Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Y-2 sublingual test group Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg. |
Drug: Y-2 sublingual tablets
OR， Qd
|
| placebo group 60 μg d-borneol |
Outcome Measures
Primary Outcome Measures
- Proportion of patients with mRS score < 1 [90 days after treatment]
Proportion of patients with mRS score < 1
Secondary Outcome Measures
- patients' mRS score [90 days after treatment]
patients' mRS score
Eligibility Criteria
Criteria
Inclusion Criteria:
Those who meet all of the following requirements:
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Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
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After the onset of the disease, the National Institutes of Stroke Scale score: 6 ≤ NIHSS ≤ 20, and the sum of the fifth upper limb score and the sixth lower limb score was 22;
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The onset time is within 48 hours (including 48 hours);
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Patients diagnosed as ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", with good prognosis after the first attack or the last attack (MRS score ≤ 1 before this attack);
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The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.
Exclusion Criteria:
Those who meet 0ne of the following items:
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Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can judge whether it is suitable for inclusion
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Severe disturbance of consciousness: the item score of La consciousness level of NIHSS was more than 1;
Transient ischemic attack (TIA)
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Systolic blood pressure was still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg after blood pressure control;
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Patients with severe mental disorders and dementia;
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Severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST > 2.0 × ULN;
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Severe active kidney disease and renal insufficiency have been diagnosed; Or serum creatinine > 1.5 × ULN;
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After the onset of the disease, the drugs with neuroprotective effect in the manual have been used
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Embolectomy or interventional therapy has been used or planned after the onset of the disease;
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Complicated with malignant tumor or undergoing anti-tumor treatment; For the subjects diagnosed with malignant tumor after enrollment, whether to continue to participate in the study can be judged by the researcher and the willingness of the subjects;
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Suffering from severe systemic diseases, the estimated survival time is less than 90 days;
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Allergic to d-borneol or edaravone or excipients;
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Patients during pregnancy, lactation and planned pregnancy;
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Major operation history within 4 weeks before enrollment;
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Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;
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The researcher thinks that it is not suitable to participate in this clinical study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijin | China |
Sponsors and Collaborators
- Peking University Third Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D2020185