AzTrials
AzTrials

Myocardial InfarctionPhase 3NCT00623623

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

A Phase 3 study testing primary PCI, enoxaparin and catheterisation in people with Myocardial Infarction, run by Boehringer Ingelheim at 201 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
primary PCI, enoxaparin and catheterisation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,899 participants
Where
201 sitesin 16 countries
Study dates
1 Mar 2008to 1 Sep 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

201 sites in 16 countries.

201 sites in 16 countries

France87 sites

  • 1123.28.3376A Boehringer Ingelheim Investigational Site

    Ambérieu-en-Bugey

  • 1123.28.3329A Boehringer Ingelheim Investigational Site

    Aubervilliers

  • 1123.28.3329B Boehringer Ingelheim Investigational Site

    Aubervilliers

  • 1123.28.3329C Boehringer Ingelheim Investigational Site

    Aubervilliers

  • 1123.28.3315A Boehringer Ingelheim Investigational Site

    Besançon

  • 1123.28.3315B Boehringer Ingelheim Investigational Site

    Besançon

  • 1123.28.3351A Boehringer Ingelheim Investigational Site

    Besançon

  • 1123.28.3351B Boehringer Ingelheim Investigational Site

    Besançon

  • 1123.28.3302A Boehringer Ingelheim Investigational Site

    Bobigny

  • 1123.28.3302B Boehringer Ingelheim Investigational Site

    Bobigny

  • 1123.28.3319A Boehringer Ingelheim Investigational Site

    Bordeaux

  • 1123.28.3319B Boehringer Ingelheim Investigational Site

    Bordeaux

  • 1123.28.3319C Boehringer Ingelheim Investigational Site

    Bordeaux

  • 1123.28.3374A Boehringer Ingelheim Investigational Site

    Bourg-en-Bresse

  • 1123.28.3383A Boehringer Ingelheim Investigational Site

    Bourg-en-Bresse

  • 1123.28.3385A Boehringer Ingelheim Investigational Site

    Bourg-en-Bresse

  • 1123.28.3347A Boehringer Ingelheim Investigational Site

    Bourges

  • 1123.28.3347B Boehringer Ingelheim Investigational Site

    Bourges

  • 1123.28.3347C Boehringer Ingelheim Investigational Site

    Bourges

  • 1123.28.3355A Boehringer Ingelheim Investigational Site

    Bron

  • 1123.28.3355B Boehringer Ingelheim Investigational Site

    Bron

  • 1123.28.3382A Boehringer Ingelheim Investigational Site

    Caluire-et-Cuire

  • 1123.28.3311A Boehringer Ingelheim Investigational Site

    Châteauroux

  • 1123.28.3311B Boehringer Ingelheim Investigational Site

    Châteauroux

  • 1123.28.3346A Boehringer Ingelheim Investigational Site

    Châteauroux

  • 1123.28.3346B Boehringer Ingelheim Investigational Site

    Châteauroux

  • 1123.28.3303A Boehringer Ingelheim Investigational Site

    Clichy

  • 1123.28.3309A Boehringer Ingelheim Investigational Site

    Dreux

  • 1123.28.3342A Boehringer Ingelheim Investigational Site

    Dreux

  • 1123.28.3337A Boehringer Ingelheim Investigational Site

    Évecquemont

  • 1123.28.3387A Boehringer Ingelheim Investigational Site

    Fort de France Cedex

  • 1123.28.3388A Boehringer Ingelheim Investigational Site

    Fort de France Cedex

  • 1123.28.3353A Boehringer Ingelheim Investigational Site

    Grenoble

  • 1123.28.3353B Boehringer Ingelheim Investigational Site

    Grenoble

  • 1123.28.3317A Boehringer Ingelheim Investigational Site

    La Tronche

  • 1123.28.3317B Boehringer Ingelheim Investigational Site

    La Tronche

  • 1123.28.3307A Boehringer Ingelheim Investigational Site

    Le Chesnay

  • 1123.28.3339A Boehringer Ingelheim Investigational Site

    Le Chesnay

  • 1123.28.3339B Boehringer Ingelheim Investigational Site

    Le Chesnay

  • 1123.28.3336A Boehringer Ingelheim Investigational Site

    Le Port-Marly

  • 1123.28.3301A Boehringer Ingelheim Investigational Site

    Lille

  • 1123.28.3301B Boehringer Ingelheim Investigational Site

    Lille

  • 1123.28.3325A Boehringer Ingelheim Investigational Site

    Lille

  • 1123.28.3325B Boehringer Ingelheim Investigational Site

    Lille

  • 1123.28.3326A Boehringer Ingelheim Investigational Site

    Lille

  • 1123.28.3318A Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3318B Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3318C Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3356A Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3356B Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3369A Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3369B Boehringer Ingelheim Investigational Site

