EUCTR2006-000192-14-IT进行中（未招募）不适用
A clinical trial comparing cangrelor to clopidogrel in subjects who require percutaneous coronary intervention. - ND
THE MEDICINES COMPANY UK0 个研究点目标入组 9,000 人开始时间: 2007年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •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 Importantly, the treating physician must have knowledge of the coronary anatomy and suitability for PCI prior to randomization, except for patients diagnosed with STEMI. Due to the compelling nature of STEMI and the high likelihood of a percutaneous intervention, these subjects may be randomized on diagnosis, preferably in the emergency department, provided there is no impediment to primary PCI.
- •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
- •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/?L), 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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