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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623623
• Other study ID #: 1123.28
• Secondary ID: 2007-001219-44
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2008
• Est. completion date: September 1, 2012

Study information

• Verified date: June 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1899
• Est. completion date: September 1, 2012
• Est. primary completion date: September 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• primary PCI
Standard primary PCI

Drug:
• enoxaparin
Adjunctive treatment

Procedure:
• catheterisation
Routine or rescue coronary intervention

Drug:
• tenecteplase
Single, weight-adjusted i.v. bolus of tenecteplase
• clopidogrel
Adjunctive treatment

Locations

Country	Name	City	State
Austria	1123.28.43009 Boehringer Ingelheim Investigational Site	Salzburg
Austria	1123.28.43010 Boehringer Ingelheim Investigational Site	Salzburg
Austria	1123.28.43001 Boehringer Ingelheim Investigational Site	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	Wien
Belgium	1123.28.32060 Boehringer Ingelheim Investigational Site	Bornem
Belgium	1123.28.32010 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1123.28.32070 Boehringer Ingelheim Investigational Site	Herentals
Belgium	1123.28.32040 Boehringer Ingelheim Investigational Site	Liège
Brazil	1123.28.55010 Boehringer Ingelheim Investigational Site	Brasilia
Brazil	1123.28.55020 Boehringer Ingelheim Investigational Site	Brasilia
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	Sao Paulo
Brazil	1123.28.55014 Boehringer Ingelheim Investigational Site	Sao Paulo
Canada	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
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	Santiago
France	1123.28.3376A Boehringer Ingelheim Investigational Site	Ambérieu en Bugey
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	Aubervilliers Cedex
France	1123.28.3351A Boehringer Ingelheim Investigational Site	Besancon
France	1123.28.3351B Boehringer Ingelheim Investigational Site	Besancon
France	1123.28.3315A Boehringer Ingelheim Investigational Site	Besançon cedex
France	1123.28.3315B Boehringer Ingelheim Investigational Site	Besançon cedex
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 Cedex
France	1123.28.3319B Boehringer Ingelheim Investigational Site	Bordeaux Cedex
France	1123.28.3319C Boehringer Ingelheim Investigational Site	Bordeaux Cedex
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	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 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	Châteauroux cedex
France	1123.28.3303A Boehringer Ingelheim Investigational Site	Clichy Cedex
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	Evecquemont
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 Cedex
France	1123.28.3339B Boehringer Ingelheim Investigational Site	Le Chesnay Cedex
France	1123.28.3336A Boehringer Ingelheim Investigational Site	Le Port-Marly
France	1123.28.3326A Boehringer Ingelheim Investigational Site	Lille
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	Lille cedex
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 3
France	1123.28.3369A Boehringer Ingelheim Investigational Site	Lyon cedex 4
France	1123.28.3369B Boehringer Ingelheim Investigational Site	Lyon cedex 4
France	1123.28.3356A Boehringer Ingelheim Investigational Site	Lyon cedex 7
France	1123.28.3356B Boehringer Ingelheim Investigational Site	Lyon cedex 7
France	1123.28.3340A Boehringer Ingelheim Investigational Site	Melun
France	1123.28.3340B Boehringer Ingelheim Investigational Site	Melun
France	1123.28.3308A Boehringer Ingelheim Investigational Site	Melun cedex
France	1123.28.3308B Boehringer Ingelheim Investigational Site	Melun cedex
France	1123.28.3379A Boehringer Ingelheim Investigational Site	Montelimar Cedex
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 Cedex 1
France	1123.28.3349B Boehringer Ingelheim Investigational Site	Nantes 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	Nice cedex 1
France	1123.28.3375A Boehringer Ingelheim Investigational Site	Oyonnax
France	1123.28.3331A Boehringer Ingelheim Investigational Site	Paris
France	1123.28.3371A Boehringer Ingelheim Investigational Site	Paris
France	1123.28.3334A Boehringer Ingelheim Investigational Site	Paris cedex 10
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 Cedex
France	1123.28.3352A Boehringer Ingelheim Investigational Site	Pringy Cedex
France	1123.28.3341A Boehringer Ingelheim Investigational Site	Quincy-sous-Senart
France	1123.28.3378A Boehringer Ingelheim Investigational Site	Romans sur Isère
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	1123.28.3310A Boehringer Ingelheim Investigational Site	Rouen cedex
France	1123.28.3310B Boehringer Ingelheim Investigational Site	Rouen cedex
France	1123.28.3344A Boehringer Ingelheim Investigational Site	Rouen Cedex
