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Rt-PA in the Treatment of Acute Ischemic Stroke

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rt-PA 0.9 mg/kg verum or placebo Intravenous
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Female or male inpatients Age: 18 - 80 years. Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage. Onset of symptoms between 3 and 4 hours prior to initiation of administration of study drug. Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder. Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country. Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are willing to participate voluntarily and must be able to understand an explanation of the contents of he information sheet. Willingness and ability to comply with the protocol. Exclusion Criteria: Evidence of intracranial hemorrhage (ICH) on the CT-scan. Symptoms of ischaemic attack began more than 4 hours and 30 minutes prior to infusion start or when time of symptom onset is unknown. Minor neurological deficit or symptoms rapidly improving before start of infusion. Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques. Epileptic seizure at onset of stroke Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory History of prior stroke and concomitant diabetes. * Prior stroke within the last 3 months Platelet below 100,000/mm3. * Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits. Blood glucose <50 or > 400 mg/dl (< 2.77 or > 22.15 mmol / l). * Known haemorraghic diathesis Patients receiving oral anticoagulants. * Manifest or recent severe or dangerous bleeding Known history of or suspected intracranial haemorrhage Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture. bacterial endocarditis, pericarditis.* Acute pancreatitis Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation Neoplasm with increased bleeding risk

Sites / Locations

  • 135.312.43004 Boehringer Ingelheim Investigational Site
  • 135.312.43007 Boehringer Ingelheim Investigational Site
  • 135.312.43010 Boehringer Ingelheim Investigational Site
  • 135.312.43001 Boehringer Ingelheim Investigational Site
  • 135.312.43012 Boehringer Ingelheim Investigational Site
  • 135.312.43013 Boehringer Ingelheim Investigational Site
  • 135.312.43008 Boehringer Ingelheim Investigational Site
  • 135.312.43006 Boehringer Ingelheim Investigational Site
  • 135.312.43003 Boehringer Ingelheim Investigational Site
  • 135.312.43002 Boehringer Ingelheim Investigational Site
  • 135.312.32006 O.L. Vrouwziekenhuis
  • 135.312.32002 Boehringer Ingelheim Investigational Site
  • 135.312.32014 Boehringer Ingelheim Investigational Site
  • 135.312.32001 Boehringer Ingelheim Investigational Site
  • 135.312.32011 Boehringer Ingelheim Investigational Site
  • 135.312.32005 Boehringer Ingelheim Investigational Site
  • 135.312.32016 Boehringer Ingelheim Investigational Site
  • 135.312.42004 Boehringer Ingelheim Investigational Site
  • 135.312.42001 Boehringer Ingelheim Investigational Site
  • 135.312.42002 Boehringer Ingelheim Investigational Site
  • 135.312.45005 Boehringer Ingelheim Investigational Site
  • 135.312.45002 Boehringer Ingelheim Investigational Site
  • 135.312.45001 Boehringer Ingelheim Investigational Site
  • 135.312.45004 Boehringer Ingelheim Investigational Site
  • 135.312.35801 Boehringer Ingelheim Investigational Site
  • 135.312.35805 Boehringer Ingelheim Investigational Site
  • 135.312.35802 Boehringer Ingelheim Investigational Site
  • 135.312.33009 Boehringer Ingelheim Investigational Site
  • 135.312.33016 Boehringer Ingelheim Investigational Site
  • 135.312.33013 Boehringer Ingelheim Investigational Site
  • 135.312.33017 Boehringer Ingelheim Investigational Site
  • 135.312.33008 Boehringer Ingelheim Investigational Site
  • 135.312.33014 Boehringer Ingelheim Investigational Site
  • 135.312.33015 Boehringer Ingelheim Investigational Site
  • 135.312.33019 Boehringer Ingelheim Investigational Site
  • 135.312.33001 Boehringer Ingelheim Investigational Site
  • 135.312.33024 Boehringer Ingelheim Investigational Site
  • 135.312.33021 Boehringer Ingelheim Investigational Site
  • 135.312.33002 Boehringer Ingelheim Investigational Site
  • 135.312.33004 Boehringer Ingelheim Investigational Site
  • 135.312.33003 Boehringer Ingelheim Investigational Site
  • 135.312.33007 Boehringer Ingelheim Investigational Site
  • 135.312.33006 Boehringer Ingelheim Investigational Site
  • 135.312.33020 Boehringer Ingelheim Investigational Site
  • 135.312.33018 Boehringer Ingelheim Investigational Site
  • 135.312.33023 Boehringer Ingelheim Investigational Site
  • 135.312.33010 Boehringer Ingelheim Investigational Site
  • 135.312.33005 Boehringer Ingelheim Investigational Site
  • 135.312.33012 Boehringer Ingelheim Investigational Site
  • 135.312.33011 Boehringer Ingelheim Investigational Site
  • 135.312.33022 Boehringer Ingelheim Investigational Site
  • 135.312.49031 Boehringer Ingelheim Investigational Site
  • 135.312.49011 Boehringer Ingelheim Investigational Site
  • 135.312.49037 Boehringer Ingelheim Investigational Site
  • 135.312.49017 Boehringer Ingelheim Investigational Site
  • 135.312.49038 Boehringer Ingelheim Investigational Site
  • 135.312.49041 Boehringer Ingelheim Investigational Site
  • 135.312.49023 Boehringer Ingelheim Investigational Site
  • 135.312.49001 Boehringer Ingelheim Investigational Site
  • 135.312.49008 Boehringer Ingelheim Investigational Site
  • 135.312.49014 Boehringer Ingelheim Investigational Site
  • 135.312.49020 Boehringer Ingelheim Investigational Site
  • 135.312.49004 Boehringer Ingelheim Investigational Site
  • 135.312.49003 Boehringer Ingelheim Investigational Site
  • 135.312.49018 Boehringer Ingelheim Investigational Site
  • 135.312.49002 Boehringer Ingelheim Investigational Site
  • 135.312.49006 Boehringer Ingelheim Investigational Site
  • 135.312.49005 Boehringer Ingelheim Investigational Site
  • 135.312.49025 Boehringer Ingelheim Investigational Site
  • 135.312.49009 Boehringer Ingelheim Investigational Site
  • 135.312.30004 Boehringer Ingelheim Investigational Site
  • 135.312.30005 Boehringer Ingelheim Investigational Site
  • 135.312.30002 Boehringer Ingelheim Investigational Site
  • 135.312.36002 University of Debrecen
  • 135.312.36001 Aladár Petz County Hospital
  • 135.312.36006 BAZ County and Teaching Hospital
  • 135.312.39020 Università degli Studi
  • 135.312.39013 A. O. Universitaria di Careggi
  • 135.312.39019 Ospedale Santa Maria Annunziata
  • 135.312.39022 Ospedale di Imperia
  • 135.312.39024 Istituto Scientifico San Raffaele
  • 135.312.39002 A. O. di Padova - Policlinico Universitario
  • 135.312.39005 A. O. di Perugia - Policlinico Monteluce
  • 135.312.39023 P. O. di Piacenza
  • 135.312.39016 A. O. Ospedale Santa Corona
  • 135.312.39006 Ospedale Santa Chiara
  • 135.312.39003 A. O. Arcispedale "Santa Maria Nuova"
  • 135.312.39001 A. O. Policlinico Umberto I
  • 135.312.39025 Università di Roma "La Sapienza"
  • 135.312.39018 Ospedale S. Maria della Misericordia
  • 135.312.39009 Ospedale Maggiore di BorgoTrento
  • 135.312.39004 Ospedale Civile
  • 135.312.31001
  • 135.312.31007 Medisch Spectrum Twente
  • 135.312.47001 Boehringer Ingelheim Investigational Site
  • 135.312.47003 Boehringer Ingelheim Investigational Site
  • 135.312.47006 Boehringer Ingelheim Investigational Site
  • 135.312.48004 Medical University of Gdansk
  • 135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease
  • 135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole
  • 135.312.48001 Institute of Psychiatry & Neurology in Warsaw
  • 135.312.48002 Dr. Anna Gostynska Wolski Hospital
  • 135.312.35101 Hospitais da Universidade de Coimbra
  • 135.312.35106 Hospital de Santa Maria
  • 135.312.35102 Hospital de Santo António
  • 135.312.35105 Hospital de São Sebastião, EPE
  • 135.312.42103 NEURON PLUS s.r.o
  • 135.312.42102 Hospital Levoca
  • 135.312.42104 Jessenius Faculty of Medicine Commenius University
  • 135.312.42101 Faculty Hospital
  • 135.312.42105 Boehringer Ingelheim Investigational Site
  • 135.312.34019 Boehringer Ingelheim Investigational Site
  • 135.312.34006 Boehringer Ingelheim Investigational Site
  • 135.312.34001 Boehringer Ingelheim Investigational Site
  • 135.312.34002 Boehringer Ingelheim Investigational Site
  • 135.312.34003 Boehringer Ingelheim Investigational Site
  • 135.312.34011 Boehringer Ingelheim Investigational Site
  • 135.312.34007 Boehringer Ingelheim Investigational Site
  • 135.312.34009 Boehringer Ingelheim Investigational Site
  • 135.312.34010 Boehringer Ingelheim Investigational Site
  • 135.312.34020 Boehringer Ingelheim Investigational Site
