EUCTR2006-000192-14-GB进行中（未招募）1 期
A clinical trial comparing cangrelor to clopidogrel in subjects who require percutaneous coronary intervention. - CHAMPION PCI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,000
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
- •To be included in this study, subjects must meet the following criteria:
- •1. Male or non-pregnant female at least 18 years of age
- •2. Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation
- •3. Provide written informed consent before initiation of any study-related procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if they present with any of the following:
- •1 .Planned staged PCI procedure where the second stage will occur ? 30 days after the first intervention
- •2 Admission planned for <12 hrs following PCI
- •3 Known or suspected pregnancy, or lactating females
- •4.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
- •5.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
- •6.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)
- •7.Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- •8.Receipt of a clopidogrel dose exceeding the maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization (subjects receiving chronic clopidogrel therapy at a dose of 75 mg are eligible)
- •9.Not a candidate for PCI
- •10.Inability to swallow study capsules
- •11.Allergy, hypersensitivity, or contraindication to clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose
- •12.Treatment with other investigational agents or devices within the 30 days preceding randomization, planned use of investigational drugs or devices, or previous enrollment in this trial
- •13.Known alcohol or illicit substance abuse
- •14.Inability to give informed consent or high likelihood of being unavailable for follow-up.
研究者
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