Effects of Crestor on Inflammation of Atherosclerotic Plaques

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

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