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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00623623
First received: February 15, 2008
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Procedure: primary PCI
Drug: enoxaparin
Procedure: catheterisation
Drug: tenecteplase
Drug: clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Congestive heart failure (CHF) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Recurrent myocardial infarction (reinfarction) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for non-cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ischaemic stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Intracranial haemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major non-intracranial bleeds including blood transfusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Minor non-intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Total non-intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Total disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total non-disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total stroke (all types) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and CHF [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and non-fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serious repeat target vessel revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serious resuscitated ventricular fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 1891
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Drug: enoxaparin
Adjunctive treatment
Procedure: catheterisation
Routine or rescue coronary intervention
Drug: tenecteplase
Single, weight-adjusted i.v. bolus of tenecteplase
Drug: clopidogrel
Adjunctive treatment
primary PCI
Standard primary PCI
Procedure: primary PCI
Standard primary PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623623

  Hide Study Locations
Locations
Austria
1123.28.43010 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1123.28.43009 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1123.28.43007 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
1123.28.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
1123.28.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
1123.28.43008 Boehringer Ingelheim Investigational Site
Wien, Austria
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, Belgium
Brazil
1123.28.55020 Boehringer Ingelheim Investigational Site
Brasilia, Brazil
1123.28.55010 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
1123.28.55028 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1123.28.55018 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1123.28.55016 Boehringer Ingelheim Investigational Site
Sao Lourenço do Sul, Brazil
1123.28.55014 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1123.28.55004 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Canada, Alberta
1123.28.11006 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1123.28.11505 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
1123.28.11002 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
Chile
1123.28.13005 Boehringer Ingelheim Investigational Site
Santiago, Chile
1123.28.13004 Boehringer Ingelheim Investigational Site
Santiago, Chile
1123.28.13003 Boehringer Ingelheim Investigational Site
Santiago, Chile
1123.28.13002 Boehringer Ingelheim Investigational Site
Santiago, Chile
1123.28.13001 Boehringer Ingelheim Investigational Site
Santiago, Chile
1123.28.13006 Boehringer Ingelheim Investigational Site
Santiago, Chile
France
1123.28.3376A Boehringer Ingelheim Investigational Site
Ambérieu en Bugey, France
1123.28.3329C Boehringer Ingelheim Investigational Site
Aubervilliers Cedex, France
1123.28.3329A Boehringer Ingelheim Investigational Site
Aubervilliers Cedex, France
1123.28.3329B Boehringer Ingelheim Investigational Site
Aubervilliers Cedex, France
1123.28.3351B Boehringer Ingelheim Investigational Site
Besancon, France
1123.28.3351A Boehringer Ingelheim Investigational Site
Besancon, France
1123.28.3315B Boehringer Ingelheim Investigational Site
Besançon cedex, France
1123.28.3315A Boehringer Ingelheim Investigational Site
Besançon cedex, France
1123.28.3302B Boehringer Ingelheim Investigational Site
Bobigny, France
1123.28.3302A 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
1123.28.3347B Boehringer Ingelheim Investigational Site
Bourges, France
1123.28.3347A Boehringer Ingelheim Investigational Site
Bourges, France
1123.28.3347C Boehringer Ingelheim Investigational Site
Bourges, France
1123.28.3355B Boehringer Ingelheim Investigational Site
Bron, France
1123.28.3355A 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
1123.28.3346B Boehringer Ingelheim Investigational Site
Châteauroux cedex, France
1123.28.3346A 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
1123.28.3388A Boehringer Ingelheim Investigational Site
Fort de France Cedex, France
1123.28.3387A 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
1123.28.3339B Boehringer Ingelheim Investigational Site
Le Chesnay Cedex, France
1123.28.3339A 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
1123.28.3318B Boehringer Ingelheim Investigational Site
Lyon cedex 3, France
1123.28.3318A Boehringer Ingelheim Investigational Site
Lyon cedex 3, France
1123.28.3318C Boehringer Ingelheim Investigational Site
Lyon cedex 3, France
1123.28.3369B Boehringer Ingelheim Investigational Site
Lyon cedex 4, France
1123.28.3369A 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
1123.28.3328C Boehringer Ingelheim Investigational Site
Montfermeil, France
1123.28.3328A Boehringer Ingelheim Investigational Site
Montfermeil, France
1123.28.3328B Boehringer Ingelheim Investigational Site
Montfermeil, France
1123.28.3313B Boehringer Ingelheim Investigational Site
Nantes, France
1123.28.3313A 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
1123.28.3322B Boehringer Ingelheim Investigational Site
Nice cedex 1, France
1123.28.3322A 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
1123.28.3345C Boehringer Ingelheim Investigational Site
Rouen, France
1123.28.3345B Boehringer Ingelheim Investigational Site
Rouen, France
1123.28.3344A Boehringer Ingelheim Investigational Site
Rouen Cedex, France
1123.28.3310B Boehringer Ingelheim Investigational Site
Rouen cedex, France
1123.28.3310A 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, France
Germany
1123.28.49006 Boehringer Ingelheim Investigational Site
Berlin, Germany
1123.28.49002 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
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
1123.28.30010 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
1123.28.30007 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
1123.28.30005 Boehringer Ingelheim Investigational Site
Thiva, Greece
1123.28.30009 Boehringer Ingelheim Investigational Site
Veroia, Greece
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), Italy
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, Norway
Peru
1123.28.19004 Boehringer Ingelheim Investigational Site
Lima, Peru
1123.28.19001 Boehringer Ingelheim Investigational Site
Lima, Peru
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, Poland
Russian Federation
1123.28.77005 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1123.28.70005 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
1123.28.77009 Boehringer Ingelheim Investigational Site
Irkutsk, Russian Federation
1123.28.70009 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
1123.28.77006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1123.28.70007 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, Russian Federation
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
1123.28.38105 Boehringer Ingelheim Investigational Site
Zemun, Serbia
1123.28.38104 Boehringer Ingelheim Investigational Site
Zemun, Serbia
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, Spain
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, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00623623     History of Changes
Other Study ID Numbers: 1123.28, 2007-001219-44
Study First Received: February 15, 2008
Last Updated: April 30, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Agência Nacional de Vigilância Sanitária - ANVISA
Canada: Health Canada
Chile:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175
Great Britain: Medicines and Healthcare products Regulatory Agency (MHRA)
Greece: Ethics Committee
Italy: Ethics Committee
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Peru:
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Agencia Espanola del Medicamento y Productos Sanitarios Campezo 1. 28022 Madrid

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Clopidogrel
Tenecteplase
Tissue Plasminogen Activator
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014