Status:
COMPLETED
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Coronary Heart Disease, Graft Occlusion, Vascular
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT01245634
Start Date
December 1 2010
End Date
May 1 2013
Last Update
November 2 2016
Active Locations (38)
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1
Huntsville, Alabama, United States, 35801
2
Tucson, Arizona, United States, 85710
3
Los Angeles, California, United States, 90022
4
Los Angeles, California, United States