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

Primary Purpose

Atherosclerosis, Inflammation

Status

Unknown status

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Atorvastatin

Lifestyle counseling

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Defense medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Lifestyle counseling

Arm Description

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

Outcomes

Primary Outcome Measures

Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques

Secondary Outcome Measures

Flow-mediated vasodilation of brachial artery determined by ultrasonography

Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1

Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine

Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography

Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides

Full Information

NCT ID

NCT00920101

First Posted

June 12, 2009

Last Updated

March 11, 2013

Sponsor

National Defense Medical College, Japan

1. Study Identification

Unique Protocol Identification Number

NCT00920101

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Defense Medical College, Japan

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Inflammation

Keywords

atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Active Comparator

Arm Title

Lifestyle counseling

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle counseling

Intervention Description

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 Measure Information:

Title

Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques

Time Frame