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

Inflammation Clinical Trial

Official title:

Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00920101
• Other study ID #: NDMC570
• Status: Recruiting
• Phase: Phase 4
• First received: June 12, 2009
• Last updated: March 11, 2013
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: National Defense Medical College, Japan
• Contact: Makoto Ayaori, MD
• Phone: 81429951617
• Email: ayaori[@]ndmc.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Plaque, Atherosclerotic

Intervention

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.

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.

Locations

Country	Name	City	State
Japan	National Defense medical College	Tokotozawa	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical College, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques		Baseline and 3 months after intervention	No
Secondary	Flow-mediated vasodilation of brachial artery determined by ultrasonography		Baseline and 3 months after intervention	No
Secondary	Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1		Baseline and 3 months after intervention	No
Secondary	Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine		Baseline and 3 months after intervention	No
Secondary	Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography		Baseline and 3 months after intervention	No
Secondary	Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides		Baseline and 3 months after intervention	No