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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: AstraZeneca; Astrazeneca (direct); InfraReDx (indirect); Texas Heart Institute (Wafic Said Molecular Cardiology Research Lab)
• Treatments: Rosuvastatin Calcium

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 < 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