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
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