Atherosclerosis Clinical Trial
Official title:
Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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