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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01245634
First received: November 19, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention Phase
Coronary Heart Disease, Graft Occlusion, Vascular
 Drug: RO4905417
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lumen diameter of saphenous vein grafts, as assessed by invasive angiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients needing revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (including major adverse cardiovascular events) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245634

  Hide Study Locations
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
Los Angeles, California, United States, 90022
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, 62769
Springfield, Illinois, United States, 62702
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, 23229
Richmond, Virginia, United States, 23225
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, M5G 2C4
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H4J 1C5
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H2W 1T8
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01245634     History of Changes
Other Study ID Numbers: BP25601
Study First Received: November 19, 2010
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013