NCT01245634已完成2 期
Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 384
- 主要终点
- Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
A
Experimental
干预措施: RO4905417 (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
时间窗: 1 year
次要结局
- Proportion of patients needing revascularization(1 year)
- Safety: Incidence of adverse events (including major adverse cardiovascular events)(1 year)
- Lumen diameter of saphenous vein grafts, as assessed by invasive angiography(1 year)
研究者
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