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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.

Primary Purpose

Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BO-653
Sponsored by
Chugai Pharma USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Occlusion, Vascular focused on measuring BO-653, Coronary restenosis, Stent restenosis, LDL oxidative inhibitor, Antioxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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. 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.

Sites / Locations

  • St. Luke's Medical Center
  • University of Arizona Sarver Heart Center
  • Cardiovascular Associates of the Peninsula
  • Foundation for Cardiovascular Medicine
  • La Mesa Cardiac Center
  • Clinical Research Center of California
  • Veterans Affairs Medical Center
  • University of Florida Health Science Center
  • Miami International Cardiology Consultants
  • Mediquest Research Group
  • Midwest Heart Research Foundation
  • Iowa Heart Center
  • Alton Ochsner Medical Foundation
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Baystate Medical Center
  • Borgess Medical Center
  • Michigan Heart
  • Minneapolis Heart Institute Foundation
  • St. Louis University
  • Nevada Cardiology Associates
  • University of Rochester Medical Center
  • Asheville Cardiology Associates, PA
  • Northwestern Memorial Hospital
  • Oklahoma Foundation for Cardiovascular Research
  • Austin Heart
  • IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
  • University of Texas Health Science Center
  • University of Utah

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 4, 2003
Last Updated
June 23, 2005
Sponsor
Chugai Pharma USA
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1. Study Identification

Unique Protocol Identification Number
NCT00055510
Brief Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharma USA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
Keywords
BO-653, Coronary restenosis, Stent restenosis, LDL oxidative inhibitor, Antioxidant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BO-653

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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. 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.
Facility Information:
Facility Name
St. Luke's Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona Sarver Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cardiovascular Associates of the Peninsula
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Foundation for Cardiovascular Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
La Mesa Cardiac Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Clinical Research Center of California
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Veterans Affairs Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Miami International Cardiology Consultants
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Mediquest Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Midwest Heart Research Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Alton Ochsner Medical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cardiology Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Asheville Cardiology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Oklahoma Foundation for Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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