Using Human Urinary Kallidinogenase to Treat Acute Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.