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
EudraCT ID
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Not applicable
Primary completion date:
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
- 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.)
- Require continued use of non-statin lipid modifying therapies or therapy with any other lipid regulating medications
- History of statin intolerance
Inclusion and exclusion 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
GSK Investigational Site
CAMBRIDGE, Cambridgeshire, United Kingdom, CB2 2GG
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website