Using Human Urinary Kallidinogenase to Treat Acute Ischemic Stroke
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)
This study is testing whether a treatment called Human Urinary Kallidin can help reduce inflammation and improve recovery in people who have just had an acute ischemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Harbin Medical University Academic / other |
| Locations | 1 site (Harbin, Heilongjiang) |
| Trial ID | NCT06696703 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Human Urinary Kallidinogen (HUK) on inflammatory factors in patients with acute ischemic stroke (AIS). It involves a total of 200 patients who will be divided into two groups: one receiving HUK treatment within 48 hours of stroke onset and the other receiving standard clinical treatment. The study will monitor changes in inflammatory markers and assess the correlation between these factors and patient outcomes over a 90-day follow-up period. The aim is to clarify the efficacy and safety of HUK in the acute phase of AIS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with their first acute ischemic stroke and with a baseline NIHSS score between 3 and 25.
Not a fit: Patients with cerebral hemorrhage, severe allergies to HUK, or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: While this approach is novel, previous studies have explored the role of inflammatory factors in stroke recovery, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018; 2. First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2） 3. Age≥18 years, male or female; 4. 3≤Baseline NIHSS≤25; 5. Written informed consent obtained from the patient or legally responsible person. Exclusion Criteria: 1. Cerebral hemorrhage and the acute phase of other hemorrhagic diseases； 2. Previously allergic or intolerant to injectable HUK； 3. 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; 4. Stent surgery after the AIS onset or planned interventional therapy; 5. Pregnancy, lactation or planned pregnancy； 6. Life expectancy of less than 3months or inability to complete the study for other reasons； 7. Unwilling to be followed up or poor compliance； 8. Current participation in other clinical research; 9. Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).
Where this trial is running
Harbin, Heilongjiang
- Zhongling Zhang — Harbin, Heilongjiang, China (Recruiting)
Study contacts
- Principal investigator: Zhongling Zhang — First Affiliated Hospital, Harbin Medical University
- Study coordinator: Zhongling Zhang
- Email: zhang777hyd@163.com
- Phone: +8613503615988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.