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.
1 other identifier
interventional
N/A
1 country
29
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.
Trial Health
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29 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2003
CompletedFirst Posted
Study publicly available on registry
March 5, 2003
CompletedJune 24, 2005
February 1, 2004
March 4, 2003
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- The study physician must assure you:
- Are at least 18 years of age and have achieved a successful stent placement procedure as defined by ≤ 10% residual stenosis, no residual dissection, TIMI flow \> 3 (complete perfusion), and lack of procedural coronary perforation utilizing an FDA-approved stent, excluding self-expanding, coil, polymer and pharmacologic coated (heparin OK) stents.
- Have at least one untreated target lesion in a native coronary artery meeting study entry criteria for diameter (≥ 2.5mm and ≤ 3.5mm), stenosis (≥ 50% and \< 100%), and stent length (≥ 13mm and ≤ 36mm, or total of two stents ≤ 45mm).
- Have a documented history of angina pectoris or a positive functional study.
- Have no symptoms suggestive of an MI (heart attack) OR have cardiac isoenzymes (CK-MB) within normal range at least 24 hours prior to stent procedure.
- Use effective birth control measures, or are unable to conceive children.
- Are willing to have a repeat angiogram after 6 months.
You may not qualify if:
- The study physician must assure you:
- Have not had any coronary intervention within 30 days before, and for an expected 30 days after stenting.
- Have not had a cerebrovascular accident or transient ischemic attack within 90 days prior to stent placement.
- Have not had stent procedure as a bridge to non-emergency planned bypass.
- Have not had a stent placed within the target vessel less than 9 months ago, or less than 5mm from the closest edge of an adjacent lesion.
- Do not have an unprotected left main coronary artery disease.
- Do not have a left ventricular ejection fraction of \< 30%.
- Do not have a target lesion that is located at the ostium (\< 2mm from origin of left anterior descending, right coronary artery, or circumflex vessel), involves a side branch ≥2.0mm diameter, is moderately to severely calcified, or requires use of an atherectomy device.
- Have not had a heart transplant.
- Do not have a 12-lead ECG with a QTc interval pre- or post stent placement ≥ 460 msec (males), or ≥ 470 msec (females).
- Do not have any medical, surgical or psychiatric condition, or be medical unstable as would prevent you from safely participating in the trial.
- Do not have clinically relevant bleeding, clotting, or immune disorders or be intolerant of platelet inhibitors and/or anticoagulants.
- Are not taking rifampin, carbamazepine, phenobarbitol, cyclophosphamide, ifosfamide, artemisinin, mephenytoin, phenytoin, or cholestyramine.
- Have no clinically significant laboratory abnormality (specified: creatinine ≥ 2.2 mg/dl, liver function tests ≥ 2.0 times the upper limit of normal).
- Have not participated in any investigational study within past 30 days.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724, United States
Cardiovascular Associates of the Peninsula
Burlingame, California, 94010, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
La Mesa Cardiac Center
La Mesa, California, 91942, United States
Clinical Research Center of California
San Diego, California, 92117, United States
Veterans Affairs Medical Center
San Diego, California, 92161, United States
University of Florida Health Science Center
Jacksonville, Florida, 32209, United States
Miami International Cardiology Consultants
Miami Beach, Florida, 33140, United States
Mediquest Research Group
Ocala, Florida, 34474, United States
Midwest Heart Research Foundation
Lombard, Illinois, 60148, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Alton Ochsner Medical Foundation
New Orleans, Louisiana, 70121, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
St. Louis University
St Louis, Missouri, 63110, United States
Nevada Cardiology Associates
Las Vegas, Nevada, 89109, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Asheville Cardiology Associates, PA
Asheville, North Carolina, 28803, United States
Northwestern Memorial Hospital
Elyria, Ohio, 44035, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120, United States
Austin Heart
Austin, Texas, 78756, United States
IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
Houston, Texas, 77030, United States
University of Texas Health Science Center
San Antonio, Texas, 78229-3900, United States
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2003
First Posted
March 5, 2003
Last Updated
June 24, 2005
Record last verified: 2004-02