Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232531
Status:
UNKNOWN
Last Update Posted:
2007-01-29
First Post:
2005-10-03
Brief Title:
Oxford Niaspan Study Effects of Niaspan on Atherosclerosis and Endothelial Function
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
AIM 1 will test the hypothesis that elevation of high-density lipoprotein HDL through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery Plaque quantification will be with magnetic resonance imaging MRI
AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus who typically have low high-density lipoprotein cholesterol HDL-C and high risk of cardiovascular events
AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus who typically have low high-density lipoprotein cholesterol HDL-C and high risk of cardiovascular events
Detailed Description:
Patients will be randomised to receive either Niaspan 2000mg each night or placebo Niaspan will be commenced at 375mg daily and increased to 500mg then to 750 and 1000mg daily at weekly intervals After 4 weeks the dose will be increased to 1500mg daily and after a further one month the study dose of 2000mg daily2 will be instigated Immediately before randomization to exclude patients unable to tolerate MRI because of claustrophobia and 6 and 12 months after commencing treatment participants will undergo MR examination
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