CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
rosuvastatindrug
Likely dose
rosuvastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01837823
NCT01837823Phase 2Completed

YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering

Icahn School of Medicine at Mount Sinai·interventional·Posted Apr 23, 2013·Updated Feb 13, 2018

In Brief

A Phase 2 clinical trial evaluating rosuvastatin for Obstructive Coronary Artery Disease and Coronary Artery Disease. Completed, enrolled 91 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2013
Enrollment StartJul 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.2 years ago

Interventions

rosuvastatindrug

All subjects will receive rosuvastatin 40mg/day for 8-12 weeks