A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Medicure
- 入组人数
- 535
- 试验地点
- 13
- 主要终点
- The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
研究概览
简要总结
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, 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
- 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
- •Age ≥18 years of age
- •Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one or more native coronary target lesions
- •Written informed consent
排除标准
- •Primary PCI for STEMI as index procedure
- •Prior STEMI within 48 hours before randomization
- •Prior PCI within 30 days before randomization
- •Planned staged PCI within the subsequent 24 hours after index PCI
- •Use of abciximab within 7 days before randomization
- •Use of tirofiban or eptifibatide within 12 hours before randomization
- •Use of low-molecular weight heparin within 12 hours before randomization
- •Use of bivalirudin within 12 hours before randomization
研究组 & 干预措施
Short Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
干预措施: Short Tirofiban (Drug)
Eptifibatide (Integrilin)
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
干预措施: Eptifibatide (Drug)
Long Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI.
Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).
干预措施: Long Tirofiban (Drug)
结局指标
主要结局
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
时间窗: 48 hours or hospital discharge, whichever came first
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
次要结局
- The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization(48 hours or hospital discharge, whichever came first)
- Individual Components of Death, Urgent Target Revascularization or Major Bleeding(48 hours or hospital discharge, whichever came first)
- Individual Components of Periprocedural Myonecrosis(48 hours or hospital discharge, whichever came first)
- The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding(48 hours or hospital discharge, whichever came first)