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临床试验/EUCTR2018-002161-19-SK
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)

Fakultní nemocnice Královské Vinohrady0 个研究点目标入组 40 人开始时间: 2019年4月15日最近更新:
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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