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Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

Primary Purpose

Atherosclerotic Vascular Disease

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

atorvastatin

placebo

Sponsored by

Merck Sharp & Dohme LLC

About this trial

This is an interventional treatment trial for Atherosclerotic Vascular Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10 mg Atorvastatin

80 mg Atorvastatin

Arm Description

10 mg atorvastatin + placebo

80 mg atorvastatin + placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

First Posted

June 19, 2008

Last Updated

October 8, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00703261

Brief Title

Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

Official Title

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerotic Vascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mg Atorvastatin

Arm Type

Active Comparator

Arm Description

10 mg atorvastatin + placebo

Arm Title

80 mg Atorvastatin

Arm Type

Active Comparator

Arm Description

80 mg atorvastatin + placebo

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment

Description

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.

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

27956407

Citation

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.

Results Reference

derived

PubMed Identifier

24070911

Citation

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.

Results Reference

derived

PubMed Identifier

23727083

Citation

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.

Results Reference

derived

Learn more about this trial

Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

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