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

NCT ID: NCT00920101

Last Updated: 2013-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Atherosclerosis Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Lifestyle counseling

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Lipitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical College, Japan

OTHER

Sponsor Role lead

Responsible Party

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Makoto Ayaori

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katsunori Ikewaki

Role: PRINCIPAL_INVESTIGATOR

National Defense Medical College

Locations

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National Defense medical College

Tokotozawa, Saitama, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Makoto Ayaori, MD

Role: CONTACT

81429951617

Harumi Kondo, PhD

Role: CONTACT

81429951617

Facility Contacts

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Makoto Ayaori, MD

Role: primary

81429951617

Other Identifiers

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NDMC570

Identifier Type: -

Identifier Source: org_study_id

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