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临床试验/NL-OMON50482
NL-OMON50482已完成不适用

COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions - Compare Crush

Research Maatschap Cardiologen Rotterdam Zuid0 个研究点目标入组 729 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
729

研究概览

简要总结

Trial is onging in other countries

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Consecutive patients with STEMI planned for primary PCI
  • - Deferred written informed consent within 4 hours after initial treatment
  • - Adult men and women aged at least 18 years
  • - Symptoms of acute MI of more than 30 min but less than 6 hours
  • - New persistent ST-segment elevation >= 1 mm in two or more contiguous ECG

排除标准

  • - Contraindication to prasugrel (e.g., hypersensitivity, active bleeding,
  • history of previous intracranial bleed, history of any CVA, including TIA,
  • moderate to severe hepatic impairment, GI bleed within the past 6 months, major
  • surgery within past 4 weeks)
  • - Patient who has received loading dose of Clopidogrel or ticagrelor for the
  • index event or are on chronic treatment of ticagrelor. However, patients on
  • maintenance dose clopidogrel for at least 7 days are included in the study. See
  • appendix A (patient on clopidogrel maintenance dose)
  • - Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring
  • chronic therapy)
  • - Planned fibrinolytic treatment
  • - Patient requiring dialysis
  • - Known, clinically important thrombocytopenia
  • - Known clinically important anaemia
  • - Known pregnancy or lactation
  • - Need for a concomitant systemic therapy with strong inhibitors or strong
  • inducers of CYP3A
  • - Condition which may either put the patient at risk or influence the result of
  • the study (e.g., cardiogenic shock or severe hemodynamic instability, active
  • cancer, risk for non-compliance, risk for being lost to follow up)
  • - Patient unable to swallow oral medication (i.e. intubated patients)

研究者

发起方
Research Maatschap Cardiologen Rotterdam Zuid

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