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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
892
each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.
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.
Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.
mRS recover to 0-1
Time frame: 90 days
•mRS at 90 days after randomization
mRS (0-6); the scale ranges from 0 to 5, where 0 indicates no symptoms, and 5 signifies severe disability requiring continuous care and assistance. 6, denotes death.
Time frame: 90 days
• Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization;
Changes in NIHSS; the total score ranges from 0 to 42, with lower scores indicating better neurological status.
Time frame: from baseline to 1 day, 7 days and 28 days
• Proportion of patients with early neurological deterioration at 1 day after randomization;
early neurological deterioration
Time frame: at 1 day
• Proportion of subjects with combined vascular events at 90 days after randomization.
combined vascular events
Time frame: 90 days
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