YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well
known that the reduction of cholesterol levels by statin therapy is associated with
significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II
trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin
respectively reduced progression of coronary atherosclerosis, even causing plaque regression
of some lesions. CAD clinical events are related to plaque instability due to lipid content
and activity within the atherosclerotic plaque. The investigators recently completed the
YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was
associated with a reduction in the amount of lipid in obstructive coronary plaques, as
measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and
build upon these results, and to provide mechanistic insights into the potential benefits of
intensive statin therapy on atherosclerotic plaques.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
AstraZeneca Astrazeneca (direct) InfraReDx (indirect) Texas Heart Institute (Wafic Said Molecular Cardiology Research Lab)