ISRCTN12219184已完成未知
Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI)
Sheffield Teaching Hospitals NHS Trust0 个研究点目标入组 180 人开始时间: 2015年5月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
2018 results in https://pubmed.ncbi.nlm.nih.gov/29930021/ (added 17/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Male or female >18 years
- •3. Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease
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. Endstage renal failure requiring dialysis
- •18. History of alcohol or drug abuse in the last year
- •19. Comorbidity associated with life expectancy <1 year
- •20. Females of childbearing 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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