Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001219-44 | EudraCT Number | EudraCT |
Not provided
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This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.
The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.
All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase | Experimental | Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention |
|
| primary PCI | Other | Standard primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary PCI | Procedure | Standard primary PCI |
| |
| enoxaparin |
| 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 |
| 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 |
Not provided
Inclusion criteria:
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
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1123.28.43009 Boehringer Ingelheim Investigational Site | Salzburg | Austria | ||||
| 1123.28.43010 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41619999 | Derived | 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. | |
| 39952376 | Derived |
Not provided
Not provided
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Open-label, prospective, randomised, parallel, comparative international multicentre trial
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tenecteplase (Group A) | Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment) |
| FG001 | Primary PCI (Group B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Adjunctive treatment |
|
| catheterisation | Procedure | Routine or rescue coronary intervention |
|
| tenecteplase | Drug | Single, weight-adjusted i.v. bolus of tenecteplase |
|
| clopidogrel | Drug | Adjunctive treatment |
|
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 |
| Salzburg |
| Austria |
| 1123.28.43001 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43002 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43003 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43004 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43005 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43007 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.43008 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1123.28.32060 Boehringer Ingelheim Investigational Site | Bornem | Belgium |
| 1123.28.32010 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1123.28.32070 Boehringer Ingelheim Investigational Site | Herentals | Belgium |
| 1123.28.32040 Boehringer Ingelheim Investigational Site | Liège | Belgium |
| 1123.28.55010 Boehringer Ingelheim Investigational Site | Brasília | Brazil |
| 1123.28.55020 Boehringer Ingelheim Investigational Site | Brasília | Brazil |
| 1123.28.55008 Boehringer Ingelheim Investigational Site | Cabo Frio | Brazil |
| 1123.28.55017 Boehringer Ingelheim Investigational Site | Campinas | Brazil |
| 1123.28.55007 Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil |
| 1123.28.55001 Boehringer Ingelheim Investigational Site | Recife | Brazil |
| 1123.28.55018 Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil |
| 1123.28.55028 Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil |
| 1123.28.55016 Boehringer Ingelheim Investigational Site | Sao Lourenço Do Sul | Brazil |
| 1123.28.55004 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 1123.28.55014 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 1123.28.11006 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1123.28.11505 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1123.28.11002 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 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 | Santiago | Chile |
| 1123.28.3376A Boehringer Ingelheim Investigational Site | Ambérieu-en-Bugey | France |
| 1123.28.3329A Boehringer Ingelheim Investigational Site | Aubervilliers | France |
| 1123.28.3329B Boehringer Ingelheim Investigational Site | Aubervilliers | France |
| 1123.28.3329C Boehringer Ingelheim Investigational Site | Aubervilliers | France |
| 1123.28.3315A Boehringer Ingelheim Investigational Site | Besançon | France |
| 1123.28.3315B Boehringer Ingelheim Investigational Site | Besançon | France |
| 1123.28.3351A Boehringer Ingelheim Investigational Site | Besançon | France |
| 1123.28.3351B Boehringer Ingelheim Investigational Site | Besançon | France |
| 1123.28.3302A Boehringer Ingelheim Investigational Site | Bobigny | France |
| 1123.28.3302B Boehringer Ingelheim Investigational Site | Bobigny | France |
| 1123.28.3319A Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1123.28.3319B Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1123.28.3319C Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1123.28.3374A Boehringer Ingelheim Investigational Site | Bourg-en-Bresse | France |
| 1123.28.3383A Boehringer Ingelheim Investigational Site | Bourg-en-Bresse | France |
| 1123.28.3385A Boehringer Ingelheim Investigational Site | Bourg-en-Bresse | 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 | Bourges | France |
