NCT02206646已完成不适用
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® (Tenecteplase) in Korean Patients With Acute Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 987
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations:
- Unexpected adverse drug reactions
- Frequency and nature of adverse events (AEs)
- Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metalyse
weight-adjusted dose
干预措施: Metalyse (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 30 days
30-day mortality after the Metalyse® Injection
时间窗: 30 days
Outcome assessment - 'Improvement' or 'Failure'
时间窗: 30 days
'Improvement' was defined as survival on 30 days and 'Failure' as death on 30 days after the Metalyse treatment.
次要结局
未报告次要终点
研究者
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