A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11,145
- 试验地点
- 1
- 主要终点
- The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
研究概览
简要总结
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (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
- 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
- •Patients may be included in the study if they meet all of the following criteria:
- •Male or non-pregnant female at least 18 years of age
- •Patients undergoing percutaneous coronary intervention (PCI):
- •Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
- •Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
- •ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
- •Provide written informed consent
排除标准
- •Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- •Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
- •Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
- •Abciximab usage within 7 days preceding randomization
- •Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- •Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding
研究组 & 干预措施
cangrelor
Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.
干预措施: Clopidogrel 600 mg post cangrelor (Drug)
cangrelor
Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.
干预措施: cangrelor P2Y12 (platelet) inhibitor (Drug)
clopidogrel
Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion.
During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.
干预措施: Clopidogrel - 300 or 600 mg (study arm) (Drug)
结局指标
主要结局
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
时间窗: 48 hours after randomization
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)
次要结局
- Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)(48 hours after randomization)
- Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild(48 hours after randomization)