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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245634

Enrollment

384

Registered

2010-11-22

Start date

2010-12-31

Completion date

2013-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Graft Occlusion, Vascular

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.

Interventions

DRUGPlacebo

iv infusion every 4 weeks, 32 weeks

DRUGRO4905417

20 mg/kg iv infusion every 4 weeks, 32 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026