Last updated: 11/04/2018 12:50:28

Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging

GSK study ID
TMT106468
Clinicaltrials.gov ID
NCT00368589
EudraCT ID
2005-005703-42
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 12 week, randomised, double blind study evaluating the effects of low dose (10mg) and high dose (80mg) atorvastatin on macrophage activity and carotid plaque inflammation as determined by Ultra small Super-Paramagnetic Iron Oxide (USPIO) enhanced carotid Magnetic Resonance Imaging (MRI)
Trial description: A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. Heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. Currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. This new method of scanning using magnetic resonance imaging (MRI) and a special agent called Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. If this effect can be measured using MRI scanning with the use of Sinerim then the results of this study will provide additional clinical validation of the use of MRI scanning combined with agents such as Sinerem®.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: atorvastatin
    • Enrollment:
    47
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    atherosclerotic carotid disease, Atherosclerosis
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    July 2006 to August 2007
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Positive Sinerem®-enhanced MRI of carotid plaque confirmed by a consultant neuroradiologist
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Positive Sinerem®-enhanced MRI of carotid plaque confirmed by a consultant neuroradiologist
    • Must either be statin naive or have been on a stable dose of a statin(Permitted statins and total daily dose are as follows: atorvastatin =10mg, simvastatin =40mg, pravastatin =40mg, fluvastatin =80mg, rosuvastatin =10mg for =4 weeks prior to screening, with no evidence of statin intolerability.) Exclusion criteria:
    • Require continued use of non-statin lipid modifying therapies or therapy with any other lipid regulating medications
    • History of statin intolerance
    • History of chronic viral hepatitis or other liver dysfunction
    • Renal impairment with serum creatinine >2.5 mg/dl (>221 mol/L)
    • History of myopathy or inflammatory muscle disease, or 3 times more than the upper limit of normal levels of total creatinine kinase in serum
    • Doppler assessment of less than 40% stenosis during screening assessment
    • Allergy to dextran and iron salts
    • Contraindication to MRI scanning
    • Planned carotid surgery or endovascular intervention earlier than 10 weeks within the study period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    CAMBRIDGE, Cambridgeshire, United Kingdom, CB2 2GG
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-28-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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