NCT00920101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

4.3 years

First QC Date

June 12, 2009

Last Update Submit

March 11, 2013

Conditions

AtherosclerosisInflammation

Keywords

atherosclerotic plaqueshypercholesterolemiaHMG-CoA reductase inhibitorstatinlipid-lowering therapy

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques

    Baseline and 3 months after intervention

Secondary Outcomes (5)

  • Flow-mediated vasodilation of brachial artery determined by ultrasonography

    Baseline and 3 months after intervention

  • Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1

    Baseline and 3 months after intervention

  • Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine

    Baseline and 3 months after intervention

  • Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography

    Baseline and 3 months after intervention

  • Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides

    Baseline and 3 months after intervention

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR
Drug: Atorvastatin

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.

Behavioral: Lifestyle counseling

Interventions

AtorvastatinDRUG

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.

Also known as: Lipitor
Atorvastatin
Lifestyle counselingBEHAVIORAL

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

Lifestyle counseling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with accumulation of FDG-PET in carotid artery or aorta

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Defense medical College

Tokotozawa, Saitama, 359-8513, Japan

RECRUITING

MeSH Terms

Conditions

AtherosclerosisInflammationPlaque, AtheroscleroticHypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Katsunori Ikewaki

    National Defense Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Makoto Ayaori, MD

CONTACT

81429951617ayaori@ndmc.ac.jp

Harumi Kondo, PhD

CONTACT

81429951617harumi@ndmc.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

JP(1)