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

NCT06517173 | Recruiting Phase 3

• 1 other identifier: Y-3-LC-04
• Study Type: interventional
• Target: 998
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Ischemic Stroke

Keywords

Subjects within 48 hours

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with Modified Rankin Scale(mRS) score ≤ 1 on the 90th day of treatment

  Measure the scores of subjects using the Modified Rankin Scale(mRS) scale.Measure on the 90th day of treatment to evaluate the effectiveness of the medication.The Modified Rankin Scale(mRS) score of this study ranged from 0 to 5. The higher the score, the worse the recovery, and the lower the score, the better the recovery.

  On the 90th day of treatment

Secondary Outcomes (4)

• Good functional prognosis on the 90th day of treatment

  On the 90th day of treatment

• Modified Rankin Scale(mRS) displacement analysis on the 90th day of treatment;

  On the 90th day of treatment

• The proportion of National Institute of Health stroke scale(NIHSS) scores reduced by ≥ 4 compared to baseline on the 10th and 30th day of treatment;

  On the 10th and 30th day of treatment

• The proportion of individuals with Barthel Index score ≥ 95 on the 90th day of treatment on the Activities of Daily Living Scale.

  On the 90th day of treatment

Study Arms (2)

Y-3 for injection test group

EXPERIMENTAL

The special solvent Y-3 for injection was extracted with a sterile syringe and injected into a Y-3 lyophilized powder vial for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h

Drug: Y-3 for injection

Placebo control group

PLACEBO COMPARATOR

The special solvent Y-3 for injection was extracted with a sterile syringe and injected into the lyophilized powder vial of Y-3 simulant for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h

Drug: Placebo control group

Interventions

Y-3 for injection DRUG

Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.

Y-3 for injection test group

Placebo control group DRUG

Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.

Placebo control group

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 81 years, male or female;
• After onset of disease, ischemic stroke meeting the following characteristics: 7≤ NIHSS(National Institutes of Stroke score)≤20 , and the sum of the scores of the item 5 upper limb and item 6 lower limb ≥ 2 points. If patients received thrombolytic therapy, they would be screened and assessed by NIHSS score after thrombolysis;
• Within 48 hours (inclusive) of onset;
• Patients who were diagnosed as ischemic stroke according to Key Points in Diagnosis of Various Major Cerebrovascular Diseases 2019 in China and recovered well after the first or last onset of disease (mRS score ≤ 1 point before this episode);
• The patient or his/her legal representative voluntarily signed informed consent form approved by the Ethics Committee.

You may not qualify if:

• Intracranial hemorrhagic disease by cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if it was only oozing, the investigator could determine whether it was suitable for enrollment;
• Severe disturbance of consciousness: NIHSS score \> 1 on item 1a level of consciousness;
• Transient ischemic attack (TIA);
• Systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control;
• Previous diagnosis of severe mental disorders and severe dementia;
• Previously diagnosed with depression or anxiety;
• Receiving antidepressant or anxiolytic therapy;
• Have been diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or alanine aminotransferase or aspartate aminotransferase \> 2.0 × upper limit of normal;
• Have been diagnosed with severe active renal disease, renal dysfunction; or serum creatinine \> 1.5 × upper limit of normal;
• After this episode, drugs with brain cell protective effect clarified in the package insert have been applied, such as commercially available edaravone,concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, citicoline, piracetam, oxiracetam, butylphenyl peptide, human urinary kininogenase (urinary kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (brain protein hydrolysate), deproteinized calf serum injection, deproteinized calf blood extract injection, etc.;
• Thrombectomy or interventional therapy has been applied or planned after this episode;
• Previous diagnosis of concurrent malignancy and ongoing anti-tumor therapy;
• Previous diagnosis of severe systemic disease with expected survival times \< 90 days;
• The patient is pregnant, lactating and the patient/patient's partner may become pregnant and plans to become pregnant during the trial;
• Previously known hypersensitivity to the product or any of its excipients (15-hydroxystearate polyethylene glycol, propylene glycol, mannitol, potassium dihydrogen phosphate, dipotassium hydrogen phosphate trihydrate);

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Neurodawn Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University Beijing

Beijing, Beijing Municipality, 100000, China

RECRUITING

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MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS（Statistics Analysis System）software.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 24, 2024
• Study Start: July 24, 2024
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)