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Acute Ischemic StrokePhase 2NCT06429384

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

A Phase 2 study testing Y-3 Injection/Y-3 blank injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Y-3 Injection/Y-3 blank injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
30 sitesChina
Study dates
4 Jun 2023to 24 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • Only those who meet all the following criteria can be included in the group:
  • Age ≥ 18 years old and<81 years old, regardless of gender;
  • After the onset of this disease, the National Institutes of Research Stroke Scale score was 6 ≤ NIHSS ≤ 20 points, and the sum of the 5th upper limb and 6th lower limb scores was ≥ 2 points. If patients receiving thrombolysis treatment were screened and evaluated based on the NIHSS score after thrombolysis;
  • Within 48 hours (including 48 hours) of onset;
  • Diagnosed as ischemic stroke according to the "Key Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019", with good recovery after the first or last onset (mRS score ≤ 1 point before this onset);
  • Obtain informed consent from the patient or their legal representative voluntarily signed and approved by the ethics committee.

Who cannot join

  • -
  • Those who meet one of the following criteria during filtering cannot be included in the group:
  • Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment;
  • Severe consciousness disorder: The item score of NIHSS's 1a consciousness level is greater than 1 point;
  • Transient ischemic attack (TIA);
  • After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
Show all 20Show fewer
  • Previously diagnosed patients with severe mental disorders and severe dementia;
  • Patients previously diagnosed with depression or anxiety disorder;
  • Patients undergoing antidepressant or anti anxiety treatment;
  • Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc; Or ALT or AST>2.0 × ULN;
  • Diagnosed with severe active kidney disease or renal insufficiency; Or serum creatinine>1.5 × ULN;
  • After the onset of the disease, drugs with brain cytoprotection in the instructions have been used, such as edaravone, concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, CDPC, piracetam, oxiracetam, butylphenylpeptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (cerebroprotein hydrolysate), calf serum deproteinized injection Calf blood deproteinized extract injection, etc;
  • After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;
  • Previously diagnosed with concurrent malignant tumors and undergoing anti-tumor treatment;
  • Previously diagnosed with severe systemic diseases, with an estimated survival period of<90 days;
  • The patient is in pregnancy, lactation, and there is a possibility of pregnancy in the patient/patient partner who plans to conceive during the trial period;
  • Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide);
  • A history of major surgeries within 4 weeks prior to enrollment and assessed by the researcher as affecting neurological function scores or affecting 90 day survival;
  • Have participated in other clinical studies or are currently participating in other clinical studies within the first 30 days of randomization;
  • The researcher believes that it is not suitable to participate in this clinical study.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

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

    Baotou, Inner Mongolia, 014000

  • Inner Mongolia Baotou Steel Hospital

    Baotou, Inner Mongolia, 014100

  • Beijing Tiantan Hospital, Capital Medical University Beijing

    Beijing, Beijing Municipality, 100000

  • Beipiao Central Hospital

    Beipiao, Liaoning, 122100

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061000

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410000

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163000

  • Dongyang City People's Hospital

    Dongyang, Zhejiang, 322100

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • Inner Mongolia International Mongolian Medicine Hospital

    Hohhot, Inner Mongolia, 010000

  • Huai 'an First People's Hospital

    Huai'an, Jiangsu, 223001

  • Shandong Third Hospital

    Jinan, Shandong, 250000

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu, 222000

  • Lianyungang Second People's Hospital

    Lianyungang, Jiangsu, 222000

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Tancheng County First People's Hospital

    Linyi, Shandong, 276100

  • Liuzhou Workers Hospital

    Liuzhou, Guangxi, 545000

  • Nanyang Second People's Hospital

    Nanyang, Henan, 473000

  • Nanyang South Stone Hospital

    Nanyang, Henan, 473000

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473000

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

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

    Shenyang, Liaoning, 110000

  • Shenyang First People's Hospital

    Shenyang, Liaoning, 110000

  • Taizhou Second People's Hospital

    Taizhou, Jiangsu, 225300

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong, 277500

  • Xuzhou Central Hospital (Old Hospital Area)

    Xuzhou, Jiangsu, 221000

  • Xuzhou Central Hospital（New compound）

    Xuzhou, Jiangsu, 221000

  • Xuzhou First People's Hospital

    Xuzhou, Jiangsu, 221000

Other trials in China

About this study

Official title: Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial

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.

Read more

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, \&gt; 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

Read the detailed 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.

Being tested
Y-3 Injection/Y-3 blank injection
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Y-3 Injection/Y-3 blank injectionDrug

    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;

Study groups in NCT06429384
Study groupRoleWhat they receive
Y-3 low-dose group (20 mg/dose, qd)ExperimentalY-3 injection 20mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Receives: Drug: Y-3 Injection/Y-3 blank injection
Y-3 medium dose group (40 mg/dose, qd)ExperimentalY-3 injection 40mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Receives: Drug: Y-3 Injection/Y-3 blank injection
Y-3 high-dose group (60 mg/dose, qd)ExperimentalY-3 injection 60mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Receives: Drug: Y-3 Injection/Y-3 blank injection
Blank control groupPlacebo comparatorY-3 blank injection 10ml was diluted with about 250 ml normal saline, intravenous infusion, qd, and continuous medication for 10 days.
Receives: Drug: Y-3 Injection/Y-3 blank injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .

