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

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 85
Updated:	8/3/2016
Start Date:	December 2010
End Date:	May 2013

Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

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.

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)
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)

We found this trial at

sites

Clinical Trial Facility in Durham North Carolina

Durham, North Carolina

605

from 02139

Durham, NC