Effects of Crestor on Inflammation of Atherosclerotic Plaques

Early Phase 1

Completed

• Conditions: Atherosclerosis; Inflammatory Activity in Carotid Arteries
• Interventions: Drug: placebo; Drug: rosuvastatin

• Registration Number: NCT00689416
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-03
• Status Verified: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden