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
Overview
- Phase
- Phase 1
- Intervention
- atorvastatin
- Conditions
- Atherosclerotic Vascular Disease
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 83
- Primary Endpoint
- Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
10 mg Atorvastatin
10 mg atorvastatin + placebo
Intervention: atorvastatin
10 mg Atorvastatin
10 mg atorvastatin + placebo
Intervention: placebo
80 mg Atorvastatin
80 mg atorvastatin + placebo
Intervention: atorvastatin
80 mg Atorvastatin
80 mg atorvastatin + placebo
Intervention: placebo
Outcomes
Primary Outcomes
Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment
Time Frame: 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 Outcomes
- Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants(Baseline and Week 12)