Rt-PA in the Treatment of Acute Ischemic Stroke

NCT00153036 | Completed Phase 3

• 1 other identifier: 135.312
• Study Type: interventional
• Target: 821
• Locations: 19 countries
• Sites: 142

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.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

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

  at day 90

Secondary Outcomes (1)

• Global outcome of four neurologic and disability scores combined

  at day 90

Interventions

rt-PA 0.9 mg/kg verum or placebo Intravenous DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (142)

135.312.43004 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

135.312.43007 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

135.312.43010 Boehringer Ingelheim Investigational Site

Klagenfurt, Austria

Location

135.312.43001 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

135.312.43012 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

135.312.43013 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

135.312.43008 Boehringer Ingelheim Investigational Site

Ma.Gugging/Klosterneuburg, Austria

Location

135.312.43006 Boehringer Ingelheim Investigational Site

Salzburg, Austria

Location

135.312.43003 Boehringer Ingelheim Investigational Site

Sankt Pölten, Austria

Location

135.312.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

135.312.32006 O.L. Vrouwziekenhuis

Aalst, Belgium

Location

135.312.32002 Boehringer Ingelheim Investigational Site

Anderlecht, Belgium

Location

135.312.32014 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

135.312.32001 Boehringer Ingelheim Investigational Site

Bruges, Belgium

Location

135.312.32016 Boehringer Ingelheim Investigational Site

Godinne, Belgium

Location

135.312.32011 Boehringer Ingelheim Investigational Site

Kortrijk, Belgium

Location

135.312.32005 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

135.312.42001 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

135.312.42004 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, Czechia

Location

135.312.42002 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

135.312.45005 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

135.312.45002 Boehringer Ingelheim Investigational Site

Aarhus, Denmark

Location

135.312.45001 Boehringer Ingelheim Investigational Site

Copenhagen NV, Denmark

Location

135.312.45004 Boehringer Ingelheim Investigational Site

Glostrup Municipality, Denmark

Location

135.312.35801 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

135.312.35805 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

135.312.35802 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

135.312.33009 Boehringer Ingelheim Investigational Site

Auch, France

Location

135.312.33016 Boehringer Ingelheim Investigational Site

Besançon, France

Location

135.312.33013 Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

135.312.33017 Boehringer Ingelheim Investigational Site

Bourg-en-Bresse, France

Location

135.312.33008 Boehringer Ingelheim Investigational Site

Dijon, France

Location

135.312.33014 Boehringer Ingelheim Investigational Site

Grenoble Cédex 9, France

Location

135.312.33015 Boehringer Ingelheim Investigational Site

Lille, France

Location

135.312.33019 Boehringer Ingelheim Investigational Site

Limoges, France

Location

135.312.33001 Boehringer Ingelheim Investigational Site

Lyon, France

Location

135.312.33024 Boehringer Ingelheim Investigational Site

Mantes-la-Jolie, France

Location

135.312.33021 Boehringer Ingelheim Investigational Site

Meaux, France

Location

135.312.33002 Boehringer Ingelheim Investigational Site

Montpellier, France

Location

135.312.33004 Boehringer Ingelheim Investigational Site

Nancy, France

Location

135.312.33003 Boehringer Ingelheim Investigational Site

Nice, France

Location

135.312.33006 Boehringer Ingelheim Investigational Site

Paris, France

Location

135.312.33007 Boehringer Ingelheim Investigational Site

Paris, France

Location

135.312.33020 Boehringer Ingelheim Investigational Site

Pau, France

Location

135.312.33018 Boehringer Ingelheim Investigational Site

Perpignan, France

Location

135.312.33023 Boehringer Ingelheim Investigational Site

Pontoise, France

Location

135.312.33010 Boehringer Ingelheim Investigational Site

Saint-Herblain, France

Location

135.312.33005 Boehringer Ingelheim Investigational Site

Toulouse, France

Location

135.312.33012 Boehringer Ingelheim Investigational Site

Toulouse, France

Location

135.312.33011 Boehringer Ingelheim Investigational Site

Tours, France

Location

135.312.33022 Boehringer Ingelheim Investigational Site

Versailles, France

Location

135.312.49031 Boehringer Ingelheim Investigational Site

Altenburg, Germany

Location

135.312.49011 Boehringer Ingelheim Investigational Site

Bamberg, Germany

Location

135.312.49037 Boehringer Ingelheim Investigational Site

Beeskow, Germany

Location

135.312.49017 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

135.312.49008 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

135.312.49038 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

135.312.49041 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

135.312.49023 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

135.312.49001 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

135.312.49014 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

135.312.49020 Boehringer Ingelheim Investigational Site

Ludwigshafen am Rhein, Germany

Location

135.312.49004 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

135.312.49003 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

135.312.49018 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

135.312.49002 Boehringer Ingelheim Investigational Site

Minden, Germany

Location

135.312.49006 Boehringer Ingelheim Investigational Site

München, Germany

Location

135.312.49005 Boehringer Ingelheim Investigational Site

Siegen, Germany

Location

135.312.49025 Boehringer Ingelheim Investigational Site

Teupitz, Germany

Location

135.312.49009 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

135.312.30004 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

135.312.30005 Boehringer Ingelheim Investigational Site

Larissa, Greece

Location

135.312.30002 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

135.312.36002 University of Debrecen

Debrecen, Hungary

Location

135.312.36001 Aladár Petz County Hospital

Győr, Hungary

Location

135.312.36006 BAZ County and Teaching Hospital

Miskolc, Hungary

Location

135.312.39020 Università degli Studi

Coppito (aq), Italy

Location

135.312.39013 A. O. Universitaria di Careggi

Florence, Italy

Location

135.312.39019 Ospedale Santa Maria Annunziata

Florence, Italy

Location

135.312.39022 Ospedale di Imperia

Imperia, Italy

Location

135.312.39024 Istituto Scientifico San Raffaele

Milan, Italy

Location

135.312.39002 A. O. di Padova - Policlinico Universitario

Padua, Italy

Location

135.312.39005 A. O. di Perugia - Policlinico Monteluce

Perugia, Italy

Location

135.312.39023 P. O. di Piacenza

Piacenza, Italy

Location

135.312.39016 A. O. Ospedale Santa Corona

Pietra Ligure (sv), Italy

Location

135.312.39006 Ospedale Santa Chiara

Pisa, Italy

Location

135.312.39003 A. O. Arcispedale "Santa Maria Nuova"

Reggio Emilia, Italy

Location

135.312.39001 A. O. Policlinico Umberto I

Roma, Italy

Location

135.312.39025 Università di Roma "La Sapienza"

Roma, Italy

Location

135.312.39018 Ospedale S. Maria della Misericordia

Udine, Italy

Location

135.312.39009 Ospedale Maggiore di BorgoTrento

Verona, Italy

Location

135.312.39004 Ospedale Civile

Vicenza, Italy

Location

135.312.31001

Amsterdam, Netherlands

Location

135.312.31007 Medisch Spectrum Twente

Enschede, Netherlands

Location

135.312.47001 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

135.312.47003 Boehringer Ingelheim Investigational Site

Trondheim, Norway

Location

135.312.47006 Boehringer Ingelheim Investigational Site

Tønsberg, Norway

Location

135.312.48004 Medical University of Gdansk

Gdansk, Poland

Location

135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease

Katowice, Poland

Location

135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole

Opole, Poland

Location

135.312.48001 Institute of Psychiatry & Neurology in Warsaw

Warsaw, Poland

Location

135.312.48002 Dr. Anna Gostynska Wolski Hospital

Warsaw, Poland

Location

135.312.35101 Hospitais da Universidade de Coimbra

Coimbra, Portugal

Location

135.312.35106 Hospital de Santa Maria

Lisbon, Portugal

Location

135.312.35102 Hospital de Santo António

Porto, Portugal

Location

135.312.35105 Hospital de São Sebastião, EPE

Santa Maria da Feira, Portugal

Location

135.312.42103 NEURON PLUS s.r.o

Bratislava, Slovakia

Location

135.312.42102 Hospital Levoca

Levoča, Slovakia

Location

135.312.42104 Jessenius Faculty of Medicine Commenius University

Martin, Slovakia

Location

135.312.42101 Faculty Hospital

Nitra, Slovakia

Location

135.312.42105 Boehringer Ingelheim Investigational Site

Trnava, Slovakia

Location

135.312.34019 Boehringer Ingelheim Investigational Site

Albacete, Spain

Location

135.312.34006 Boehringer Ingelheim Investigational Site

Badalona / Barcelona, Spain

Location

135.312.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

135.312.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

135.312.34003 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

135.312.34011 Boehringer Ingelheim Investigational Site

Bilbao, Spain

Location

135.312.34007 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

135.312.34009 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

135.312.34010 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

135.312.34020 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

135.312.34017 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

135.312.34018 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

135.312.34014 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

135.312.46007 Boehringer Ingelheim Investigational Site

Lidköping, Sweden

Location

135.312.46003 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

135.312.46005 Boehringer Ingelheim Investigational Site

Skövde, Sweden

Location

135.312.46002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

135.312.46004 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

135.312.41003 Boehringer Ingelheim Investigational Site

Aarau, Switzerland

Location

135.312.41001 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

135.312.41004 Boehringer Ingelheim Investigational Site

Lausanne, Switzerland

Location

135.312.41002 Boehringer Ingelheim Investigational Site

Sankt Gallen, Switzerland

Location

135.312.44025 Boehringer Ingelheim Investigational Site

Aberdeen, United Kingdom

Location

135.312.44002 Boehringer Ingelheim Investigational Site

Bournemouth, United Kingdom

Location

135.312.44023 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

135.312.44026 Boehringer Ingelheim Investigational Site

Dundee, United Kingdom

Location

135.312.44003 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

135.312.44006 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

135.312.44024 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

135.312.44018 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

135.312.44030 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32430395 DERIVED

• 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.

  PMID: 19850525 DERIVED

• 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.

  PMID: 18815396 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2003
• Primary Completion: February 1, 2008
• Last Updated: May 16, 2014

Record last verified: 2014-04

Locations

CZ (3); FR (24); PL (5); DK (4); PT (4); NL (2); BE (7); GR (3); SL (5); IT (16); DE (19); CH (4); HU (3); AU (10); FI (3); NO (3); SE (5); GB (9); ES (13)