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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01245634
First received: November 19, 2010
Last updated: February 5, 2015
Last verified: February 2015
History of Changes

November 19, 2010
February 5, 2015
December 2010
May 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01245634 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Coronary Heart Disease, Graft Occlusion, Vascular
  • Drug: Placebo
    iv infusion every 4 weeks, 32 weeks
  • Drug: RO4905417
    20 mg/kg iv infusion every 4 weeks, 32 weeks
  • Experimental: A
    Intervention: Drug: RO4905417
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
May 2013
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01245634
BP25601
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP