EUCTR2014-004783-38-GB进行中（未招募）1 期
Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI) - STEEL 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
- 180
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
入选标准
- •1. Provision of informed consent prior to any study specific procedures.
- •2. Male or female aged greater than 18 years.
- •3. Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease.
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed.
- •2. Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known).
- •3. Intention to use platelet function tests or genotyping to guide antiplatelet therapy.
- •4. Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor.
- •5. Treatment with antiplatelet medication apart from aspirin or clopidogrel that cannot be stopped 10 days prior to PCI (e.g. ticagrelor, prasugrel, dipyridamole, ticlopidine, abciximab, tirofiban), for example because of continuing indication.
- •6. Planned treatment or consideration of treatment with oral antiplatelet medication other than aspirin or clopidogrel following PCI.
- •7. Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
- •8. Myocardial infarction within the past 12 months.
- •9. Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
- •10. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk.
- •11. Haemoglobin < 100 g/L or other evidence of active bleeding.
- •12. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
- •13. History of acute or chronic liver disease (e.g. cirrhosis).
- •14. Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer.
- •15. Requirement for ongoing treatment with simvastatin or lovastatin at a dose greater than 40 mg per day.
- •16. Treatment with a CYP3A4 substrate with a narrow therapeutic index (e.g. cyclosporine, quinidine).
- •17. End-stage renal failure requiring dialysis.
- •18. History of alcohol or drug abuse in the last year.
- •19. Co-morbidity associated with life expectancy less than 1 year.
- •20. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication.
- •21. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.
研究者
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