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Graft Occlusion, VascularPhase 2/3NCT00055510

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 Phase 2/3 study testing BO-653 in people with Graft Occlusion, Vascular and Coronary Restenosis, run by Chugai Pharma USA at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BO-653
How many people
Not given
Where
29 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites
  • Asheville Cardiology Associates, PA

    Asheville, North Carolina, 28803

  • Austin Heart

    Austin, Texas, 78756

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cardiovascular Associates of the Peninsula

    Burlingame, California, 94010

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Northwestern Memorial Hospital

    Elyria, Ohio, 44035

  • IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center

    Houston, Texas, 77030

  • University of Florida Health Science Center

    Jacksonville, Florida, 32209

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • La Mesa Cardiac Center

    La Mesa, California, 91942

  • Nevada Cardiology Associates

    Las Vegas, Nevada, 89109

  • Midwest Heart Research Foundation

    Lombard, Illinois, 60148

  • Miami International Cardiology Consultants

    Miami Beach, Florida, 33140

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Alton Ochsner Medical Foundation

    New Orleans, Louisiana, 70121

  • Mediquest Research Group

    Ocala, Florida, 34474

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73120

  • St. Luke's Medical Center

    Phoenix, Arizona, 85006

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Texas Health Science Center

    San Antonio, Texas, 78229-3900

  • Clinical Research Center of California

    San Diego, California, 92117

  • Veterans Affairs Medical Center

    San Diego, California, 92161

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St. Louis University

    St Louis, Missouri, 63110

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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.

Being tested
BO-653
Keywords
BO-653, Coronary restenosis, Stent restenosis, LDL oxidative inhibitor, Antioxidant
Medical subject headings
Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BO-653Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2003 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055510
Sponsor's protocol ID
BO-004
Status last verified
Feb 2004
First submitted
4 Mar 2003
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BO-653 in people with Graft Occlusion, Vascular and Coronary Restenosis, run by Chugai Pharma USA at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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