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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
primary PCI
enoxaparin
catheterisation
tenecteplase
clopidogrel
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1123.28.43009 Boehringer Ingelheim Investigational Site
  • 1123.28.43010 Boehringer Ingelheim Investigational Site
  • 1123.28.43001 Boehringer Ingelheim Investigational Site
  • 1123.28.43002 Boehringer Ingelheim Investigational Site
  • 1123.28.43003 Boehringer Ingelheim Investigational Site
  • 1123.28.43004 Boehringer Ingelheim Investigational Site
  • 1123.28.43005 Boehringer Ingelheim Investigational Site
  • 1123.28.43007 Boehringer Ingelheim Investigational Site
  • 1123.28.43008 Boehringer Ingelheim Investigational Site
  • 1123.28.32060 Boehringer Ingelheim Investigational Site
  • 1123.28.32010 Boehringer Ingelheim Investigational Site
  • 1123.28.32070 Boehringer Ingelheim Investigational Site
  • 1123.28.32040 Boehringer Ingelheim Investigational Site
  • 1123.28.55010 Boehringer Ingelheim Investigational Site
  • 1123.28.55020 Boehringer Ingelheim Investigational Site
  • 1123.28.55008 Boehringer Ingelheim Investigational Site
  • 1123.28.55017 Boehringer Ingelheim Investigational Site
  • 1123.28.55007 Boehringer Ingelheim Investigational Site
  • 1123.28.55001 Boehringer Ingelheim Investigational Site
  • 1123.28.55018 Boehringer Ingelheim Investigational Site
  • 1123.28.55028 Boehringer Ingelheim Investigational Site
  • 1123.28.55016 Boehringer Ingelheim Investigational Site
  • 1123.28.55004 Boehringer Ingelheim Investigational Site
  • 1123.28.55014 Boehringer Ingelheim Investigational Site
  • 1123.28.11006 Boehringer Ingelheim Investigational Site
  • 1123.28.11505 Boehringer Ingelheim Investigational Site
  • 1123.28.11002 Boehringer Ingelheim Investigational Site
  • 1123.28.13001 Boehringer Ingelheim Investigational Site
  • 1123.28.13002 Boehringer Ingelheim Investigational Site
  • 1123.28.13003 Boehringer Ingelheim Investigational Site
  • 1123.28.13004 Boehringer Ingelheim Investigational Site
  • 1123.28.13005 Boehringer Ingelheim Investigational Site
  • 1123.28.13006 Boehringer Ingelheim Investigational Site
  • 1123.28.3376A Boehringer Ingelheim Investigational Site
  • 1123.28.3329A Boehringer Ingelheim Investigational Site
  • 1123.28.3329B Boehringer Ingelheim Investigational Site
  • 1123.28.3329C Boehringer Ingelheim Investigational Site
  • 1123.28.3351A Boehringer Ingelheim Investigational Site
  • 1123.28.3351B Boehringer Ingelheim Investigational Site
  • 1123.28.3315A Boehringer Ingelheim Investigational Site
  • 1123.28.3315B Boehringer Ingelheim Investigational Site
  • 1123.28.3302A Boehringer Ingelheim Investigational Site
  • 1123.28.3302B Boehringer Ingelheim Investigational Site
  • 1123.28.3319A Boehringer Ingelheim Investigational Site
  • 1123.28.3319B Boehringer Ingelheim Investigational Site
  • 1123.28.3319C Boehringer Ingelheim Investigational Site
  • 1123.28.3374A Boehringer Ingelheim Investigational Site
  • 1123.28.3385A Boehringer Ingelheim Investigational Site
  • 1123.28.3383A Boehringer Ingelheim Investigational Site
  • 1123.28.3347A Boehringer Ingelheim Investigational Site
  • 1123.28.3347B Boehringer Ingelheim Investigational Site
  • 1123.28.3347C Boehringer Ingelheim Investigational Site
  • 1123.28.3355A Boehringer Ingelheim Investigational Site
  • 1123.28.3355B Boehringer Ingelheim Investigational Site
  • 1123.28.3382A Boehringer Ingelheim Investigational Site
  • 1123.28.3311A Boehringer Ingelheim Investigational Site
  • 1123.28.3311B Boehringer Ingelheim Investigational Site
  • 1123.28.3346A Boehringer Ingelheim Investigational Site
  • 1123.28.3346B Boehringer Ingelheim Investigational Site
  • 1123.28.3303A Boehringer Ingelheim Investigational Site
  • 1123.28.3309A Boehringer Ingelheim Investigational Site
  • 1123.28.3342A Boehringer Ingelheim Investigational Site
  • 1123.28.3337A Boehringer Ingelheim Investigational Site
  • 1123.28.3387A Boehringer Ingelheim Investigational Site
  • 1123.28.3388A Boehringer Ingelheim Investigational Site
  • 1123.28.3353A Boehringer Ingelheim Investigational Site
  • 1123.28.3353B Boehringer Ingelheim Investigational Site
  • 1123.28.3317A Boehringer Ingelheim Investigational Site
  • 1123.28.3317B Boehringer Ingelheim Investigational Site
  • 1123.28.3339A Boehringer Ingelheim Investigational Site
  • 1123.28.3339B Boehringer Ingelheim Investigational Site
  • 1123.28.3307A Boehringer Ingelheim Investigational Site
  • 1123.28.3336A Boehringer Ingelheim Investigational Site
  • 1123.28.3301A Boehringer Ingelheim Investigational Site
  • 1123.28.3301B Boehringer Ingelheim Investigational Site
  • 1123.28.3325A Boehringer Ingelheim Investigational Site
  • 1123.28.3325B Boehringer Ingelheim Investigational Site
  • 1123.28.3326A Boehringer Ingelheim Investigational Site
  • 1123.28.3318A Boehringer Ingelheim Investigational Site
  • 1123.28.3318B Boehringer Ingelheim Investigational Site
  • 1123.28.3318C Boehringer Ingelheim Investigational Site
  • 1123.28.3369A Boehringer Ingelheim Investigational Site
  • 1123.28.3369B Boehringer Ingelheim Investigational Site
  • 1123.28.3356A Boehringer Ingelheim Investigational Site
  • 1123.28.3356B Boehringer Ingelheim Investigational Site
  • 1123.28.3308A Boehringer Ingelheim Investigational Site
  • 1123.28.3308B Boehringer Ingelheim Investigational Site
  • 1123.28.3340A Boehringer Ingelheim Investigational Site
  • 1123.28.3340B Boehringer Ingelheim Investigational Site
  • 1123.28.3379A Boehringer Ingelheim Investigational Site
  • 1123.28.3328A Boehringer Ingelheim Investigational Site
  • 1123.28.3328B Boehringer Ingelheim Investigational Site
  • 1123.28.3328C Boehringer Ingelheim Investigational Site
  • 1123.28.3349A Boehringer Ingelheim Investigational Site
  • 1123.28.3349B Boehringer Ingelheim Investigational Site
  • 1123.28.3313A Boehringer Ingelheim Investigational Site
  • 1123.28.3313B Boehringer Ingelheim Investigational Site
  • 1123.28.3322A Boehringer Ingelheim Investigational Site
  • 1123.28.3322B Boehringer Ingelheim Investigational Site
  • 1123.28.3322C Boehringer Ingelheim Investigational Site
  • 1123.28.3366A Boehringer Ingelheim Investigational Site
  • 1123.28.3375A Boehringer Ingelheim Investigational Site
  • 1123.28.3334A Boehringer Ingelheim Investigational Site
  • 1123.28.3331A Boehringer Ingelheim Investigational Site
  • 1123.28.3371A Boehringer Ingelheim Investigational Site
  • 1123.28.3357A Boehringer Ingelheim Investigational Site
  • 1123.28.3338A Boehringer Ingelheim Investigational Site
  • 1123.28.3316A Boehringer Ingelheim Investigational Site
  • 1123.28.3352A Boehringer Ingelheim Investigational Site
  • 1123.28.3341A Boehringer Ingelheim Investigational Site
  • 1123.28.3378A Boehringer Ingelheim Investigational Site
  • 1123.28.3310A Boehringer Ingelheim Investigational Site
  • 1123.28.3310B Boehringer Ingelheim Investigational Site
  • 1123.28.3344A Boehringer Ingelheim Investigational Site
  • 1123.28.3345A Boehringer Ingelheim Investigational Site
  • 1123.28.3345B Boehringer Ingelheim Investigational Site
  • 1123.28.3345C Boehringer Ingelheim Investigational Site
  • 1123.28.3377A Boehringer Ingelheim Investigational Site
  • 1123.28.3384A Boehringer Ingelheim Investigational Site
  • 1123.28.3373A Boehringer Ingelheim Investigational Site
  • 1123.28.49002 Boehringer Ingelheim Investigational Site
  • 1123.28.49006 Boehringer Ingelheim Investigational Site
  • 1123.28.49008 Boehringer Ingelheim Investigational Site
  • 1123.28.49012 Boehringer Ingelheim Investigational Site
  • 1123.28.49052 Boehringer Ingelheim Investigational Site
  • 1123.28.49026 Boehringer Ingelheim Investigational Site
  • 1123.28.30012 Boehringer Ingelheim Investigational Site
  • 1123.28.30001 Boehringer Ingelheim Investigational Site
  • 1123.28.30003 Boehringer Ingelheim Investigational Site
  • 1123.28.30011 Boehringer Ingelheim Investigational Site
  • 1123.28.30014 Boehringer Ingelheim Investigational Site
  • 1123.28.30006 Boehringer Ingelheim Investigational Site
  • 1123.28.30002 Boehringer Ingelheim Investigational Site
  • 1123.28.30007 Boehringer Ingelheim Investigational Site
  • 1123.28.30010 Boehringer Ingelheim Investigational Site
  • 1123.28.30005 Boehringer Ingelheim Investigational Site
  • 1123.28.30009 Boehringer Ingelheim Investigational Site
  • 1123.28.39201 Boehringer Ingelheim Investigational Site
  • 1123.28.39002A Boehringer Ingelheim Investigational Site
  • 1123.28.39022 Boehringer Ingelheim Investigational Site
  • 1123.28.39004A Boehringer Ingelheim Investigational Site
  • 1123.28.39200A Boehringer Ingelheim Investigational Site
  • 1123.28.39001A Boehringer Ingelheim Investigational Site
  • 1123.28.39011 Boehringer Ingelheim Investigational Site
  • 1123.28.39082 Boehringer Ingelheim Investigational Site
  • 1123.28.39083 Boehringer Ingelheim Investigational Site
  • 1123.28.39008A Boehringer Ingelheim Investigational Site
  • 1123.28.39081 Boehringer Ingelheim Investigational Site
  • 1123.28.39041 Boehringer Ingelheim Investigational Site
  • 1123.28.47005 Boehringer Ingelheim Investigational Site
  • 1123.28.47001 Boehringer Ingelheim Investigational Site
  • 1123.28.47002 Boehringer Ingelheim Investigational Site
  • 1123.28.19001 Boehringer Ingelheim Investigational Site
  • 1123.28.19004 Boehringer Ingelheim Investigational Site
  • 1123.28.48002 Boehringer Ingelheim Investigational Site
  • 1123.28.48006 Boehringer Ingelheim Investigational Site
  • 1123.28.48009 Boehringer Ingelheim Investigational Site
  • 1123.28.48001 Boehringer Ingelheim Investigational Site
  • 1123.28.70005 Boehringer Ingelheim Investigational Site
  • 1123.28.77005 Boehringer Ingelheim Investigational Site
  • 1123.28.70001 Boehringer Ingelheim Investigational Site
  • 1123.28.77001 Boehringer Ingelheim Investigational Site
  • 1123.28.70009 Boehringer Ingelheim Investigational Site
  • 1123.28.77009 Boehringer Ingelheim Investigational Site
  • 1123.28.70002 Boehringer Ingelheim Investigational Site
  • 1123.28.77002 Boehringer Ingelheim Investigational Site
  • 1123.28.70008 Boehringer Ingelheim Investigational Site
  • 1123.28.77008 Boehringer Ingelheim Investigational Site
  • 1123.28.77003 Boehringer Ingelheim Investigational Site
  • 1123.28.70003 Boehringer Ingelheim Investigational Site
  • 1123.28.70006 Boehringer Ingelheim Investigational Site
  • 1123.28.70007 Boehringer Ingelheim Investigational Site
  • 1123.28.77006 Boehringer Ingelheim Investigational Site
  • 1123.28.70004 Boehringer Ingelheim Investigational Site
  • 1123.28.77004 Boehringer Ingelheim Investigational Site
  • 1123.28.38101 Boehringer Ingelheim Investigational Site
  • 1123.28.38103 Boehringer Ingelheim Investigational Site
  • 1123.28.38104 Boehringer Ingelheim Investigational Site
  • 1123.28.38106 Boehringer Ingelheim Investigational Site
  • 1123.28.38107 Boehringer Ingelheim Investigational Site
  • 1123.28.38109 Boehringer Ingelheim Investigational Site
  • 1123.28.38108 Boehringer Ingelheim Investigational Site
  • 1123.28.38110 Boehringer Ingelheim Investigational Site
  • 1123.28.38111 Boehringer Ingelheim Investigational Site
  • 1123.28.38104 Boehringer Ingelheim Investigational Site
  • 1123.28.38105 Boehringer Ingelheim Investigational Site
  • 1123.28.34001 Boehringer Ingelheim Investigational Site
  • 1123.28.34004 Boehringer Ingelheim Investigational Site
  • 1123.28.34003 Boehringer Ingelheim Investigational Site
  • 1123.28.34007 Boehringer Ingelheim Investigational Site
  • 1123.28.34002 Boehringer Ingelheim Investigational Site
  • 1123.28.34011 Boehringer Ingelheim Investigational Site
  • 1123.28.44600 Boehringer Ingelheim Investigational Site
  • 1123.28.44610 Boehringer Ingelheim Investigational Site
  • 1123.28.44210 Boehringer Ingelheim Investigational Site
  • 1123.28.44220 Boehringer Ingelheim Investigational Site
  • 1123.28.44200 Boehringer Ingelheim Investigational Site
  • 1123.28.44620 Boehringer Ingelheim Investigational Site
  • 1123.28.44110 Boehringer Ingelheim Investigational Site
  • 1123.28.44630 Boehringer Ingelheim Investigational Site
  • 1123.28.44100 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tenecteplase

primary PCI

Arm Description

Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention

Standard primary PCI

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
February 15, 2008
Last Updated
June 6, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00623623
Brief Title
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2008 (Actual)
Primary Completion Date
September 1, 2012 (Actual)
Study Completion Date
September 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1899 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenecteplase
Arm Type
Experimental
Arm Description
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Arm Title
primary PCI
Arm Type
Other
Arm Description
Standard primary PCI
Intervention Type
Procedure
Intervention Name(s)
primary PCI
Intervention Description
Standard primary PCI
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
Adjunctive treatment
Intervention Type
Procedure
Intervention Name(s)
catheterisation
Intervention Description
Routine or rescue coronary intervention
Intervention Type
Drug
Intervention Name(s)
tenecteplase
Intervention Description
Single, weight-adjusted i.v. bolus of tenecteplase
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
Adjunctive treatment
Primary Outcome Measure Information:
Title
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
Description
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 Outcome Measure Information:
Title
Number of Patients With All Cause Mortality
Description
This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.
Time Frame
30 days
Title
Number of Patients With Cardiac Mortality
Description
This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.
Time Frame
30 days
Title
Number of Patients With Cardiogenic Shock
Description
This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.
Time Frame
30 days
Title
Number of Patients With Congestive Heart Failure (CHF)
Description
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
Title
Number of Patients With Recurrent Myocardial Infarction (Reinfarction)
Description
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
Title
Number of Patients With Rehospitalisation for Cardiac Reasons
Description
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
Title
Number of Patients With Rehospitalisation for Non-cardiac Reasons
Description
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
Title
Number of Patients With Serious Repeat Target Vessel Revascularization
Description
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
Title
Number of Patients With All Cause Death and Shock
Description
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
Title
Number of Patients With All Cause Death and Shock and CHF
Description
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
Title
Number of Patients With All Cause Death and Shock and Reinfarction
Description
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
Title
Number of Patients With Total Fatal Stroke
Description
This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported
Time Frame
30 days
Title
Number of Patients With Total Disabling Stroke
Description
This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported
Time Frame
30 days
Title
Number of Patients With Total Non-disabling Stroke
Description
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
Title
Number of Patients With Intracranial Haemorrhage
Description
This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported
Time Frame
30 days
Title
Number of Patients With Ischaemic Stroke
Description
This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported
Time Frame
30 days
Title
Number of Patients With Total Stroke (All Types)
Description
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
Title
Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions
Description
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
Title
Number of Patients With Minor Non-intracranial Bleeds
Description
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
Title
Number of Patients With Total Non-intracranial Bleeds
Description
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
Title
Number of Patients With Serious Resuscitated Ventricular Fibrillation
Description
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
Title
Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures
Description
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
Title
Number of Patients With All Cause Death and Non-fatal Stroke
Description
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
Title
Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1123.28.43009 Boehringer Ingelheim Investigational Site
City
Salzburg
Country
Austria
Facility Name
1123.28.43010 Boehringer Ingelheim Investigational Site
City
Salzburg
Country
Austria
Facility Name
1123.28.43001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43003 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43005 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43007 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.43008 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1123.28.32060 Boehringer Ingelheim Investigational Site
City
Bornem
Country
Belgium
Facility Name
1123.28.32010 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1123.28.32070 Boehringer Ingelheim Investigational Site
City
Herentals
Country
Belgium
Facility Name
1123.28.32040 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1123.28.55010 Boehringer Ingelheim Investigational Site
City
Brasilia
Country
Brazil
Facility Name
1123.28.55020 Boehringer Ingelheim Investigational Site
City
Brasilia
Country
Brazil
Facility Name
1123.28.55008 Boehringer Ingelheim Investigational Site
City
Cabo Frio
Country
Brazil
Facility Name
1123.28.55017 Boehringer Ingelheim Investigational Site
City
Campinas
Country
Brazil
Facility Name
1123.28.55007 Boehringer Ingelheim Investigational Site
City
Porto Alegre
Country
Brazil
Facility Name
1123.28.55001 Boehringer Ingelheim Investigational Site
City
Recife
Country
Brazil
Facility Name
1123.28.55018 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro
Country
Brazil
Facility Name
1123.28.55028 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro
Country
Brazil
Facility Name
1123.28.55016 Boehringer Ingelheim Investigational Site
City
Sao Lourenço do Sul
Country
Brazil
Facility Name
