Status:
COMPLETED
Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
Lead Sponsor:
GlaxoSmithKline
Conditions:
Atherosclerotic Carotid Disease
Atheroma
Eligibility:
All Genders
18-80 years
Brief Summary
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, dependi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00368589
Start Date
July 1 2006
End Date
August 1 2007
Last Update
April 16 2015
Active Locations (1)
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1
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG