A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease, Graft Occlusion, Vascular
• Intervention / Treatment: Drug: RO4905417; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
    • Toronto, Ontario, Canada, M4N 3M5
    • Toronto, Ontario, Canada, M5G 2C4
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
    • Montreal, Quebec, Canada, H3T 1E2
    • Montreal, Quebec, Canada, H4J 1C5
    • Montreal, Quebec, Canada, H1T 1C8
    • Montreal, Quebec, Canada, H2X 0A9
    • Quebec City, Quebec, Canada, G1V 4G5
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
  • Arizona
    • Tucson, Arizona, United States, 85710
  • California
    • Los Angeles, California, United States
    • Los Angeles, California, United States, 90022
  • Florida
    • Atlantis, Florida, United States, 33462
    • Jacksonville, Florida, United States, 32216
    • Kissimmee, Florida, United States, 34741
  • Georgia
    • Macon, Georgia, United States, 31201
  • Illinois
    • Springfield, Illinois, United States, 62702
    • Springfield, Illinois, United States, 62769
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
  • Kentucky
    • Lexington, Kentucky, United States, 405360293
  • Michigan
    • Dearborn, Michigan, United States, 48123
    • Petoskey, Michigan, United States, 49770
    • Royal Oak, Michigan, United States, 48073
    • Troy, Michigan, United States, 48085
  • Minnesota
    • Duluth, Minnesota, United States, 55805
    • Saint Paul, Minnesota, United States, 55102
  • Missouri
    • Washington, Missouri, United States, 63090
  • New York
    • Stony Brook, New York, United States, 11794
  • North Carolina
    • Durham, North Carolina, United States, 27710
  • Ohio
    • Toledo, Ohio, United States, 43606
  • Tennessee
    • Memphis, Tennessee, United States, 38120
  • Texas
    • Dallas, Texas, United States, 75390-9063
  • Utah
    • Salt Lake City, Utah, United States, 84124
  • Virginia
    • Richmond, Virginia, United States, 23229
    • Richmond, Virginia, United States, 23225

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: RO4905417; 20 mg/kg iv infusion every 4 weeks, 32 weeks
Placebo Comparator: B	Drug: Placebo; iv infusion every 4 weeks, 32 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography	1 year
Proportion of patients needing revascularization	1 year
Safety: Incidence of adverse events (including major adverse cardiovascular events)	1 year

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 19, 2010
• First Posted (Estimate): November 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Complications; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Graft Occlusion, Vascular
• Other Study ID Numbers: BP25601