1123.28.55004 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1123.28.55014 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1123.28.11006 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1123.28.11505 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1123.28.11002 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1123.28.13001 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.13002 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.13003 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.13004 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.13005 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.13006 Boehringer Ingelheim Investigational Site
City
Santiago
Country
Chile
Facility Name
1123.28.3376A Boehringer Ingelheim Investigational Site
City
Ambérieu en Bugey
Country
France
Facility Name
1123.28.3329A Boehringer Ingelheim Investigational Site
City
Aubervilliers Cedex
Country
France
Facility Name
1123.28.3329B Boehringer Ingelheim Investigational Site
City
Aubervilliers Cedex
Country
France
Facility Name
1123.28.3329C Boehringer Ingelheim Investigational Site
City
Aubervilliers Cedex
Country
France
Facility Name
1123.28.3351A Boehringer Ingelheim Investigational Site
City
Besancon
Country
France
Facility Name
1123.28.3351B Boehringer Ingelheim Investigational Site
City
Besancon
Country
France
Facility Name
1123.28.3315A Boehringer Ingelheim Investigational Site
City
Besançon cedex
Country
France
Facility Name
1123.28.3315B Boehringer Ingelheim Investigational Site
City
Besançon cedex
Country
France
Facility Name
1123.28.3302A Boehringer Ingelheim Investigational Site
City
Bobigny
Country
France
Facility Name
1123.28.3302B Boehringer Ingelheim Investigational Site
City
Bobigny
Country
France
Facility Name
1123.28.3319A Boehringer Ingelheim Investigational Site
City
Bordeaux Cedex
Country
France
Facility Name
1123.28.3319B Boehringer Ingelheim Investigational Site
City
Bordeaux Cedex
Country
France
Facility Name
1123.28.3319C Boehringer Ingelheim Investigational Site
City
Bordeaux Cedex
Country
France
Facility Name
1123.28.3374A Boehringer Ingelheim Investigational Site
City
Bourg en Bresse
Country
France
Facility Name
1123.28.3385A Boehringer Ingelheim Investigational Site
City
Bourg en Bresse
Country
France
Facility Name
1123.28.3383A Boehringer Ingelheim Investigational Site
City
Bourg-en-Bresse
Country
France
Facility Name
1123.28.3347A Boehringer Ingelheim Investigational Site
City
Bourges
Country
France
Facility Name
1123.28.3347B Boehringer Ingelheim Investigational Site
City
Bourges
Country
France
Facility Name
1123.28.3347C Boehringer Ingelheim Investigational Site
City
Bourges
Country
France
Facility Name
1123.28.3355A Boehringer Ingelheim Investigational Site
City
Bron
Country
France
Facility Name
1123.28.3355B Boehringer Ingelheim Investigational Site
City
Bron
Country
France
Facility Name
1123.28.3382A Boehringer Ingelheim Investigational Site
City
Caluire et Cuire
Country
France
Facility Name
1123.28.3311A Boehringer Ingelheim Investigational Site
City
Châteauroux cedex
Country
France
Facility Name
1123.28.3311B Boehringer Ingelheim Investigational Site
City
Châteauroux cedex
Country
France
Facility Name
1123.28.3346A Boehringer Ingelheim Investigational Site
City
Châteauroux cedex
Country
France
Facility Name
1123.28.3346B Boehringer Ingelheim Investigational Site
City
Châteauroux cedex
Country
France
Facility Name
1123.28.3303A Boehringer Ingelheim Investigational Site
City
Clichy Cedex
Country
France
Facility Name
1123.28.3309A Boehringer Ingelheim Investigational Site
City
Dreux
Country
France
Facility Name
1123.28.3342A Boehringer Ingelheim Investigational Site
City
Dreux
Country
France
Facility Name
1123.28.3337A Boehringer Ingelheim Investigational Site
City
Evecquemont
Country
France
Facility Name
1123.28.3387A Boehringer Ingelheim Investigational Site
City
Fort De France Cedex
Country
France
Facility Name
1123.28.3388A Boehringer Ingelheim Investigational Site
City
Fort De France Cedex
Country
France
Facility Name
1123.28.3353A Boehringer Ingelheim Investigational Site
City
Grenoble
Country
France
Facility Name
1123.28.3353B Boehringer Ingelheim Investigational Site
City
Grenoble
Country
France
Facility Name
1123.28.3317A Boehringer Ingelheim Investigational Site
City
La Tronche
Country
France
Facility Name
1123.28.3317B Boehringer Ingelheim Investigational Site
City
La Tronche
Country
France
Facility Name
1123.28.3339A Boehringer Ingelheim Investigational Site
City
Le Chesnay Cedex
Country
France
Facility Name
1123.28.3339B Boehringer Ingelheim Investigational Site
City
Le Chesnay Cedex
Country
France
Facility Name
1123.28.3307A Boehringer Ingelheim Investigational Site
City
Le Chesnay
Country
France
Facility Name
1123.28.3336A Boehringer Ingelheim Investigational Site
City
Le Port-Marly
Country
France
Facility Name
1123.28.3301A Boehringer Ingelheim Investigational Site
City
Lille Cedex
Country
France
Facility Name
1123.28.3301B Boehringer Ingelheim Investigational Site
City
Lille Cedex
Country
France
Facility Name
1123.28.3325A Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
1123.28.3325B Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
1123.28.3326A Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
1123.28.3318A Boehringer Ingelheim Investigational Site
City
Lyon cedex 3
Country
France
Facility Name
1123.28.3318B Boehringer Ingelheim Investigational Site
City
Lyon cedex 3
Country
France
Facility Name
1123.28.3318C Boehringer Ingelheim Investigational Site
City
Lyon cedex 3
Country
France
Facility Name
1123.28.3369A Boehringer Ingelheim Investigational Site
City
Lyon cedex 4
Country
France
Facility Name
1123.28.3369B Boehringer Ingelheim Investigational Site
City
Lyon cedex 4
Country
France
Facility Name
1123.28.3356A Boehringer Ingelheim Investigational Site
City
Lyon cedex 7
Country
France
Facility Name
1123.28.3356B Boehringer Ingelheim Investigational Site
City
Lyon cedex 7
Country
France
Facility Name
1123.28.3308A Boehringer Ingelheim Investigational Site
City
Melun cedex
Country
France
Facility Name
1123.28.3308B Boehringer Ingelheim Investigational Site
City
Melun cedex
Country
France
Facility Name
1123.28.3340A Boehringer Ingelheim Investigational Site
City
Melun
Country
France
Facility Name
1123.28.3340B Boehringer Ingelheim Investigational Site
City
Melun
Country
France
Facility Name
1123.28.3379A Boehringer Ingelheim Investigational Site
City
Montelimar Cedex
Country
France
Facility Name
1123.28.3328A Boehringer Ingelheim Investigational Site
City
Montfermeil
Country
France
Facility Name
1123.28.3328B Boehringer Ingelheim Investigational Site
City
Montfermeil
Country
France
Facility Name
1123.28.3328C Boehringer Ingelheim Investigational Site
City
Montfermeil
Country
France
Facility Name
1123.28.3349A Boehringer Ingelheim Investigational Site
City
Nantes Cedex 1
Country
France
Facility Name
1123.28.3349B Boehringer Ingelheim Investigational Site
City
Nantes Cedex 1
Country
France
Facility Name
1123.28.3313A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1123.28.3313B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
1123.28.3322A Boehringer Ingelheim Investigational Site
City
Nice cedex 1
Country
France
Facility Name
1123.28.3322B Boehringer Ingelheim Investigational Site
City
Nice cedex 1
Country
France
Facility Name
1123.28.3322C Boehringer Ingelheim Investigational Site
City
Nice cedex 1
Country
France
Facility Name
1123.28.3366A Boehringer Ingelheim Investigational Site
City
Nice cedex 1
Country
France
Facility Name
1123.28.3375A Boehringer Ingelheim Investigational Site
City
Oyonnax
Country
France
Facility Name
1123.28.3334A Boehringer Ingelheim Investigational Site
City
Paris cedex 10
Country
France
Facility Name
1123.28.3331A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1123.28.3371A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1123.28.3357A Boehringer Ingelheim Investigational Site
City
Pessac
Country
France
Facility Name
1123.28.3338A Boehringer Ingelheim Investigational Site
City
Poissy
Country
France
Facility Name
1123.28.3316A Boehringer Ingelheim Investigational Site
City
Pringy Cedex
Country
France
Facility Name
1123.28.3352A Boehringer Ingelheim Investigational Site
City
Pringy Cedex
Country
France
Facility Name
1123.28.3341A Boehringer Ingelheim Investigational Site
City
Quincy-sous-Senart
Country
France
Facility Name
1123.28.3378A Boehringer Ingelheim Investigational Site
City
Romans sur Isère
Country
France
Facility Name
1123.28.3310A Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
1123.28.3310B Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
1123.28.3344A Boehringer Ingelheim Investigational Site
City
Rouen Cedex
Country
France
Facility Name
1123.28.3345A Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1123.28.3345B Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1123.28.3345C Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1123.28.3377A Boehringer Ingelheim Investigational Site
City
Valence Cedex 9
Country
France
Facility Name
1123.28.3384A Boehringer Ingelheim Investigational Site
City
Valence Cedex 9
Country
France
Facility Name
1123.28.3373A Boehringer Ingelheim Investigational Site
City
Vienne Cedex 9
Country
France
Facility Name
