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.

June 23, 2005 updated by: Chugai Pharma USA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • St. Luke's Medical Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona Sarver Heart Center
    • California
      • Burlingame, California, United States, 94010
        • Cardiovascular Associates of the Peninsula
      • La Jolla, California, United States, 92037
        • Foundation for Cardiovascular Medicine
      • La Mesa, California, United States, 91942
        • La Mesa Cardiac Center
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center
      • San Diego, California, United States, 92117
        • Clinical Research Center of California
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Science Center
      • Miami Beach, Florida, United States, 33140
        • Miami International Cardiology Consultants
      • Ocala, Florida, United States, 34474
        • Mediquest Research Group
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Research Foundation
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Alton Ochsner Medical Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cardiology Associates
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates, PA
    • Ohio
      • Elyria, Ohio, United States, 44035
        • Northwestern Memorial Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Houston, Texas, United States, 77030
        • IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharma USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 4, 2003

First Submitted That Met QC Criteria

March 4, 2003

First Posted (Estimate)

March 5, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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