Acute Cerebral Ischemic Stroke, ACIS
Conditions
Interventions
primidone group:oral primidone, 50 mg two times a day and secondary preventive medication for 90±7 days.
control group:oral placebo 1 tablet, two times a day and secondary preventive medication for 90±7 days.
Sponsors
The First Hospital of Yichang
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Cerebral infarction patients diagnosed in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018; 2. Cerebral infarction was confirmed by head CT or MRI; 3. The onset time of acute cerebral infarction is less than 3 days; 4. Age 18-80 years old, gender is not limited; 5. Those who refuse to treat with mechanical thrombectomy/thrombolysis or cannot do mechanical thrombectomy/thrombolysis beyond the time window; 6. 5=NIHSS score =22; 7. Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Patients with transient ischemic attack, lacunar infarction of non-responsible lesions, cerebral hemorrhage after cerebral infarction, subarachnoid hemorrhage, and intracranial hemorrhage detected by craniocerebral CT scan; 2. Hemiplegia caused by brain tumor, brain trauma, brain host worm disease and metabolic disorder was confirmed by examination; 3. Therapeutic neuroprotective agents have been applied after stroke, including commercially available nimodipine, ganglioside, citicoline, piracetam, and urocalidinogenase; 4. Patients with thrombolysis or mechanical thrombolysis; 5. Patients with coagulation dysfunction and digestive ulcer who cannot take aspirin; 6. Patients with serious primary diseases such as cardiovascular, liver (ALT or AST > 1.5 times the upper limit of normal value), kidney (BUN > 1.2 times the upper limit of normal value, Cr > the upper limit of normal value), endocrine system and hematopoietic system; 7. People who are allergic to primidone; 8. Drug or alcohol dependent; 9. Pregnancy intention or pregnancy test positive women of childbearing age and breastfeeding women; 10. Participants in other clinical trials within the last 3 months; 11. Patients with malignant tumors or receiving anti-tumor therapy; 12. Patients deemed unsuitable for clinical trials by the investigator. 13. History of aneurysms (including intracranial aneurysms and peripheral aneurysms)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale;National Institute of Health stroke scale;Mental, speech, and motor functional neurological signs;Recurrence rate of cerebral infarction events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood RIPK1 levels;Peripheral blood interleukin-1 ß;Blood concentration of primidone;Blood RIPK3 levels;Blood MLKL levels;Peripheral blood interleukin-8;Peripheral blood interleukin-10;Peripheral blood tumor necrosis factor a;Peripheral blood SOD; | — |
Countries
China
Contacts
Public ContactXichang Liu
The First Hospital of Yichang
Outcome results
None listed