EUCTR2006-000192-14-DE进行中（未招募）不适用
A Clinical Trial Comparing Cangrelor To Clopidogrel In Subjects WhoRequire Percutaneous Coronary Intervention - Champion PCI
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
- 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 and one of the following:
- •2a. NSTEMI: Troponin I or T > upper limit of normal within 24-hours of randomization [or if troponin results are unavailable at that time, creatine kinase– myocardial band isoenzyme (CK-MB) > upper limit of normal]
- •2b. UA: Ischemic chest discomfort (angina or anginal equivalent) occurring at rest and lasting = 10 minutes within the 24 hours prior to randomization AND dynamic ECG changes† WITH either age= 65 years old and/or diabetes. 2c. STEMI: ECG changes including persistent [>20 minutes] ST-segment elevation in 2 or more contiguous leads
- •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
- •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
- •15. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours (applicable to UA and NSTEMI patients
研究者
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