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Effects of Crestor on Inflammation of Atherosclerotic Plaques

NCT ID: NCT00689416

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Atherosclerosis Inflammatory Activity in Carotid Arteries

Keywords

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imaging biomarkers MRI FDG-PET/CT scanning Crestor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

40 mg, tablet, once daily for 3 months.

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

40 mg, tablet, once daily for 3 months

Interventions

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rosuvastatin

40 mg, tablet, once daily for 3 months.

Intervention Type DRUG

placebo

40 mg, tablet, once daily for 3 months

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Mölndal, Sweden

Principal Investigators

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Håkan Ahlström, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Sweden

Maria Leonsson-Zachrissson, MD, Study Physician

Role: STUDY_CHAIR

AstraZeneca R&D Mölndal

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D4411M00010

Identifier Type: -

Identifier Source: org_study_id