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Cerebrovascular AccidentPhase 3NCT00153036

Rt-PA in the Treatment of Acute Ischemic Stroke

A Phase 3 study of Cerebrovascular Accident, run by Boehringer Ingelheim at 142 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cerebrovascular Accident
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
821 participants
Where
142 sitesin 19 countries
Study dates
Apr 2003to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

142 sites in 19 countries.

142 sites in 19 countries

France24 sites

  • 135.312.33009 Boehringer Ingelheim Investigational Site

    Auch

  • 135.312.33016 Boehringer Ingelheim Investigational Site

    Besançon

  • 135.312.33013 Boehringer Ingelheim Investigational Site

    Bordeaux

  • 135.312.33017 Boehringer Ingelheim Investigational Site

    Bourg-en-Bresse

  • 135.312.33008 Boehringer Ingelheim Investigational Site

    Dijon

  • 135.312.33014 Boehringer Ingelheim Investigational Site

    Grenoble Cédex 9

  • 135.312.33015 Boehringer Ingelheim Investigational Site

    Lille

  • 135.312.33019 Boehringer Ingelheim Investigational Site

    Limoges

  • 135.312.33001 Boehringer Ingelheim Investigational Site

    Lyon

  • 135.312.33024 Boehringer Ingelheim Investigational Site

    Mantes-la-Jolie

  • 135.312.33021 Boehringer Ingelheim Investigational Site

    Meaux

  • 135.312.33002 Boehringer Ingelheim Investigational Site

    Montpellier

  • 135.312.33004 Boehringer Ingelheim Investigational Site

    Nancy

  • 135.312.33003 Boehringer Ingelheim Investigational Site

    Nice

  • 135.312.33006 Boehringer Ingelheim Investigational Site

    Paris

  • 135.312.33007 Boehringer Ingelheim Investigational Site

    Paris

  • 135.312.33020 Boehringer Ingelheim Investigational Site

    Pau

  • 135.312.33018 Boehringer Ingelheim Investigational Site

    Perpignan

  • 135.312.33023 Boehringer Ingelheim Investigational Site

    Pontoise

  • 135.312.33010 Boehringer Ingelheim Investigational Site

    Saint-Herblain

  • 135.312.33005 Boehringer Ingelheim Investigational Site

    Toulouse

  • 135.312.33012 Boehringer Ingelheim Investigational Site

    Toulouse

  • 135.312.33011 Boehringer Ingelheim Investigational Site

    Tours

  • 135.312.33022 Boehringer Ingelheim Investigational Site

    Versailles

Other trials in France

Germany19 sites

  • 135.312.49031 Boehringer Ingelheim Investigational Site

    Altenburg

  • 135.312.49011 Boehringer Ingelheim Investigational Site

    Bamberg

  • 135.312.49037 Boehringer Ingelheim Investigational Site

    Beeskow

  • 135.312.49017 Boehringer Ingelheim Investigational Site

    Bochum

  • 135.312.49008 Boehringer Ingelheim Investigational Site

    Cologne

  • 135.312.49038 Boehringer Ingelheim Investigational Site

    Frankfurt am Main

  • 135.312.49041 Boehringer Ingelheim Investigational Site

    Hamburg

  • 135.312.49023 Boehringer Ingelheim Investigational Site

    Hanover

  • 135.312.49001 Boehringer Ingelheim Investigational Site

    Heidelberg

  • 135.312.49014 Boehringer Ingelheim Investigational Site

    Leipzig

  • 135.312.49020 Boehringer Ingelheim Investigational Site

    Ludwigshafen am Rhein

  • 135.312.49004 Boehringer Ingelheim Investigational Site

    Magdeburg

  • 135.312.49003 Boehringer Ingelheim Investigational Site

    Mainz

  • 135.312.49018 Boehringer Ingelheim Investigational Site

    Mannheim

  • 135.312.49002 Boehringer Ingelheim Investigational Site

    Minden

  • 135.312.49006 Boehringer Ingelheim Investigational Site

    München

  • 135.312.49005 Boehringer Ingelheim Investigational Site

    Siegen

  • 135.312.49025 Boehringer Ingelheim Investigational Site

    Teupitz

  • 135.312.49009 Boehringer Ingelheim Investigational Site

    Wiesbaden

Other trials in Germany

Italy16 sites

  • 135.312.39020 Università degli Studi

    Coppito (aq)

  • 135.312.39013 A. O. Universitaria di Careggi

    Florence

  • 135.312.39019 Ospedale Santa Maria Annunziata

    Florence

  • 135.312.39022 Ospedale di Imperia

    Imperia

  • 135.312.39024 Istituto Scientifico San Raffaele

    Milan

  • 135.312.39002 A. O. di Padova - Policlinico Universitario

    Padova

  • 135.312.39005 A. O. di Perugia - Policlinico Monteluce

    Perugia

  • 135.312.39023 P. O. di Piacenza

    Piacenza

  • 135.312.39016 A. O. Ospedale Santa Corona

    Pietra Ligure (sv)

  • 135.312.39006 Ospedale Santa Chiara

    Pisa

  • 135.312.39003 A. O. Arcispedale "Santa Maria Nuova"

    Reggio Emilia

  • 135.312.39001 A. O. Policlinico Umberto I

    Roma

  • 135.312.39025 Università di Roma "La Sapienza"

    Roma

  • 135.312.39018 Ospedale S. Maria della Misericordia

    Udine

  • 135.312.39009 Ospedale Maggiore di BorgoTrento

    Verona

  • 135.312.39004 Ospedale Civile

    Vicenza

Other trials in Italy

Spain13 sites

  • 135.312.34019 Boehringer Ingelheim Investigational Site

    Albacete

  • 135.312.34006 Boehringer Ingelheim Investigational Site

    Badalona / Barcelona

  • 135.312.34001 Boehringer Ingelheim Investigational Site

    Barcelona

  • 135.312.34002 Boehringer Ingelheim Investigational Site

    Barcelona

  • 135.312.34003 Boehringer Ingelheim Investigational Site

    Barcelona

  • 135.312.34011 Boehringer Ingelheim Investigational Site

    Bilbao

  • 135.312.34007 Boehringer Ingelheim Investigational Site

    Girona

  • 135.312.34009 Boehringer Ingelheim Investigational Site

    Madrid

  • 135.312.34010 Boehringer Ingelheim Investigational Site

    Madrid

  • 135.312.34020 Boehringer Ingelheim Investigational Site

    Madrid

  • 135.312.34017 Boehringer Ingelheim Investigational Site

    Santiago de Compostela

  • 135.312.34018 Boehringer Ingelheim Investigational Site

    Seville

  • 135.312.34014 Boehringer Ingelheim Investigational Site

    Zaragoza

Other trials in Spain

Austria10 sites

  • 135.312.43004 Boehringer Ingelheim Investigational Site

    Graz

  • 135.312.43007 Boehringer Ingelheim Investigational Site

    Innsbruck

  • 135.312.43010 Boehringer Ingelheim Investigational Site

    Klagenfurt

  • 135.312.43001 Boehringer Ingelheim Investigational Site

    Linz

  • 135.312.43012 Boehringer Ingelheim Investigational Site

    Linz

  • 135.312.43013 Boehringer Ingelheim Investigational Site

    Linz

  • 135.312.43008 Boehringer Ingelheim Investigational Site

    Ma.Gugging/Klosterneuburg

  • 135.312.43006 Boehringer Ingelheim Investigational Site

    Salzburg

  • 135.312.43003 Boehringer Ingelheim Investigational Site

    Sankt Pölten

  • 135.312.43002 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

United Kingdom9 sites

  • 135.312.44025 Boehringer Ingelheim Investigational Site

    Aberdeen

  • 135.312.44002 Boehringer Ingelheim Investigational Site

    Bournemouth

  • 135.312.44023 Boehringer Ingelheim Investigational Site

    Cambridge

  • 135.312.44026 Boehringer Ingelheim Investigational Site

    Dundee

  • 135.312.44003 Boehringer Ingelheim Investigational Site

    Glasgow

  • 135.312.44006 Boehringer Ingelheim Investigational Site

    Glasgow

  • 135.312.44024 Boehringer Ingelheim Investigational Site

    Glasgow

  • 135.312.44018 Boehringer Ingelheim Investigational Site

    Liverpool

  • 135.312.44030 Boehringer Ingelheim Investigational Site

    London

Other trials in United Kingdom

Belgium7 sites

  • 135.312.32006 O.L. Vrouwziekenhuis

    Aalst

  • 135.312.32002 Boehringer Ingelheim Investigational Site

    Anderlecht

  • 135.312.32014 Boehringer Ingelheim Investigational Site

    Antwerp

  • 135.312.32001 Boehringer Ingelheim Investigational Site

    Bruges

  • 135.312.32016 Boehringer Ingelheim Investigational Site

    Godinne

  • 135.312.32011 Boehringer Ingelheim Investigational Site

    Kortrijk

  • 135.312.32005 Boehringer Ingelheim Investigational Site

    Leuven

Other trials in Belgium

Poland5 sites

  • 135.312.48004 Medical University of Gdansk

    Gdansk

  • 135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease

    Katowice

  • 135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole

    Opole

  • 135.312.48001 Institute of Psychiatry & Neurology in Warsaw

    Warsaw

  • 135.312.48002 Dr. Anna Gostynska Wolski Hospital

    Warsaw

Other trials in Poland

Slovakia5 sites

  • 135.312.42103 NEURON PLUS s.r.o

