Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.
The primary objective of this randomized, double blind, placebo controlled pilot study is to determine if therapies aimed at lowering LDL cholesterol (HMGCoA reductase inhibitor – simvastatin) or increasing HDL cholesterol (Niaspan) will induce regression of carotid atherosclerotic plaque in vivo using MRI imaging techniques. MR plaque morphology at baseline will be compared to that after 6 and 12 months of therapy and changes in MR characteristics will be compared to changes in lipoprotein parameters and urinary isoprostanes. The effect of moderate LDL reduction, aggressive LDL reduction and the combination of aggressive LDL reduction and HDL elevation on MRI plaque characteristics will be compared by randomly assigning subjects (n=69) with carotid disease (>30% stenosis by ultrasound criteria) to one of three treatment arms;
- Simvastatin 20 mg daily and placebo Niaspan (n=23)
- Simvastatin 80 mg daily and placebo Niaspan (n=23)
- Simvastatin 20 mg daily and active Niaspan (n=23) Treatment group 2 and 3 will have roughly equivalent LDL lowering because of the synergistic LDL lowering effect of the combination of simvastatin and Niaspan.
|Established Carotid Atherosclerosis||Drug: Niacin/simvastatin compared to simvastatin alone at 2 doses||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Magnetic Resonance Characterization of Carotid Atherosclerotic Plaque in Vivo: Effect of High Density Lipoprotein Elevation on Plaque Morphology|
- Change in MRI estimates of carotid atherosclerosis
- Change in lipoproteins and inflammatory markers
|Study Start Date:||January 2000|
|Estimated Study Completion Date:||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307307
|Principal Investigator:||Muredach P Reilly, MB MSCE||University of Pennsylvania|