    Lyon

  • 1123.28.3308A Boehringer Ingelheim Investigational Site

    Melun

  • 1123.28.3308B Boehringer Ingelheim Investigational Site

    Melun

  • 1123.28.3340A Boehringer Ingelheim Investigational Site

    Melun

  • 1123.28.3340B Boehringer Ingelheim Investigational Site

    Melun

  • 1123.28.3379A Boehringer Ingelheim Investigational Site

    Montélimar

  • 1123.28.3328A Boehringer Ingelheim Investigational Site

    Montfermeil

  • 1123.28.3328B Boehringer Ingelheim Investigational Site

    Montfermeil

  • 1123.28.3328C Boehringer Ingelheim Investigational Site

    Montfermeil

  • 1123.28.3313A Boehringer Ingelheim Investigational Site

    Nantes

  • 1123.28.3313B Boehringer Ingelheim Investigational Site

    Nantes

  • 1123.28.3349A Boehringer Ingelheim Investigational Site

    Nantes

  • 1123.28.3349B Boehringer Ingelheim Investigational Site

    Nantes

  • 1123.28.3322A Boehringer Ingelheim Investigational Site

    Nice

  • 1123.28.3322B Boehringer Ingelheim Investigational Site

    Nice

  • 1123.28.3322C Boehringer Ingelheim Investigational Site

    Nice

  • 1123.28.3366A Boehringer Ingelheim Investigational Site

    Nice

  • 1123.28.3375A Boehringer Ingelheim Investigational Site

    Oyonnax

  • 1123.28.3331A Boehringer Ingelheim Investigational Site

    Paris

  • 1123.28.3334A Boehringer Ingelheim Investigational Site

    Paris

  • 1123.28.3371A Boehringer Ingelheim Investigational Site

    Paris

  • 1123.28.3357A Boehringer Ingelheim Investigational Site

    Pessac

  • 1123.28.3338A Boehringer Ingelheim Investigational Site

    Poissy

  • 1123.28.3316A Boehringer Ingelheim Investigational Site

    Pringy

  • 1123.28.3352A Boehringer Ingelheim Investigational Site

    Pringy

  • 1123.28.3341A Boehringer Ingelheim Investigational Site

    Quincy-sous-Sénart

  • 1123.28.3378A Boehringer Ingelheim Investigational Site

    Romans-sur-Isère

  • 1123.28.3310A Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3310B Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3344A Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3345A Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3345B Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3345C Boehringer Ingelheim Investigational Site

    Rouen

  • 1123.28.3377A Boehringer Ingelheim Investigational Site

    Valence

  • 1123.28.3384A Boehringer Ingelheim Investigational Site

    Valence

  • 1123.28.3373A Boehringer Ingelheim Investigational Site

    Vienne

Other trials in France

Russia17 sites

  • 1123.28.70005 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1123.28.77005 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1123.28.70009 Boehringer Ingelheim Investigational Site

    Irkutsk

  • 1123.28.77009 Boehringer Ingelheim Investigational Site

    Irkutsk

  • 1123.28.70002 Boehringer Ingelheim Investigational Site

    Kemerovo

  • 1123.28.77002 Boehringer Ingelheim Investigational Site

    Kemerovo

  • 1123.28.70008 Boehringer Ingelheim Investigational Site

    Murmansk

  • 1123.28.77008 Boehringer Ingelheim Investigational Site

    Murmansk

  • 1123.28.77003 Boehringer Ingelheim Investigational Site

    Nizhny Novgorod

  • 1123.28.70003 Boehringer Ingelheim Investigational Site

    Nizhnyi Novgorod

  • 1123.28.70006 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1123.28.70007 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1123.28.77006 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1123.28.70004 Boehringer Ingelheim Investigational Site

