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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

  Show 38 Study Locations
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 17, 2013