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Tests urinary kallidinogenase in people with stroke from narrowed large arteries

Tests urinary kallidinogenase in adults with acute ischemic stroke from artery narrowing.

Key facts

Who runs it
Yi Yang
Where
Changchun, ChinaSee the site
Trial code
Registry title
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
Status
Not yet recruiting
People taking part
986 people, planned
Started
15 Mar 2024
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Urinary kallidinogenase for injection
  • Guideline-prescribed medical therapy
Record updated
28 February 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a stroke caused by a clogged large artery in the front of the brain within the last 48 hours. It tests urinary kallidinogenase.

Age
18 years or older
Sex
All sexes can join
Disease stage
Acute stroke (cerebral infarction) from large artery atherosclerosis in the front of the brain, within 48h of onset. NIHSS score from 6 to 15. Moderate to severe narrowing or blockage of the affected vessel. mRS score of 2 or less before the stroke.
Earlier treatment
People who planned or had emergency reperfusion therapy (intravenous thrombolysis or emergency thrombectomy) cannot join. People who regularly took ACEI drugs before cannot join.

Main reasons for not taking part

  • Transient ischemic attack
  • Emergency reperfusion therapy (thrombolysis or thrombectomy) planned or received
  • Severe disturbance of consciousness (GCS 8 or less)
  • Stroke caused by a blood clot from the heart, or high-risk heart conditions such as atrial fibrillation
  • Pregnant or breastfeeding women, or life expectancy under 3 months

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Age ≥18 years old
  • Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15
  • Moderate to severe stenosis or occlusion of offending vessels
  • The mRS Score ≤2 before onset
  • Subjects or their legal representatives agreed to the treatment and signed the informed consent form

Who cannot take part

  • Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy)
  • Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly
  • Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment
  • Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg
  • Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.)
  • Other conditions considered by the investigator to be inappropriate for enrollment
  • Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN)
  • Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds)
  • Transient ischemic attack
  • Severe disturbance of consciousness:GCS ≤8
  • Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons
  • Unwilling to be followed up or poor treatment compliance

Where in China

  • First Hospital of Jilin UniversityChangchun, ChinaContact: Yi Yang, MD,PhDNo longer taking part

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

The 2 groups in the trial

  • Urinary Kallidinogenase groupTreatment being tested

    Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.

    Treatment: Urinary kallidinogenase for injection

  • Control groupOther group

    Patients are only treated with guideline-prescribed basic medical therapy.

    Treatment: Guideline-prescribed medical therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
Plain-language title
Tests urinary kallidinogenase in people with stroke from narrowed large arteriesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 February 2024