STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within 6-24 Hours or Rescue Coronary Intervention Versus a Strategy of Standard Primary PCI in Patients With Acute Myocardial Infarction Within 3 Hours of Onset of Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,899
- 试验地点
- 200
- 主要终点
- Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
研究概览
简要总结
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.
The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.
All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
干预措施: enoxaparin (Drug)
Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
干预措施: catheterisation (Procedure)
Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
干预措施: tenecteplase (Drug)
Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
干预措施: clopidogrel (Drug)
primary PCI
Standard primary PCI
干预措施: primary PCI (Procedure)
结局指标
主要结局
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
时间窗: 30 days
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).
次要结局
- Number of Patients With All Cause Mortality(30 days)
- Number of Patients With Cardiogenic Shock(30 days)
- Number of Patients With Recurrent Myocardial Infarction (Reinfarction)(30 days)
- Number of Patients With Rehospitalisation for Cardiac Reasons(30 days)
- Number of Patients With Rehospitalisation for Non-cardiac Reasons(30 days)
- Number of Patients With Cardiac Mortality(30 days)
- Number of Patients With Congestive Heart Failure (CHF)(30 days)
- Number of Patients With Serious Repeat Target Vessel Revascularization(30 days)
- Number of Patients With All Cause Death and Shock(30 days)
- Number of Patients With All Cause Death and Shock and CHF(30 days)
- Number of Patients With All Cause Death and Shock and Reinfarction(30 days)
- Number of Patients With Total Fatal Stroke(30 days)
- Number of Patients With Total Disabling Stroke(30 days)
- Number of Patients With Total Non-disabling Stroke(30 days)
- Number of Patients With Intracranial Haemorrhage(30 days)
- Number of Patients With Ischaemic Stroke(30 days)
- Number of Patients With Total Stroke (All Types)(30 days)
- Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions(30 days)
- Number of Patients With Minor Non-intracranial Bleeds(30 days)
- Number of Patients With Total Non-intracranial Bleeds(30 days)
- Number of Patients With Serious Resuscitated Ventricular Fibrillation(30 days)
- Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures(30 days)
- Number of Patients With All Cause Death and Non-fatal Stroke(30 days)
- Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke(30 days)