Clinical Trial: A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: November 19, 2010
Date Started: December 2010
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
