Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke

This is an interventional treatment trial for Stroke Read More

Inclusion Criteria:

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Those who meet all of the following requirements:

1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
2. 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;
3. The onset time is within 48 hours (including 48 hours);
4. 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);
5. The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

Exclusion Criteria:

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Those who meet 0ne of the following items:

1. 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
2. Severe disturbance of consciousness: the item score of La consciousness level of NIHSS was more than 1;

Transient ischemic attack (TIA)

4. Systolic blood pressure was still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg after blood pressure control;

5. Patients with severe mental disorders and dementia;

6. Severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST > 2.0 × ULN;

7. Severe active kidney disease and renal insufficiency have been diagnosed; Or serum creatinine > 1.5 × ULN;

8. After the onset of the disease, the drugs with neuroprotective effect in the manual have been used

9. Embolectomy or interventional therapy has been used or planned after the onset of the disease;

10. 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;

11. Suffering from severe systemic diseases, the estimated survival time is less than 90 days;

12. Allergic to d-borneol or edaravone or excipients;

13. Patients during pregnancy, lactation and planned pregnancy;

14. Major operation history within 4 weeks before enrollment;

15. Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;

16. The researcher thinks that it is not suitable to participate in this clinical study