A Phase 2 interventional study of Placebo and RO4905417 in Coronary Heart Disease, Graft Occlusion, Vascular, sponsored by Hoffmann-La Roche. Completed at 38 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Prevention
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 384 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RO4905417
Drug: Placebo
iv infusion every 4 weeks, 32 weeks
20 mg/kg iv infusion every 4 weeks, 32 weeks
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
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.