NCT00808964Unknown2 期
Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
研究概览
简要总结
This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. The study will evaluate subjects undergoing primary, elective, off-pump CABG surgery with median sternotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent prior to initiation of any study related procedures
- •Male or female subjects at least 18 years of age
- •Subject is accepted for primary, elective off-pump CABG surgery with planned sternotomy without other planned concomitant cardiac surgical procedures
- •New York Heart Association (NYHA) Class III or less heart failure
- •Available for follow-up assessments
排除标准
- •Prior surgery with median sternotomy
- •Prior CABG surgery
- •Women of childbearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives,barrier methods, or other contraception deemed adequate by the investigator); women who are pregnant or lactating
- •Stroke within the previous 6 months
- •History of stroke with residual neurological deficit
- •Intracranial neoplasm, arteriovenous malformation or aneurysm
- •Any prior exposure to NU172
- •Contraindication to unfractionated heparin
- •Refusal to undergo blood transfusion, should it be necessary
- •Symptomatic gout
- •Serum uric acid >11mg/dL at screening
- •Known bleeding diathesis
- •Known thrombotic diathesis
- •Participation in any study of an investigational device, drug or biologic within 30 days prior to planned surgery
- •Any other disease or condition that, in the judgment of the investigator would interfere with the subject's ability to comply with study procedures and requirements
结局指标
主要结局
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
时间窗: 30 day follow-up visit
次要结局
- Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery(24 hours)
研究者
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