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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BO-653 | Drug |
Major Inclusion Criteria - Others Stipulated within the Protocol
The study physician must assure you:
Major Exclusion Criteria - Others Stipulated within the Protocol
The study physician must assure you:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Medical Center | Phoenix | Arizona | 85006 | United States | ||
| University of Arizona Sarver Heart Center |
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| 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 |
| ID | Term |
|---|---|
| D006083 | Graft Occlusion, Vascular |
| D023903 | Coronary Restenosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C106512 | 2,3-dihydro-5-hydroxy-2,2-dipentyl-4,6-di-tert-butylbenzofuran |
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