Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 13,220
- 试验地点
- 607
- 主要终点
- Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
研究概览
简要总结
Primary Objective:
- To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide
Secondary Objectives:
- To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide
- To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide
- To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide
- To document the safety of Otamixaban as compared to UFH + eptifibatide
- To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide
详细描述
Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.
The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Otamixaban (Drug)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Placebo (for UFH) (Drug)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Placebo (for Eptifibatide) (Drug)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Otamixaban (Drug)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Placebo (for UFH) (Drug)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion)
- Drug B: Placebo (for UFH)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Placebo (for Eptifibatide)
干预措施: Placebo (for Eptifibatide) (Drug)
UFH + Eptifibatide
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Placebo (for Otamixaban)
- Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
干预措施: Placebo (for Otamixaban) (Drug)
UFH + Eptifibatide
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Placebo (for Otamixaban)
- Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
干预措施: UFH (Drug)
UFH + Eptifibatide
From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:
- Drug A: Placebo (for Otamixaban)
- Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion)
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
- Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
干预措施: Eptifibatide (Drug)
结局指标
主要结局
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
时间窗: from randomization (day 1) to day 7
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)
时间窗: from day 1 to day 7
次要结局
- Adjudicated all-cause death(from day 1 to day 30)
- Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke(from day 1 to day 7)
- Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction(from day 1 to day 30)
- Adjudicated Procedural thrombotic complications during the index PCI(during index PCI)