Actively Recruiting

Phase 3
Age: 18Years - 81Years
All Genders
NCT06517173

Y-3 for Injection in the Treatment of Acute Ischemic Stroke

Led by Beijing Tiantan Hospital · Updated on 2024-09-19

998

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

Sponsors

B

Beijing Tiantan Hospital

Lead Sponsor

N

Neurodawn Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset

CONDITIONS

Official Title

Y-3 for Injection in the Treatment of Acute Ischemic Stroke

Who Can Participate

Age: 18Years - 81Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and less than 81 years, male or female
  • Ischemic stroke with NIHSS score between 7 and 20 and limb motor scores of 2 or more
  • Onset of stroke symptoms within 48 hours (inclusive)
  • Diagnosed ischemic stroke with good recovery before current episode (mRS score 1 or less)
  • Signed informed consent form by patient or legal representative
Not Eligible

You will not qualify if you...

  • Brain bleeding conditions diagnosed by imaging, including hemorrhagic stroke and hematomas
  • Severe consciousness disturbance with NIHSS consciousness score greater than 1
  • Transient ischemic attack (TIA)
  • Systolic blood pressure 220 mmHg or higher or diastolic blood pressure 120 mmHg or higher after control
  • Severe mental disorders or dementia
  • Diagnosed depression or anxiety
  • Currently receiving antidepressant or anti-anxiety treatment
  • Severe active liver disease or elevated liver enzymes above twice the normal limit
  • Severe active kidney disease or renal dysfunction with high serum creatinine
  • Use of certain brain protective drugs after the current stroke episode
  • Planned or performed thrombectomy or interventional therapy after current episode
  • Diagnosis of cancer with ongoing anti-tumor treatment
  • Severe systemic disease with expected survival less than 90 days
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Known allergy to study drug or ingredients
  • Major surgery within 4 weeks affecting neurological score or survival
  • Participation in another clinical study within 30 days or ongoing
  • Investigator judgment considers participation inappropriate

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, Beijing Municipality, China, 100000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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