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

Tracking Information
First Submitted Date ICMJE	November 19, 2010
First Posted Date ICMJE	November 22, 2010
Last Update Posted Date	November 2, 2016
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 19, 2010)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01245634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 19, 2010)	Lumen diameter of saphenous vein grafts, as assessed by invasive angiography [ Time Frame: 1 year ]; Proportion of patients needing revascularization [ Time Frame: 1 year ]; Safety: Incidence of adverse events (including major adverse cardiovascular events) [ Time Frame: 1 year ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Official Title ICMJE	Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Coronary Heart Disease, Graft Occlusion, Vascular
Intervention ICMJE	Drug: Placebo iv infusion every 4 weeks, 32 weeks; Drug: RO4905417 20 mg/kg iv infusion every 4 weeks, 32 weeks
Study Arms	Experimental: A Intervention: Drug: RO4905417; Placebo Comparator: B Intervention: Drug: Placebo
Publications *	Stähli BE, Tardif JC, Carrier M, Gallo R, Emery RW, Robb S, Cournoyer D, Blondeau L, Johnson D, Mann J, Lespérance 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 19, 2010)	384
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2013
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01245634
Other Study ID Numbers ICMJE	BP25601
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hoffmann-La Roche
Study Sponsor ICMJE	Hoffmann-La Roche
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP