Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial

Last updated: June 3, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed

Phase

2

Condition

Blood Clots

Thrombosis

Stroke

Treatment

Y-3 Injection/Y-3 blank injection

Clinical Study ID

NCT06429384
Y-3-LC-02
  • Ages 18-80
  • All Genders

Study Summary

The objective of this clinical trial was to explore the efficacy and safety of Y-3 injection at different doses in patients with acute ischemic stroke within 48 hours of onset.

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants.

Subjects press 1:1:1: 1 ratio of patients were randomly divided into Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60mg/ time, qd) and placebo control group, with 60 cases in each group. Random stratification factors include:

Time of onset (≤24 hours, > 24 hours). The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.

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

Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.

Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.

Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.

Stroke-related scale scores were performed at 10, 30, and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale (MSAS) and Hamilton Anxiety Scale (HAMA) were performed on the 10th and 90th days after the use of experimental drugs. Adverse events were recorded during treatment and follow-up to further assess safety

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Only those who meet all the following criteria can be included in the group:
  1. Age ≥ 18 years old and<81 years old, regardless of gender;

  2. After the onset of this disease, the National Institutes of Research Stroke Scalescore was 6 ≤ NIHSS ≤ 20 points, and the sum of the 5th upper limb and 6th lowerlimb scores was ≥ 2 points. If patients receiving thrombolysis treatment werescreened and evaluated based on the NIHSS score after thrombolysis;

  3. Within 48 hours (including 48 hours) of onset;

  4. Diagnosed as ischemic stroke according to the "Key Diagnostic Points for VariousMajor Cerebrovascular Diseases in China 2019", with good recovery after the first orlast onset (mRS score ≤ 1 point before this onset);

  5. Obtain informed consent from the patient or their legal representative voluntarilysigned and approved by the ethics committee.

Exclusion

Exclusion Criteria:

  • Those who meet one of the following criteria during filtering cannot be included in the group:
  1. Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke,epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoidhemorrhage, etc; If it is only oozing blood, the researcher can determine whether itis suitable for enrollment;

  2. Severe consciousness disorder: The item score of NIHSS's 1a consciousness level isgreater than 1 point;

  3. Transient ischemic attack (TIA);

  4. After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;

  5. Previously diagnosed patients with severe mental disorders and severe dementia;

  6. Patients previously diagnosed with depression or anxiety disorder;

  7. Patients undergoing antidepressant or anti anxiety treatment;

  8. Diagnosed with severe active liver diseases, such as acute hepatitis, chronic activehepatitis, liver cirrhosis, etc; Or ALT or AST>2.0 × ULN;

  9. Diagnosed with severe active kidney disease or renal insufficiency; Or serumcreatinine>1.5 × ULN;

  10. After the onset of the disease, drugs with brain cytoprotection in the instructionshave been used, such as edaravone, concentrated solution of edaravone and dextranolfor injection, nimodipine, ganglioside, CDPC, piracetam, oxiracetam,butylphenylpeptide, human urinary kallidinogenase (Urinary Kallidinogenase),cinepazide, rat nerve growth factor, cerebrolysin (cerebroprotein hydrolysate), calfserum deproteinized injection Calf blood deproteinized extract injection, etc;

  11. After the onset of this disease, thrombectomy or interventional therapy has beenapplied or planned to be applied;

  12. Previously diagnosed with concurrent malignant tumors and undergoing anti-tumortreatment;

  13. Previously diagnosed with severe systemic diseases, with an estimated survivalperiod of<90 days;

  14. The patient is in pregnancy, lactation, and there is a possibility of pregnancy inthe patient/patient partner who plans to conceive during the trial period;

  15. Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodiumhydroxide);

  16. A history of major surgeries within 4 weeks prior to enrollment and assessed by theresearcher as affecting neurological function scores or affecting 90 day survival;

  17. Have participated in other clinical studies or are currently participating in otherclinical studies within the first 30 days of randomization;

  18. The researcher believes that it is not suitable to participate in this clinicalstudy.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Y-3 Injection/Y-3 blank injection
Phase: 2
Study Start date:
June 04, 2023
Estimated Completion Date:
December 24, 2023

Study Description

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants, who were randomly assigned to Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60 mg/ time, qd) and placebo control group in a ratio of 1:1:1:1. Each group had 60 cases.

Random stratification factors included: onset time (≤24 hours, > 24 hours).The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.

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

Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.Stroke-related scale scores were performed on the 10th, 30th and 90th days after the first use of the experimental drug, and Montgomery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAMA) scores were performed on the 10th and 90th days after the first use of the experimental drug. Adverse events were recorded during treatment and follow-up to further assess safety.

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University Beijing

    Beijing, Beijing 100000
    China

    Site Not Available

  • Liuzhou Workers Hospital

    Liuzhou, Guangxi 545000
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061000
    China

    Site Not Available

  • Harrison International Peace Hospital

    Hengshui, Hebei 053000
    China

    Site Not Available

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang 163000
    China

    Site Not Available

  • Daqing People's Hospital

    Daqing, Heilongjiang 163000
    China

    Site Not Available

  • Nanyang Second People's Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Nanyang South Stone Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan 473000
    China

    Site Not Available

  • Hunan Provincial People's Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • Inner Mongolia Baotou Steel Hospital

    Baotou, Inner Mongolia Autonomous Region 014100
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia Autonomous Region 014000
    China

    Site Not Available

  • Inner Mongolia International Mongolian Medicine Hospital

    Hohhot, Inner Mongolia Autonomous Region 010000
    China

    Site Not Available

  • Huai 'an First People's Hospital

    Huai'an, Jiangsu 223001
    China

    Site Not Available

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu 222000
    China

    Site Not Available

  • Lianyungang Second People's Hospital

    Lianyungang, Jiangsu 222000
    China

    Site Not Available

  • Taizhou Second People's Hospital

    Taizhou, Jiangsu 225300
    China

    Site Not Available

  • Xuzhou Central Hospital (Old Hospital Area)

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Xuzhou Central Hospital(New compound)

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Xuzhou First People's Hospital

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi 337000
    China

    Site Not Available

  • Beipiao Central Hospital

    Beipiao, Liaoning 122100
    China

    Site Not Available

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning 121000
    China

    Site Not Available

  • Chinese People's Liberation Army Northern Theater Command General Hospital

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Shenyang First People's Hospital

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Shandong Third Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong 252000
    China

    Site Not Available

  • Tancheng County First People's Hospital

    Linyi, Shandong 276100
    China

    Site Not Available

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong 277500
    China

    Site Not Available

  • Dongyang City People's Hospital

    Dongyang, Zhejiang 322100
    China

    Site Not Available

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