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

This study is currently recruiting participants.

Verified March 2013 by National Defense Medical College, Japan

Sponsor:

Information provided by (Responsible Party):

Makoto Ayaori, National Defense Medical College, Japan

ClinicalTrials.gov Identifier:

NCT00920101

First received: June 12, 2009

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2009

Last Updated Date

March 11, 2013

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00920101 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Flow-mediated vasodilation of brachial artery determined by ultrasonography [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]
Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1 [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]
Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]
Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]
Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides [ Time Frame: Baseline and 3 months after intervention ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Atherosclerosis
Inflammation

Intervention ^ICMJE

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 Name: Lipitor
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.

Study Arm (s)

Active Comparator: Atorvastatin
Intervention: Drug: Atorvastatin
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.

Intervention: Behavioral: Lifestyle counseling

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Makoto Ayaori, MD	81429951617	ayaori@ndmc.ac.jp
Contact: Harumi Kondo, PhD	81429951617	harumi@ndmc.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00920101

Other Study ID Numbers ^ICMJE

NDMC570

Has Data Monitoring Committee

Responsible Party

Makoto Ayaori, National Defense Medical College, Japan

Study Sponsor ^ICMJE

National Defense Medical College, Japan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Katsunori Ikewaki

National Defense Medical College

Information Provided By

National Defense Medical College, Japan

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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