Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06848894

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

Led by Beijing Tiantan Hospital · Updated on 2025-03-28

1204

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to explore the efficacy and safety of Human Urinary Kallidinogenase for acute ischemic stroke patients receiving intravenous thrombolysis and/or endovascular treatment.

CONDITIONS

Official Title

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke in the anterior circulation within 24 hours of symptom onset
  • NIHSS score between 4 and 25 at enrollment
  • Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA, or endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, or bridging therapy
  • Independent in daily activities before stroke (mRS score 1 or less)
  • Patient or legal representative able and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Alberta Stroke Program Early Computed Tomography Score (ASPECT) of 6 or less on preoperative CT scan
  • Prior treatment with Human Urinary Kallidinogenase after stroke onset
  • Allergy to Human Urinary Kallidinogenase, related drugs, or other medications and foods
  • History of coagulation disorders, systemic bleeding, thrombocytopenia, or hemorrhagic diseases at enrollment
  • Use of anticoagulants such as warfarin or rivaroxaban, or heparin within 48 hours after stroke onset
  • Regular use of ACE inhibitor antihypertensive drugs within one week before enrollment
  • Chronic liver disease or liver dysfunction with elevated ALT/AST (>3 times upper limit normal)
  • Kidney dysfunction or dialysis with elevated serum creatinine (>2 times upper limit normal)
  • Severe cardiopulmonary disease unsuitable for the study
  • Contraindications to intravenous thrombolysis or endovascular treatment
  • Life expectancy less than 3 months due to lethal diseases
  • Pregnancy, lactation, or women of childbearing age not using effective contraception or lacking negative pregnancy test
  • Inability to complete the study due to mental illness, cognitive or emotional disorders, physical or geographical factors
  • Participation in another clinical trial currently
  • Other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

W

Wang Yilong, MD, PhD

CONTACT

W

Wang Tingting, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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