NCT00703261

Brief Summary

The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2008

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

June 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 30, 2011

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

June 19, 2008

Results QC Date

October 25, 2011

Last Update Submit

October 8, 2015

Conditions

Atherosclerotic Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment

    Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.

    Baseline and Week 12

Secondary Outcomes (1)

  • Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants

    Baseline and Week 12

Study Arms (2)

10 mg Atorvastatin

ACTIVE COMPARATOR

10 mg atorvastatin + placebo

Drug: atorvastatinDrug: placebo

80 mg Atorvastatin

ACTIVE COMPARATOR

80 mg atorvastatin + placebo

Drug: atorvastatinDrug: placebo

Interventions

atorvastatinDRUG

Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.

Also known as: Lipitor
10 mg Atorvastatin80 mg Atorvastatin
placeboDRUG

Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.

10 mg Atorvastatin80 mg Atorvastatin

Eligibility Criteria

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

You may qualify if:

  • Male or Female ages 30 to 80
  • Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening

You may not qualify if:

  • Participant has human immunodeficiency virus (HIV), Hepatitis B or C
  • Participant uses illegal drugs
  • Participant has Type I diabetes
  • Participant has a history of claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Singh P, Emami H, Subramanian S, Maurovich-Horvat P, Marincheva-Savcheva G, Medina HM, Abdelbaky A, Alon A, Shankar SS, Rudd JH, Fayad ZA, Hoffmann U, Tawakol A. Coronary Plaque Morphology and the Anti-Inflammatory Impact of Atorvastatin: A Multicenter 18F-Fluorodeoxyglucose Positron Emission Tomographic/Computed Tomographic Study. Circ Cardiovasc Imaging. 2016 Dec;9(12):e004195. doi: 10.1161/CIRCIMAGING.115.004195.

    PMID: 27956407DERIVED

  • Subramanian S, Emami H, Vucic E, Singh P, Vijayakumar J, Fifer KM, Alon A, Shankar SS, Farkouh M, Rudd JHF, Fayad ZA, Van Dyke TE, Tawakol A. High-dose atorvastatin reduces periodontal inflammation: a novel pleiotropic effect of statins. J Am Coll Cardiol. 2013 Dec 24;62(25):2382-2391. doi: 10.1016/j.jacc.2013.08.1627. Epub 2013 Sep 24.

    PMID: 24070911DERIVED

  • Tawakol A, Fayad ZA, Mogg R, Alon A, Klimas MT, Dansky H, Subramanian SS, Abdelbaky A, Rudd JH, Farkouh ME, Nunes IO, Beals CR, Shankar SS. Intensification of statin therapy results in a rapid reduction in atherosclerotic inflammation: results of a multicenter fluorodeoxyglucose-positron emission tomography/computed tomography feasibility study. J Am Coll Cardiol. 2013 Sep 3;62(10):909-17. doi: 10.1016/j.jacc.2013.04.066. Epub 2013 May 30.

    PMID: 23727083DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 23, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 9, 2015

Results First Posted

November 30, 2011

Record last verified: 2015-10