Status:
COMPLETED
YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Texas Heart Institute (Wafic Said Molecular Cardiology Research Lab)
AstraZeneca
Conditions:
Obstructive Coronary Artery Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
Detailed Description
YELLOW II is a single site study and will assess the regression of plaque lipid content and changes in plaque morphology from atherosclerotic lesions after high-dose statin therapy by utilizing NIRS, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01837823
Start Date
July 1 2013
End Date
April 1 2015
Last Update
February 13 2018
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029