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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atherosclerotic Vascular Disease

Intervention / Treatment
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* Drug: atorvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 mg Atorvastatin<br>10 mg atorvastatin + placebo | Drug: atorvastatin<br>* Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.<br>* Other names: Lipitor;Drug: placebo<br>* 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.<br>|
| Active Comparator: 80 mg Atorvastatin<br>80 mg atorvastatin + placebo | Drug: atorvastatin<br>* Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.<br>* Other names: Lipitor;Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 12 |