Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital

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。