acute ischemic stroke
Conditions
Interventions
Intervention group:TBN for Injection, i.v.drip
Placebo group:Placebo for Injection, i.v.drip
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years (including 18 years and 75 years), gender is not limited; 2.Diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2018); 3.The time window from the acute onset of stroke to the start of the infusion of experimental drugs is <=6 hours, and in the case of wake-up stroke,or when the onset time of symptom cannot be accurately obtained due to aphasia or disturbance of consciousness, the time of last performance should be taken as the onset time; 4.patients with a first episode or relapse (good prognosis after the last episode, mRS score is 0-1); 5.A score of 4 <= NIHSS score <= 24 at the time of visit; 6.Sujetcts who are willing to use effective contraceptive methods from the time of signing the informed consent to 6 months after the last dose; 7.Subjects and/or their legal representative agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Disturbance of consciousness (NIHSS score 1a is >= 2); 2.Neuroimaging evidence of intracranial hemorrhage (e.g., parenchymal hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.); 3.Transient ischemic attack (TIA); 4.Patients who are ready to undergo or have already undergone endovascular treatment; 5.Imaging test results showing the infarct area of the middle cerebral artery ischemic area is >1/3,or ASPECT score of is 3.0 times the upper limit of normal, or other known severe renal insufficiency diseases; 7.Severe hepatic impairment. 3.0 times the upper limit of normal, or other known liver disease such as active hepatitis, cirrhosis, liver failure, etc. 8.Patients with a known history of diabetes, or admission tests suggesting: blood glucose 16.8 mmol/L; 9.and body temperature (axillary) > 38 ?; 10.Poorly controlled hypertension, with a systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=100 mmHg in lying down before randomization; 11.Heart rate 120 beats /min; 12.Patients with acute myocardial infarction or interventional therapy in the past 6 months, heart failure (classfied as Class ?-? according to NYHA ); 13.Combined with convulsions or epilepsy, psychiatric disorders, or cognitive disorders that prevent them from cooperating; 14.Combined with malignant tumors, blood, digestion or serious diseases of the other systems; 15.Allergic to the test drugs or similar ingredients or to the materials used in imaging examination; 16.Female patients during pregnancy or lactation, or female patients of childbearing age with a positive pregnancy test result; 17.Patients with suspected or confirmed alcohol dependence, or who have consumed more than 3 units of alcohol (men) or 2 units of alcohol (women) in the 24 hours prior to the onset of the study (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine); 18.Patients with a variety of illnesses and medical conditions that would seriously affect the evaluation of efficacy prior to the onset of the disease; 19.Participated in other clinical studies within 30 days before screening, or is participating in other clinical studies; 20.Other circumstances that the investigator considered unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with an mRS score of 0-1 on the 90th +/- 5th da; | — |
Countries
China
Contacts
Public ContactYongjun.Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed