Citicoline (Ceraxon) in acute stroke: assessment of clinical efficacy and effects on cerebral perfusion

Novel neuroimaging techniques provide quantitative assessment of cerebral perfusion in acute stroke and reveal the heterogeneity of ischemic zone. Neuroprotective agents play major role in the treatment of acute stroke as they are intended to restore functioning of potentially viable tissue. This prospective open-label study included 50 patients (mean age 60.9 years) with acute hemispheric stroke within the first 24 hours of symptoms onset. Patients were divided into 2 arms (25 patients in each arm) to receive standard of care (control arm) or standard of care plus citicoline (Ceraxon) 1 g b.i.d. as I.V. injection for 10 days. Clinical symptoms were assessed with NIHSS; neuroimaging included DWI to confirm ischemic lesion and perfusion CT to assess cerebral perfusion. Patients in both arms demonstrated significant clinical improvement on Day 10 with no significant difference between treatment arms (mean NIHSS score was 9.4 in control arm and 8.4 in Ceraxon arm, p=0.87). Perfusion CT on admission showed perfusion deficit in all patients. Mismatch regions on perfusion CT compared to DWI indicating potentially viable tissue (“penumbra”) were found in 75% of patients in control arm and in 69% of patients in Ceraxon arm. No difference between perfusion parameters in the “core” vs. “penumbra” on initial imaging was shown. On Day 10 there were no changes of cerebral perfusion values in the “core” regions, while in “penumbra” in Ceraxon arm CBF increased significantly CBF (p=0.013) with no significant differences vs. intact hemisphere, that is consistent with cerebral perfusion improvement. Thus, treatment with Ceraxon in the first 10 days of acute stroke may result in improvement of cerebral perfusion in the potentially viable tissue.