Clinical Trial

Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke

Not Yet Recruiting Phase 3
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Summary
This study aims to evaluate the efficacy of Y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had AIS caused by LVO and will receive EVT. Moreover, we expect to evaluate the safety of using Y-6 sublingual tablet in such study population. This study rationale is based on the following scheme: in patients with acute ischemic stroke caused by LVO, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. Dexborneol has anti-inflammatory effects and Cilostazol has antiplatelet effects and BBB protection; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with AIS after reperfusion therapy. The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0\~1 score at 90 days after randomization. The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, 1 day, 7 days, 28 days and 90 days after randomization, and in case of any events.
Trial Details
NCT Number NCT07040085
Lead Sponsor Beijing Tiantan Hospital
Collaborators: Neurodawn Pharmaceutical Co., Ltd.
Conditions Stroke
Enrollment 892 participants
Start Date 2025-08-05
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-26