NCT00168792终止4 期
A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,671
- 试验地点
- 177
- 主要终点
- Death or cardiogenic shock or congestive heart failure within 90 days
研究概览
简要总结
To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients giving informed consent
- •Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset
- •Patients scheduled to undergo primary PCI
- •Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation
- •(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)
排除标准
- 未提供
结局指标
主要结局
Death or cardiogenic shock or congestive heart failure within 90 days
时间窗: 90 days
次要结局
- Rehospitalisation for cardiogenic shock(90 days)
- Rehospitalisation for other cardiac reasons(90 days)
- Congestive heart failure(90 days)
- N-terminal pro-brain natriuretic peptide (NT pro-BNP)(90 days)
- Disabling stroke(90 days)
- Total stroke(90 days)
- Rehospitalisation for stroke or ICH (intrancranial haemorrhage)(90 days)
- Rehospitalisation for congestive heart failure(90 days)
- Death or cardiogenic shock or congestive heart failure within 30 days(30 days)
- Cardiogenic shock or congestive heart failure within 90 days(90 days)
- Death(90 days)
- Cardiogenic shock(90 days)
- Reinfarction(90 days)
- Repeat target vessel revascularisation (TVR)(90 days)
研究者
研究点 (177)
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