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OpenTrials
Completed

NCT Number: NCT00689416

Effects of Crestor on Inflammation of Atherosclerotic Plaques

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Inflammatory Activity in Carotid Arteries Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

40 mg, tablet, once daily for 3 months.

Other names: Crestor

Placebo

Drug

40 mg, tablet, once daily for 3 months

Primary outcomes

  1. 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

  1. 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.

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

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

  3. Change in 18FDG uptake in terms of SUV.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2009
First posted
Jun 3, 2008
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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