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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
384
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
Time frame: 1 year
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography
Time frame: 1 year
Proportion of patients needing revascularization
Time frame: 1 year
Safety: Incidence of adverse events (including major adverse cardiovascular events)
Time frame: 1 year
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Atlantis, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Macon, Georgia, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
...and 28 more locations