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

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

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 Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: enoxaparin; Procedure: catheterisation; Drug: tenecteplase; Drug: clopidogrel; Procedure: primary PCI

• Study Type: Interventional
• Enrollment (Actual): 1899
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Clopidogrel; Enoxaparin; Tenecteplase
• Other Study ID Numbers: 1123.28; 2007-001219-44 (EudraCT Number: EudraCT)