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.
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
- Conditions the study is for
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- 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
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.
- First posted5 Mar 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Occlusion, VascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Chugai Pharma USA
- Sponsor type
- Industry (pharma, biotech, devices)
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00055510
- Acronym / sponsor ID
- BO-004
- Keywords
- BO-653, Coronary restenosis, Stent restenosis, LDL oxidative inhibitor, Antioxidant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chugai Pharma USAIndustry (pharma, biotech, devices)
- First posted
- 5 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BO-653 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
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.