Clinical trial NCT05700097: Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Dose-Finding, Multi-center Study to Assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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。

Primary outcomes:
measure: Primary Efficacy Outcome
timeFrame: 90 days
measure: Primary Safety Outcome
timeFrame: 90 days
Secondary outcomes:
measure: Infarction Volume
timeFrame: 14 days
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 72 hours， 7 days， 14 days， 90days
measure: Excellent functional outcome
timeFrame: 14 days
measure: Modified Rankin Scale (mRS) distribution
timeFrame: 14 days， 90 days
measure: Barthel index (BI)
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage(sICH)
timeFrame: 14 days
measure: AEs
timeFrame: 72 hours，7 days， 14 days
measure: SAEs
timeFrame: 72 hours，7 days， 14 days，90days
Other outcomes:
measure: Biomarkes
timeFrame: 14 days
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital, Capital Medical University, Beijing, China
name: Yongjun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: