Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Basic treatmen + TBN injection
Control group:Basic Treatmen + Saline Injection
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with aged of 18 to 65 years old (include the boundary value); (2) Patients has been diagnosed with acute ischemic stroke clinically confirmed according to "the guidelines of diagnosis and treatment of acute ischemic stroke, China, 2018"; (3) Patients for whom study treatment with TBN injection or placebo can be initiated within 6 hours after the time the patient was last known normal. For patients who awaken with stroke symptoms or unable to provide the time of symptom onset for the reasons of aphasia, disturbance of consciousness and so on, the time of onset is defined as when the patient was last awake and symptom-free or known to be normal; (4) The first-episode patients, or the recrudesce patients whom were prognosis well after the last episode (mRS scores from 0 to 1); (5) Patients with the National Institutes of Health Stroke Scale (NIHSS) score of 4 to 24 (include the boundary value) when diagnosing; (6) Patient would like to taken action with contraceptives within 6 months from the signature of Informed Consent Form to last dosing; (7) Patients should comprehend and comply with the research process, volunteered for the study, signed and dated a written Informed Consent Form either from the patient personally or from the patient's legal guardian.
Exclusion criteria
Exclusion criteria: (1) Recurrent cerebral infarction patients whose mRS score >1; (2) Patients with unconsciousness at the onset of stroke (the 1a tested item of NIHSS = 2); (3) Patients with intracranial hemorrhage inspected by CT or MRI, such as hemorrhagic apoplexy, epidural hematoma, intracranial hematoma, cerebroventricular heaemorrhage, subarachnoid hemorrhage, and so on; (4) Patients with middle cerebral artery occlusion infract >1/3, or ASPECT score =7; (5) Transient ischemic stroke (TIA); (6) Patients who have received or are planning to receive endovascular treatment; (7) Patients with severe renal impairment. (e.g., creatinine clearance rate 1.5 * ULN, or others known renal insufficiency diseases); (8) Patients with severe hepatic impairment. (e.g., ALT, AST > 2.5 * ULN, or others known hepatic diseases, such as acute hepatitis, chronic hepatitis, liver cirrhosis, and so on); (9) Patients with abnormal of in admission blood routine examination, include: white blood cell 16.8mmol/L, body temperature > 38 oC, others clinical significant abnormal results at laboratory examination which were judged unsuitable for study participation by the (sub) investigator; (10) Uncontrolled hypertension (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg); (11) Patients with heart rate 120 times/min. Patients with acute myocardial infarction, interventional therapy, heart failure grade III and IV (NYHA classification); (12) Patients with seizure, unable or unwilling to cooperation for the reasons of complicated by others mental diseases, dementia; (13) Patients complicated by malignant tumor, hematological, digestive or others system severe diseases; (14) Patients who were allergic to TBN, analogue chemical molecule entity, or material of imageological examination; (15) Female patients with blood pregnancy positive, in gestation or suckling period; (16) Patients with alcohol and substance dependence before the 6 months of premorbid stroke, alcohol drinking over 14 unite per week within 6 months, 1 unite=285 ml beers (alcohol concentration: 3.5%), or 25 mL spirit (alcohol concentration: 40%), or 85 mL wine (alcohol concentration: 12%), or alcoholism before the 24 hours of premorbid stroke; (17) Patients with a past history of disease or constitution which might seriously affect the evaluation of therapeutic efficiency; (18) Patients who have received other clinical trials within the 30 days of randomization, or have participated in another trials prior to randomization; (19) Patients otherwise judged unsuitable for study participation by the (sub) investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NIHSS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS grade;NIHSS Score;Barthel index scale;The Montreal Cognitive Assessment;Stroke Impact Scale;EuroQol-5 Dimensions; | — |
Countries
China
Contacts
Public ContactYongjun Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed