Acute ischemic stroke
Conditions
Interventions
Y-2 Sublingual Tablets:Edaravone 30mg + d-camphenol 6mg
Y-2 placebo:60 µg d-camphenol
Sponsors
The Third Hospital of Peking University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old and = 2; 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
Exclusion criteria: 1. Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; if only bleeding, whether it is suitable for inclusion can be judged according to the researcher; 2. Severe disturbance of consciousness: NIHSS score of 1A consciousness level was more than 1; 3. Transient ischemic attack (TIA); 4. After the blood pressure was controlled, the systolic blood pressure was still higher than or equal to 220mmhg or the diastolic blood pressure was higher than or equal to 120mmhg; 5. Patients with severe mental disorders and dementia; 6. Severe active liver diseases, such as acute hepatitis, chronic active hepatitis and cirrhosis, have been diagnosed, or ALT or ast > 2.0 x ULN; 7. Severe active nephropathy and renal insufficiency have been diagnosed, or serum creatinine > 1.5 x ULN; 8. After the onset of the disease, the drugs with neuroprotective effect in the instructions have been applied, such as edaravone, concentrated solution of Edaravone and camphenol for injection, nimodipine, ganglioside, Cytidine Diphosphate Choline, piracetam, oxiracetam, butylphthalide, human urinary kallidinogenase (urinary kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (brain protein hydrolysate) Deproteinized calf serum injection, deproteinized calf blood extract injection, etc; 9. Embolectomy or interventional therapy has been used or planned after the onset of the disease; 10. Patients with malignant tumor or undergoing anti-tumor treatment can continue to participate in the study according to the researcher's judgment 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-camphenol 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score; | — |
Countries
China
Contacts
Public ContactChen Rong
Yantai YenePharma Co.,Ltd
Outcome results
None listed