Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease

Inclusion Criteria:

Standard:

1. Male or female subjects, age 18 years or greater; and
2. Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.

Angiographic:

1. Evidence of coronary heart disease
2. Identification of a target native coronary artery for the plaque volume measurement.

Exclusion Criteria:

Standard:

1. Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
2. Previous heart or other organ transplantation;

3. Treatment with any of the following agents within 4 weeks prior to randomization:

   • Immunosuppressive agents (cyclosporine, azathioprine);
   • Rifampin; and
   • Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.

4. Any of the following manifestations of cardiac disease:

   • Myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
   • Clinically significant heart disease; and
   • Coronary artery bypass surgery within previous 3 months.
5. Stroke (CVA) within previous 3 months;
6. Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
7. Uncontrolled diabetes mellitus;
8. Uncontrolled hypertension; and
9. Nephrotic syndrome, significant nephropathy, or other significant renal disease.

Angiographic:

1. Presence of any lesion with greater than 50% reduction in lumen diameter; or
2. Any lesion with a greater than 50% occlusion in the left main coronary artery;
3. A target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);
4. A target vessel that is itself a bypass graft.