Acute ischemic stroke
Conditions
Interventions
0.3mg/kg CN-105 peptide group for injection:CN-105 peptide for injection, dose of 0.3mg/kg, intravenous infusion, every 6 hours, total of 13 doses
Placebo group:Placebo, intravenous infusion, every 6 hours, total of 13 doses
1.0mg/kg CN-105 peptide group for injection:CN-105 peptide for injection, dose of 1.0mg/kg, intravenous infusion, every 6 hours, total of 13 doses
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30-80 years (inclusive) at the time of signing the Informed Consent Form (ICF), regardless of gender; 2. Patients diagnosed with AIS according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd Edition) and the investigator's judgment; 3. Patients who can receive the first dose of the trial drug within 12 hours of symptom onset (symptom onset is calculated from the time the patient last appeared normal; for strokes occurring during sleep, symptom onset is calculated from the time the patient was last observed to be normal or self-reported to be normal); 4. Patients who have undergone or are planning to undergo intravenous thrombolysis; 5. Subjects with a National Institutes of Health Stroke Scale (NIHSS) score of >=4 and <=25 before intravenous thrombolysis; 6. Understand and comply with the study procedures, voluntarily participate, and the subject or guardian or impartial witness has signed the ICF; 7. The subjects promised that they had no plans to have children or donate sperm or eggs within 3 months from the time they signed the informed consent form to the last medication, and that they would voluntarily adopt one or more contraceptive measures to strictly prevent pregnancy (such as intrauterine devices, condoms);
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial hemorrhage indicated by CT/MRI after admission, or post-stroke hemorrhagic transformation of cerebral infarction; if only oozing, the investigators may determine suitability for inclusion; 2. Imaging shows middle cerebral artery infarct involving >1/3 of the territory, or ASPECTS =180 mmHg or diastolic BP >=100 mmHg; 7. Severe disturbance of consciousness: NIHSS item 1a score >=2; 8. Modified Rankin Scale (mRS) score >=2 prior to current stroke onset; 9. Severe renal insufficiency: e.g., dialysis-dependent patients, diagnosed severe active renal disease, or creatinine clearance 3x upper limit of normal; 11. INR >1.7 or PT >15 s, or irreversible coagulopathy due to underlying disease; 12. History of severe cardiovascular disease meeting any of the following: 1) Heart failure (NYHA class >=III); 2) Unstable angina within 3 months; 3) Any supraventricular or ventricular arrhythmia requiring treatment; 4) Clinically significant QTc prolongation (reference: male >450 ms, female >470 ms) (Note: QTc must be calculated using Fridericia’s formula); 5) Complete atrioventricular block or treated left/right bundle branch block; 6) Acute myocardial infarction or intervention within past month; 13. Severe head trauma or encephalitis within 6 months prior to screening; 14. History of prior intracranial hemorrhage; 15. History of or current intracranial tumor or intracranial aneurysm; 16. Concurrent malignancy (excluding non-melanoma in situ skin cancer with complete remission and no recurrence for >=5 years, as deemed eligible by investigator); or other serious disease with life expectancy 22.22 mmol/L (400 mg/dL); 18. Patients with epilepsy; patients with other psychiatric disorders preventing or unwilling to cooperate; patients with dementia; 19. Patients with hypersensitivity or known allergy to any component of the investigational product; 20. Pregnant or lactating females; or positive pregnancy test in women of childbearing potential; 21. Participation in another clinical trial within 90 days prior to randomization, or currently enrolled in another clinical trial; 22. Other conditions deemed unsuitable for study participation by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS) score shift analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS) score shift analysis;Change in NIHSS(National Institutes of Health Stroke Scale) score from baseline;Proportion with Modified Rankin Scale (mRS) score 0–1 and 0–2;EQ-5D(EuroQol Five Dimensions Questionnaire, EQ-5D) score;Proportion with NIHSS(National Institutes of Health Stroke Scale) reduction =4 points or NIHSS 0–1;Barthel Index (BI) score and change from baselin; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed