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

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: rosuvastatin
  • 40 mg, tablet, once daily for 3 months.
• Drug: placebo
  • 40 mg, tablet, once daily for 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary 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
  • Time Frame: MRI scan at enrolment visit and within group after 3 months.
    Safety Issue?: No

Secondary 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
  • 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.
    Safety Issue?: No
• Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.
  • Time Frame: At enrolment visit and within group after 3 months treatment.
    Safety Issue?: No
• Change in 18FDG uptake in terms of SUV.
  • Time Frame: At randomisation visit (baseline) and within group after 3 months treatment.
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Håkan Ahlström, MD, Professor Principal Investigator Uppsala University Sweden  

Overall Contact: AstraZeneca Clinical Study Information + 46 31 776 10 00 maria.eriksson-lepkowska@astrazeneca.com

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689416

Study ID Number: D4411M00010

ClinicalTrials.gov Identifier: NCT00689416

Health Authority: Sweden: Regional Ethical Review Board