A randomized controlled trial of alteplase (rt-PA) vs standard treatment in acute ischemic hemispheric stroke in patients aged more than 80 years where thrombolysis is initiated within 3 hours after stroke onset

INTERVENTION: Trade Name: ACTILYSE Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Alteplase Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: .9‐ CONDITION: acute ischemic stroke ; MedDRA version: 9.1 Level: LLT Classification code 10043647 Term: Thrombotic stroke PRIMARY OUTCOME: Main Objective: To collect efficacy and safety data on alteplase (rt‐PA) in patients aged more than 80 years old, to demonstrate that the treatment of these patients within 3 hours of onset of symptoms of acute ischemic stroke with rt PA compared to patients receiving standard treatment, will result in an improved clinical outcome with a favourable benefit/risk ratio Primary end point(s): Patients (%) with favourable outcome at day 90, according to: modified Rankin Scale (mRS) 0‐2 Secondary Objective: ‐ Study efficacy measures along 90 days; ‐ Study prognostic factors; ‐ Set, in this patient population, a neurological severity cut‐off point, if any, below which, benefit/risk ratio of thrombolityc therapy is advantageous INCLUSION CRITERIA: ‐ Female or male inpatients ‐ Age > 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 haemorrhage. ‐ Onset of symptoms < 3 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, acco