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
1 other identifier
interventional
384
2 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 22, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 2, 2016
November 1, 2016
2.4 years
November 19, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Los Angeles, California, 90022, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Atlantis, Florida, 33462, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Springfield, Illinois, 62702, United States
Unknown Facility
Springfield, Illinois, 62769, United States
Unknown Facility
Fort Wayne, Indiana, 46804, United States
Unknown Facility
Lexington, Kentucky, 405360293, United States
Unknown Facility
Dearborn, Michigan, 48123, United States
Unknown Facility
Petoskey, Michigan, 49770, United States
Unknown Facility
Royal Oak, Michigan, 48073, United States
Unknown Facility
Troy, Michigan, 48085, United States
Unknown Facility
Duluth, Minnesota, 55805, United States
Unknown Facility
Saint Paul, Minnesota, 55102, United States
Unknown Facility
Washington, Missouri, 63090, United States
Unknown Facility
Stony Brook, New York, 11794, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Dallas, Texas, 75390-9063, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
Richmond, Virginia, 23225, United States
Unknown Facility
Richmond, Virginia, 23229, United States
Unknown Facility
Saint John, New Brunswick, E2L 4L2, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 3A7, Canada
Unknown Facility
Hamilton, Ontario, L8L 2X2, Canada
Unknown Facility
Toronto, Ontario, M4N 3M5, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montreal, Quebec, H1T 1C8, Canada
Unknown Facility
Montreal, Quebec, H2X 0A9, Canada
Unknown Facility
Montreal, Quebec, H3A 1A1, Canada
Unknown Facility
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Montreal, Quebec, H4J 1C5, Canada
Unknown Facility
Québec, Quebec, G1V 4G5, Canada
Related Publications (1)
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.
PMID: 26796402DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 22, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11