Effects of Crestor on Inflammation of Atherosclerotic Plaques - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689416

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	Phase 0

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation

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. ] [ Designated as safety issue: No ]

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. ] [ 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 ]

Estimated Enrollment:	74
Study Start Date:	December 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rosuvastatin 40 mg, tablet, once daily for 3 months.
2: Placebo Comparator	Drug: placebo 40 mg, tablet, once daily for 3 months

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689416

Contacts

Contact: AstraZeneca Clinical Study Information

+ 46 31 776 10 00

maria.eriksson-lepkowska@astrazeneca.com

Locations

Sweden
Research Site	Recruiting
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:	AstraZeneca R&D Mölndal, Sweden ( Björn Carlsson, MD, PhD, Medical Science Director, Discovery Medicine CDT )
Study ID Numbers:	D4411M00010
Study First Received:	May 30, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00689416
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

imaging biomarkers
MRI
FDG-PET/CT scanning
Crestor

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Rosuvastatin

Vascular Diseases
Arteriosclerosis
Inflammation

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009