Clinical trial NCT00185042: Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Keywords: Atherosclerosis, intravascular ultrasound
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: To compare the effect of CS-505 versus placebo when added to usual medical care on:
measure: - change from baseline in total atheroma volume in
measure: various arteries;
measure: - changes in minimum luminal diameter and percent
measure: diameter stenosis;
measure: - incidence and time to first occurrence of
measure: cardiovascular events.
measure: To compare the safety of CS-505 versus placebo
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Fort Collins
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Clearwater
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Hudson
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Mansfield
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Doylestown
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
References:
citation: 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.