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NCT06696703Recruiting

Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)

Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)

Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
16 Nov 2024
Start date
1 Jan 2024
Primary completion date
1 Dec 2025
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Diseases
Stroke
NCT number
NCT06696703

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Jan 2024 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).

Other illness

  • Cerebral hemorrhage and the acute phase of other hemorrhagic diseases;

Other

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongling Zhang
Coordinator of this site? Confirm its status
HarbinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.