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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Coronary Artery Disease Using Intravascular Ultrasound (IVUS)

The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).

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.