Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy

Coronary artery disease (CHD) remains to be a leading cause of death in most countries (1)
(2). It is well known that reducing cholesterol level by statin therapy is associated with
significant reduction in plaque burden. REVERSAL (3) and ASTEROID (4) trials showed that in
patients with coronary artery disease lipid-lowering with atorvastatin or rosuvastatin
respectively reduced progression of coronary atherosclerosis and even cause repression of
some lesions. CHD clinical events are related to plaque instability due to lipid content
within the atherosclerotic plaque. High dose atorvastatin has shown to reduce the plaque
lipid contents on serial IVUS analysis at 12 months. Therefore reduction in lipid content
and thereby the plaque burden by lipid lowering therapy may stabilize the plaque and reduce
cardiovascular events. High sensitivity C-reactive Protein (HsCRP) is an inflammatory
biomarker that independently predicts future vascular events. In JUPITER (5) trial
rosuvastatin (Crestor) significantly reduced the incidence of major cardiovascular events in
apparently healthy people with elevated HsCRP. IVUS was utilized to demonstrate change in
coronary artery vessel wall morphology over a relatively short period of time, but provided
no data on the lipid content in the vessel wall. The application of NIR spectroscopy to
identify lipid deposition within coronary arteries has been validated in ex vivo studies.
Infrared spectra are collected as follows: Light of discrete wavelengths from a laser is
directed onto the tissue sample via glass fibers. Light scattered from the samples is
collected in fibers and launched into a spectrometer. The plot of signal intensity as a
function of wavelength was used to develop chemometric models to discriminate lipid-cores
from non-atherosclerotic tissue, and from atherosclerotic tissue that is predominantly
fibrotic and from blood elements.

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