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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185042

Enrollment

534

Registered

2005-09-16

Start date

2002-11-30

Completion date

2005-07-31

Last updated

2007-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Atherosclerosis, intravascular ultrasound

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).

Interventions

DRUGPactimibe, CS-505

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026