YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Condition: Obstructive Coronary Artery Disease; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
Intervention: rosuvastatin
Intervention description: All subjects will receive rosuvastatin 40mg/day for 8-12 weeks
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary artery disease; Lipid; Regression; Plaque

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 < 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