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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arteriosclerosis
Inflammation
Plaque, Atherosclerotic
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
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2014