Acute Ischemic StrokePhase 2NCT05700097
Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy
A Phase 2 study testing Dengzhanxixin Injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Dengzhanxixin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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。
Trial locations and contacts
1 site in 1 country.
About this study
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
To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dengzhanxixin Injection, Placebo injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengzhanxixin InjectionDrug
Also called Dengzhanxixin Zhusheye
Experimental arms for low, and high dose for the standard protocol
Placebo injectionDrug
Also called Placebo
placebo control arm for the standard protocol
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Arm | Experimental | 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. Receives: Drug: Dengzhanxixin Injection |
| High Dose Arm | Experimental | Dengzhanxixin injection 80ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day. Receives: Drug: Dengzhanxixin Injection |
| Placebo Arm | Placebo comparator | Placebo injection 80ml/day. Placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day. Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Primary Safety Outcome
Proportion of patients with adverse events at 90 days.
Measured: 90 days
Secondary outcomes (8)
Infarction Volume
Infarction volume at 14 days compared to baseline
Measured: 14 days
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.
Measured: 72 hours， 7 days， 14 days， 90days
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.
Measured: 14 days
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.
Measured: 14 days， 90 days
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.
Measured: 90 days
Symptomatic intracranial hemorrhage(sICH)
Proportion of subjects with symptomatic intracranial hemorrhage (sICH)
Measured: 14 days
AEs
Proportion of subjects with AEs
Measured: 72 hours，7 days， 14 days
SAEs
Proportion of subjects with SAEs
Measured: 72 hours，7 days， 14 days，90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, M.D., Principal investigator, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700097
- Sponsor's protocol ID
- NCRC-2022-02
- Status last verified
- Jan 2023
- First submitted
- 16 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05700097
- Acronym / sponsor ID
- NCRC-2022-02
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Arm | Experimental | Drug: Dengzhanxixin InjectionDengzhanxixin 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. |
| High Dose Arm | Experimental | Drug: Dengzhanxixin InjectionDengzhanxixin injection 80ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day. |
| Placebo Arm | Placebo comparator | Drug: Placebo injectionPlacebo injection 80ml/day. Placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengzhanxixin InjectionAlso: Dengzhanxixin ZhusheyeExperimental arms for low, and high dose for the standard protocol | Drug | High Dose Arm, Low Dose Arm |
| Placebo injectionAlso: Placeboplacebo control arm for the standard protocol | Drug | Placebo Arm |
Primary outcome
Primary Efficacy Outcome
Time frame: 90 days
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
Time frame: 90 days
Proportion of patients with adverse events at 90 days.
8 secondary outcomes
Infarction Volume
Time frame: 14 days
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 72 hours， 7 days， 14 days， 90days
Excellent functional outcome
Time frame: 14 days
Modified Rankin Scale (mRS) distribution
Time frame: 14 days， 90 days
Barthel index (BI)
Time frame: 90 days
Symptomatic intracranial hemorrhage(sICH)
Time frame: 14 days
AEs
Time frame: 72 hours，7 days， 14 days
SAEs
Time frame: 72 hours，7 days， 14 days，90days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang, M.D. principal investigator
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dengzhanxixin Injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Outcome (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.