EUCTR2010-021591-28-CZ进行中（未招募）不适用
A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention - Phoenix
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or non-pregnant female at least 18 years of age
- •2.Patients undergoing PCI:
- •a.Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
- •b.Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
- •c.STEMI patients (diagnostic angiography not required)
- •3.Provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3000
排除标准
- •1.Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
- •2.Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered =12 hours prior to randomization)
- •3.Abciximab usage within 7 days preceding randomization
- •4.Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- •5.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
- •6.Impaired hemostasis: known international normalized ratio (INR) >1.5; 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), or history of thrombocytopenia or neutropenia associated with clopidogrel
- •7.Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
- •8.Admission planned for <12 hours following PCI
- •9.Planned staged PCI procedure where the second stage will occur =30 days after the first intervention
- •10.Inability to give informed consent or comply with study related procedures, or high likelihood of being unavailable for follow-up
- •11.Known or suspected pregnancy, or lactating females
- •12.Allergy, hypersensitivity, or contraindication to aspirin, clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose
- •13.Active treatment with other investigational agents or devices at the time of randomization or planned use during the 30 day follow-up period
- •14.Previous enrollment in this trial
研究者
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