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 - ECASS III

Phase 1

Conditions: Acute ischemic hemispheric stroke

Registration Number: EUCTR2005-003176-38-SK

Lead Sponsor: Boehringer Ingelheim France

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

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 30 minutes 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 distinguishablefrom 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 defered 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 the
information sheet.
Willingness and ability to comply with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Evidence of intracranial hemorrhage (ICH) on the CT-scan.
Symptoms of ischaemic attack began more than 4 hours 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
Patients with any history of prior stroke and concomitant diabetes
Prior stroke within the last 3 months
Platelet count of 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 < 2.77 or > 22.15 mmol / l.
Known haemorraghic diathesis
Patients receiving oral anticoagulants, e.g. warfarin sodium
Manifest or recent severe or dangerous bleeding
Known history of or suspected intracranial haemorrhage
Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
Any 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.
Known 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
Severe liver disease, including hepatic failure, cirrhosis, portal hypertension
oesaphageal varices) and active hepatitis
Major surgery or significant trauma in past 3 months.
Current or recent (within 3 months) participation in another investigational drug treatment protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 hours 30 minutes of onset of symptoms of acute ischemic stroke with rt-PA compared to the placebo-treated patients will result in an improved clinical outcome without increase of fatality rate.;Secondary Objective: Not defined;Primary end point(s): mRS 0-1 (favourable outcome) at day 90

Secondary Outcome Measures

Name	Time	Method

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