Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

Launched by BEIJING TIANTAN HOSPITAL · Jan 16, 2023

Keywords

ClinConnect Summary

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.

Gender

ALL

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。