NCT07040085

Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke

Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: a Randomised, Double-blind, Multicenter, Placebo-controlled Phase 3 Trial (FUTURE-2)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 892 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Y-6	each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.
DRUG	Y-6 placebo	each tablet of Y-6 placebo contained 0.06 mg of dexborneol and 0 mg of cilostazol. Both groups took one tablet q12h for 28 days.

Timeline

• Start date: 2025-08-05
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-06-26
• Last updated: 2025-06-26