Y-3 injection for treating acute ischemic stroke

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Y-3 in Chinese Subjects with Acute Ischemic Stroke

This study is testing if an injection called Y-3 can help people who have had an acute ischemic stroke within the last 48 hours feel better and recover more effectively.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 998 (estimated)
• Ages: 18 Years to 81 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06517173 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of Y-3 for injection in patients with acute ischemic stroke occurring within 48 hours of onset. It employs a multi-center, randomized, double-blind, parallel, placebo-controlled design, with participants assigned to either the Y-3 group or a placebo group in a 1:1 ratio. The treatment lasts for 10 days, followed by a 90-day follow-up period to assess outcomes. Key assessments include NIHSS scores and pharmacokinetic analysis of blood samples.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced an ischemic stroke with specific NIHSS scores within 48 hours of onset.

Not a fit: Patients with intracranial hemorrhagic diseases or those who do not meet the NIHSS criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Other studies have shown promise in treating acute ischemic stroke with novel interventions, but the specific approach of Y-3 for injection is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital Capital Medical University Beijing — Beijing, Beijing Municipality, China (Recruiting)

Conditions Acute Ischemic Stroke; Subjects within 48 hours