Ischemic stroke 3 and 4 hours 30 minutes before treatment
Conditions
Interventions
Trade Name: Actilyse
Product Name: Actilyse
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Alteplase
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Boehringer Ingelheim Pharma Ges mbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic, Hungary
Outcome results
None listed