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Completed

NCT Number: NCT01245634

A Study of RO4905417 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.

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Key information

Conditions

Coronary Heart Disease, Graft Occlusion, Vascular Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saint John, New Brunswick, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

iv infusion every 4 weeks, 32 weeks

RO4905417

Drug

20 mg/kg iv infusion every 4 weeks, 32 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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