1123.28.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1123.28.49006 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1123.28.49008 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1123.28.49012 Boehringer Ingelheim Investigational Site
City
Duisburg
Country
Germany
Facility Name
1123.28.49052 Boehringer Ingelheim Investigational Site
City
Frankenthal
Country
Germany
Facility Name
1123.28.49026 Boehringer Ingelheim Investigational Site
City
Sömmerda
Country
Germany
Facility Name
1123.28.30012 Boehringer Ingelheim Investigational Site
City
Alexandroupolis
Country
Greece
Facility Name
1123.28.30001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1123.28.30003 Boehringer Ingelheim Investigational Site
City
Chalikida
Country
Greece
Facility Name
1123.28.30011 Boehringer Ingelheim Investigational Site
City
Katerini
Country
Greece
Facility Name
1123.28.30014 Boehringer Ingelheim Investigational Site
City
Kavala
Country
Greece
Facility Name
1123.28.30006 Boehringer Ingelheim Investigational Site
City
Korinthos
Country
Greece
Facility Name
1123.28.30002 Boehringer Ingelheim Investigational Site
City
Leivadia
Country
Greece
Facility Name
1123.28.30007 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1123.28.30010 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1123.28.30005 Boehringer Ingelheim Investigational Site
City
Thiva
Country
Greece
Facility Name
1123.28.30009 Boehringer Ingelheim Investigational Site
City
Veroia
Country
Greece
Facility Name
1123.28.39201 Boehringer Ingelheim Investigational Site
City
Ferrara
Country
Italy
Facility Name
1123.28.39002A Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1123.28.39022 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1123.28.39004A Boehringer Ingelheim Investigational Site
City
Imperia
Country
Italy
Facility Name
1123.28.39200A Boehringer Ingelheim Investigational Site
City
Lagosanto (FE)
Country
Italy
Facility Name
1123.28.39001A Boehringer Ingelheim Investigational Site
City
Monza
Country
Italy
Facility Name
1123.28.39011 Boehringer Ingelheim Investigational Site
City
Monza
Country
Italy
Facility Name
1123.28.39082 Boehringer Ingelheim Investigational Site
City
Pescia (Pistoia)
Country
Italy
Facility Name
1123.28.39083 Boehringer Ingelheim Investigational Site
City
Pescia (Pistoia)
Country
Italy
Facility Name
1123.28.39008A Boehringer Ingelheim Investigational Site
City
Pistoia
Country
Italy
Facility Name
1123.28.39081 Boehringer Ingelheim Investigational Site
City
Pistoia
Country
Italy
Facility Name
1123.28.39041 Boehringer Ingelheim Investigational Site
City
Sanremo (IM)
Country
Italy
Facility Name
1123.28.47005 Boehringer Ingelheim Investigational Site
City
Hamar
Country
Norway
Facility Name
1123.28.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1123.28.47002 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1123.28.19001 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1123.28.19004 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1123.28.48002 Boehringer Ingelheim Investigational Site
City
Gniezno
Country
Poland
Facility Name
1123.28.48006 Boehringer Ingelheim Investigational Site
City
Gniezno
Country
Poland
Facility Name
1123.28.48009 Boehringer Ingelheim Investigational Site
City
Grodzisk Wielopolski
Country
Poland
Facility Name
1123.28.48001 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1123.28.70005 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1123.28.77005 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1123.28.70001 Boehringer Ingelheim Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
1123.28.77001 Boehringer Ingelheim Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
1123.28.70009 Boehringer Ingelheim Investigational Site
City
Irkutsk
Country
Russian Federation
Facility Name
1123.28.77009 Boehringer Ingelheim Investigational Site
City
Irkutsk
Country
Russian Federation
Facility Name
1123.28.70002 Boehringer Ingelheim Investigational Site
City
Kemerovo
Country
Russian Federation
Facility Name
1123.28.77002 Boehringer Ingelheim Investigational Site
City
Kemerovo
Country
Russian Federation
Facility Name
1123.28.70008 Boehringer Ingelheim Investigational Site
City
Murmansk
Country
Russian Federation
Facility Name
1123.28.77008 Boehringer Ingelheim Investigational Site
City
Murmansk
Country
Russian Federation
Facility Name
1123.28.77003 Boehringer Ingelheim Investigational Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
1123.28.70003 Boehringer Ingelheim Investigational Site
City
Nizhnyi Novgorod
Country
Russian Federation
Facility Name
1123.28.70006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1123.28.70007 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1123.28.77006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1123.28.70004 Boehringer Ingelheim Investigational Site
