Effects of Crestor on Inflammation of Atherosclerotic Plaques

Condition(s) targeted: Atherosclerosis; Inflammatory Activity in Carotid Arteries

Intervention: rosuvastatin (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Håkan Ahlström, MD, Professor, Principal Investigator, Affiliation: Uppsala University Sweden
Maria Leonsson-Zachrissson, MD, Study Physician, Study Chair, Affiliation: AstraZeneca R&D Mölndal

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

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: Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation

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

Primary outcome: 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:

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

AstraZeneca Clinical Study Information, Phone: + 46 31 776 10 00, Email: maria.eriksson-lepkowska@astrazeneca.com

Research Site, Uppsala, Sweden; Recruiting

Starting date: December 2007
Ending date: February 2009
Last updated: May 30, 2008