    Tomsk

  • 1123.28.77004 Boehringer Ingelheim Investigational Site

    Tomsk

  • 1123.28.70001 Boehringer Ingelheim Investigational Site

    Yekaterinburg

  • 1123.28.77001 Boehringer Ingelheim Investigational Site

    Yekaterinburg

Other trials in Russia

Italy12 sites

  • 1123.28.39201 Boehringer Ingelheim Investigational Site

    Ferrara

  • 1123.28.39002A Boehringer Ingelheim Investigational Site

    Genova

  • 1123.28.39022 Boehringer Ingelheim Investigational Site

    Genova

  • 1123.28.39004A Boehringer Ingelheim Investigational Site

    Imperia

  • 1123.28.39200A Boehringer Ingelheim Investigational Site

    Lagosanto (FE)

  • 1123.28.39001A Boehringer Ingelheim Investigational Site

    Monza

  • 1123.28.39011 Boehringer Ingelheim Investigational Site

    Monza

  • 1123.28.39082 Boehringer Ingelheim Investigational Site

    Pescia (Pistoia)

  • 1123.28.39083 Boehringer Ingelheim Investigational Site

    Pescia (Pistoia)

  • 1123.28.39008A Boehringer Ingelheim Investigational Site

    Pistoia

  • 1123.28.39081 Boehringer Ingelheim Investigational Site

    Pistoia

  • 1123.28.39041 Boehringer Ingelheim Investigational Site

    Sanremo (IM)

Other trials in Italy

Brazil11 sites

  • 1123.28.55010 Boehringer Ingelheim Investigational Site

    Brasília

  • 1123.28.55020 Boehringer Ingelheim Investigational Site

    Brasília

  • 1123.28.55008 Boehringer Ingelheim Investigational Site

    Cabo Frio

  • 1123.28.55017 Boehringer Ingelheim Investigational Site

    Campinas

  • 1123.28.55007 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 1123.28.55001 Boehringer Ingelheim Investigational Site

    Recife

  • 1123.28.55018 Boehringer Ingelheim Investigational Site

    Rio de Janeiro

  • 1123.28.55028 Boehringer Ingelheim Investigational Site

    Rio de Janeiro

  • 1123.28.55016 Boehringer Ingelheim Investigational Site

    Sao Lourenço Do Sul

  • 1123.28.55004 Boehringer Ingelheim Investigational Site

    São Paulo

  • 1123.28.55014 Boehringer Ingelheim Investigational Site

    São Paulo

Other trials in Brazil

Greece11 sites

  • 1123.28.30012 Boehringer Ingelheim Investigational Site

    Alexandroupoli

  • 1123.28.30001 Boehringer Ingelheim Investigational Site

    Athens

  • 1123.28.30003 Boehringer Ingelheim Investigational Site

    Chalikida

  • 1123.28.30006 Boehringer Ingelheim Investigational Site

    Corinth

  • 1123.28.30011 Boehringer Ingelheim Investigational Site

    Katerini

  • 1123.28.30014 Boehringer Ingelheim Investigational Site

    Kavala

  • 1123.28.30002 Boehringer Ingelheim Investigational Site

    Livadeia

  • 1123.28.30005 Boehringer Ingelheim Investigational Site

    Thebes

  • 1123.28.30007 Boehringer Ingelheim Investigational Site

    Thessaloniki

  • 1123.28.30010 Boehringer Ingelheim Investigational Site

    Thessaloniki

  • 1123.28.30009 Boehringer Ingelheim Investigational Site

    Véroia

Other trials in Greece

Serbia11 sites

  • 1123.28.38101 Boehringer Ingelheim Investigational Site

    Belgrade

  • 1123.28.38103 Boehringer Ingelheim Investigational Site

    Belgrade

  • 1123.28.38104 Boehringer Ingelheim Investigational Site

    Belgrade

  • 1123.28.38106 Boehringer Ingelheim Investigational Site

    Niš

  • 1123.28.38107 Boehringer Ingelheim Investigational Site

    Niš

  • 1123.28.38109 Boehringer Ingelheim Investigational Site

    Šabac

  • 1123.28.38108 Boehringer Ingelheim Investigational Site

    Smederevo

  • 1123.28.38110 Boehringer Ingelheim Investigational Site

    Vršac

  • 1123.28.38111 Boehringer Ingelheim Investigational Site

    Zaječar

  • 1123.28.38104 Boehringer Ingelheim Investigational Site

    Zemun

  • 1123.28.38105 Boehringer Ingelheim Investigational Site

    Zemun

Other trials in Serbia

Austria9 sites

  • 1123.28.43009 Boehringer Ingelheim Investigational Site

    Salzburg

  • 1123.28.43010 Boehringer Ingelheim Investigational Site

    Salzburg

  • 1123.28.43001 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43002 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43003 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43004 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43005 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43007 Boehringer Ingelheim Investigational Site

