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Effects of Crestor on Inflammation of Atherosclerotic Plaques

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689416
First received: May 30, 2008
Last updated: June 29, 2009
Last verified: June 2009

May 30, 2008
June 29, 2009
December 2007
Not Provided
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00689416 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • Change in carotid MRI contrast enhancement in terms of Ktrans and Vp. [ Time Frame: At enrolment visit and within group after 3 months treatment. ] [ Designated as safety issue: No ]
  • Change in 18FDG uptake in terms of SUV. [ Time Frame: At randomisation visit (baseline) and within group after 3 months treatment. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Crestor on Inflammation of Atherosclerotic Plaques
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Atherosclerosis
  • Inflammatory Activity in Carotid Arteries
  • Drug: rosuvastatin
    40 mg, tablet, once daily for 3 months.
    Other Name: Crestor
  • Drug: placebo
    40 mg, tablet, once daily for 3 months
  • Experimental: 1
    Intervention: Drug: rosuvastatin
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
June 2009
Not Provided

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00689416
D4411M00010
No
Björn Carlsson, MD, PhD, Medical Science Director, Discovery Medicine CDT, AstraZeneca R&D Mölndal, Sweden
AstraZeneca
Not Provided
Principal Investigator: Håkan Ahlström, MD, Professor Uppsala University Sweden
Study Chair: Maria Leonsson-Zachrissson, MD, Study Physician AstraZeneca R&D Mölndal
AstraZeneca
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP