Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368589
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2006-08-22
Brief Title:
Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study 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
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None