Phase 2
N=91
YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Obstructive Coronary Artery Disease · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01837823 ↗Enrolled (actual)
91
Serious AEs
3.5%
Results posted
Feb 2018
Primary outcome: Primary: Correlation Between Plaque Morphology and HDL Functionality — 0.30 beta coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rosuvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Plaque Morphology and HDL Functionality |
0.30 | — |
| PRIMARY Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP |
-0.27 | — |
| SECONDARY Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max) |
416.6; 400.2 | — |
| SECONDARY Fibrous Cap Thickness (FCT) by OCT |
100.9; 108.6 | 0.054 |
| SECONDARY IVUS Imaging Measures |
38.75; 38.93; 75.93; 75.79 | 0.50 |
| SECONDARY Inflammatory and Lipid Parameters |
153.3; 115.0; 86.8; 50.6; 41.2; 42.2 | — |
| SECONDARY Lesion LCBI |
142.84; 141.93 | — |
| SECONDARY LCBI 4mm at Same Anatomical Site |
416.6; 383.2 | — |
| SECONDARY Change in Atheroma Volume |
182.3; 182.7 | — |
| SECONDARY Biomarker Release |
30.; 0.35 | — |
| SECONDARY Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max |
0.07 | — |
| SECONDARY Plaque Morphology as Related to Haptoglobin |
440.3; 403.0; 411.0; 393.9 | — |
| SECONDARY Mechanism of Reverse Cholesterol Transport |
0.81; 0.84 | — |
| SECONDARY Correlation of Changes in Plaque Morphology |
— | — |
| SECONDARY MACE |
33 | — |
| SECONDARY MACE |
33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients >18 years of age and willing to participate.
- Fluency in either English or Spanish.
- Stable patients who will undergo cardiac catheterization and PCI (intent to stent).
- Patient is willing to go on high-dose cholesterol lowering medication for the duration of the study
- Signed written Informed Consent.
- Women of childbearing potential must agree to be on an acceptable method of birth control/contraceptive such as barrier method (condoms/diaphragm); hormonal contraceptives (birth control pills, implants (Norplant) or injections (Depo-Provera)); Intrauterine Device.
- Proposed non-culprit YELLOW study lesion with max 4mm LCBI ≥ 150.
Exclusion Criteria
- Patients who have acute myocardial infarction (ST-segment elevation presentation, new Q waves or non-ST segment elevation with CK-MB > 5 times above the upper normal (31.5 ng/ml) within 72 hours).
- Patients who are in cardiogenic shock.
- Patients requiring coronary artery bypass graft surgery.
- Patients with platelet count 2.0 mg/dL.
- Pregnant women and women of childbearing potential who intend to have children during the duration of the trial.
- Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period.
- Active autoimmune disease.
- Nursing mothers
Data sourced from ClinicalTrials.gov (NCT01837823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.