EUCTR2018-000765-36-BE进行中（未招募）1 期
A multi-center, open-label, randomized, study to assess the onset of platelet aggregation inhibition after a single subcutaneous injection of ACT-246475 in adults with acute myocardial infarction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
入选标准
- •- Informed consent obtained prior to any study-mandated procedure,
- •- Males aged from 18 to 85 and postmenopausal females aged up to 85 years,
- •- Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization,
- •- Subjects presenting a type I AMI including STEMI or NSTEMI.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Cardiogenic shock or severe hemodynamic instability,
- •- Cardiopulmonary resuscitation,
- •- Loading dose of any oral P2Y12 receptor antagonist prior to randomization,
- •- Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization,
- •- Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease).
研究者
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