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

Sponsor

National Defense Medical College, Japan (Other)

Overall Status

Unknown status

CT.gov ID

NCT00920101

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Inflammation	Drug: Atorvastatin Behavioral: Lifestyle counseling	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atorvastatin	Drug: Atorvastatin Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less. Other Names: Lipitor
Placebo Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Active Comparator: Atorvastatin

Drug: Atorvastatin

Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less.

Other Names:

Lipitor

Placebo Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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