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At present, the treatment of acute ischemic stroke includes intravenous thrombolysis, intravascular interventional therapy (including arterial thrombolysis, mechanical thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2 sublingual tablet is an innovative drug developed by Yantai yinuoyi Biomedical Technology Co., Ltd. with independent intellectual property rights. This product is a free radical scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block the pathological change process caused by cerebral ischemia from two ways, and play a synergistic therapeutic role in cerebral ischemia injury.
At present, the treatment of acute ischemic stroke includes intravenous thrombolysis, intravascular interventional therapy (including arterial thrombolysis, mechanical thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2 sublingual tablet is an innovative drug developed by Yantai Yinuoyi Biomedical Technology Co., Ltd. with independent intellectual property rights. This product is a free radical scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block the pathological change process caused by cerebral ischemia from two ways, and play a synergistic therapeutic role in cerebral ischemia injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-2 sublingual test group | Experimental | Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg. |
|
| placebo group | Sham Comparator | 60 μg d-borneol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y-2 sublingual tablets | Drug | 30mg Edaravone+6mg d-borneo OR, Bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score ≤ 1 | Whether patients with mRS(Modified Rankin Scale) score ≤ 1. Used to calculate the proportion of patients with mRS score ≤ 1. | 90 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| patients' mRS score | patients' modified Rankin score | 90 days after treatment initiation |
| Good functional outcome | Whether patients with mRS score ≤ 2. Used to calculate the proportion of good functional outcome (mRS ≤2) |
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Inclusion Criteria:
-
Those who meet all of the following requirements:
Exclusion Criteria:
-
Those who meet any of the following items:
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| Name | Affiliation | Role |
|---|---|---|
| Dongsheng Fan, PhD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38372981 | Derived | Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print. | |
| 37308251 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| d-borneol |
| Drug |
60 μg d-borneol OR, Bid |
|
| 90 days after treatment initiation |
| change of NIHSS score | Change of NIHSS (National Institute of Health stroke scale) score from baseline to day 14 after randomization | 14 after treatment initiation |
| NIHSS score≤1 on 14 day | Whether NIHSS (National Institute of Health stroke scale) score≤1 on 14 day. Used to calculate the proportion of NIHSS score≤1 on 14 day. | 14 after treatment initiation |
| NIHSS score≤1 on 30 day | Whether NIHSS (National Institute of Health stroke scale) score≤1 on 30 day. Used to calculate the proportion of NIHSS score≤1 on 30 day. | 30 after treatment initiation |
| NIHSS score≤1 on 90 day | Whether NIHSS (National Institute of Health stroke scale) score≤1 on 90 day. Used to calculate the proportion of NIHSS score≤1 on 90 day. | 90 after treatment initiation |
| Derived |
| Fu Y, Tang R, Chen R, Wang A, Ren J, Zhu S, Feng X, Fan D. Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):90-95. doi: 10.1136/svn-2022-002014. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |