A Randomized, Multicenter, Double-Blind, Study to Evaluate the Efficacy of Tirofiban HCl Versus Placebo in the Setting of Standard Therapies Among Subjects Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Medicure
- 主要终点
- A composite incidence of death, myocardial infarction and urgent target vessel revascularization.
研究概览
简要总结
The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention (PCI) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (MI), and urgent target vessel revascularization (uTVR) within 48 hours following study drug initiation.
A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following study drug initiation.
Patient enrollment is pending.
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
- Quadruple (Participant, Care Provider, 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
- •Age >18 years of age
- •Scheduled to undergo PCI with an approved device
- •Written informed consent
排除标准
- •Primary PCI for ST-elevation myocardial infarction (STEMI)
- •Prior PCI within 30 days
- •Prior GPIIb/IIIa use within 14 days
- •Prior enoxaparin use within 4 days
- •Prior STEMI within 30 days
- •In non-elective subjects, a rising troponin defined as a most recent pre-PCI sample greater than the sample immediately preceding it, as long as the two samples are separated by four or more hours and have been analyzed in the same hospital laboratory.
研究组 & 干预措施
Tirofiban (Aggrastat)
干预措施: Tirofiban (Aggrastat) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
A composite incidence of death, myocardial infarction and urgent target vessel revascularization.
时间窗: 48 hours
次要结局
- The occurrence of myocardial infarction.(48 hours)