Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: standard of care lipid therapy; Aggressive lipid therapy
Intervention description: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Zocor, Lipitor [any dose] and Crestor [less than 40mg]; Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
Intervention MeSH terms: Rosuvastatin Calcium; Atorvastatin; Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: YELLO; Atorvastatin; Simvastatin; Rosuvastatin; lipid therapy; Statin therapy; Coronary artery disease; CHD

Summary:

      The study will assess the regression of yellow plaque content of the lipid pool after
      aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin
      10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This
      is a single site study. A total of 100 subjects will randomized, of which 40 will receive
      intensive lipid therapy (Rosuvastatin 40mg) and 40 will receive standard care lipid lowering
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient > 18 years of age and willing to participate

          -  Stable patients who will undergo cardiac catheterization and PCI (intent to stent)

          -  Patient is willing to go on a cholesterol lowering medication for the duration of the
             study and willing to change statin therapy to the randomized statin therapy regardless
             of previous statin therapy and dose (e.g. Atorvastatin 80 mg) Patients that are
             screened for this study and are receiving another Statin such as Pravachol will be
             required to be willing to change their therapy to Rosuvastatin as per is
             randomization. If patients are receiving another statin, such as pravachol, or any
             other agent, and are at appropriate Lipid levels, they will be permitted to continue
             this therapy (if randomized to the standard therapy arm). There are a virtually
             unlimited number of possible scenarios for potential combination of all Lipid lowering
             agents at the time of enrollment that patients may be taking.

          -  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; or abstinence (no sexual activity).

          -  Fluency in English and/or Spanish

        Exclusion Criteria:

          -  Patients who have acute myocardial infarction (Q wave or non-Q wave with CK-MB > 5
             times above the upper normal (31.5 ng/ml) within 72 hours)

          -  Patients who are in cardiogenic shock

          -  Patients with left main disease or restenotic lesions

          -  Patients with elevated CK-MB (> 6.5 ng/ml) or Tnl (> 0.5ng/L) at baseline

          -  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 known hypersensitivity to HMG CO-A reductase therapy (statins)

          -  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