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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Heart Disease, Graft Occlusion, Vascular

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO4905417


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: RO4905417<br>* 20 mg/kg iv infusion every 4 weeks, 32 weeks<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* iv infusion every 4 weeks, 32 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |