Clinical trial NCT00055510: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Graft Occlusion, Vascular
Coronary Restenosis
Atherosclerosis
Keywords: BO-653
Coronary restenosis
Stent restenosis
LDL oxidative inhibitor
Antioxidant
Lead sponsor: Chugai Pharma USA
Sponsor class: INDUSTRY
First posted: 2003-03-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Sarver Heart Center
state: Arizona
city: Burlingame
country: United States
facility: Cardiovascular Associates of the Peninsula
state: California
city: La Jolla
country: United States
facility: Foundation for Cardiovascular Medicine
state: California
city: La Mesa
country: United States
facility: La Mesa Cardiac Center
state: California
city: San Diego
country: United States
facility: Clinical Research Center of California
state: California
city: San Diego
country: United States
facility: Veterans Affairs Medical Center
state: California
city: Jacksonville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Miami Beach
country: United States
facility: Miami International Cardiology Consultants
state: Florida
city: Ocala
country: United States
facility: Mediquest Research Group
state: Florida
city: Lombard
country: United States
facility: Midwest Heart Research Foundation
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: New Orleans
country: United States
facility: Alton Ochsner Medical Foundation
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cardiology Associates
state: Nevada
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates, PA
state: North Carolina
city: Elyria
country: United States
facility: Northwestern Memorial Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: IRCI Institute for Research in Cardiovascular Interventions at The Methodist DeBakey Heart Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: