Effects of Crestor on Inflammation of Atherosclerotic Plaques

Study Overview
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Brief Summary
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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.

Official Title
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Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation

Conditions
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Atherosclerosis, Inflammatory Activity in Carotid Arteries

Intervention / Treatment
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* Drug: rosuvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: rosuvastatin<br>* 40 mg, tablet, once daily for 3 months.<br>* Other names: Crestor;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 40 mg, tablet, once daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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imaging biomarkers, MRI, FDG-PET/CT scanning, Crestor