Randomized Efficacy Trial of Citicoline in Patients With Acute Ischemic Stroke "Citicoline 007"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

Acute ischemic stroke within 24 hours of onset, clinically assessed to be middle cerebral artery territory, NIH stroke scale >=5, Rankin score <=2, focal neurological deficit lasting >=60 minutes, CT (or MRI) compatible with clinical diagnosis. Must be at least 18 years of age.

Exclusion Criteria

CT/MRI evidence of brain tumor, brain stem or cerebellar infarction, subarachnoid hemorrhage or primary intracerebral hemorrhage; severe coexisting systemic disease limiting life expectancy; history of ventricular dysrhythmias, myocardial infarction, or any severe cardiovascular condition; previous disorder which would impair neurological assessment; improvement in neurological signs and symptoms during baseline assessment; preexisting medical condition that might interfere with participation; surgery needed within 24 hours; recent or planned thrombolytic (rtPA) use.