acute ischemic stroke
Conditions
Interventions
Study group:Drug therapy
control group:Placebo
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between 18 and 80 years of age (both inclusive); 2. Clinical diagnosis of ischemic stroke (diagnosis follows The Chinese Guidelines for diagnosis and Treatment of Acute Ischemic Stroke 2018); 3. The screening time should be within 8 hours after the onset of stroke, and it was expected to start receiving the experimental drugs within 8 hours after the onset of stroke; Note: Onset time is calculated from the onset time of stroke symptoms. If onset occurs during sleep, it should be taken as the onset time of the last normal appearance. 4. The subject has received or plans to receive standard intravenous thrombolysis after the onset of the disease; Standard intravenous thrombolytic therapy was defined as intravenous RT-PA thrombolytic therapy within 3 hours or 3-4.5 hours after onset of ischemic stroke. 5. NIHSS score before intravenous thrombolysis was =9 and =22; 6. Those who could independently engage in daily activities before the onset of stroke (mRS score was 0-1 before the onset); 7. Able to understand and comply with the study procedures, and the subjects who sign the informed consent form in written form are those who are willing to participate in the study (the informed consent form is signed by themselves or their legal representative);
Exclusion criteria
Exclusion criteria: 1. Plan to carry out endovascular interventional therapy for stroke (including endovascular mechanical thrombectomy, endovascular thrombosis suction, arterial thrombolysis, angioplasty and stent implantation) or arteriovenous bridging therapy; 2. After admission, CT/MRI indicated large area infarction (infarct area > 1/3 middle cerebral artery blood supply area) or posterior circulation ischemia; 3. Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes; 4. CT/MRI evidence of intracranial hemorrhage (parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extracranial hematoma) after admission, or symptoms of intracranial hemorrhage determined by researchers; 5. Previous history of intracranial hemorrhage; a history of severe head trauma, stroke, or myocardial infarction within 3 months prior to screening; 6. Intracranial tumors and giant intracranial aneurysms; 7. Accompanied by aortic arch intercalation; 8. Major surgical operations within 2 weeks prior to screening; Or had intracranial or intravertebral canal surgery within 3 months prior to screening; 9. There is active visceral hemorrhage at present; Or arterial puncture in the area that is not easy to compress hemostasis within 1 week before screening; Gastrointestinal or urinary bleeding occurred within 3 weeks prior to screening; 10. Patients with acute bleeding tendency, including: platelet count 1.7 or prothrombin time b> 15 s; 12. Low-molecular-weight heparin was treated within 24 hours before intravenous thrombolysis, thrombin inhibitor or factor Xa inhibitor was used within 48 hours; 13. Blood glucose 22.22 mmol/L; 14. Patients with severe primary liver and kidney diseases, AST or ALT 2 times higher than the normal upper limit, serum creatinine >2.0 mg/dL or >176.8 mol/L; 15. After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure =180 mmHg, or diastolic blood pressure =100 mmHg; 16. Previous hypotension or blood pressure < 90/60mmhg measured for 3 consecutive times during screening; 17. Previous history of epilepsy or epileptiform symptoms at the onset of stroke; 18. Complete atrioventricular block; Or grade I or above according to the Heart function classification of the New York Heart Association (NYHA); Or screening for hospitalization due to congestive heart failure within the previous 6 months; 19. Female subjects who are pregnant, breast-feeding or preparing for pregnancy during the study. Women of childbearing age who, in the researchers' judgment, were unable to use a medically approved reliable contraceptive method between the time they signed the informed consent and the end of the study; 20. The combination of other neurofunctional diseases, disabilities or mental diseases may affect the efficacy evaluation of this study, as determined by the researcher; 21. Screening for patients with a history of malignant tumor in the previous 5 years (if the subject is a basal cell carcinoma of the skin or carcinoma in situ of the cervix and has been cured, he/she can participate in this study); 22. Persons with a known history of allergy to 5-amino salicylic acid; 23. Those who participated i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS Score;BI index score;EQ-5D Score;All-cause mortality rate;Incidence of new vascular events; | — |
Countries
China
Contacts
Public ContactFuxin Liu
Outcome results
None listed