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.