KCT0007982招募中未知
Safety and Efficacy of Ticagrelor Versus Prasugrel Monotherapy after Percutaneous Coronary Intervention with Polymer-free Drug-Eluting Stent in Patients with Acute Coronary Syndrome
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 2,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •? 19 years of age or older and less than 75 years of age
- •? Patients who agreed to the study protocol and clinical follow-up plan, voluntarily decided to participate in this study, and gave written consent to the consent form.
- •? Patients undergoing coronary artery stenting for acute coronary syndrome
- •? In the case of women of childbearing potential, those who were confirmed negative in the pregnancy test and agreed to use an appropriate method of contraception* during this trial and for 90 days after the end of the clinical trial.
- •(*Adequate method of contraception means that women of childbearing potential, excluding postmenopausal women who have passed 52 weeks after the last menstrual period, use one of the following methods; surgical sterilization, intrauterine device, and absolute abstinence)
排除标准
- •? Subjects with known hypersensitivity or contraindications to any of the following drugs or substances: Heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, proton pump inhibitors (PPIs), cobalt chromium, stainless steel nickel, and contrast agents (However, even subjects with hypersensitivity to contrast media can be enrolled if they can be controlled by steroids and pheniramine, but if there is known anaphylaxis, they are excluded.)
- •? Pregnant women, lactating women, or subjects planning to become pregnant during the study period.
- •? Subjects planning surgery that requires discontinuation of antiplatelet drugs within 12 months of enrollment.
- •? Subjects whose remaining life expectancy is expected to be less than 1 year.
- •? Subjects who visited the hospital due to cardiogenic shock and are predicted to have a low survival rate based on medical judgment.
- •? Subjects participating in randomized research related to medical devices or drugs.
- •? Subjects who must use anticoagulants.
- •? Subjects with severe anemia with hemoglobin (Hb) of 10 g/dL or less.
- •? In cases where it is necessary to administer a drug contraindicated in combination
- •Strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
- •? Subjects who are contraindicated for ticagrelor and prasugrel administration (described in contraindications below)
- •* Ticagreler
- •? Patients with hypersensitivity to the components of this drug
- •? Patients with pathological bleeding (e.g. peptic ulcer, intracranial hemorrhage) at the time of administration
- •? Patients with a history of intracranial hemorrhage
- •? Patients with moderate to severe hepatic impairment
- •? Patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir) (concomitant administration may result in increased exposure to this drug)
- •* prasugrel
- •? Patients weighing less than 60kg or over 75 years of age; However, if the body weight is less than 60 kg, prasugrel can be reduced to 5 mg and the study can be conducted.
- •? Patients with hypersensitivity to the components of this drug.
- •? Patients with pathologically active bleeding such as peptic ulcer or intracranial hemorrhage.
- •? Patients with a history of stroke or transient ischemic attack (TIA).
- •? Patients with severe hepatic impairment (Child Pugh class C).
- •? Since this drug contains lactose, it should not be administered to patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •* Contraindications of investigational drugs (ticagrelor and prasugrel)
- •Administration of ticagrelor or prasugrel is contraindicated in patients with bleeding tendencies (e.g., recent trauma, recent surgery, coagulopathy, current or recent gastrointestinal bleeding), or patients at high risk of trauma.
研究者
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