A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI).
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5,364
- 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 (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR).
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
- •Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes.
排除标准
- •Not a candidate for PCI
- •ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
- •Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding
- •Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
- •Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
- •Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- •Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
- •Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]
研究组 & 干预措施
Cangrelor
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
干预措施: Cangrelor (Drug)
Cangrelor
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
干预措施: clopidogrel (Drug)
Cangrelor
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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
干预措施: Placebo capsules - end of PCI (Drug)
Clopidogrel
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
干预措施: clopidogrel (Drug)
Clopidogrel
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
干预措施: Placebo bolus & placebo infusion (Drug)
Clopidogrel
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
干预措施: Placebo capsules - end of 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 post randomization
mITT population; (composite incidence)
次要结局
- Incidence of All-cause Mortality(randomization through 30 days post randomization)
- Incidence of MI(randomization through 30 days post randomization)
- Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis](During index PCI)
- Incidence of GUSTO Severe / Life-threatening(randomization through 48 hours post randomization)
- Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major(randomization through 48 hours post randomization)
- Incidence of Stroke(randomization through 30 days post randomization)
- Incidence of ACUITY Major Bleeding(randomization through 48 hours post randomization)
- Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm(randomization through 48 hours post randomization)
- Incidence of All-cause Mortality or MI(randomization through 30 days post randomization)
- Incidence of IDR(randomization through 30 days post randomization)
- Incidence of Stent Thrombosis(randomization through 30 days post randomization)
- Incidence of All-cause Mortality, MI, or IDR(randomization through 30 days post randomization)