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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01245634

First received: November 19, 2010

Last updated: November 1, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2010

Last Updated Date

November 1, 2016

Start Date ^ICMJE

December 2010

Primary Completion Date

May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

384

Completion Date

May 2013

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

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

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