Trial | NCT00920101  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    30
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 Started
Jun 30
2009
Primary Completion
Sep 30
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Mar 12
2013
Estimate

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

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.

Atorvastatin Active Comparator

Lifestyle counseling Placebo Comparator

Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.

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
No Results Posted