    Vienna

  • 1123.28.43008 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

United Kingdom9 sites

  • 1123.28.44600 Boehringer Ingelheim Investigational Site

    Belfast

  • 1123.28.44610 Boehringer Ingelheim Investigational Site

    Belfast

  • 1123.28.44210 Boehringer Ingelheim Investigational Site

    Bristol

  • 1123.28.44220 Boehringer Ingelheim Investigational Site

    Bristol

  • 1123.28.44200 Boehringer Ingelheim Investigational Site

    Chippenham

  • 1123.28.44620 Boehringer Ingelheim Investigational Site

    Dundonald

  • 1123.28.44110 Boehringer Ingelheim Investigational Site

    Leicester

  • 1123.28.44630 Boehringer Ingelheim Investigational Site

    Newry

  • 1123.28.44100 Boehringer Ingelheim Investigational Site

    Nottingham

Other trials in United Kingdom

Chile6 sites

  • 1123.28.13001 Boehringer Ingelheim Investigational Site

    Santiago

  • 1123.28.13002 Boehringer Ingelheim Investigational Site

    Santiago

  • 1123.28.13003 Boehringer Ingelheim Investigational Site

    Santiago

  • 1123.28.13004 Boehringer Ingelheim Investigational Site

    Santiago

  • 1123.28.13005 Boehringer Ingelheim Investigational Site

    Santiago

  • 1123.28.13006 Boehringer Ingelheim Investigational Site

    Santiago

Other trials in Chile

Germany6 sites

  • 1123.28.49002 Boehringer Ingelheim Investigational Site

    Berlin

  • 1123.28.49006 Boehringer Ingelheim Investigational Site

    Berlin

  • 1123.28.49008 Boehringer Ingelheim Investigational Site

    Dortmund

  • 1123.28.49012 Boehringer Ingelheim Investigational Site

    Duisburg

  • 1123.28.49052 Boehringer Ingelheim Investigational Site

    Frankenthal

  • 1123.28.49026 Boehringer Ingelheim Investigational Site

    Sömmerda

Other trials in Germany

Spain6 sites

  • 1123.28.34001 Boehringer Ingelheim Investigational Site

    Almería

  • 1123.28.34004 Boehringer Ingelheim Investigational Site

    Granada

  • 1123.28.34003 Boehringer Ingelheim Investigational Site

    Huelva

  • 1123.28.34007 Boehringer Ingelheim Investigational Site

    Madrid

  • 1123.28.34002 Boehringer Ingelheim Investigational Site

    Málaga

  • 1123.28.34011 Boehringer Ingelheim Investigational Site

    Salamanca

Other trials in Spain

Belgium4 sites

  • 1123.28.32060 Boehringer Ingelheim Investigational Site

    Bornem

  • 1123.28.32010 Boehringer Ingelheim Investigational Site

    Brussels

  • 1123.28.32070 Boehringer Ingelheim Investigational Site

    Herentals

  • 1123.28.32040 Boehringer Ingelheim Investigational Site

    Liège

Other trials in Belgium

Poland4 sites

  • 1123.28.48002 Boehringer Ingelheim Investigational Site

    Gniezno

  • 1123.28.48006 Boehringer Ingelheim Investigational Site

    Gniezno

  • 1123.28.48009 Boehringer Ingelheim Investigational Site

    Grodzisk Wielopolski

  • 1123.28.48001 Boehringer Ingelheim Investigational Site

    Poznan

Other trials in Poland

Canada3 sites

  • 1123.28.11006 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1123.28.11505 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1123.28.11002 Boehringer Ingelheim Investigational Site

    Newmarket, Ontario

Other trials in Canada

Norway3 sites

  • 1123.28.47005 Boehringer Ingelheim Investigational Site

    Hamar

  • 1123.28.47001 Boehringer Ingelheim Investigational Site

    Oslo

  • 1123.28.47002 Boehringer Ingelheim Investigational Site

    Oslo

Other trials in Norway

Peru2 sites

  • 1123.28.19001 Boehringer Ingelheim Investigational Site

    Lima

  • 1123.28.19004 Boehringer Ingelheim Investigational Site

    Lima

Other trials in Peru

About this study

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

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.

