A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 3,241
- 试验地点
- 1
- 主要终点
- Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
研究概览
简要总结
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.
Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
- •Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (> upper limit of normal [ULN])
- •No ST elevation Myocardial Infarction (STEMI)
- •Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3
排除标准
- •Inability to undergo coronary angiography or PCI by Day 3
- •Prior PCI within 30 days
- •Acute STEMI
- •Cardiogenic shock
- •Anticoagulant treatment for > 24 hours prior to randomization
- •Prior treatment with fondaparinux since ACS onset
- •Requirement for oral anticoagulant (OAC) prior to Day 30
- •Creatinine clearance < 30 ml/min
研究组 & 干预措施
Otamixaban Dose 1
dosage regimen 1
干预措施: Otamixaban (XRP0673) (Drug)
Otamixaban Dose 2
dosage regimen 2
干预措施: Otamixaban (XRP0673) (Drug)
Otamixaban Dose 3
dosage regimen 3
干预措施: Otamixaban (XRP0673) (Drug)
Otamixaban Dose 4
dosage regimen 4
干预措施: Otamixaban (XRP0673) (Drug)
Otamixaban Dose 5
dosage regimen 5
干预措施: Otamixaban (XRP0673) (Drug)
UFH/Eptifibatide
干预措施: unfractionated heparin (Drug)
UFH/Eptifibatide
干预措施: eptifibatide (Drug)
结局指标
主要结局
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
时间窗: within 7 days following randomization
次要结局
- Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding(within 7 days and 30 days following randomization)
- Incidence of TIMI significant bleeding(within 7 days following randomization)
- Incidence of all bleedings(within 7 days and 30 days following randomization)
- Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor(within 30 days, 90 days and 180 days following randomization)