Coronary Heart Disease, Graft Occlusion, Vascular Clinical Trial
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
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 384 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography | 1 year | No | |
| Secondary | Lumen diameter of saphenous vein grafts, as assessed by invasive angiography | 1 year | No | |
| Secondary | Proportion of patients needing revascularization | 1 year | No | |
| Secondary | Safety: Incidence of adverse events (including major adverse cardiovascular events) | 1 year | No |