| 1123.28.3355A Boehringer Ingelheim Investigational Site | Bron | France |
| 1123.28.3355B Boehringer Ingelheim Investigational Site | Bron | France |
| 1123.28.3382A Boehringer Ingelheim Investigational Site | Caluire-et-Cuire | France |
| 1123.28.3311A Boehringer Ingelheim Investigational Site | Châteauroux | France |
| 1123.28.3311B Boehringer Ingelheim Investigational Site | Châteauroux | France |
| 1123.28.3346A Boehringer Ingelheim Investigational Site | Châteauroux | France |
| 1123.28.3346B Boehringer Ingelheim Investigational Site | Châteauroux | France |
| 1123.28.3303A Boehringer Ingelheim Investigational Site | Clichy | France |
| 1123.28.3309A Boehringer Ingelheim Investigational Site | Dreux | France |
| 1123.28.3342A Boehringer Ingelheim Investigational Site | Dreux | France |
| 1123.28.3337A Boehringer Ingelheim Investigational Site | Évecquemont | France |
| 1123.28.3387A Boehringer Ingelheim Investigational Site | Fort de France Cedex | France |
| 1123.28.3388A Boehringer Ingelheim Investigational Site | Fort de France Cedex | France |
| 1123.28.3353A Boehringer Ingelheim Investigational Site | Grenoble | France |
| 1123.28.3353B Boehringer Ingelheim Investigational Site | Grenoble | France |
| 1123.28.3317A Boehringer Ingelheim Investigational Site | La Tronche | France |
| 1123.28.3317B Boehringer Ingelheim Investigational Site | La Tronche | France |
| 1123.28.3307A Boehringer Ingelheim Investigational Site | Le Chesnay | France |
| 1123.28.3339A Boehringer Ingelheim Investigational Site | Le Chesnay | France |
| 1123.28.3339B Boehringer Ingelheim Investigational Site | Le Chesnay | France |
| 1123.28.3336A Boehringer Ingelheim Investigational Site | Le Port-Marly | France |
| 1123.28.3301A Boehringer Ingelheim Investigational Site | Lille | France |
| 1123.28.3301B Boehringer Ingelheim Investigational Site | Lille | France |
| 1123.28.3325A Boehringer Ingelheim Investigational Site | Lille | France |
| 1123.28.3325B Boehringer Ingelheim Investigational Site | Lille | France |
| 1123.28.3326A Boehringer Ingelheim Investigational Site | Lille | France |
| 1123.28.3318A Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3318B Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3318C Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3356A Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3356B Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3369A Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3369B Boehringer Ingelheim Investigational Site | Lyon | France |
| 1123.28.3308A Boehringer Ingelheim Investigational Site | Melun | France |
| 1123.28.3308B Boehringer Ingelheim Investigational Site | Melun | France |
| 1123.28.3340A Boehringer Ingelheim Investigational Site | Melun | France |
| 1123.28.3340B Boehringer Ingelheim Investigational Site | Melun | France |
| 1123.28.3379A Boehringer Ingelheim Investigational Site | Montélimar | 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 | Montfermeil | France |
| 1123.28.3313A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1123.28.3313B Boehringer Ingelheim Investigational Site | Nantes | France |
| 1123.28.3349A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1123.28.3349B Boehringer Ingelheim Investigational Site | Nantes | France |
| 1123.28.3322A Boehringer Ingelheim Investigational Site | Nice | France |
| 1123.28.3322B Boehringer Ingelheim Investigational Site | Nice | France |
| 1123.28.3322C Boehringer Ingelheim Investigational Site | Nice | France |
| 1123.28.3366A Boehringer Ingelheim Investigational Site | Nice | France |
| 1123.28.3375A Boehringer Ingelheim Investigational Site | Oyonnax | France |
| 1123.28.3331A Boehringer Ingelheim Investigational Site | Paris | France |
| 1123.28.3334A Boehringer Ingelheim Investigational Site | Paris | France |
| 1123.28.3371A Boehringer Ingelheim Investigational Site | Paris | France |
| 1123.28.3357A Boehringer Ingelheim Investigational Site | Pessac | France |
| 1123.28.3338A Boehringer Ingelheim Investigational Site | Poissy | France |
| 1123.28.3316A Boehringer Ingelheim Investigational Site | Pringy | France |
| 1123.28.3352A Boehringer Ingelheim Investigational Site | Pringy | France |
| 1123.28.3341A Boehringer Ingelheim Investigational Site | Quincy-sous-Sénart | France |
| 1123.28.3378A Boehringer Ingelheim Investigational Site | Romans-sur-Isère | France |
| 1123.28.3310A Boehringer Ingelheim Investigational Site | Rouen | France |
| 1123.28.3310B Boehringer Ingelheim Investigational Site | Rouen | France |
| 1123.28.3344A 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 | France |
| 1123.28.3377A Boehringer Ingelheim Investigational Site | Valence | France |
| 1123.28.3384A Boehringer Ingelheim Investigational Site | Valence | France |
| 1123.28.3373A Boehringer Ingelheim Investigational Site | Vienne | France |
