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

June 12, 2009
March 11, 2013
June 2009
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00920101 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atherosclerosis
  • Inflammation
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Makoto Ayaori, MD 81429951617 ayaori@ndmc.ac.jp
Contact: Harumi Kondo, PhD 81429951617 harumi@ndmc.ac.jp
Japan
 
NCT00920101
NDMC570
No
Makoto Ayaori, National Defense Medical College, Japan
National Defense Medical College, Japan
Not Provided
Principal Investigator: Katsunori Ikewaki National Defense Medical College
National Defense Medical College, Japan
March 2013

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