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

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ClinicalTrials.gov Identifier: NCT00920101
Recruitment Status : Unknown
Verified March 2013 by Makoto Ayaori, National Defense Medical College, Japan.
Recruitment status was:  Recruiting
First Posted : June 15, 2009
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Makoto Ayaori, National Defense Medical College, Japan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Inflammation Drug: Atorvastatin Behavioral: Lifestyle counseling Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging
Study Start Date : June 2009
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  1. Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques [ Time Frame: Baseline and 3 months after intervention ]

Secondary Outcome Measures :
  1. Flow-mediated vasodilation of brachial artery determined by ultrasonography [ Time Frame: Baseline and 3 months after intervention ]
  2. Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1 [ Time Frame: Baseline and 3 months after intervention ]
  3. 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 ]
  4. Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography [ Time Frame: Baseline and 3 months after intervention ]
  5. Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides [ Time Frame: Baseline and 3 months after intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920101


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

Locations
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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
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Principal Investigator: Katsunori Ikewaki National Defense Medical College
More Information
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Responsible Party: Makoto Ayaori, Assistant Professor, National Defense Medical College, Japan
ClinicalTrials.gov Identifier: NCT00920101    
Other Study ID Numbers: NDMC570
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Keywords provided by Makoto Ayaori, National Defense Medical College, Japan:
atherosclerotic plaques
hypercholesterolemia
HMG-CoA reductase inhibitor
statin
lipid-lowering therapy
Additional relevant MeSH terms:
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Atherosclerosis
Inflammation
Plaque, Atherosclerotic
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors