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

Phase 2

Completed

• Conditions: Coronary Heart Disease, Graft Occlusion, Vascular
• Interventions: Drug: RO4905417; Drug: Placebo

• Registration Number: NCT01245634
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Study Start: 2010-12
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2016-09-01
• Disposition First Submitted QC: 2016-09-01
• Disposition First Posted: 2016-09-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	RO4905417	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of patients needing revascularization	1 year
Safety: Incidence of adverse events (including major adverse cardiovascular events)	1 year
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography	1 year