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 received reperfusion therapy. 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. Cilostazol has antiplatelet effects and BBB protection and Dexborneol has anti-inflammatory effects; 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±7 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, first drug administration, immediately after reperfusion therapy(within 2 hours), 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days, 28 ± 2 days and 90 ± 7 days after randomization, and in case of any events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Take Y-6 sublingual tablets for 28 days continuously.
Take Placebo tablets of Y-6 sublingual tablet for 28 days continuously.
Liuzhou Workers' Hospital
Liuchow, Guangxi, China
RECRUITINGHunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGPingxiang people's hospital
Pingxiang, Jiangxi, China
RECRUITINGProportion of mRS score recovered to 0~1 score
The modified Rankin Scale (mRS) decreasing to 0\~1 score. mRS Mainly measures patients' independent living ability, including physical function, activity ability and participation in daily life. A score of 0 on the mRS Scale indicates no symptoms and a score of 5 indicates severe disability.
Time frame: 90±7 days after randomization
The mRS score at 90±7 days after randomization
The modified Rankin Scale (mRS) evaluated at 90±7 days after randomization. mRS Mainly measures patients' independent living ability, including physical function, activity ability and participation in daily life. A score of 0 on the mRS Scale indicates no symptoms and a score of 5 indicates severe disability.
Time frame: 90±7 days after randomization
Integrity of BBB evaluated by DCE
BBB permeability is assessed by DCE-MRI
Time frame: 96±7 hours after randomization
Changes of NIHSS score between baseline and immediately after reperfusion therapy
NIHSS score after reperfusion therapy within 2 hours changing compared with baseline NIHSS. The NIHSS score ranges from 0 to 42. The higher the score, the more severe the nerve damage.
Time frame: immediately after reperfusion therapy (within 2 hours)
Changes of NIHSS score between baseline and at 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days and 28 ± 3days after randomization
NIHSS score changing compared with baseline NIHSS. The NIHSS score ranges from 0 to 42. The higher the score, the more severe the nerve damage.
Time frame: 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days and 28 ± 3 days after randomization and baseline NIHSS score
Proportion of study patients with early progression of stroke at 24 ± 2 hours and 96 ± 7 hours after randomization
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NIHSS score increasing by ≥ 2 points, or the score of hemiplegia increasing by≥1 point, or the score of conscious disturbance increasing by ≥ 1 point compared with baseline within 7 days of onset, and intracranial hemorrhage is excepted by CT or MRI. Exacerbations not attributable to stroke are also excluded such as cardiac failure, liver and renal failure, etc.
Time frame: 24 ± 2 hours and 96 ± 7 hours after randomization
Proportion of study patients with combined vascular events at 90 ± 7 days after randomization
Symptomatic stroke, myocardial infarction and vascular death
Time frame: 90 ± 7 days after randomization