STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: primary PCI
* Drug: enoxaparin
* Procedure: catheterisation
* Drug: tenecteplase
* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age equal or greater than 18 years Onset of symptoms < 3 hours prior to randomisation 3.12-lead ECG indicative of an acute STEMI 4.Informed consent received Exclusion criteria: Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenecteplase<br>Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention | Drug: enoxaparin<br>* Adjunctive treatment<br>Procedure: catheterisation<br>* Routine or rescue coronary intervention<br>Drug: tenecteplase<br>* Single, weight-adjusted i.v. bolus of tenecteplase<br>Drug: clopidogrel<br>* Adjunctive treatment<br>|
| Other: primary PCI<br>Standard primary PCI | Procedure: primary PCI<br>* Standard primary PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. | 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). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With All Cause Mortality | This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. | 30 days | 
| Number of Patients With Cardiac Mortality | This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. | 30 days | 
| Number of Patients With Cardiogenic Shock | This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. | 30 days | 
| Number of Patients With Congestive Heart Failure (CHF) | This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. | 30 days | 
| Number of Patients With Recurrent Myocardial Infarction (Reinfarction) | This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported | 30 days | 
| Number of Patients With Rehospitalisation for Cardiac Reasons | This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported | 30 days | 
| Number of Patients With Rehospitalisation for Non-cardiac Reasons | This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported | 30 days | 
| Number of Patients With Serious Repeat Target Vessel Revascularization | This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported | 30 days | 
| Number of Patients With All Cause Death and Shock | This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported | 30 days | 
| Number of Patients With All Cause Death and Shock and CHF | This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. | 30 days | 
| Number of Patients With All Cause Death and Shock and Reinfarction | This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported | 30 days | 
| Number of Patients With Total Fatal Stroke | This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported | 30 days | 
| Number of Patients With Total Disabling Stroke | This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported | 30 days | 
| Number of Patients With Total Non-disabling Stroke | This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported | 30 days | 
| Number of Patients With Intracranial Haemorrhage | This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported | 30 days | 
| Number of Patients With Ischaemic Stroke | This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported | 30 days | 
| Number of Patients With Total Stroke (All Types) | This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported | 30 days | 
| Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions | This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported | 30 days | 
| Number of Patients With Minor Non-intracranial Bleeds | This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported | 30 days | 
| Number of Patients With Total Non-intracranial Bleeds | This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported | 30 days | 
| Number of Patients With Serious Resuscitated Ventricular Fibrillation | This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported | 30 days | 
| Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures | This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported | 30 days | 
| Number of Patients With All Cause Death and Non-fatal Stroke | This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported | 30 days | 
| Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke | This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported | 30 days |