Acute Ischemic StrokeNCT06696703
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)
A study testing Human urinary kininogenase(HUK) in people with Acute Ischemic Stroke, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Human urinary kininogenase(HUK)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;
- First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
- Age≥18 years, male or female;
- 3≤Baseline NIHSS≤25;
- Written informed consent obtained from the patient or legally responsible person.
Who cannot join
- Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
- Previously allergic or intolerant to injectable HUK；
- Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;
- Stent surgery after the AIS onset or planned interventional therapy;
- Pregnancy, lactation or planned pregnancy；
- Life expectancy of less than 3months or inability to complete the study for other reasons；
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- Unwilling to be followed up or poor compliance；
- Current participation in other clinical research;
- Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongling Zhang
Harbin, Heilongjiang, 150001
Zhongling Zhang, +8613503615988, zhang777hyd@163.com
About this study
Official title: Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)
The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.
Read the detailed description
The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Human urinary kininogenase(HUK), Placebo
- Keywords
- Acute ischemic stroke, Urinary Kallidinogen, Inflammatory factors, 90 days functional outcomes
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human urinary kininogenase(HUK)Drug
Also called Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065
Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day.
PlaceboOther
Also called Normal sodium chloride injection
Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Human Urinary Kallidinogenase for injection (HUK) | Experimental | Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment Receives: Drug: Human urinary kininogenase(HUK) |
| sham-HUK treatment | Placebo comparator | Normal sodium chloride injection plus routine clinical treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Favorable Stroke Outcome of 90 days
mRS 0-2
Measured: 90 days after treatment
The changes of the serum inflammatory markers before and after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
Measured: Baseline、1 day after treatment、3 days after treatment、90 days after treatment
Secondary outcomes (3)
The changes of NIHSS before and after treatment
National Institute of Health stroke scale, NIHSS
Measured: Baseline、7 days after treatment
Stroke recurrence rate
Ischemic stroke
Measured: 90 days after treatment
The incidence of intracranial hemorrhage
Symptomatic intracranial hemorrhage
Measured: 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongling Zhang, First Affiliated Hospital of Harbin Medical University
- Investigators
- Zhongling Zhang, Principal investigator, First Affiliated Hospital, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696703
- Sponsor's protocol ID
- 2023155
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)
- ClinicalTrials.gov ID
- NCT06696703
- Acronym / sponsor ID
- 2023155
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Urinary Kallidinogen, Inflammatory factors, 90 days functional outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Nov 2024 (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.
The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.
Detailed description
The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Urinary Kallidinogenase for injection (HUK) | Experimental | Drug: Human urinary kininogenase(HUK)Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment |
| sham-HUK treatment | Placebo comparator | Other: PlaceboNormal sodium chloride injection plus routine clinical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;
- First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
- Age≥18 years, male or female;
- 3≤Baseline NIHSS≤25;
- Written informed consent obtained from the patient or legally responsible person.
Key exclusion criteria (9 listed)
- Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
- Previously allergic or intolerant to injectable HUK；
- Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;
- Stent surgery after the AIS onset or planned interventional therapy;
- Pregnancy, lactation or planned pregnancy；
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 |
|---|---|---|
| Human urinary kininogenase(HUK)Also: Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. | Drug | Human Urinary Kallidinogenase for injection (HUK) |
| PlaceboAlso: Normal sodium chloride injectionPlacebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day. | Other | sham-HUK treatment |
Primary outcome
The Favorable Stroke Outcome of 90 days
Time frame: 90 days after treatment
mRS 0-2
The changes of the serum inflammatory markers before and after treatment
Time frame: Baseline、1 day after treatment、3 days after treatment、90 days after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
3 secondary outcomes
The changes of NIHSS before and after treatment
Time frame: Baseline、7 days after treatment
Stroke recurrence rate
Time frame: 90 days after treatment
The incidence of intracranial hemorrhage
Time frame: 90 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Zhongling Zhang principal investigator
First Affiliated Hospital, Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human urinary kininogenase(HUK) in people with Acute Ischemic Stroke, run by First Affiliated Hospital of Harbin Medical University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongling Zhang (+8613503615988, zhang777hyd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Favorable Stroke Outcome of 90 days (time frame: 90 days after treatment). 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 20 Nov 2024.