🇵 Tokotozawa, Saitama, Japan