The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

• Age between 18 and 85 years
• Focal neurological deficit
• Clinical diagnosis of acute hemispheric ischemic stroke
• CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke
• NIH Stroke Scale Score between 6 and 22, both inclusive
• Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1
• Randomization and first treatment with the trial medication within 12h after stroke onset
• Informed consent given by the patient and/or the patient's legally acceptable representative

Exclusion Criteria:

• Evidence on CT/MRI of acute or chronic intracerebral hemorrhage, SAH, AVM, cerebral aneurysm, or neoplasm
• Signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline CT scan
• Patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the NIH Stroke Scale questions 1a.
• Neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h
• Severe coexisting systemic disease that significantly limits life expectancy
• Systolic blood pressure over 220 mmHg or diastolic blood pressure over 120 mmHg on repeated measurement (interval of 30 min) prior to study entry
• Severe congestive heart failure or presentation with acute myocardial infarction at study entry
• Epilepsy or epileptic seizures at onset of stroke
• Pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc).
• Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances)
• Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment
• Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine
• Pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required
• Participation in a clinical trial with an investigational drug in the past 4 weeks