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)
1 other identifier
interventional
534
1 country
46
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2002
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedSeptember 11, 2007
September 1, 2007
September 9, 2005
September 10, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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;
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (46)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Fort Collins, Colorado, United States
Unknown Facility
Bridgeport, Connecticut, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Gainsville, Florida, United States
Unknown Facility
Hudson, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Duluth, Minnesota, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Troy, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Greenville, North Carolina, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Elyria, Ohio, United States
Unknown Facility
Mansfield, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Doylestown, Pennsylvania, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Related Publications (1)
Nissen SE, Tuzcu EM, Brewer HB, Sipahi I, Nicholls SJ, Ganz P, Schoenhagen P, Waters DD, Pepine CJ, Crowe TD, Davidson MH, Deanfield JE, Wisniewski LM, Hanyok JJ, Kassalow LM; ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators. Effect of ACAT inhibition on the progression of coronary atherosclerosis. N Engl J Med. 2006 Mar 23;354(12):1253-63. doi: 10.1056/NEJMoa054699.
PMID: 16554527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
November 1, 2002
Study Completion
July 1, 2005
Last Updated
September 11, 2007
Record last verified: 2007-09