Rt-PA in the Treatment of Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153036
First received: September 9, 2005
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Drug: rt-PA 0.9 mg/kg verum or placebo Intravenous
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 [ Time Frame: at day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global outcome of four neurologic and disability scores combined [ Time Frame: at day 90 ] [ Designated as safety issue: No ]

Enrollment: 821
Study Start Date: April 2003
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00153036

  Hide Study Locations
Locations
Austria
135.312.43004 Boehringer Ingelheim Investigational Site
Graz, Austria
135.312.43007 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
135.312.43010 Boehringer Ingelheim Investigational Site
Klagenfurt, Austria
135.312.43013 Boehringer Ingelheim Investigational Site
Linz, Austria
135.312.43001 Boehringer Ingelheim Investigational Site
Linz, Austria
135.312.43012 Boehringer Ingelheim Investigational Site
Linz, Austria
135.312.43008 Boehringer Ingelheim Investigational Site
Ma.Gugging/Klosterneuburg, Austria
135.312.43006 Boehringer Ingelheim Investigational Site
Salzburg, Austria
135.312.43003 Boehringer Ingelheim Investigational Site
St. Pölten, Austria
135.312.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
135.312.32006 O.L. Vrouwziekenhuis
Aalst, Belgium
135.312.32002 Boehringer Ingelheim Investigational Site
Anderlecht, Belgium
135.312.32014 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
135.312.32001 Boehringer Ingelheim Investigational Site
Brugge, Belgium
135.312.32011 Boehringer Ingelheim Investigational Site
Kortrijk, Belgium
135.312.32005 Boehringer Ingelheim Investigational Site
Leuven, Belgium
135.312.32016 Boehringer Ingelheim Investigational Site
Yvoir (Godinne), Belgium
Czech Republic
135.312.42001 Boehringer Ingelheim Investigational Site
Ostrava, Czech Republic
135.312.42004 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice, Czech Republic
135.312.42002 Boehringer Ingelheim Investigational Site
Prague 5, Czech Republic
Denmark
135.312.45005 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
135.312.45002 Boehringer Ingelheim Investigational Site
Aarhus, Denmark
135.312.45001 Boehringer Ingelheim Investigational Site
Copenhagen NV, Denmark
135.312.45004 Boehringer Ingelheim Investigational Site
Glostrup, Denmark
Finland
135.312.35801 Boehringer Ingelheim Investigational Site
Helsinki, Finland
135.312.35805 Boehringer Ingelheim Investigational Site
Kuopio, Finland
135.312.35802 Boehringer Ingelheim Investigational Site
Turku, Finland
France
135.312.33009 Boehringer Ingelheim Investigational Site
Auch, France
135.312.33016 Boehringer Ingelheim Investigational Site
Besançon cedex, France
135.312.33013 Boehringer Ingelheim Investigational Site
Bordeaux cedex, France
135.312.33017 Boehringer Ingelheim Investigational Site
Bourg en Bresse, France
135.312.33008 Boehringer Ingelheim Investigational Site
Dijon cedex, France
135.312.33014 Boehringer Ingelheim Investigational Site
Grenoble cédex 9, France
135.312.33015 Boehringer Ingelheim Investigational Site
Lille cedex, France
135.312.33019 Boehringer Ingelheim Investigational Site
Limoges cedex 1, France
135.312.33001 Boehringer Ingelheim Investigational Site
Lyon Cedex, France
135.312.33024 Boehringer Ingelheim Investigational Site
Mantes la Jolie, France
135.312.33021 Boehringer Ingelheim Investigational Site
Meaux, France
135.312.33002 Boehringer Ingelheim Investigational Site
Montpellier, France
135.312.33004 Boehringer Ingelheim Investigational Site
Nancy, France
135.312.33003 Boehringer Ingelheim Investigational Site
Nice cedex 1, France
135.312.33006 Boehringer Ingelheim Investigational Site
Paris, France
135.312.33007 Boehringer Ingelheim Investigational Site
Paris cedex 18, France
135.312.33020 Boehringer Ingelheim Investigational Site
Pau cedex, France
135.312.33018 Boehringer Ingelheim Investigational Site
Perpignan cedex, France
135.312.33023 Boehringer Ingelheim Investigational Site
Pontoise, France
135.312.33010 Boehringer Ingelheim Investigational Site
Saint Herblain, France
135.312.33012 Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
135.312.33005 Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
135.312.33011 Boehringer Ingelheim Investigational Site
Tours cedex 9, France
135.312.33022 Boehringer Ingelheim Investigational Site
Versailles, France
Germany
135.312.49031 Boehringer Ingelheim Investigational Site
Altenburg, Germany
135.312.49011 Boehringer Ingelheim Investigational Site
Bamberg, Germany
135.312.49037 Boehringer Ingelheim Investigational Site
Beeskow, Germany
135.312.49017 Boehringer Ingelheim Investigational Site
Bochum, Germany
135.312.49038 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
135.312.49041 Boehringer Ingelheim Investigational Site
Hamburg, Germany
135.312.49023 Boehringer Ingelheim Investigational Site
Hannover, Germany
135.312.49001 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
135.312.49008 Boehringer Ingelheim Investigational Site
Köln, Germany
135.312.49014 Boehringer Ingelheim Investigational Site
Leipzig, Germany
135.312.49020 Boehringer Ingelheim Investigational Site
Ludwigshafen am Rhein, Germany
135.312.49004 Boehringer Ingelheim Investigational Site
Magdeburg, Germany
135.312.49003 Boehringer Ingelheim Investigational Site
Mainz, Germany
135.312.49018 Boehringer Ingelheim Investigational Site
Mannheim, Germany
135.312.49002 Boehringer Ingelheim Investigational Site
Minden, Germany
135.312.49006 Boehringer Ingelheim Investigational Site
München, Germany
135.312.49005 Boehringer Ingelheim Investigational Site
Siegen, Germany
135.312.49025 Boehringer Ingelheim Investigational Site
Teupitz, Germany
135.312.49009 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
Greece
135.312.30004 Boehringer Ingelheim Investigational Site
Athens, Greece
135.312.30005 Boehringer Ingelheim Investigational Site
Larissa, Greece
135.312.30002 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Hungary
135.312.36002 University of Debrecen
Debrecen, Hungary
135.312.36001 Aladár Petz County Hospital
Györ, Hungary
135.312.36006 BAZ County and Teaching Hospital
Miskolc, Hungary
Italy
135.312.39020 Università degli Studi
Coppito (aq), Italy
135.312.39019 Ospedale Santa Maria Annunziata
Firenze, Italy
135.312.39013 A. O. Universitaria di Careggi
Firenze, Italy
135.312.39022 Ospedale di Imperia
Imperia, Italy
135.312.39024 Istituto Scientifico San Raffaele
Milano, Italy
135.312.39002 A. O. di Padova - Policlinico Universitario
Padova, Italy
135.312.39005 A. O. di Perugia - Policlinico Monteluce
Perugia, Italy
135.312.39023 P. O. di Piacenza
Piacenza, Italy
135.312.39016 A. O. Ospedale Santa Corona
Pietra Ligure (sv), Italy
135.312.39006 Ospedale Santa Chiara
Pisa, Italy
135.312.39003 A. O. Arcispedale "Santa Maria Nuova"
Reggio Emilia, Italy
135.312.39001 A. O. Policlinico Umberto I
Roma, Italy
135.312.39025 Università di Roma "La Sapienza"
Roma, Italy
135.312.39018 Ospedale S. Maria della Misericordia
Udine, Italy
135.312.39009 Ospedale Maggiore di BorgoTrento
Verona, Italy
135.312.39004 Ospedale Civile
Vicenza, Italy
Netherlands
135.312.31001
Amsterdam, Netherlands
135.312.31007 Medisch Spectrum Twente
Enschede, Netherlands
Norway
135.312.47001 Boehringer Ingelheim Investigational Site
Bergen, Norway
135.312.47003 Boehringer Ingelheim Investigational Site
Trondheim, Norway
135.312.47006 Boehringer Ingelheim Investigational Site
Tønsberg, Norway
Poland
135.312.48004 Medical University of Gdansk
Gdansk, Poland
135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease
Katowice, Poland
135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole
Opole, Poland
135.312.48001 Institute of Psychiatry & Neurology in Warsaw
Warsaw, Poland
135.312.48002 Dr. Anna Gostynska Wolski Hospital
Warsaw, Poland
Portugal
135.312.35101 Hospitais da Universidade de Coimbra
Coimbra, Portugal
135.312.35106 Hospital de Santa Maria
Lisboa, Portugal
135.312.35102 Hospital de Santo António
Porto, Portugal
135.312.35105 Hospital de São Sebastião, EPE
Santa Maria da Feira, Portugal
Slovakia
135.312.42103 NEURON PLUS s.r.o
Bratislava, Slovakia
135.312.42102 Hospital Levoca
Levoca, Slovakia
135.312.42104 Jessenius Faculty of Medicine Commenius University
Martin, Slovakia
135.312.42101 Faculty Hospital
Nitra, Slovakia
135.312.42105 Boehringer Ingelheim Investigational Site
Trnava, Slovakia
Spain
135.312.34019 Boehringer Ingelheim Investigational Site
Albacete, Spain
135.312.34006 Boehringer Ingelheim Investigational Site
Badalona / Barcelona, Spain
135.312.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
135.312.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
135.312.34003 Boehringer Ingelheim Investigational Site
Barcelona, Spain
135.312.34011 Boehringer Ingelheim Investigational Site
Bilbao, Spain
135.312.34007 Boehringer Ingelheim Investigational Site
Girona, Spain
135.312.34009 Boehringer Ingelheim Investigational Site
Madrid, Spain
135.312.34010 Boehringer Ingelheim Investigational Site
Madrid, Spain
135.312.34020 Boehringer Ingelheim Investigational Site
Madrid, Spain
135.312.34017 Boehringer Ingelheim Investigational Site
Santiago de Compostela, Spain
135.312.34018 Boehringer Ingelheim Investigational Site
Sevilla, Spain
135.312.34014 Boehringer Ingelheim Investigational Site
Zaragoza, Spain
Sweden
135.312.46007 Boehringer Ingelheim Investigational Site
Lidköping, Sweden
135.312.46003 Boehringer Ingelheim Investigational Site
Malmö, Sweden
135.312.46005 Boehringer Ingelheim Investigational Site
Skövde, Sweden
135.312.46004 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
135.312.46002 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Switzerland
135.312.41003 Boehringer Ingelheim Investigational Site
Aarau, Switzerland
135.312.41001 Boehringer Ingelheim Investigational Site
Basel, Switzerland
135.312.41004 Boehringer Ingelheim Investigational Site
Lausanne, Switzerland
135.312.41002 Boehringer Ingelheim Investigational Site
St. Gallen, Switzerland
United Kingdom
135.312.44025 Boehringer Ingelheim Investigational Site
Aberdeen, United Kingdom
135.312.44002 Boehringer Ingelheim Investigational Site
Bournemouth, United Kingdom
135.312.44023 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
135.312.44026 Boehringer Ingelheim Investigational Site
Dundee, United Kingdom
135.312.44003 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
135.312.44024 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
135.312.44006 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
135.312.44018 Boehringer Ingelheim Investigational Site
Liverpool, United Kingdom
135.312.44030 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00153036     History of Changes
Other Study ID Numbers: 135.312
Study First Received: September 9, 2005
Last Updated: April 30, 2014
Health Authority: Austria: Bundesministerium fuer Gesundheit und Frauen
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFSSAPS
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte BfArm
Great Britain: MHRA
Greece: HELLENIC REPUBLIC MINISTRY OF HEALTH AND WELFARE
Hungary: National Institute of Pharmacy, H-1051 Budapest
Italy: Comitato Etico Policlinico Umberto I - Università degli Studi di Roma La Sapienza
Netherlands: Academical Medical Centre
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Española de Medicamentos y Productos Santarios
Sweden: Medical Product Agency
Switzerland: Swissmedic

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014