acute ischemic stroke
Conditions
Interventions
experimental group:Anisodine hydrobromide injection, 1ml: 0.5mg, Chengdu First Pharmaceutical Co., Ltd
control group:Anisodine hydrobromide injection simulant, 1ml/piece, Chengdu First Pharmaceutical Co., Ltd
Sponsors
Beijing Tiantan Hospital,Capital,Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Only those who meet all the following criteria can be included in the group: (1) Age = 18 years old, regardless of gender; (2) Clinical diagnosis of ischemic stroke (diagnosis follows the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"); (3) Within 24 hours after the onset of stroke, and it is expected to start receiving experimental drugs within 24 hours after the onset of stroke; Note: The onset time is calculated from the time when the symptoms of stroke appear. If the onset occurs during sleep, the time when the last appearance is normal should be taken as the onset time. (4) The subject has received standard intravenous thrombolysis treatment since the onset of the disease, and the symptoms before the trial medication have not worsened after thrombolysis treatment; Note: The standard definition of intravenous thrombolysis therapy is: receiving rt PA thrombolysis therapy intravenously within 4.5 hours after the onset of ischemic stroke; (5) The NIHSS score before intravenous thrombolysis is = 6 and = 25 points; (6) Before the onset of this stroke, they were able to independently engage in daily life activities (with a mRS score of 0-1 before the onset); (7) The subject or guardian signs an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals who have participated in clinical studies of other drugs/devices and used investigational drugs/devices within 3 months prior to randomization; (2) After this admission, CT/MRI showed a large area of infarction; Note: According to the definition of infarct size displayed on imaging, This includes "large cerebral hemisphere infarction" (CT plain scan within 6 hours of onset shows infarction area>1/3 of the middle cerebral artery supply area, or CT plain scan shows infarction area>1/2 of the middle cerebral artery supply area within 6 hours to 7 days of onset; or MRI-DWI shows infarction volume>80ml within 6 hours of onset, or MRI-DWI shows infarction volume>145ml within 14 hours of onset) and "large cerebellar infarction" (using imaging infarction diameter>3cm). (3) Symptoms worsen after thrombolysis and before administration, and NIHSS score increases by 2 points or more; (4) Those who have received or intend to receive endovascular treatment (including mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty, and stent placement) or arteriovenous bridging treatment for this disease; (5) Stroke with rapidly improving symptoms before intravenous thrombolysis, or suspected acute ischemic symptoms caused by other reasons; (6) Evidence of intracranial hemorrhage (cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) indicated by CT/MRI after this admission, or indications of symptoms of intracranial hemorrhage judged by the researcher; (7) Previous history of intracranial hemorrhage; Have a history of severe head injury, stroke, or myocardial infarction within the first 3 months of screening; (8) Accompanying intracranial tumors and giant intracranial aneurysms; (9) Accompanied by aortic arch dissection; (10) Major surgical procedures within 2 weeks prior to screening; Have undergone intracranial or spinal surgery within the first 3 months of screening; (11) Currently accompanied by active visceral bleeding; Or if there is an arterial puncture at a site that is not easy to compress and stop bleeding within one week before screening; Or gastrointestinal or urinary system bleeding occurred within 3 weeks before screening; (12) Known to have a tendency for acute bleeding, including platelet count1.7 or prothrombin time>15 seconds; (14) Receive low molecular weight heparin treatment within 24 hours before intravenous thrombolysis, and use thrombin inhibitors or Xa factor inhibitors within 48 hours; (15) Blood glucose22.22mmol/L; (16) Those with severe primary liver and kidney diseases, AST or ALT greater than twice the normal upper limit, and serum creatinine>2.0mg/dL or>176.8 µ mol/L; (17) After active antihypertensive treatment, hypertension has not been controlled: systolic blood pressure = 180mmHg, or diastolic blood pressure = 100mmHg; (18) Individuals who have previously suffered from hypotension or whose blood pressure was less than 90/60mmHg for three consecutive measurements during screening; (19) Individuals with a history of epilepsy or experiencing symptoms of epilepsy during stroke onset; (20) Completeness atrioventricular block; Or arrhythmia, with a heart rate of100 beats/minute; Or accor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a mRS score of 0-1 on the 90th ± 7th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a NIHSS score of 0-1 on the 10th ± 2nd day;Proportion of subjects with a decrease of = 4 points in NIHSS score on the 10th ± 2nd day;The proportion of subjects with mRS scores of 0-2 on the 30th ± 4th and 90th ± 7th days;;The proportion of subjects with a mRS score of 0-1 on the 30th ± 4th day;;Analysis of the compositional differences in mRS scores on the 30th ± 4th day and the 90th ± 7th day;Proportion of subjects with a BI score of = 95 on the 90th ± 7th day;EQ-5D score on day 90 ± 7;All cause mortality within 90 ± 7 days; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital,Capital,Medical University
Outcome results
None listed