Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05700097
• Other study ID #: NCRC-2022-02
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Dengzhanxixin Injection
Experimental arms for low, and high dose for the standard protocol
• Placebo injection
placebo control arm for the standard protocol

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkes	The changes of serum high sensitivity C-reactive protein test (hs-CRP) level from baseline to 14 days	14 days
Primary	Primary Efficacy Outcome	Proportion of subjects of excellent outcome defined as modified Rankin Scale (mRS) (0-1) at 90 days. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.	90 days
Primary	Primary Safety Outcome	Proportion of patients with adverse events at 90 days.	90 days
Secondary	Infarction Volume	Infarction volume at 14 days compared to baseline	14 days
Secondary	National Institutes of Health Stroke Scale (NIHSS)	National Institutes of Health Stroke Scale (NIHSS) score changes from baseline. NIHSS is 42 point scale where 0 is the best o and 42 is the worst outcome.	72 hours, 7 days, 14 days, 90days
Secondary	Excellent functional outcome	Favourable outcome rate is defined as the proportion of subjects with modified Rankin Scale (mRS) (0-1). mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.	14 days
Secondary	Modified Rankin Scale (mRS) distribution	Ordinal distribution of Modified Rankin Scale (mRS). mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.	14 days, 90 days
Secondary	Barthel index (BI)	Proportion of subjects with Global function of daily living defined as Change in Barthel index (BI) = 95. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.	90 days
Secondary	Symptomatic intracranial hemorrhage(sICH)	Proportion of subjects with symptomatic intracranial hemorrhage (sICH)	14 days
Secondary	AEs	Proportion of subjects with AEs	72 hours,7 days, 14 days
Secondary	SAEs	Proportion of subjects with SAEs	72 hours,7 days, 14 days,90days