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.

Atherosclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055510
• Other study ID #: BO-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 4, 2003
• Last updated: June 23, 2005

Study information

• Verified date: February 2004
• Source: Chugai Pharma USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Restenosis
• Graft Occlusion, Vascular

Intervention

Drug:
• BO-653

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharma USA

Country where clinical trial is conducted

United States,