dengzhanxixin injection for acute ischemic stroke receiving reperfusion therapy

Conditions: Acute Ischemic Stroke

Summary: to assess the efficacy and safety of dengzhanxixin injection in patients with acute ischemic stroke receiving reperfusion therapy.

to evaluate the safety and efficacy of dengzhanxixin at different doses of 80ml/day, 40 ml/day, or placebo within 24 hours after the onset of ischemic stroke. the primary objective of this study is the proportion of subjects with excellent outcomes defined as mrs (0-1) among the three treatment groups at 90 days.

Eligibility criteria:
inclusion criteria: * more than or equal to 18 years old and less than 80 years old; * acute ischemic stroke confirmed by computed tomography (ct) or magnetic resonance imaging (mri) of the head; * stroke onset within 24 hours and can be treated with study drug within 24 hours of symptoms onset； * the patient has received or is planning to receive vascular reperfusion therapy after onset； * baseline nihss score is ≥4 and ≤26. * mrs ≤1 prior onset. * informed consent signed. exclusion criteria: * intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.; * the acute infarcts lesion involvement of more than one-third of middle cerebral artery (mca) territory on initial brain imaging; * rapidly improving symptoms at the discretion of the investigator; * patients who have taken dengzhanxixin injection，edaravone or other brain protective drugs after onset ; * history of intracranial hemorrhage； * history of severe head trauma, stroke or myocardial infarction in past 3 months; * diagnosised intracranial tumor and giant intracranial aneurysm； * diagnosised aortic arch dissection； * undergoing major surgery within 2 weeks prior to screening; or intracranial or intraspinal surgery within 3 months prior to screening; * currently accompanied by active visceral bleeding; or arterial puncture at a site that is not easy to compress hemostasis within 1 week before screening; or gastrointestinal or urinary system bleeding occurred within 3 weeks before screening; * those with acute bleeding tendency, including: platelet count \<100×109/l, combined with hemophilia, etc.; or those with partially activated thrombin time greater than 3 times the upper limit of normal; * oral anticoagulants, and international normalized ratio\>1.7 or prothrombin time\>15s; * diagnosed primary liver and kidney disease, ast or alt (\>2 times the uln), serum creatinine \>2.0mg/dl or \>176.8µmol/l; * persistent blood pressure elevation ( systolic ≥180 mmhg or diastolic ≥100 mmhg ), despite blood pressure lowering treatment; * those with a history of epilepsy or epilepsy-like symptoms at the onset of stroke; * complete atrioventricular block; or according to the new york heart association (nyha) cardiac function class ii or above; or have been hospitalized due to congestive heart failure within 6 months before screening; * pregnant women, nursing mothers, or reluctant to agree taking effective contraceptive measures during the period of trial subjects; * those who have other neurological diseases or disabilities or mental diseases, which may affect the efficacy evaluation of this study as judged by the investigator; * those with a history of malignant tumor within 5 years before screening (if the patient has basal cell carcinoma of the skin or carcinoma in situ of the cervix and has been cured, he/she can participate in this study); * those who participated in other drug/device clinical studies and used the experimental drug/device within 3 months before screening; * any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study。