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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00703261
First received: June 19, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Atherosclerotic Vascular Disease
Drug: atorvastatin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703261

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

No publications provided by Merck Sharp & Dohme Corp.

Additional 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
Study First Received: June 19, 2008
Results First Received: October 25, 2011
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014