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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease, Graft Occlusion, Vascular

In brief

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.

Key facts

Study ID

NCT01245634

Run by

Hoffmann-La Roche

People needed

384

Starts

2010-12-01

Expected to finish

2013-05-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Atlantis, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Dearborn, Michigan, United States
• Study site — Petoskey, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Duluth, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Washington, Missouri, United States
• Study site — Stony Brook, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Memphis, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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