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

Phase 3

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Y-3 for injection; Drug: Placebo control group

• Registration Number: NCT06517173
• Lead Sponsor: Beijing Tiantan Hospital

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

Detailed Description

A multi-center, randomized, double-blind, parallel, placebo-controlled trial design was adopted, and subjects were randomly assigned to Y-3 for injection group and placebo group in a 1:1 ratio. randomization stratification factors include: onset time (≤12 hours, \>12 hours) and research site.

Treatment was continued for 10 days (10 times), and follow-up was conducted until the 90th day from the first dose.

The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.

Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination.

Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 10 days (10 times) with Y-3 for injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out; PK blood samples from subjects were collected for population pharmacokinetic analysis.

Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.

Study Timeline

• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24
• Study Start: 2024-07-31
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 998

Inclusion Criteria

1. Age ≥ 18 years and < 81 years, male or female;
2. 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;
3. Within 48 hours (inclusive) of onset;
4. 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);
5. The patient or his/her legal representative voluntarily signed informed consent form approved by the Ethics Committee.

Exclusion Criteria

1. 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;
2. Severe disturbance of consciousness: NIHSS score > 1 on item 1a level of consciousness;
3. Transient ischemic attack (TIA);
4. Systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control;
5. Previous diagnosis of severe mental disorders and severe dementia;
6. Previously diagnosed with depression or anxiety;
7. Receiving antidepressant or anxiolytic therapy;
8. 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;
9. Have been diagnosed with severe active renal disease, renal dysfunction; or serum creatinine > 1.5 × upper limit of normal;
10. 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.;
11. Thrombectomy or interventional therapy has been applied or planned after this episode;
12. Previous diagnosis of concurrent malignancy and ongoing anti-tumor therapy;
13. Previous diagnosis of severe systemic disease with expected survival times < 90 days;
14. The patient is pregnant, lactating and the patient/patient's partner may become pregnant and plans to become pregnant during the trial;
15. 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);
16. History of major surgery within 4 weeks prior to enrollment that impacts neurological score assessed by the investigator or impacts 90-day survival;
17. Participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study;
18. Investigator considered inappropriate for participation in this clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Y-3 for injection test group	Y-3 for injection	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
Placebo control group	Placebo control group	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale(mRS) displacement analysis on the 90th day of treatment;	On the 90th day of treatment	Measure the scores of subjects using the Modified Rankin Scale(mRS). 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.
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	Measure the scores of subjects using the National Institute of Health stroke scale(NIHSS). Measure on the 10th and 30th day of treatment to evaluate the effectiveness of the medication.National Institute of Health stroke scale(NIHSS) A larger difference from baseline means a better patient recovery, and a smaller difference means a worse patient recovery.
Good functional prognosis on the 90th day of treatment	On the 90th day of treatment	Modified Rankin Scale(mRS) score corrected based on baseline National Institute of Health stroke scale(NIHSS) score. The baseline National Institute of Health stroke scale(NIHSS) score of 4-7 is 0 on the 90 day Modified Rankin Scale(mRS) score; The baseline National Institute of Health stroke scale(NIHSS) score of 8-14 is 0-1 on a 90 day Modified Rankin Scale(mRS) score; The baseline National Institute of Health stroke scale(NIHSS) score is 15-25, with a 90 day Modified Rankin Scale(mRS) score of 0-2. Measure on the 90th day of treatment to evaluate the effectiveness of the medication.
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	Measure the scores of subjects using the Barthel Index scale. Measure on the 90th day of treatment to evaluate the effectiveness of the medication.The total score of the Barthel Index is 100.The higher the Barthel Index scale score, the better the recovery, and the lower the score, the worse the recovery.

Trial Locations

Locations (1)

Beijing Tiantan Hospital Capital Medical University Beijing; 🇨🇳 Beijing, Beijing, China