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Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

Primary Purpose

Acute Ischemic Stroke

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dengzhanxixin Injection
Placebo injection
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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。

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose Arm

High Dose Arm

Placebo Arm

Arm Description

Dengzhanxixin injection 40ml/day, placebo 40ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day; placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day.

Dengzhanxixin injection 80ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.

Placebo injection 80ml/day. Placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.

Outcomes

Primary Outcome Measures

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.
Primary Safety Outcome
Proportion of patients with adverse events at 90 days.

Secondary Outcome Measures

Infarction Volume
Infarction volume at 14 days compared to baseline
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.
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.
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.
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.
Symptomatic intracranial hemorrhage(sICH)
Proportion of subjects with symptomatic intracranial hemorrhage (sICH)
AEs
Proportion of subjects with AEs
SAEs
Proportion of subjects with SAEs

Full Information

First Posted
November 16, 2022
Last Updated
January 16, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05700097
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Arm
Arm Type
Experimental
Arm Description
Dengzhanxixin injection 40ml/day, placebo 40ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day; placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day.
Arm Title
High Dose Arm
Arm Type
Experimental
Arm Description
Dengzhanxixin injection 80ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo injection 80ml/day. Placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.
Intervention Type
Drug
Intervention Name(s)
Dengzhanxixin Injection
Other Intervention Name(s)
Dengzhanxixin Zhusheye
Intervention Description
Experimental arms for low, and high dose for the standard protocol
Intervention Type
Drug
Intervention Name(s)
Placebo injection
Other Intervention Name(s)
Placebo
Intervention Description
placebo control arm for the standard protocol
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome
Description
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.
Time Frame
90 days
Title
Primary Safety Outcome
Description
Proportion of patients with adverse events at 90 days.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Infarction Volume
Description
Infarction volume at 14 days compared to baseline
Time Frame
14 days
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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.
Time Frame
72 hours, 7 days, 14 days, 90days
Title
Excellent functional outcome
Description
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.
Time Frame
14 days
Title
Modified Rankin Scale (mRS) distribution
Description
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.
Time Frame
14 days, 90 days
Title
Barthel index (BI)
Description
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.
Time Frame
90 days
Title
Symptomatic intracranial hemorrhage(sICH)
Description
Proportion of subjects with symptomatic intracranial hemorrhage (sICH)
Time Frame
14 days
Title
AEs
Description
Proportion of subjects with AEs
Time Frame
72 hours,7 days, 14 days
Title
SAEs
Description
Proportion of subjects with SAEs
Time Frame
72 hours,7 days, 14 days,90days
Other Pre-specified Outcome Measures:
Title
Biomarkes
Description
The changes of serum high sensitivity C-reactive protein test (hs-CRP) level from baseline to 14 days
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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。
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, M.D.
Organizational Affiliation
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

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Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

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