Key result
Phase II trial evaluates sublingual Y-6 tablets in acute ischaemic stroke from large vessel occlusion.
Why the study?
Clinical outcomes can remain disappointing even after successful recanalisation with endovascular treatment for acute ischaemic stroke, highlighting the need for solutions to futile recanalisation.
Does early treatment with Y-6 sublingual tablets (cilostazol and dexborneol) improve the percentage of patients achieving an mRS score of 0-1 at 90 days in patients with acute ischemic stroke undergoing endovascular treatment?
RCT (n=300)
Double-blind, double-dummy
Centralised competitive randomisation
Yes
Does early treatment with Y-6 sublingual tablets (cilostazol and dexborneol) improve the percentage of patients achieving an mRS score of 0-1 at 90 days in patients with acute ischemic stroke undergoing endovascular treatment?
This trial will provide preliminary phase II evidence on whether early multitarget combination therapy with cilostazol and dexborneol before reperfusion therapy improves functional outcomes in acute ischemic stroke.
BACKGROUND: Acute ischaemic stroke, due to its high mortality and disability rates, imposes a significant economic and social burden worldwide. Typically, endovascular treatment within the therapeutic window is provided to salvage the ischaemic penumbra; however, even when recanalisation is successful during endovascular treatment, the clinical outcomes may still be disappointing. This highlights the necessity of further research, so as to discover better solutions to futile recanalisation and improve patient outcomes. OBJECTIVE: To investigate the efficacy and safety of Y-6 sublingual tablets (cilostazol and dexborneol) compared with a placebo in the treatment of patients with acute ischaemic stroke caused by large vessel occlusion. METHOD: The efficacy and safety of Y-6 sublingual tablets in patients with acute ischaemic stroke are evaluated in a phase II, randomised, double-blind, double-dummy, placebo-controlled, parallel clinical trial. Eligible patients having provided informed consent are randomised into five groups for a 28-day treatment period. The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0-1 at 90 days. DISCUSSION: The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion. TRIAL REGISTRATION NUMBER: NCT06138834.
No takes yet. Share an insight, caveat, or question.
Wang et al. (2025) conducted an RCT in Acute ischaemic stroke with large vessel occlusion (n=300). Y-6 sublingual tablets (cilostazol and dexborneol) vs. Placebo was evaluated on Percentage of patients achieving modified Rankin Scale (mRS) score of 0-1 at 90 days. Y-6 sublingual tablets are being evaluated for efficacy and safety in patients with acute ischaemic stroke caused by large vessel occlusion in this ongoing phase II trial, with no clinical results reported yet.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: