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Effects of Crestor on Inflammation of Atherosclerotic Plaques

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689416
First Posted: June 3, 2008
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Atherosclerosis Inflammatory Activity in Carotid Arteries Drug: rosuvastatin Drug: placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]
  • Change in carotid MRI contrast enhancement in terms of Ktrans and Vp. [ Time Frame: 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. ]

Estimated Enrollment: 74
Study Start Date: December 2007
Study Completion Date: June 2009
Arms Assigned Interventions
Experimental: 1 Drug: rosuvastatin
40 mg, tablet, once daily for 3 months.
Other Name: Crestor
Placebo Comparator: 2 Drug: placebo
40 mg, tablet, once daily for 3 months

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689416


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Håkan Ahlström, MD, Professor Uppsala University Sweden
Study Chair: Maria Leonsson-Zachrissson, MD, Study Physician AstraZeneca R&D Mölndal
  More Information

Responsible Party: Björn Carlsson, MD, PhD, Medical Science Director, Discovery Medicine CDT, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00689416     History of Changes
Other Study ID Numbers: D4411M00010
First Submitted: May 30, 2008
First Posted: June 3, 2008
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
imaging biomarkers
MRI
FDG-PET/CT scanning
Crestor

Additional relevant MeSH terms:
Inflammation
Atherosclerosis
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors