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: October 28, 2013
Last verified: October 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153036

  Show 142 Study Locations
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: October 28, 2013
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 April 22, 2014