Cilostazole versus clopidogrel in acute large-vessel moderate and moderate-to-severe ischemic stroke: a randomized controlled trial.

BACKGROUND

More than one-third of all ischemic strokes are induced by large vessel occlusion (LVO). All the wide-scale trials that assessed the impacts of cilostazol versus clopidogrel in stroke management have been conducted in Asia and involved patients with minor stroke or TIA. Our trial is the first-ever study to evaluate cilostazol versus clopidogrel in acute LVO with moderate to severe ischemic stroke in North Africa.

OBJECTIVES

We assessed the efficacy and safety of cilostazol versus clopidogrel in first-ever LVO moderate and moderate to severe ischemic stroke patients.

METHODS

580 moderate and moderate-to-severe LVO ischemic stroke participants were randomly enrolled to receive loading and maintenance doses of cilostazol or clopidogrel.

RESULTS

580 patients were included in the intention-to-treat analysis. 29 (10.0%) participants in the cilostazol arm and 43 (14.8%) participants in the clopidogrel arm experienced a new stroke (HR 0.37; 95% CI, 0.29-0.73; P-value = 0.03). Eight participants (2.8%) in the cilostazol arm and 17 patients (5.9%) in the clopidogrel arm had drug-related hemorrhagic complications (HR 0.29; 95% CI, 0.18-0.63; P-value = 0.008).

CONCLUSION

Patients who experienced acute LVO moderate and moderate-to-severe ischemic stroke and received loading and maintenance doses of cilostazol within the first 24 h after stroke onset had better clinical outcomes based on recurrent stroke rates and better safety outcomes regarding hemorrhagic transformation of brain infarction and drug-induced peripheral hemorrhagic side effects compared to those who received loading and maintenance doses of clopidogrel. There were no significant differences between the two groups regarding death due to vascular events and unfavorable mRS after three months of stroke onset.

REGISTRATION: Retrospectively registered on ClinicalTrials.gov, NCT06242145, 27-01-2024.