Atherosclerosis, Inflammatory Activity in Carotid Arteries
Conditions
Keywords
imaging biomarkers, MRI, FDG-PET/CT scanning, Crestor
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.
Interventions
DRUGrosuvastatin
40 mg, tablet, once daily for 3 months.
DRUGplacebo
40 mg, tablet, once daily for 3 months
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | MRI scan at enrolment visit and within group after 3 months. |
Secondary
| Measure | Time frame |
|---|---|
| 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 | MRI scan at enrolment visit and within group after 3 months. 18FDG at randomisation visit (baseline) and within group after 3 months treatment. |
| Change in carotid MRI contrast enhancement in terms of Ktrans and Vp. | At enrolment visit and within group after 3 months treatment. |
| Change in 18FDG uptake in terms of SUV. | At randomisation visit (baseline) and within group after 3 months treatment. |
Countries
Sweden
Outcome results
None listed