Being tested
primary PCI, enoxaparin, catheterisation, tenecteplase, clopidogrel
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • primary PCIProcedure or surgery

    Standard primary PCI

  • enoxaparinDrug

    Adjunctive treatment

  • catheterisationProcedure or surgery

    Routine or rescue coronary intervention

  • tenecteplaseDrug

    Single, weight-adjusted i.v. bolus of tenecteplase

  • clopidogrelDrug

    Adjunctive treatment

Study groups in NCT00623623
Study groupRoleWhat they receive
TenecteplaseExperimentalEarly tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Receives: Drug: enoxaparin; Procedure: catheterisation; Drug: tenecteplase; Drug: clopidogrel
primary PCIOtherStandard primary PCI
Receives: Procedure: primary PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 30 days

Secondary outcomes (24)

  1. 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.

    Measured: 30 days

  2. 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.

    Measured: 30 days

  3. 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.

    Measured: 30 days

  4. 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.

    Measured: 30 days

  5. 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

    Measured: 30 days

  6. 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

    Measured: 30 days

  7. 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

    Measured: 30 days

  8. 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

    Measured: 30 days

  9. 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

    Measured: 30 days

  10. 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.

    Measured: 30 days

  11. 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

    Measured: 30 days

  12. 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

    Measured: 30 days

  13. 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

    Measured: 30 days

  14. 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

    Measured: 30 days

  15. 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

    Measured: 30 days

  16. 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

    Measured: 30 days

  17. 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

    Measured: 30 days

  18. 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

    Measured: 30 days

  19. 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

    Measured: 30 days

  20. 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

    Measured: 30 days

  21. 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

    Measured: 30 days

  22. 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

    Measured: 30 days

  23. 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

    Measured: 30 days

  24. 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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2008 (estimated)
  2. Study start1 Mar 2008
  3. Primary completion1 Sep 2012
  4. Study completion1 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,899 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623623
Sponsor's protocol ID
1123.28
Other IDs
2007-001219-44
Status last verified
Jun 2019
First submitted
15 Feb 2008
Last updated
1 Aug 2019

Publications

  • Armstrong PW, Zheng Y, Welsh RC, Sinnaeve PR, Van de Werf F, Westerhout CM, Bainey KR. Primary percutaneous coronary intervention within the first hour: Insights from early-treated patients with ST-elevation myocardial infarction. Am Heart J. 2026 May;295:107363. doi: 10.1016/j.ahj.2026.107363. Epub 2026 Jan 29.

    PubMed 41619999

  • Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Temple T, Ly E, Bogaerts K, Sinnaeve P, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials. Am Heart J. 2025 Jun;284:20-31. doi: 10.1016/j.ahj.2025.02.002. Epub 2025 Feb 12.

    PubMed 39952376

  • Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Kerr Saraiva JF, Sepulveda P, Rosell-Ortiz F, French JK, Music LB, Temple T, Ly E, Bogaerts K, Sinnaeve PR, Danays T, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged >/=75 Years in STREAM-1 and 2. Circ Cardiovasc Interv. 2024 Dec;17(12):e014251. doi: 10.1161/CIRCINTERVENTIONS.124.014251. Epub 2024 Dec 17.

    PubMed 39689189

  • 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.

    PubMed 28525886

  • 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.

    PubMed 26783237

  • 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.

    PubMed 26304934

  • 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.

    PubMed 25691510

  • 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.

    PubMed 25161043

  • 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.

    PubMed 24916050

  • 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.

    PubMed 23473396

  • 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.

    PubMed 20598969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing primary PCI, enoxaparin and catheterisation in people with Myocardial Infarction, run by Boehringer Ingelheim at 201 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in France, Russia, Italy, Brazil, Greece and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623623, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.

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