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New treatment option for Acute Ischemic Stroke
Official title Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)
ClinicalTrials.gov ID: NCT06696703
What this study is testing
What is Human urinary kininogenase(HUK)?
Human urinary kininogenase(HUK) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Also referred to as Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Stent surgery after the AIS onset or planned treatment therapy;
- Pregnancy, lactation or planned pregnancy；
- Life expectancy of less than 3months or inability to complete the study for other reasons；
See the full eligibility criteria
- 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.
- 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 treatment therapy;
- Pregnancy, lactation or planned pregnancy；
- Life expectancy of less than 3months or inability to complete the study for other reasons；
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.