| 1123.28.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1123.28.49006 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1123.28.49008 Boehringer Ingelheim Investigational Site | Dortmund | Germany |
| 1123.28.49012 Boehringer Ingelheim Investigational Site | Duisburg | Germany |
| 1123.28.49052 Boehringer Ingelheim Investigational Site | Frankenthal | Germany |
| 1123.28.49026 Boehringer Ingelheim Investigational Site | Sömmerda | Germany |
| 1123.28.30012 Boehringer Ingelheim Investigational Site | Alexandroupoli | Greece |
| 1123.28.30001 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1123.28.30003 Boehringer Ingelheim Investigational Site | Chalikida | Greece |
| 1123.28.30006 Boehringer Ingelheim Investigational Site | Corinth | Greece |
| 1123.28.30011 Boehringer Ingelheim Investigational Site | Katerini | Greece |
| 1123.28.30014 Boehringer Ingelheim Investigational Site | Kavala | Greece |
| 1123.28.30002 Boehringer Ingelheim Investigational Site | Livadeia | Greece |
| 1123.28.30005 Boehringer Ingelheim Investigational Site | Thebes | Greece |
| 1123.28.30007 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1123.28.30010 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1123.28.30009 Boehringer Ingelheim Investigational Site | Véroia | Greece |
| 1123.28.39201 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1123.28.39002A Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1123.28.39022 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1123.28.39004A Boehringer Ingelheim Investigational Site | Imperia | Italy |
| 1123.28.39200A Boehringer Ingelheim Investigational Site | Lagosanto (FE) | Italy |
| 1123.28.39001A Boehringer Ingelheim Investigational Site | Monza | Italy |
| 1123.28.39011 Boehringer Ingelheim Investigational Site | Monza | Italy |
| 1123.28.39082 Boehringer Ingelheim Investigational Site | Pescia (Pistoia) | Italy |
| 1123.28.39083 Boehringer Ingelheim Investigational Site | Pescia (Pistoia) | Italy |
| 1123.28.39008A Boehringer Ingelheim Investigational Site | Pistoia | Italy |
| 1123.28.39081 Boehringer Ingelheim Investigational Site | Pistoia | Italy |
| 1123.28.39041 Boehringer Ingelheim Investigational Site | Sanremo (IM) | Italy |
| 1123.28.47005 Boehringer Ingelheim Investigational Site | Hamar | Norway |
| 1123.28.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1123.28.47002 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1123.28.19001 Boehringer Ingelheim Investigational Site | Lima | Peru |
| 1123.28.19004 Boehringer Ingelheim Investigational Site | Lima | Peru |
| 1123.28.48002 Boehringer Ingelheim Investigational Site | Gniezno | Poland |
| 1123.28.48006 Boehringer Ingelheim Investigational Site | Gniezno | Poland |
| 1123.28.48009 Boehringer Ingelheim Investigational Site | Grodzisk Wielopolski | Poland |
| 1123.28.48001 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 1123.28.70005 Boehringer Ingelheim Investigational Site | Chelyabinsk | Russia |
| 1123.28.77005 Boehringer Ingelheim Investigational Site | Chelyabinsk | Russia |
| 1123.28.70009 Boehringer Ingelheim Investigational Site | Irkutsk | Russia |
| 1123.28.77009 Boehringer Ingelheim Investigational Site | Irkutsk | Russia |
| 1123.28.70002 Boehringer Ingelheim Investigational Site | Kemerovo | Russia |
| 1123.28.77002 Boehringer Ingelheim Investigational Site | Kemerovo | Russia |
| 1123.28.70008 Boehringer Ingelheim Investigational Site | Murmansk | Russia |
| 1123.28.77008 Boehringer Ingelheim Investigational Site | Murmansk | Russia |
| 1123.28.77003 Boehringer Ingelheim Investigational Site | Nizhny Novgorod | Russia |
| 1123.28.70003 Boehringer Ingelheim Investigational Site | Nizhnyi Novgorod | Russia |
| 1123.28.70006 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1123.28.70007 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1123.28.77006 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1123.28.70004 Boehringer Ingelheim Investigational Site | Tomsk | Russia |
| 1123.28.77004 Boehringer Ingelheim Investigational Site | Tomsk | Russia |
| 1123.28.70001 Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
| 1123.28.77001 Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
| 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 | Belgrade | Serbia |
| 1123.28.38106 Boehringer Ingelheim Investigational Site | Niš | Serbia |
| 1123.28.38107 Boehringer Ingelheim Investigational Site | Niš | Serbia |
| 1123.28.38108 Boehringer Ingelheim Investigational Site | Smederevo | Serbia |
| 1123.28.38109 Boehringer Ingelheim Investigational Site | Šabac | Serbia |
| 1123.28.38110 Boehringer Ingelheim Investigational Site | Vršac | Serbia |
| 1123.28.38111 Boehringer Ingelheim Investigational Site | Zaječar | Serbia |
| 1123.28.38104 Boehringer Ingelheim Investigational Site | Zemun | Serbia |
| 1123.28.38105 Boehringer Ingelheim Investigational Site | Zemun | Serbia |
