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

Inclusion Criteria: Standard: Male or female subjects, age 18 years or greater; and Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography. Angiographic: Evidence of coronary heart disease Identification of a target native coronary artery for the plaque volume measurement. Exclusion Criteria: Standard: Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months; Previous heart or other organ transplantation; 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. 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. Stroke (CVA) within previous 3 months; Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%; Uncontrolled diabetes mellitus; Uncontrolled hypertension; and Nephrotic syndrome, significant nephropathy, or other significant renal disease. Angiographic: Presence of any lesion with greater than 50% reduction in lumen diameter; or Any lesion with a greater than 50% occlusion in the left main coronary artery; 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); A target vessel that is itself a bypass graft.