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

Boehringer Ingelheim1,899 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,899

Conditions

Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Age equal or greater than 18 years 2. 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

Locations (201)

1123.28.43009 Boehringer Ingelheim Investigational Site

Salzburg, Austria

1123.28.43010 Boehringer Ingelheim Investigational Site

Salzburg, Austria

1123.28.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

1123.28.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

1123.28.43003 Boehringer Ingelheim Investigational Site

Vienna, Austria

Outcomes

Primary Outcomes

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).

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 30 days