    Bratislava

  • 135.312.42102 Hospital Levoca

    Levoča

  • 135.312.42104 Jessenius Faculty of Medicine Commenius University

    Martin

  • 135.312.42101 Faculty Hospital

    Nitra

  • 135.312.42105 Boehringer Ingelheim Investigational Site

    Trnava

Other trials in Slovakia

Sweden5 sites

  • 135.312.46007 Boehringer Ingelheim Investigational Site

    Lidköping

  • 135.312.46003 Boehringer Ingelheim Investigational Site

    Malmö

  • 135.312.46005 Boehringer Ingelheim Investigational Site

    Skövde

  • 135.312.46002 Boehringer Ingelheim Investigational Site

    Stockholm

  • 135.312.46004 Boehringer Ingelheim Investigational Site

    Stockholm

Other trials in Sweden

Denmark4 sites

  • 135.312.45005 Boehringer Ingelheim Investigational Site

    Aalborg

  • 135.312.45002 Boehringer Ingelheim Investigational Site

    Aarhus

  • 135.312.45001 Boehringer Ingelheim Investigational Site

    Copenhagen NV

  • 135.312.45004 Boehringer Ingelheim Investigational Site

    Glostrup Municipality

Other trials in Denmark

Portugal4 sites

  • 135.312.35101 Hospitais da Universidade de Coimbra

    Coimbra

  • 135.312.35106 Hospital de Santa Maria

    Lisbon

  • 135.312.35102 Hospital de Santo António

    Porto

  • 135.312.35105 Hospital de São Sebastião, EPE

    Santa Maria da Feira

Other trials in Portugal

Switzerland4 sites

  • 135.312.41003 Boehringer Ingelheim Investigational Site

    Aarau

  • 135.312.41001 Boehringer Ingelheim Investigational Site

    Basel

  • 135.312.41004 Boehringer Ingelheim Investigational Site

    Lausanne

  • 135.312.41002 Boehringer Ingelheim Investigational Site

    Sankt Gallen

Other trials in Switzerland

Czechia3 sites

  • 135.312.42001 Boehringer Ingelheim Investigational Site

    Ostrava

  • 135.312.42004 Boehringer Ingelheim Investigational Site

    Ostrava-Vitkovice

  • 135.312.42002 Boehringer Ingelheim Investigational Site

    Prague

Other trials in Czechia

Finland3 sites

  • 135.312.35801 Boehringer Ingelheim Investigational Site

    Helsinki

  • 135.312.35805 Boehringer Ingelheim Investigational Site

    Kuopio

  • 135.312.35802 Boehringer Ingelheim Investigational Site

    Turku

Other trials in Finland

Greece3 sites

  • 135.312.30004 Boehringer Ingelheim Investigational Site

    Athens

  • 135.312.30005 Boehringer Ingelheim Investigational Site

    Larissa

  • 135.312.30002 Boehringer Ingelheim Investigational Site

    Thessaloniki

Other trials in Greece

Hungary3 sites

  • 135.312.36002 University of Debrecen

    Debrecen

  • 135.312.36001 Aladár Petz County Hospital

    Győr

  • 135.312.36006 BAZ County and Teaching Hospital

    Miskolc

Other trials in Hungary

Norway3 sites

  • 135.312.47001 Boehringer Ingelheim Investigational Site

    Bergen

  • 135.312.47006 Boehringer Ingelheim Investigational Site

    Tønsberg

  • 135.312.47003 Boehringer Ingelheim Investigational Site

    Trondheim

Other trials in Norway

Netherlands2 sites

  • 135.312.31001

    Amsterdam

  • 135.312.31007 Medisch Spectrum Twente

    Enschede

Other trials in Netherlands

About this study

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

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.

Being tested
rt-PA 0.9 mg/kg verum or placebo Intravenous
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rt-PA 0.9 mg/kg verum or placebo IntravenousDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at day 90

Secondary outcomes (1)

  1. Global outcome of four neurologic and disability scores combined

    Measured: at day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153036
Sponsor's protocol ID
135.312
Status last verified
Apr 2014
First submitted
9 Sep 2005
Last updated
16 May 2014
Results posted
No

Publications

  • 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.

    PubMed 32430395

  • 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.

    PubMed 19850525

  • 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.

    PubMed 18815396

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Cerebrovascular Accident, run by Boehringer Ingelheim at 142 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in France, Germany, Italy, Spain, Austria and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (time frame: at day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00153036, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.

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