Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
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;
1. Simvastatin 20 mg daily and placebo Niaspan (n=23)
2. Simvastatin 80 mg daily and placebo Niaspan (n=23)
3. 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Kos Pharmaceuticals Merck Sharp & Dohme Corp. The Dana Foundation