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Tests urinary kallidinogenase with clot-removal treatment for acute ischemic stroke

Tests kallidinogenase alongside endovascular therapy in adults with acute stroke from a large vessel blockage.

Key facts

Who runs it
Huashan Hospital
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
Status
Recruiting
People taking part
120 people, planned
Started
17 Apr 2024
Planned end
Dec 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Experimental: Human Urinary Kallidinogenase
  • Placebo Comparator: Placebo
Record updated
4 December 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 sudden stroke caused by a blocked large brain artery. They must be getting a procedure to remove the clot within 24 hours.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Acute stroke in the front part of the brain, with a blocked large artery (internal carotid artery, M1 or M2 segment of the middle cerebral artery). The ASPECT score on emergency CT is 7 or higher. The infarct core is 10 mL or more and less than 100 mL. The ratio of low-blood-flow brain tissue to infarct core is above 1.2.
Earlier treatment
Receiving endovascular treatment (a procedure to remove the clot) within 24 hours, without a clot-dissolving drug first (non-bridged). Not regularly taking ACEI blood pressure drugs, or able to stop them.

Main reasons for not taking part

  • Severe heart, liver or kidney problems, or clotting problems
  • Allergy to Human Urinary Kallidinogenase or contrast agent
  • Bleeding inside the skull on CT or MRI
  • Earlier brain bleeding, brain tumour, brain injury or other brain disease
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged)
  • Age ≥18 years old
  • The mRS score was 0-1 before onset
  • ASPECT score of infarction on emergency CT ≥7
  • Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery)
  • Emergency CTP or DWI suggesting infarct core body ≥10 mL and <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.2
  • Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate)

Who cannot take part

  • Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases
  • Taking ACEI antihypertensive drugs regularly and could not stop
  • Participant with major surgery or severe trauma in the past 2 weeks
  • Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications
  • CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.)
  • Poor compliance and cannot fully follow the study protocol
  • Pregnancy or lactation

Where in China

  • Huashan HospitalShanghai, ChinaContact: Qiang Dong, M.D.Taking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.

The 2 groups in the trial

  • Human Urinary KallidinogenaseTreatment being tested

    Treatment: Experimental: Human Urinary Kallidinogenase

  • PlaceboPlacebo, for comparison

    Treatment: Placebo Comparator: Placebo

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
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study
Plain-language title
Tests urinary kallidinogenase with clot-removal treatment for acute ischemic strokeGenerated 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
4 December 2024