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

Phase 2

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT00185042
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-10
• Last Update Posted: 2007-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segment

Secondary Outcome Measures

Name	Time	Method
To compare the effect of CS-505 versus placebo when added to usual medical care on:
- change from baseline in total atheroma volume in
various arteries;
- changes in minimum luminal diameter and percent
diameter stenosis;
- incidence and time to first occurrence of
cardiovascular events.
To compare the safety of CS-505 versus placebo