A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8,882
- 试验地点
- 1
- 主要终点
- Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
研究概览
简要总结
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
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, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Clopidogrel
clopidogrel capsules (600 mg) + placebo bolus & infusion (to match) + placebo capsules (to match) post infusion
干预措施: Placebo capsules - end of infusion (Drug)
Cangrelor
placebo capsules (to match) + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
干预措施: Cangrelor (P2Y12 inhibitor) (Drug)
Cangrelor
placebo capsules (to match) + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
干预措施: clopidogrel (oral P2Y12 inhibitor) (Drug)
Cangrelor
placebo capsules (to match) + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
干预措施: Placebo capsules - as soon as possible after randomization (Drug)
Clopidogrel
clopidogrel capsules (600 mg) + placebo bolus & infusion (to match) + placebo capsules (to match) post infusion
干预措施: clopidogrel (oral P2Y12 inhibitor) (Drug)
Clopidogrel
clopidogrel capsules (600 mg) + placebo bolus & infusion (to match) + placebo capsules (to match) post infusion
干预措施: Placebo bolus & placebo infusion (Drug)
结局指标
主要结局
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
时间窗: randomization through 48 hours after randomization
(composite incidence)
次要结局
- Incidence of IDR(randomization through 30 days after randomization)
- Incidence of All-cause Mortality and MI(randomization through 48 hours after randomization)
- Individual Incidence of All-cause Mortality(randomization through 48 hours after randomization)
- Individual Incidence of IDR(randomization through 48 hours after randomization)
- Incidence of Stroke(randomization through 30 days after randomization)
- Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI(during index PCI)
- Incidence of All-cause Mortality, MI or IDR(randomization through 30 days after randomization)
- Incidence of All-cause Mortality or MI(randomization through 30 days after randomization)
- Incidence of All-cause Mortality(randomization through 30 days after randomization)
- Incidence of MI(randomization through 30 days after randomization)
- Incidence of GUSTO Severe / Life-threatening Bleeding(randomization through 48 hours after randomization)
- Incidence of All Cause Mortality(randomization through 1 year after randomization)
- Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding(randomization through 48 hours after randomization)
- Incidence of ACUITY Major Bleeding(randomization through 48 hours after randomization)
- Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)(randomization through 48 hours after randomization)