France	1123.28.3377A Boehringer Ingelheim Investigational Site	Valence Cedex 9
France	1123.28.3384A Boehringer Ingelheim Investigational Site	Valence Cedex 9
France	1123.28.3373A Boehringer Ingelheim Investigational Site	Vienne Cedex 9
Germany	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
Greece	1123.28.30012 Boehringer Ingelheim Investigational Site	Alexandroupolis
Greece	1123.28.30001 Boehringer Ingelheim Investigational Site	Athens
Greece	1123.28.30003 Boehringer Ingelheim Investigational Site	Chalikida
Greece	1123.28.30011 Boehringer Ingelheim Investigational Site	Katerini
Greece	1123.28.30014 Boehringer Ingelheim Investigational Site	Kavala
Greece	1123.28.30006 Boehringer Ingelheim Investigational Site	Korinthos
Greece	1123.28.30002 Boehringer Ingelheim Investigational Site	Leivadia
Greece	1123.28.30007 Boehringer Ingelheim Investigational Site	Thessaloniki
Greece	1123.28.30010 Boehringer Ingelheim Investigational Site	Thessaloniki
Greece	1123.28.30005 Boehringer Ingelheim Investigational Site	Thiva
Greece	1123.28.30009 Boehringer Ingelheim Investigational Site	Veroia
Italy	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)
Norway	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
Peru	1123.28.19001 Boehringer Ingelheim Investigational Site	Lima
Peru	1123.28.19004 Boehringer Ingelheim Investigational Site	Lima
Poland	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
Russian Federation	1123.28.70005 Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	1123.28.77005 Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	1123.28.70001 Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	1123.28.77001 Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	1123.28.70009 Boehringer Ingelheim Investigational Site	Irkutsk
Russian Federation	1123.28.77009 Boehringer Ingelheim Investigational Site	Irkutsk
Russian Federation	1123.28.70002 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1123.28.77002 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1123.28.70008 Boehringer Ingelheim Investigational Site	Murmansk
Russian Federation	1123.28.77008 Boehringer Ingelheim Investigational Site	Murmansk
Russian Federation	1123.28.77003 Boehringer Ingelheim Investigational Site	Nizhny Novgorod
Russian Federation	1123.28.70003 Boehringer Ingelheim Investigational Site	Nizhnyi Novgorod
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	St. Petersburg
Russian Federation	1123.28.70004 Boehringer Ingelheim Investigational Site	Tomsk
Russian Federation	1123.28.77004 Boehringer Ingelheim Investigational Site	Tomsk
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	Belgrade
Serbia	1123.28.38106 Boehringer Ingelheim Investigational Site	Nis
Serbia	1123.28.38107 Boehringer Ingelheim Investigational Site	Nis
Serbia	1123.28.38109 Boehringer Ingelheim Investigational Site	Sabac
Serbia	1123.28.38108 Boehringer Ingelheim Investigational Site	Smederevo
Serbia	1123.28.38110 Boehringer Ingelheim Investigational Site	Vrsac
Serbia	1123.28.38111 Boehringer Ingelheim Investigational Site	Zajecar
Serbia	1123.28.38104 Boehringer Ingelheim Investigational Site	Zemun
Serbia	1123.28.38105 Boehringer Ingelheim Investigational Site	Zemun
Spain	1123.28.34001 Boehringer Ingelheim Investigational Site	Almeria
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	Malaga
Spain	1123.28.34011 Boehringer Ingelheim Investigational Site	Salamanca
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Greece,  Italy,  Norway,  Peru,  Poland,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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.	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.	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.	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.	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	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	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	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	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	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.	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	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	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	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	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	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	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	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	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	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	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	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	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	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	30 days

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