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

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.