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

National Defense Medical College, Japan

Status and phase: Unknown; Phase 4

Conditions: Inflammation; Atherosclerosis

Treatments: Drug: Atorvastatin; Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00920101

NDMC570

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin

Lifestyle counseling

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle counseling