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

Primary Purpose

Coronary Heart Disease, Graft Occlusion, Vascular

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO4905417
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease, Graft Occlusion, Vascular

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01245634
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Graft Occlusion, Vascular

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv infusion every 4 weeks, 32 weeks
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
20 mg/kg iv infusion every 4 weeks, 32 weeks
Primary Outcome Measure Information:
Title
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography
Time Frame
1 year
Title
Proportion of patients needing revascularization
Time Frame
1 year
Title
Safety: Incidence of adverse events (including major adverse cardiovascular events)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
405360293
Country
United States
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26796402
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.
Results Reference
derived

Learn more about this trial

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

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