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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245634
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease, Graft Occlusion, Vascular Drug: Placebo Drug: RO4905417 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: RO4905417
20 mg/kg iv infusion every 4 weeks, 32 weeks

Placebo Comparator: B Drug: Placebo
iv infusion every 4 weeks, 32 weeks

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Lumen diameter of saphenous vein grafts, as assessed by invasive angiography [ Time Frame: 1 year ]
  2. Proportion of patients needing revascularization [ Time Frame: 1 year ]
  3. Safety: Incidence of adverse events (including major adverse cardiovascular events) [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245634

  Hide Study Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Tucson, Arizona, United States, 85710
United States, California
Los Angeles, California, United States, 90022
Los Angeles, California, United States
United States, Florida
Atlantis, Florida, United States, 33462
Jacksonville, Florida, United States, 32216
Kissimmee, Florida, United States, 34741
United States, Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Springfield, Illinois, United States, 62702
Springfield, Illinois, United States, 62769
United States, Indiana
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Lexington, Kentucky, United States, 405360293
United States, Michigan
Dearborn, Michigan, United States, 48123
Petoskey, Michigan, United States, 49770
Royal Oak, Michigan, United States, 48073
Troy, Michigan, United States, 48085
United States, Minnesota
Duluth, Minnesota, United States, 55805
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Washington, Missouri, United States, 63090
United States, New York
Stony Brook, New York, United States, 11794
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Toledo, Ohio, United States, 43606
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Dallas, Texas, United States, 75390-9063
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Richmond, Virginia, United States, 23225
Richmond, Virginia, United States, 23229
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H2X 0A9
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H4J 1C5
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01245634     History of Changes
Other Study ID Numbers: BP25601
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Graft Occlusion, Vascular
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Postoperative Complications
Pathologic Processes