EUCTR2018-002161-19-SK进行中(未招募)1 期
Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction - DAPT-SHOCK-AMI study (PRAGUE-23)
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
- 40
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. Age more than 18
- •2. Acute myocardial infarction as per ESC/ACC/AHA23 indicated to emergency percutaneous coronary intervention (primary PCI strategy)
- •3. Cardiogenic shock resulting from acute myocardial infarction in admission (occurence of two or more of the following criteria):
- •- systolic blood preassure < 90mmHg
- •- necessity of vasopressor and/or inotropes use
- •- signs of organ perfusion - cyanosis, cold body extremities, unconsciousness, congestive heart failure
- •4. Signed informed consent
- •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 304
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
排除标准
- •1. Contraindication to anti-platelet ticagrelor/cangrelor treatment
- •- recent (< 6 months) major bleeding
- •-recent (< 1 month) major surgery/injury
- •-intracranial bleeding in anamnesis
- •-stroke/TIA in anamnesis
- •-Ticagrelor/Cangrelor intolerance
- •-serious liver indeficiency
- •-concomitant use of CYP3A4 inhibitor (eg. ketokonazole, clarithromycin, nefazodon, ritonavir, atazanavir)
- •2. Oral use of P2Y12 inhibitor before admission (Clopidogrel = 300mg, Ticagrelor 180 mg, Prasugrel 60 mg)
- •3. Necessity of concomitant chronic anticoagulant treatment for atrial fibrillation, artificial valve, tromboembolism etc.)
研究者
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