| 1123.28.34001 Boehringer Ingelheim Investigational Site | Almería | Spain |
| 1123.28.34004 Boehringer Ingelheim Investigational Site | Granada | Spain |
| 1123.28.34003 Boehringer Ingelheim Investigational Site | Huelva | Spain |
| 1123.28.34007 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1123.28.34002 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1123.28.34011 Boehringer Ingelheim Investigational Site | Salamanca | Spain |
| 1123.28.44600 Boehringer Ingelheim Investigational Site | Belfast | United Kingdom |
| 1123.28.44610 Boehringer Ingelheim Investigational Site | Belfast | United Kingdom |
| 1123.28.44210 Boehringer Ingelheim Investigational Site | Bristol | United Kingdom |
| 1123.28.44220 Boehringer Ingelheim Investigational Site | Bristol | United Kingdom |
| 1123.28.44200 Boehringer Ingelheim Investigational Site | Chippenham | United Kingdom |
| 1123.28.44620 Boehringer Ingelheim Investigational Site | Dundonald | United Kingdom |
| 1123.28.44110 Boehringer Ingelheim Investigational Site | Leicester | United Kingdom |
| 1123.28.44630 Boehringer Ingelheim Investigational Site | Newry | United Kingdom |
| 1123.28.44100 Boehringer Ingelheim Investigational Site | Nottingham | United Kingdom |
| 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. |
| 39689189 | Derived | 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. |
| 28525886 | Derived | 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. |
| 26783237 | Derived | 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. |
| 26304934 | Derived | 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. |
| 25691510 | Derived | 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. |
| 25161043 | Derived | 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. |
| 24916050 | Derived | 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. |
| 23473396 | Derived | 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. |
| 20598969 | Derived | 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. |
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards. Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS): All consented patients either randomised by Interactive Voice Response System (IVRS) or treated (i.e., manually allocated to treatment group) by the investigator. This population is also referred to as the intention-to-treat population (ITT).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tenecteplase (Group A) | Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment) |
| BG001 | Primary PCI (Group B) | Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards. Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | FAS | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | FAS | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full analysis set (FAS): All consented patients either randomised by Interactive Voice Response System (IVRS) or treated (i.e., manually allocated to treatment group) by the investigator. This population is also referred to as the intention-to-treat population (ITT). | Posted | Count of Participants | Participants | 30 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | FAS | Posted | Count of Participants | Participants | 30 days |
|
|
From first drug administration until end of tiral, up to 30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenecteplase (Group A) | Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment) | 43 | 949 | 146 | 949 | 0 | 949 |
| EG001 | Primary PCI (Group B) | Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards. Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines. | 42 | 948 | 164 | 948 | 0 | 948 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accelerated idioventricular rhythm | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myocardial rupture | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Parasystole | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Postinfarction angina | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Necrosis | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sputum purulent | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Toxic shock syndrome | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fat embolism | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood electrolytes abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulse absent | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myeloproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neuromyopathy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mechanical ventilation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
| |
| Resuscitation | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Not provided
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D002404 | Catheterization |
| D000077785 | Tenecteplase |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
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