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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. Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on 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. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. 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. Clinical research trials and 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. health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like 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.. 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. Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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. clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their 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. condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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.  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.
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.
For Condition: Coronary Restenosis,Graft Occlusion, Vascular,Atherosclerosis
Status: Completed
Sponsor(s): Chugai Pharma USA ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Major Inclusion Criteria – Others Stipulated within the Protocol 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. Major Exclusion Criteria – Others Stipulated within the Protocol 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 ichemic 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, pheyntoin, 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. - Are not allergic or intolerant to soybean products. - Are not taking vitamin E in excess of 150 I.U. per day and that you are unwilling to stop.
Total Enrollment:
Location and Contact Information:
Mediquest Research Group
Ocala, Florida, 34474
United States
St. Luke's Medical Center
Phoenix, Arizona, 85006
United States
Asheville Cardiology Associates, PA
Asheville, North Carolina, 28803
United States
La Mesa Cardiac Center
La Mesa, California, 91942
United States
Northwestern Memorial Hospital
Elyria, Ohio, 44035
United States
Nevada Cardiology Associates
Las Vegas, Nevada, 89109
United States
Austin Heart
Austin, Texas, 78756
United States
St. Louis University
St. Louis, Missouri, 63110
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037
United States
Iowa Heart Center
Des Moines, Iowa, 50314
United States
Clinical Research Center of California
San Diego, California, 92117
United States
Cardiovascular Associates of the Peninsula
Burlingame, California, 94010
United States
Veterans Affairs Medical Center
San Diego, California, 92161
United States
Midwest Heart Research Foundation
Lombard, Illinois, 60148
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
Houston, Texas, 77030
United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
United States
Miami International Cardiology Consultants
Miami, Florida, 33140
United States
University of Texas Health Science Center
San Antonio, Texas, 78229-3900
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Florida Health Science Center
Jacksonville, Florida, 32209
United States
Alton Ochsner Medical Foundation
New Orleans, Louisiana, 70121
United States
Michigan Heart
Ypsilanti, Michigan, 48197
United States
Borgess Medical Center
Kalamazoo, Michigan, 49048
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: BO-004;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055510
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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.
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