City
Tomsk
Country
Russian Federation
Facility Name
1123.28.77004 Boehringer Ingelheim Investigational Site
City
Tomsk
Country
Russian Federation
Facility Name
1123.28.38101 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1123.28.38103 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1123.28.38104 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1123.28.38106 Boehringer Ingelheim Investigational Site
City
Nis
Country
Serbia
Facility Name
1123.28.38107 Boehringer Ingelheim Investigational Site
City
Nis
Country
Serbia
Facility Name
1123.28.38109 Boehringer Ingelheim Investigational Site
City
Sabac
Country
Serbia
Facility Name
1123.28.38108 Boehringer Ingelheim Investigational Site
City
Smederevo
Country
Serbia
Facility Name
1123.28.38110 Boehringer Ingelheim Investigational Site
City
Vrsac
Country
Serbia
Facility Name
1123.28.38111 Boehringer Ingelheim Investigational Site
City
Zajecar
Country
Serbia
Facility Name
1123.28.38104 Boehringer Ingelheim Investigational Site
City
Zemun
Country
Serbia
Facility Name
1123.28.38105 Boehringer Ingelheim Investigational Site
City
Zemun
Country
Serbia
Facility Name
1123.28.34001 Boehringer Ingelheim Investigational Site
City
Almeria
Country
Spain
Facility Name
1123.28.34004 Boehringer Ingelheim Investigational Site
City
Granada
Country
Spain
Facility Name
1123.28.34003 Boehringer Ingelheim Investigational Site
City
Huelva
Country
Spain
Facility Name
1123.28.34007 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1123.28.34002 Boehringer Ingelheim Investigational Site
City
Malaga
Country
Spain
Facility Name
1123.28.34011 Boehringer Ingelheim Investigational Site
City
Salamanca
Country
Spain
Facility Name
1123.28.44600 Boehringer Ingelheim Investigational Site
City
Belfast
Country
United Kingdom
Facility Name
1123.28.44610 Boehringer Ingelheim Investigational Site
City
Belfast
Country
United Kingdom
Facility Name
1123.28.44210 Boehringer Ingelheim Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
1123.28.44220 Boehringer Ingelheim Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
1123.28.44200 Boehringer Ingelheim Investigational Site
City
Chippenham
Country
United Kingdom
Facility Name
1123.28.44620 Boehringer Ingelheim Investigational Site
City
Dundonald
Country
United Kingdom
Facility Name
1123.28.44110 Boehringer Ingelheim Investigational Site
City
Leicester
Country
United Kingdom
Facility Name
1123.28.44630 Boehringer Ingelheim Investigational Site
City
Newry
Country
United Kingdom
Facility Name
1123.28.44100 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28525886
Citation
Shavadia J, Welsh R, Gershlick A, Zheng Y, Huber K, Halvorsen S, Steg PG, Van de Werf F, Armstrong PW. Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study. J Am Heart Assoc. 2016 Jun 13;5(6):e003559. doi: 10.1161/JAHA.116.003559.
Results Reference
derived
PubMed Identifier
26783237
Citation
Bainey KR, Fresco C, Zheng Y, Halvorsen S, Carvalho A, Ostojic M, Goldstein P, Gershlick AH, Westerhout CM, Van de Werf F, Armstrong PW; STREAM Investigators. Implications of ischaemic area at risk and mode of reperfusion in ST-elevation myocardial infarction. Heart. 2016 Apr;102(7):527-33. doi: 10.1136/heartjnl-2015-308075. Epub 2016 Jan 18.
Results Reference
derived
PubMed Identifier
26304934
Citation
Shavadia J, Zheng Y, Dianati Maleki N, Huber K, Halvorsen S, Goldstein P, Gershlick AH, Wilcox R, Van de Werf F, Armstrong PW. Infarct Size, Shock, and Heart Failure: Does Reperfusion Strategy Matter in Early Presenting Patients With ST-Segment Elevation Myocardial Infarction? J Am Heart Assoc. 2015 Aug 24;4(8):e002049. doi: 10.1161/JAHA.115.002049.
Results Reference
derived
PubMed Identifier
25691510
Citation
Gershlick AH, Westerhout CM, Armstrong PW, Huber K, Halvorsen S, Steg PG, Ostojic M, Goldstein P, Carvalho AC, Van de Werf F, Wilcox RG. Impact of a pharmacoinvasive strategy when delays to primary PCI are prolonged. Heart. 2015 May;101(9):692-8. doi: 10.1136/heartjnl-2014-306686. Epub 2015 Feb 17.
Results Reference
derived
PubMed Identifier
25161043
Citation
Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.
Results Reference
derived
PubMed Identifier
24916050
Citation
Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.
Results Reference
derived
PubMed Identifier
23473396
Citation
Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.
Results Reference
derived
PubMed Identifier
20598969
Citation
Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
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STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

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