Effects of Crestor on Inflammation of Atherosclerotic Plaques

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689416
• Other study ID #: D4411M00010
• Status: Completed
• Phase: Phase 0
• First received: May 30, 2008
• Last updated: June 29, 2009
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammatory Activity in Carotid Arteries

Intervention

Drug:
• rosuvastatin
40 mg, tablet, once daily for 3 months.
• placebo
40 mg, tablet, once daily for 3 months

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.		At enrolment visit and within group after 3 months treatment.	No
Secondary	Change in 18FDG uptake in terms of SUV.		At randomisation visit (baseline) and within group after 3 months treatment.	No