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

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ClinicalTrials.gov Identifier: NCT00703261
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : November 30, 2011
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Atherosclerotic Vascular Disease Drug: atorvastatin Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 10 mg Atorvastatin
10 mg atorvastatin + placebo
Drug: atorvastatin
Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.
Other Name: Lipitor
Drug: placebo
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.
Active Comparator: 80 mg Atorvastatin
80 mg atorvastatin + placebo
Drug: atorvastatin
Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.
Other Name: Lipitor
Drug: placebo
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 Measures :
  1. 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 Outcome Measures :
  1. Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants [ 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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703261


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00703261     History of Changes
Other Study ID Numbers: 0000-081
2007_651
First Posted: June 23, 2008    Key Record Dates
Results First Posted: November 30, 2011
Last Update Posted: October 9, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Vascular Diseases
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors