A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
- Conditions
- Graft Occlusion, VascularCoronary RestenosisAtherosclerosis
- Registration Number
- NCT00055510
- Lead Sponsor
- Chugai Pharma USA
- Brief Summary
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive substance) in preventing restenosis (closure of vessel) within six months after stent implantation. Patients must be enrolled into this study within 24 hours after the stenting procedure.
Additionally, over a 1- to 9-month post-stent period, the study will compare the safety and effectiveness of BO-653 versus placebo for measures of coronary artery vessel size by quantitative coronary angiography, major adverse cardiac events, and effects on the oxidative status of plasma lipids and other plasma components.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
St. Luke's Medical Center
🇺🇸Phoenix, Arizona, United States
University of Arizona Sarver Heart Center
🇺🇸Tucson, Arizona, United States
Cardiovascular Associates of the Peninsula
🇺🇸Burlingame, California, United States
Foundation for Cardiovascular Medicine
🇺🇸La Jolla, California, United States
La Mesa Cardiac Center
🇺🇸La Mesa, California, United States
Clinical Research Center of California
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center
🇺🇸San Diego, California, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Miami International Cardiology Consultants
🇺🇸Miami Beach, Florida, United States
Mediquest Research Group
🇺🇸Ocala, Florida, United States
Scroll for more (19 remaining)St. Luke's Medical Center🇺🇸Phoenix, Arizona, United States