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

Phase 1

Completed

• Conditions: Atherosclerotic Vascular Disease
• Interventions: Drug: atorvastatin; Drug: placebo

• Registration Number: NCT00703261
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-10-25
• Results First Submitted QC: 2011-10-25
• Results First Posted: 2011-11-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
80 mg Atorvastatin	placebo	80 mg atorvastatin + placebo
10 mg Atorvastatin	placebo	10 mg atorvastatin + placebo
80 mg Atorvastatin	atorvastatin	80 mg atorvastatin + placebo
10 mg Atorvastatin	atorvastatin	10 mg atorvastatin + placebo

Primary Outcome Measures

Name	Time	Method
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment	Baseline and Week 12	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

Name	Time	Method
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants	Baseline and Week 12	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.