ABSTRACT NUMBER: ESOC2026LT18 LT18 - EFFICACY AND SAFETY OF CILOSTAZOL PLUS GINKGO BILOBA AND ASPIRIN VERSUS CLOPIDOGREL PLUS ASPIRIN IN ACUTE ISCHEMIC STROKE: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL

Abstract Background and aims Neurological deterioration (ND) during hospitalization and early recurrent stroke are linked to poor outcomes after acute ischemic stroke (AIS). Cilostazol combined with ginkgo biloba extract (GBE) has been proposed as an alternative antiplatelet strategy, but evidence versus clopidogrel-based dual antiplatelet therapy (DAPT) is limited. We compared cilostazol/GBE plus aspirin with clopidogrel plus aspirin in non-cardioembolic AIS. Methods In this multicenter, randomized, double-blind, active-controlled trial, we conducted an exploratory analysis at 18 stroke centers in Korea (December 2022–May 2025), adults with non-cardioembolic AIS within 72 hours were randomized 1:1 to cilostazol 200 mg plus GBE 160 mg or clopidogrel 75 mg; both received aspirin 100 mg daily for 90 days. The primary outcome was a composite of in-hospital ND or recurrent stroke within 90 days. Secondary outcomes included recurrent stroke, bleeding, and functional independence at 90 days. Results Of 475 screened patients, 444 were analyzed (mean age 64.2 years; 27.5% women). The primary outcome occurred in 7.8% with cilostazol/GBE and 3.5% with clopidogrel (hazard ratio [HR] 2.28, 95% CI 0.98–5.28; P=0.055). In-hospital ND was more frequent with cilostazol/GBE (5.5% vs 0.9%; HR 6.35, 95% CI 1.42–28.35; P=0.016). Recurrent ischemic stroke (2.8% vs 2.2%) and 90-day functional independence (mRS 0–2: 90.5% vs 90.2%) did not differ. Conclusions In non-cardioembolic AIS, cilostazol/GBE plus aspirin did not reduce early ND or recurrent stroke compared with clopidogrel-based DAPT, and was associated with a higher rate of in-hospital ND. Conflict of interest Figure 1 - belongs to Results Figure 2 - belongs to Conclusions