Effects of Crestor on Inflammation of Atherosclerotic Plaques

NCT00689416 | Completed Early Phase 1

• 1 other identifier: D4411M00010
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis; Inflammatory Activity in Carotid Arteries

Keywords

imaging biomarkers; MRI; FDG-PET/CT scanning; Crestor

Outcome Measures

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

  MRI scan at enrolment visit and within group after 3 months.

Secondary Outcomes (3)

• 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.

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

  At enrolment visit and within group after 3 months treatment.

• Change in 18FDG uptake in terms of SUV.

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

Study Arms (2)

1

EXPERIMENTAL

Drug: rosuvastatin

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

rosuvastatin DRUG

40 mg, tablet, once daily for 3 months.

Also known as: Crestor

1

placebo DRUG

40 mg, tablet, once daily for 3 months

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Håkan Ahlström, MD, Professor

  Uppsala University Sweden

  PRINCIPAL INVESTIGATOR

• Maria Leonsson-Zachrissson, MD, Study Physician

  AstraZeneca R&D Mölndal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: December 1, 2007
• Study Completion: June 1, 2009
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

SE (1)