NCT01837823

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

April 5, 2013

Results QC Date

January 9, 2017

Last Update Submit

January 16, 2018

Conditions

Obstructive Coronary Artery DiseaseCoronary Artery Disease

Keywords

Coronary artery diseaseLipidRegressionPlaque

Outcome Measures

Primary Outcomes (2)

  • Correlation Between Plaque Morphology and HDL Functionality

    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.

    baseline and 8-12 weeks

  • Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP

    Correlation between the change in plaque morphology composition by intravascular imaging with inflammatory cell activity.

    baseline and 8-12 weeks

Secondary Outcomes (14)

  • Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max)

    baseline and at 8-12 weeks

  • Fibrous Cap Thickness (FCT) by OCT

    baseline and at 8-12 weeks

  • IVUS Imaging Measures

    Baseline and 8 weeks

  • Inflammatory and Lipid Parameters

    baseline and at 8-12 weeks

  • Lesion LCBI

    at baseline and at 8-12 weeks

  • +9 more secondary outcomes

Study Arms (1)

rosuvastatin

EXPERIMENTAL

All subjects will receive rosuvastatin 40mg/day

Drug: rosuvastatin

Interventions

rosuvastatinDRUG

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

Also known as: Crestor
rosuvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • Kini AS, Vengrenyuk Y, Shameer K, Maehara A, Purushothaman M, Yoshimura T, Matsumura M, Aquino M, Haider N, Johnson KW, Readhead B, Kidd BA, Feig JE, Krishnan P, Sweeny J, Milind M, Moreno P, Mehran R, Kovacic JC, Baber U, Dudley JT, Narula J, Sharma S. Intracoronary Imaging, Cholesterol Efflux, and Transcriptomes After Intensive Statin Treatment: The YELLOW II Study. J Am Coll Cardiol. 2017 Feb 14;69(6):628-640. doi: 10.1016/j.jacc.2016.10.029. Epub 2016 Oct 29.

    PMID: 27989886DERIVED

MeSH Terms

Conditions

Coronary Artery DiseasePlaque, Amyloid

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Annapoorna Kini
Organization
Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai
annapoorna.kini@mountsinai.org
212-241-4181

Study Officials

  • Annapoorna Kini, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Jason Kovacic, MD, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 23, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 13, 2018

Results First Posted

February 13, 2018

Record last verified: 2018-01

Locations

US(1)