Clinical trial NCT01245634: A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Official title: Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease, Graft Occlusion, Vascular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \> 18 and \> 85 years of age
* Patients undergoing primary multi-vessel CABG with at least one saphenous vein graft. with or without cardiopulmonary bypass
* Body mass index (BMI) \</= 35 kg/m2

Exclusion Criteria:

* Participation in previous studies evaluating RO4905417
* Positive for HIV, receiving antiretroviral drugs, or immuno-suppressed
* Acute infection at screening or active chronic infection within 3 months prior to CABG surgery
* Patients undergoing emergency cardiac surgery for an immediately life-threatening condition
* Patients undergoing concomitant valve surgery
* History of CABG (only patients without prior CABG surgery will be admitted to the study)
* Left ventricular ejection fraction \< 20%
* History of transient ischemic attack or stroke within the 12 weeks prior to the CABG procedure
* Significant renal or liver impairment
* Malignancy diagnosed within the previous 5 years (except for successfully resected basal cell cancer)

Primary outcomes:
measure: Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
timeFrame: 1 year
Secondary outcomes:
measure: Lumen diameter of saphenous vein grafts, as assessed by invasive angiography
timeFrame: 1 year
measure: Proportion of patients needing revascularization
timeFrame: 1 year
measure: Safety: Incidence of adverse events (including major adverse cardiovascular events)
timeFrame: 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Atlantis
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Dearborn
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Washington
country: United States
state: Missouri
city: Stony Brook
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Saint John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Stahli BE, Tardif JC, Carrier M, Gallo R, Emery RW, Robb S, Cournoyer D, Blondeau L, Johnson D, Mann J, Lesperance J, Guertin MC, L'Allier PL. Effects of P-Selectin Antagonist Inclacumab in Patients Undergoing Coronary Artery Bypass Graft Surgery: SELECT-CABG Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):344-6. doi: 10.1016/j.jacc.2015.10.071. No abstract available.