  • 135.312.34017 Boehringer Ingelheim Investigational Site
  • 135.312.34018 Boehringer Ingelheim Investigational Site
  • 135.312.34014 Boehringer Ingelheim Investigational Site
  • 135.312.46007 Boehringer Ingelheim Investigational Site
  • 135.312.46003 Boehringer Ingelheim Investigational Site
  • 135.312.46005 Boehringer Ingelheim Investigational Site
  • 135.312.46002 Boehringer Ingelheim Investigational Site
  • 135.312.46004 Boehringer Ingelheim Investigational Site
  • 135.312.41003 Boehringer Ingelheim Investigational Site
  • 135.312.41001 Boehringer Ingelheim Investigational Site
  • 135.312.41004 Boehringer Ingelheim Investigational Site
  • 135.312.41002 Boehringer Ingelheim Investigational Site
  • 135.312.44025 Boehringer Ingelheim Investigational Site
  • 135.312.44002 Boehringer Ingelheim Investigational Site
  • 135.312.44023 Boehringer Ingelheim Investigational Site
  • 135.312.44026 Boehringer Ingelheim Investigational Site
  • 135.312.44003 Boehringer Ingelheim Investigational Site
  • 135.312.44006 Boehringer Ingelheim Investigational Site
  • 135.312.44024 Boehringer Ingelheim Investigational Site
  • 135.312.44018 Boehringer Ingelheim Investigational Site
  • 135.312.44030 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90

Secondary Outcome Measures

Global outcome of four neurologic and disability scores combined

Full Information

First Posted
September 9, 2005
Last Updated
April 30, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00153036
Brief Title
Rt-PA in the Treatment of Acute Ischemic Stroke
Official Title
ECASS III - European Cooperative Acute Stroke Study III: A Placebo Controlled Trial of Alteplase (Rt-PA) in Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4 Hours 30 Minutes After Stroke Onset
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an improved clinical outcome without increase of fatality rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
821 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rt-PA 0.9 mg/kg verum or placebo Intravenous
Primary Outcome Measure Information:
Title
modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90
Time Frame
at day 90
Secondary Outcome Measure Information:
Title
Global outcome of four neurologic and disability scores combined
Time Frame
at day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or male inpatients Age: 18 - 80 years. Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage. Onset of symptoms between 3 and 4 hours prior to initiation of administration of study drug. Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder. Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country. Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are willing to participate voluntarily and must be able to understand an explanation of the contents of he information sheet. Willingness and ability to comply with the protocol. Exclusion Criteria: Evidence of intracranial hemorrhage (ICH) on the CT-scan. Symptoms of ischaemic attack began more than 4 hours and 30 minutes prior to infusion start or when time of symptom onset is unknown. Minor neurological deficit or symptoms rapidly improving before start of infusion. Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques. Epileptic seizure at onset of stroke Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory History of prior stroke and concomitant diabetes. * Prior stroke within the last 3 months Platelet below 100,000/mm3. * Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits. Blood glucose <50 or > 400 mg/dl (< 2.77 or > 22.15 mmol / l). * Known haemorraghic diathesis Patients receiving oral anticoagulants. * Manifest or recent severe or dangerous bleeding Known history of or suspected intracranial haemorrhage Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture. bacterial endocarditis, pericarditis.* Acute pancreatitis Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation Neoplasm with increased bleeding risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
135.312.43004 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
135.312.43007 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
135.312.43010 Boehringer Ingelheim Investigational Site
City
Klagenfurt
Country
Austria
Facility Name
135.312.43001 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
135.312.43012 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
135.312.43013 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
135.312.43008 Boehringer Ingelheim Investigational Site
City
Ma.Gugging/Klosterneuburg
Country
Austria
Facility Name
135.312.43006 Boehringer Ingelheim Investigational Site
City
Salzburg
Country
Austria
Facility Name
135.312.43003 Boehringer Ingelheim Investigational Site
City
St. Pölten
Country
Austria
Facility Name
135.312.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
135.312.32006 O.L. Vrouwziekenhuis
City
Aalst
Country
Belgium
Facility Name
135.312.32002 Boehringer Ingelheim Investigational Site
City
Anderlecht
Country
Belgium
Facility Name
135.312.32014 Boehringer Ingelheim Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
135.312.32001 Boehringer Ingelheim Investigational Site
City
Brugge
Country
Belgium
Facility Name
135.312.32011 Boehringer Ingelheim Investigational Site
City
Kortrijk
Country
Belgium
Facility Name
135.312.32005 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
135.312.32016 Boehringer Ingelheim Investigational Site
City
Yvoir (Godinne)
Country
Belgium
Facility Name
135.312.42004 Boehringer Ingelheim Investigational Site
City
Ostrava-Vitkovice
Country
Czech Republic
Facility Name
135.312.42001 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
135.312.42002 Boehringer Ingelheim Investigational Site
City
Prague 5
Country
Czech Republic
Facility Name
135.312.45005 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
135.312.45002 Boehringer Ingelheim Investigational Site
City
Aarhus
Country
Denmark
Facility Name
135.312.45001 Boehringer Ingelheim Investigational Site
City
Copenhagen NV
Country
Denmark
Facility Name
135.312.45004 Boehringer Ingelheim Investigational Site
City
Glostrup
Country
Denmark
Facility Name
135.312.35801 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
135.312.35805 Boehringer Ingelheim Investigational Site
City
Kuopio
Country
Finland
Facility Name
135.312.35802 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
135.312.33009 Boehringer Ingelheim Investigational Site
City
Auch
Country
France
Facility Name
135.312.33016 Boehringer Ingelheim Investigational Site
City
Besançon cedex
Country
France
Facility Name
135.312.33013 Boehringer Ingelheim Investigational Site
City
Bordeaux cedex
Country
France
Facility Name
135.312.33017 Boehringer Ingelheim Investigational Site
City
Bourg en Bresse
Country
France
Facility Name
135.312.33008 Boehringer Ingelheim Investigational Site
City
Dijon cedex
Country
France
Facility Name
135.312.33014 Boehringer Ingelheim Investigational Site
City
Grenoble cédex 9
Country
France
Facility Name
135.312.33015 Boehringer Ingelheim Investigational Site
City
Lille cedex
Country
France
Facility Name
135.312.33019 Boehringer Ingelheim Investigational Site
City
Limoges cedex 1
Country
France
Facility Name
135.312.33001 Boehringer Ingelheim Investigational Site
City
Lyon Cedex
Country
France
Facility Name
135.312.33024 Boehringer Ingelheim Investigational Site
City
Mantes la Jolie
Country
France
Facility Name
135.312.33021 Boehringer Ingelheim Investigational Site
City
Meaux
Country
France
Facility Name
135.312.33002 Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
135.312.33004 Boehringer Ingelheim Investigational Site
City
Nancy
Country
France
Facility Name
135.312.33003 Boehringer Ingelheim Investigational Site
City
Nice cedex 1
Country
France
Facility Name
135.312.33007 Boehringer Ingelheim Investigational Site
City
Paris cedex 18
Country
France
Facility Name
135.312.33006 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
135.312.33020 Boehringer Ingelheim Investigational Site
City
Pau cedex
Country
France
Facility Name
135.312.33018 Boehringer Ingelheim Investigational Site
City
Perpignan cedex
Country
France
Facility Name
135.312.33023 Boehringer Ingelheim Investigational Site
City
Pontoise
Country
France
Facility Name
135.312.33010 Boehringer Ingelheim Investigational Site
City
Saint Herblain
Country
France
Facility Name
135.312.33005 Boehringer Ingelheim Investigational Site
City
Toulouse cedex 9
Country
France
Facility Name
135.312.33012 Boehringer Ingelheim Investigational Site
City
Toulouse cedex 9
Country
France
Facility Name
135.312.33011 Boehringer Ingelheim Investigational Site
City
Tours cedex 9
Country
France
Facility Name
135.312.33022 Boehringer Ingelheim Investigational Site
City
Versailles
Country
France
Facility Name
135.312.49031 Boehringer Ingelheim Investigational Site
City
Altenburg
Country
Germany
Facility Name
135.312.49011 Boehringer Ingelheim Investigational Site
City
Bamberg
Country
Germany
Facility Name
135.312.49037 Boehringer Ingelheim Investigational Site
City
Beeskow
Country
Germany
Facility Name
135.312.49017 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
135.312.49038 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
135.312.49041 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
135.312.49023 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
135.312.49001 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
135.312.49008 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
135.312.49014 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
135.312.49020 Boehringer Ingelheim Investigational Site
City
Ludwigshafen am Rhein
Country
Germany
Facility Name
135.312.49004 Boehringer Ingelheim Investigational Site
City
Magdeburg
Country
Germany
Facility Name
135.312.49003 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
135.312.49018 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
135.312.49002 Boehringer Ingelheim Investigational Site
City
Minden
Country
Germany
Facility Name
135.312.49006 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
135.312.49005 Boehringer Ingelheim Investigational Site
City
Siegen
Country
Germany
Facility Name
135.312.49025 Boehringer Ingelheim Investigational Site
City
Teupitz
Country
Germany
Facility Name
135.312.49009 Boehringer Ingelheim Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
135.312.30004 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
135.312.30005 Boehringer Ingelheim Investigational Site
City
Larissa
Country
Greece
Facility Name
135.312.30002 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
135.312.36002 University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
135.312.36001 Aladár Petz County Hospital
City
Györ
Country
Hungary
Facility Name
135.312.36006 BAZ County and Teaching Hospital
City
Miskolc
Country
Hungary
Facility Name
135.312.39020 Università degli Studi
City
Coppito (aq)
Country
Italy
Facility Name
135.312.39013 A. O. Universitaria di Careggi
City
Firenze
Country
Italy
Facility Name
135.312.39019 Ospedale Santa Maria Annunziata
City
Firenze
Country
Italy
Facility Name
135.312.39022 Ospedale di Imperia
City
Imperia
Country
Italy
Facility Name
135.312.39024 Istituto Scientifico San Raffaele
City
Milano
Country
Italy
Facility Name
135.312.39002 A. O. di Padova - Policlinico Universitario
City
Padova
Country
Italy
Facility Name
135.312.39005 A. O. di Perugia - Policlinico Monteluce
City
Perugia
Country
Italy
Facility Name
135.312.39023 P. O. di Piacenza
City
Piacenza
Country
Italy
Facility Name
135.312.39016 A. O. Ospedale Santa Corona
City
Pietra Ligure (sv)
Country
Italy
Facility Name
135.312.39006 Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
135.312.39003 A. O. Arcispedale "Santa Maria Nuova"
City
Reggio Emilia
Country
Italy
Facility Name
135.312.39001 A. O. Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
135.312.39025 Università di Roma "La Sapienza"
City
Roma
Country
Italy
Facility Name
135.312.39018 Ospedale S. Maria della Misericordia
City
Udine
Country
Italy
Facility Name
135.312.39009 Ospedale Maggiore di BorgoTrento
City
Verona
Country
Italy
Facility Name
135.312.39004 Ospedale Civile
City
Vicenza
Country
Italy
Facility Name
135.312.31001
City
Amsterdam
Country
Netherlands
Facility Name
135.312.31007 Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
135.312.47001 Boehringer Ingelheim Investigational Site
City
Bergen
Country
Norway
Facility Name
135.312.47003 Boehringer Ingelheim Investigational Site
City
Trondheim
Country
Norway
Facility Name
135.312.47006 Boehringer Ingelheim Investigational Site
City
Tønsberg
Country
Norway
Facility Name
135.312.48004 Medical University of Gdansk
City
Gdansk
Country
Poland
Facility Name
135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease
City
Katowice
Country
Poland
Facility Name
135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole
City
Opole
Country
Poland
Facility Name
135.312.48001 Institute of Psychiatry & Neurology in Warsaw
City
Warsaw
Country
Poland
Facility Name
135.312.48002 Dr. Anna Gostynska Wolski Hospital
City
Warsaw
Country
Poland
Facility Name
135.312.35101 Hospitais da Universidade de Coimbra
