YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
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ClinicalTrials.gov Identifier: NCT01837823 |
Recruitment Status :
Completed
First Posted : April 23, 2013
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Coronary Artery Disease Coronary Artery Disease | Drug: rosuvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: rosuvastatin
All subjects will receive rosuvastatin 40mg/day
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Drug: rosuvastatin
All subjects will receive rosuvastatin 40mg/day for 8-12 weeks
Other Name: Crestor |
- Correlation Between Plaque Morphology and HDL Functionality [ Time Frame: baseline and 8-12 weeks ]Correlation between the changes in plaque morphology composition by intravascular imaging with changes in HDL functionality. HDL functionality is measured by the Cholesterol Efflux Capacity (CEC). Plaque morphology is represented by the Fibrous Cap Thickness.
- Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP [ Time Frame: baseline and 8-12 weeks ]Correlation between the change in plaque morphology composition by intravascular imaging with inflammatory cell activity.
- Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max) [ Time Frame: baseline and at 8-12 weeks ]
Maximum LCBI 4mm (ΔLCBI4mm max) of the non-culprit YELLOW lesion at baseline and 8-12 weeks thereafter.
LCBI4mm max : 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow.
- Fibrous Cap Thickness (FCT) by OCT [ Time Frame: baseline and at 8-12 weeks ]ΔFibrous Cap Thickness measured by OCT at baseline and at 8-12 weeks
- IVUS Imaging Measures [ Time Frame: Baseline and 8 weeks ]Correlation between ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in specific IVUS (ΔPlaque burden) imaging measures. Plaque burden is Plaque + Media divided by Total Plaque Area in %.
- Inflammatory and Lipid Parameters [ Time Frame: baseline and at 8-12 weeks ]ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in inflammatory and lipid parameters responses to patient-derived samples.
- Lesion LCBI [ Time Frame: at baseline and at 8-12 weeks ]As related to other outcomes, change in LCBI measured across the entire lesion (rather than ΔLCBI4mm max). The LCBI Score, computed as the fraction of valid pixels within the scanned region that exceeded a LCP probability of 0.6 multiplied by 1000, summarized the amount of LCP in the entire scanned region of the coronary vessel on a 0-to-1000 scale .
- LCBI 4mm at Same Anatomical Site [ Time Frame: at baseline and at 8-12 weeks ]
As related to other outcomes, change in LCBI 4mm measured at the identical anatomical site at both time points, as defined by the LCBI4mm max site at baseline (rather than ΔLCBI4mm max).
LCBI4mm: 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow.
- Change in Atheroma Volume [ Time Frame: baseline and at 8-12 weeks ]Change in total atheroma volume (TAV) and lumen cross sectional area on OCT.
- Biomarker Release [ Time Frame: within 24 hrs of PCI ]Post procedure CK-MB, Troponin-I release at final YELLOW lesion PCI.
- Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max [ Time Frame: baseline ]Correlation of baseline lipid parameters with baseline LCBI4mm max
- Plaque Morphology as Related to Haptoglobin [ Time Frame: baseline and at 8-12 weeks ]To relate changes in plaque lipid content and morphology to the patient haptoglobin genotype.
- Mechanism of Reverse Cholesterol Transport [ Time Frame: baseline and at 8-12 weeks ]To assess the mechanism of reverse cholesterol transport that arises with high-dose statin therapy, as related to changes in plaque lipid content and morphology, and systemic vascular inflammation. Reverse cholesterol transport (RCT) is a pathway by which accumulated cholesterol is transported from the vessel wall to the liver for excretion, thus preventing atherosclerosis.
- Correlation of Changes in Plaque Morphology [ Time Frame: baseline and at 8-12 weeks ]
Correlation of changes in plaque morphology by OCT, IVUS and NIRS with the perturbations in peripheral blood mononuclear cell transcriptome using microarray analysis.
data not collected for this measure.
- MACE [ Time Frame: at 30 days ]Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days.
- MACE [ Time Frame: at 1 year ]Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 1 year.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 100,000 cell/mm3.
- Patients who have co-morbidity which reduces life expectancy to one year.
- Patients who are currently participating in another investigational drug/device study.
- Patients with liver disease.
- Patient with creatinine > 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837823
United States, New York | |
Icahn School of Medicine at Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Annapoorna Kini, MD | Icahn School of Medicine at Mount Sinai | |
Principal Investigator: | Jason Kovacic, MD, PhD | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Annapoorna Kini, Professor of Medicine, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT01837823 |
Other Study ID Numbers: |
GCO 12-1507 HS#: 12-00741 |
First Posted: | April 23, 2013 Key Record Dates |
Results First Posted: | February 13, 2018 |
Last Update Posted: | February 13, 2018 |
Last Verified: | January 2018 |
Coronary artery disease Lipid Regression Plaque |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Inflammation Pathologic Processes Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |