Back to resultsEffects of Crestor on Inflammation of Atherosclerotic Plaques
Primary Purpose
Atherosclerosis, Inflammatory Activity in Carotid Arteries
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
rosuvastatin
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Atherosclerosis focused on measuring imaging biomarkers, MRI, FDG-PET/CT scanning, Crestor
Eligibility Criteria
Inclusion Criteria:
- Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
- Signed written Informed Consent.
- Healthy men 18 - 70 years, women 60 - 70
Exclusion Criteria:
- Use of a statin within six months before randomization.
- Use of lipid altering medication other than statins within the last six months.
- Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
- Total cholesterol > 8, LDL-C > 6 or TG > 6 mmol/L at enrolment
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Comparison between the active and the placebo group regarding changes in MRI contrast enhancement in terms of the transfer constant (Ktrans) for the carotid region
Secondary Outcome Measures
Comparison between the active and the placebo group regarding changes in MRI contrast enhancement measured as fractional plasma volume (Vp) and changes in 18FDG uptake in terms of standardised uptake value (SUV), respectively
Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.
Change in 18FDG uptake in terms of SUV.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689416
Brief Title
Effects of Crestor on Inflammation of Atherosclerotic Plaques
Official Title
Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these techniques are promising for future proof of principle studies. A number of patients will receive placebo as a control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Inflammatory Activity in Carotid Arteries
Keywords
imaging biomarkers, MRI, FDG-PET/CT scanning, Crestor
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
40 mg, tablet, once daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
40 mg, tablet, once daily for 3 months
Primary Outcome Measure Information:
Title
Comparison between the active and the placebo group regarding changes in MRI contrast enhancement in terms of the transfer constant (Ktrans) for the carotid region
Time Frame
MRI scan at enrolment visit and within group after 3 months.
Secondary Outcome Measure Information:
Title
Comparison between the active and the placebo group regarding changes in MRI contrast enhancement measured as fractional plasma volume (Vp) and changes in 18FDG uptake in terms of standardised uptake value (SUV), respectively
Time Frame
MRI scan at enrolment visit and within group after 3 months. 18FDG at randomisation visit (baseline) and within group after 3 months treatment.
Title
Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.
Time Frame
At enrolment visit and within group after 3 months treatment.
Title
Change in 18FDG uptake in terms of SUV.
Time Frame
At randomisation visit (baseline) and within group after 3 months treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
Signed written Informed Consent.
Healthy men 18 - 70 years, women 60 - 70
Exclusion Criteria:
Use of a statin within six months before randomization.
Use of lipid altering medication other than statins within the last six months.
Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
Total cholesterol > 8, LDL-C > 6 or TG > 6 mmol/L at enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håkan Ahlström, MD, Professor
Organizational Affiliation
Uppsala University Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Leonsson-Zachrissson, MD, Study Physician
Organizational Affiliation
AstraZeneca R&D Mölndal
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effects of Crestor on Inflammation of Atherosclerotic Plaques
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