Effects of Crestor on Inflammation of Atherosclerotic Plaques

Early Phase 1CompletedNCT00689416

AstraZeneca74 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Atherosclerosis Inflammatory Activity in Carotid Arteries

Interventions

rosuvastatinDRUG

40 mg, tablet, once daily for 3 months.

placeboDRUG

40 mg, tablet, once daily for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.

Time frame: At enrolment visit and within group after 3 months treatment.

Change in 18FDG uptake in terms of SUV.

Time frame: At randomisation visit (baseline) and within group after 3 months treatment.

Data from ClinicalTrials.gov

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