Effects of Crestor on Inflammation of Atherosclerotic Plaques

June 29, 2009 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: rosuvastatin
40 mg, tablet, once daily for 3 months.
Other Names:
  • Crestor
Placebo Comparator: 2
Drug: placebo
40 mg, tablet, once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
MRI scan at enrolment visit and within group after 3 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
At randomisation visit (baseline) and within group after 3 months treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Håkan Ahlström, MD, Professor, Uppsala University Sweden
  • Study Chair: Maria Leonsson-Zachrissson, MD, Study Physician, AstraZeneca R&D Mölndal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4411M00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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