Back to resultsEffects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
Primary Purpose
Atherosclerotic Carotid Disease, Atheroma, Atherosclerosis
Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
atorvastatin
Sponsored by
About this trial
This is an observational trial for Atherosclerotic Carotid Disease focused on measuring atherosclerotic plaque, USPIO, Atheroma, thrombo-embolic stroke, magnetic resonance imaging, Ultra small Super-Paramagnetic Iron Oxide
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
Secondary Outcome Measures
Baseline corrected changes in USPIO-enhanced MRI signal in carotid plaques.Changes from baseline in tensile stress, micro-emboli counts, soluble plasma biomarkers at 12 weeks in low and high dose atorvastatin groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00368589
Brief Title
Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
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)
Study Type
Observational
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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, 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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Carotid Disease, Atheroma, Atherosclerosis
Keywords
atherosclerotic plaque, USPIO, Atheroma, thrombo-embolic stroke, magnetic resonance imaging, Ultra small Super-Paramagnetic Iron Oxide
7. Study Design
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
Secondary Outcome Measure Information:
Title
Baseline corrected changes in USPIO-enhanced MRI signal in carotid plaques.Changes from baseline in tensile stress, micro-emboli counts, soluble plasma biomarkers at 12 weeks in low and high dose atorvastatin groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2GG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19477353
Citation
Tang TY, Howarth SP, Miller SR, Graves MJ, Patterson AJ, U-King-Im JM, Li ZY, Walsh SR, Brown AP, Kirkpatrick PJ, Warburton EA, Hayes PD, Varty K, Boyle JR, Gaunt ME, Zalewski A, Gillard JH. The ATHEROMA (Atorvastatin Therapy: Effects on Reduction of Macrophage Activity) Study. Evaluation using ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging in carotid disease. J Am Coll Cardiol. 2009 Jun 2;53(22):2039-50. doi: 10.1016/j.jacc.2009.03.018.
Results Reference
derived
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Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
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