NCT00172419

Brief Summary

Inflammation is important in the both pathogenesis and outcome of atherosclerosis. Plaques containing numerous inflammatory cells, particular macrophages, have a high risk of rupture.We hypothesize that statin-induced plaque regression could be monitored clinically by use of FDG PET/CT approach, and can be detected noninvasively earlier than previously reported.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 5, 2009

Status Verified

December 1, 2008

Enrollment Period

1.8 years

First QC Date

September 12, 2005

Last Update Submit

January 2, 2009

Conditions

Hyperlipidemia

Keywords

statin, inflammation, FDG, positron emission tomography

Outcome Measures

Primary Outcomes (1)

  • Plaque location and activity at baseline, and compare with the follow-up scans site by site.

    12 w

Secondary Outcomes (2)

  • Lipid profile

    12 w

  • Biomarkers

    12 w

Study Arms (1)

Atorvastatin

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin, 40 mg/day for 12 weeks

Also known as: Atorvastatin (Lipitor, 40mg)
Atorvastatin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10012, Taiwan

Location

Related Publications (1)

  • Chang YY, Wu YW, Lee JK, Lin YM, Lin YT, Kao HL, Hung CS, Lin HJ, Lin YH. Effects of 12 weeks of atorvastatin therapy on myocardial fibrosis and circulating fibrosis biomarkers in statin-naive patients with hypertension with atherosclerosis. J Investig Med. 2016 Oct;64(7):1194-9. doi: 10.1136/jim-2016-000092. Epub 2016 Jul 18.

    PMID: 27430242DERIVED

MeSH Terms

Conditions

HyperlipidemiasInflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Wei-Shiung Yang, MD, phD

    Department of Internal Medicine, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 5, 2009

Record last verified: 2008-12

Locations

TW(1)