BACKGROUND:Cilostazol, an inhibitor of phosphodiesterase 3, has various pleiotropic effects besides its antiplatelet activity. This study examined the efficacy of cilostazol for the treatment of acute perforating artery infarction. METHODS: In this prospective, randomized, open-label, blinded-end point trial, 100 patients with cerebral infarction in the territory of the lenticulostriate arteries were enrolled within 48 h of onset. Patients were randomly treated with both cilostazol and ozagrel for 14 days (n = 50, cilostazol group) or ozagrel alone for 14 days (n = 50, control group). The primary end point was the proportion of favorable outcomes 30 days after randomization as defined by a modified Rankin Scale (mRS) score of 0-2. Secondary end points included the incidence of neurological deterioration (an increase of ≥ 2 on the National Institutes of Health Stroke Scale within 7 days). RESULTS: Favorable outcomes (mRS scores 0-2) were similar in both groups (81.3 and 82.0% in the cilostazol and control groups, respectively). The incidence of neurological deterioration was lower in the cilostazol group than the control group (12.5 and 16.0%, respectively) with a 21.9% relative risk reduction, although the difference was not statistically significant. CONCLUSIONS:Cilostazol did not prevent the neurological deterioration of perforating artery infarction.
RCT Entities:
BACKGROUND:Cilostazol, an inhibitor of phosphodiesterase 3, has various pleiotropic effects besides its antiplatelet activity. This study examined the efficacy of cilostazol for the treatment of acute perforating artery infarction. METHODS: In this prospective, randomized, open-label, blinded-end point trial, 100 patients with cerebral infarction in the territory of the lenticulostriate arteries were enrolled within 48 h of onset. Patients were randomly treated with both cilostazol and ozagrel for 14 days (n = 50, cilostazol group) or ozagrel alone for 14 days (n = 50, control group). The primary end point was the proportion of favorable outcomes 30 days after randomization as defined by a modified Rankin Scale (mRS) score of 0-2. Secondary end points included the incidence of neurological deterioration (an increase of ≥ 2 on the National Institutes of Health Stroke Scale within 7 days). RESULTS: Favorable outcomes (mRS scores 0-2) were similar in both groups (81.3 and 82.0% in the cilostazol and control groups, respectively). The incidence of neurological deterioration was lower in the cilostazol group than the control group (12.5 and 16.0%, respectively) with a 21.9% relative risk reduction, although the difference was not statistically significant. CONCLUSIONS:Cilostazol did not prevent the neurological deterioration of perforating artery infarction.