A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
NCT ID: NCT01245634
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
384 participants
INTERVENTIONAL
2010-12-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A
RO4905417
20 mg/kg iv infusion every 4 weeks, 32 weeks
B
Placebo
iv infusion every 4 weeks, 32 weeks
Interventions
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Placebo
iv infusion every 4 weeks, 32 weeks
RO4905417
20 mg/kg iv infusion every 4 weeks, 32 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
85 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Huntsville, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Atlantis, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Macon, Georgia, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Lexington, Kentucky, United States
Dearborn, Michigan, United States
Petoskey, Michigan, United States
Royal Oak, Michigan, United States
Troy, Michigan, United States
Duluth, Minnesota, United States
Saint Paul, Minnesota, United States
Washington, Missouri, United States
Stony Brook, New York, United States
Durham, North Carolina, United States
Toledo, Ohio, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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BP25601
Identifier Type: -
Identifier Source: org_study_id