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

Roche

Status and phase

Completed

Phase 2

Conditions

Coronary Heart Disease, Graft Occlusion, Vascular

Treatments

Drug: RO4905417

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01245634

BP25601

Details and patient eligibility

About

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.

Enrollment

384 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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)