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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
  Purpose

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 Intervention Phase
Atherosclerosis
Inflammation
 Drug: Atorvastatin
Behavioral: Lifestyle counseling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Defense Medical College, Japan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920101

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

Locations
Japan
National Defense medical College Recruiting
Tokotozawa, Saitama, Japan, 359-8513
Contact: Makoto Ayaori, MD     81429951617     ayaori@ndmc.ac.jp    
Sponsors and Collaborators
National Defense Medical College, Japan
Investigators
Principal Investigator: Katsunori Ikewaki National Defense Medical College
  More Information

No publications provided

Responsible Party: Makoto Ayaori, Assistant Professor, National Defense Medical College, Japan
ClinicalTrials.gov Identifier: NCT00920101     History of Changes
Other Study ID Numbers: NDMC570
Study First Received: June 12, 2009
Last Updated: March 11, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by National Defense Medical College, Japan:
atherosclerotic plaques
hypercholesterolemia
HMG-CoA reductase inhibitor
statin
lipid-lowering therapy

Additional relevant MeSH terms:
Atherosclerosis
Inflammation
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013