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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Atherosclerosis
• Intervention / Treatment: Drug: Atorvastatin; Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Makoto Ayaori, MD; Phone Number: 81429951617; Email: ayaori@ndmc.ac.jp
• Study Contact Backup: Name: Harumi Kondo, PhD; Phone Number: 81429951617; Email: harumi@ndmc.ac.jp

Study Locations

• Japan
  • Saitama
    • Tokotozawa, Saitama, Japan, 359-8513
      • Recruiting
      • National Defense Medical College
      • Contact: Makoto Ayaori, MD; Phone Number: 81429951617; Email: ayaori@ndmc.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Defense Medical College, Japan
• Investigators: Principal Investigator: Katsunori Ikewaki, National Defense Medical College

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (ESTIMATE): June 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: HMG-CoA reductase inhibitor; hypercholesterolemia; statin; lipid-lowering therapy; atherosclerotic plaques
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Inflammation; Atherosclerosis; Plaque, Atherosclerotic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: NDMC570