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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

Female or male inpatients
18 - 80 completed years
Clinical diagnosis of ischemic stroke causing a measurable neurological deficit 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 distinguishable from an episode of generalized ischemia, 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 regulathory 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 on the CT - scan
Symptoms of ischaemic attack began more than 4 hours 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 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 within the last 3 months
Platelet count below 100,000/mm3

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: Global outcome at day 90.;Primary end point(s): mRS 0 - 1 (favourable outcome) at day 90

Secondary Outcome Measures

Name	Time	Method

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