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.
Completed · Phase 2/Phase 3
Conditions studied: Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
In brief
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.
Key facts
- Study ID
- NCT00055510
- Run by
- Chugai Pharma USA
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Midwest Heart Research Foundation — Lombard, Illinois, United States
- Iowa Heart Center — Des Moines, Iowa, United States
- Alton Ochsner Medical Foundation — New Orleans, Louisiana, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- Borgess Medical Center — Kalamazoo, Michigan, United States
- Michigan Heart — Ypsilanti, Michigan, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- St. Louis University — St Louis, Missouri, United States
- Nevada Cardiology Associates — Las Vegas, Nevada, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Asheville Cardiology Associates, PA — Asheville, North Carolina, United States
- Northwestern Memorial Hospital — Elyria, Ohio, United States
- Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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