City
Coimbra
Country
Portugal
Facility Name
135.312.35106 Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
135.312.35102 Hospital de Santo António
City
Porto
Country
Portugal
Facility Name
135.312.35105 Hospital de São Sebastião, EPE
City
Santa Maria da Feira
Country
Portugal
Facility Name
135.312.42103 NEURON PLUS s.r.o
City
Bratislava
Country
Slovakia
Facility Name
135.312.42102 Hospital Levoca
City
Levoca
Country
Slovakia
Facility Name
135.312.42104 Jessenius Faculty of Medicine Commenius University
City
Martin
Country
Slovakia
Facility Name
135.312.42101 Faculty Hospital
City
Nitra
Country
Slovakia
Facility Name
135.312.42105 Boehringer Ingelheim Investigational Site
City
Trnava
Country
Slovakia
Facility Name
135.312.34019 Boehringer Ingelheim Investigational Site
City
Albacete
Country
Spain
Facility Name
135.312.34006 Boehringer Ingelheim Investigational Site
City
Badalona / Barcelona
Country
Spain
Facility Name
135.312.34001 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
135.312.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
135.312.34003 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
135.312.34011 Boehringer Ingelheim Investigational Site
City
Bilbao
Country
Spain
Facility Name
135.312.34007 Boehringer Ingelheim Investigational Site
City
Girona
Country
Spain
Facility Name
135.312.34009 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
135.312.34010 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
135.312.34020 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
135.312.34017 Boehringer Ingelheim Investigational Site
City
Santiago de Compostela
Country
Spain
Facility Name
135.312.34018 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
135.312.34014 Boehringer Ingelheim Investigational Site
City
Zaragoza
Country
Spain
Facility Name
135.312.46007 Boehringer Ingelheim Investigational Site
City
Lidköping
Country
Sweden
Facility Name
135.312.46003 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
135.312.46005 Boehringer Ingelheim Investigational Site
City
Skövde
Country
Sweden
Facility Name
135.312.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
135.312.46004 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
135.312.41003 Boehringer Ingelheim Investigational Site
City
Aarau
Country
Switzerland
Facility Name
135.312.41001 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
135.312.41004 Boehringer Ingelheim Investigational Site
City
Lausanne
Country
Switzerland
Facility Name
135.312.41002 Boehringer Ingelheim Investigational Site
City
St. Gallen
Country
Switzerland
Facility Name
135.312.44025 Boehringer Ingelheim Investigational Site
City
Aberdeen
Country
United Kingdom
Facility Name
135.312.44002 Boehringer Ingelheim Investigational Site
City
Bournemouth
Country
United Kingdom
Facility Name
135.312.44023 Boehringer Ingelheim Investigational Site
City
Cambridge
Country
United Kingdom
Facility Name
135.312.44026 Boehringer Ingelheim Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
135.312.44003 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
135.312.44006 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
135.312.44024 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
135.312.44018 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
135.312.44030 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32430395
Citation
Alper BS, Foster G, Thabane L, Rae-Grant A, Malone-Moses M, Manheimer E. Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances. BMJ Evid Based Med. 2020 Oct;25(5):168-171. doi: 10.1136/bmjebm-2020-111386. Epub 2020 May 19.
Results Reference
derived
PubMed Identifier
19850525
Citation
Bluhmki E, Chamorro A, Davalos A, Machnig T, Sauce C, Wahlgren N, Wardlaw J, Hacke W. Stroke treatment with alteplase given 3.0-4.5 h after onset of acute ischaemic stroke (ECASS III): additional outcomes and subgroup analysis of a randomised controlled trial. Lancet Neurol. 2009 Dec;8(12):1095-102. doi: 10.1016/S1474-4422(09)70264-9. Epub 2009 Oct 21.
Results Reference
derived
PubMed Identifier
18815396
Citation
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/135/135.312_U08-2199.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/135/135.312_literature.pdf
Description
Related Info

Learn more about this trial

Rt-PA in the Treatment of Acute Ischemic Stroke

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