    The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .

    Measured: 90th day of treatment

Secondary outcomes (4)

  1. Grade analysis of mRS Score on the 90th day of treatment;

    Grade analysis of mRS Score on the 90th day of treatment;

    Measured: 90th day of treatment

  2. The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;

    The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;

    Measured: 90th day of treatment

  3. Changes in NIH Stroke Scale from baseline on day 10 of treatment;

    Changes in NIH Stroke Scale from baseline on day 10 of treatment;

    Measured: 10th day of treatment

  4. Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.

    Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.The content of NIHSS score included: consciousness level (consciousness level, consciousness level questioning, consciousness level command), gaze, visual field, facial paralysis, upper limb movement, lower limb movement, body aid movement, sensation, language, dysarthria, neglect. The score ranges from 0 to 42, with higher scores indicating more severe nerve damage.Score 0 to 1: normal or nearly normal Scores 1-4: mild stroke/minor stroke .5 to 15 points: moderate stroke .15-20 points: moderate to severe stroke Scores 21-42: severe stroke

    Measured: On the 10th and 30th day of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start4 Jun 2023
  3. Primary completion18 Nov 2023
  4. Study completion24 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429384
Sponsor's protocol ID
Y-3-LC-02
Status last verified
Jun 2024
First submitted
3 Apr 2024
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.

    PubMed 19834014

  • Emberson J, Lees KR, Lyden P, Blackwell L, Albers G, Bluhmki E, Brott T, Cohen G, Davis S, Donnan G, Grotta J, Howard G, Kaste M, Koga M, von Kummer R, Lansberg M, Lindley RI, Murray G, Olivot JM, Parsons M, Tilley B, Toni D, Toyoda K, Wahlgren N, Wardlaw J, Whiteley W, del Zoppo GJ, Baigent C, Sandercock P, Hacke W; Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014 Nov 29;384(9958):1929-35. doi: 10.1016/S0140-6736(14)60584-5. Epub 2014 Aug 5.

    PubMed 25106063

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

    PubMed 31662037

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.

    PubMed 29367334

  • van Horn N, Kniep H, Leischner H, McDonough R, Deb-Chatterji M, Broocks G, Thomalla G, Brekenfeld C, Fiehler J, Hanning U, Flottmann F. Predictors of poor clinical outcome despite complete reperfusion in acute ischemic stroke patients. J Neurointerv Surg. 2021 Jan;13(1):14-18. doi: 10.1136/neurintsurg-2020-015889. Epub 2020 May 15.

    PubMed 32414889

  • Lee SH, Kim BJ, Han MK, Park TH, Lee KB, Lee BC, Yu KH, Oh MS, Cha JK, Kim DH, Nah HW, Lee J, Lee SJ, Kim JG, Park JM, Kang K, Cho YJ, Hong KS, Park HK, Choi JC, Kim JT, Choi K, Kim DE, Ryu WS, Kim WJ, Shin DI, Yeo M, Sohn SI, Hong JH, Lee J, Lee JS, Khatri P, Bae HJ. Futile reperfusion and predicted therapeutic benefits after successful endovascular treatment according to initial stroke severity. BMC Neurol. 2019 Jan 15;19(1):11. doi: 10.1186/s12883-019-1237-2.

    PubMed 30646858

  • Meyer L, Alexandrou M, Leischner H, Flottmann F, Deb-Chatterji M, Abdullayev N, Maus V, Politi M, Roth C, Kastrup A, Thomalla G, Mpotsaris A, Fiehler J, Papanagiotou P. Mechanical thrombectomy in nonagenarians with acute ischemic stroke. J Neurointerv Surg. 2019 Nov;11(11):1091-1094. doi: 10.1136/neurintsurg-2019-014785. Epub 2019 Apr 27.

    PubMed 31030188

  • Chamorro A, Lo EH, Renu A, van Leyen K, Lyden PD. The future of neuroprotection in stroke. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):129-135. doi: 10.1136/jnnp-2020-324283. Epub 2020 Nov 4.

    PubMed 33148815

  • Li J, Zhang L, Xu C, Shen YY, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Chen R, Zhang ZP, Luo CX, Li F, Zhu DY. A pain killer without analgesic tolerance designed by co-targeting PSD-95-nNOS interaction and alpha2-containning GABAARs. Theranostics. 2021 Apr 3;11(12):5970-5985. doi: 10.7150/thno.58364. eCollection 2021.

    PubMed 33897893

  • Li J, Zhang L, Xu C, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Luo CX, Li F, Zhu DY. Prolonged Use of NMDAR Antagonist Develops Analgesic Tolerance in Neuropathic Pain via Nitric Oxide Reduction-Induced GABAergic Disinhibition. Neurotherapeutics. 2020 Jul;17(3):1016-1030. doi: 10.1007/s13311-020-00883-w.

    PubMed 32632774

  • Kaur H, Prakash A, Medhi B. Drug therapy in stroke: from preclinical to clinical studies. Pharmacology. 2013;92(5-6):324-34. doi: 10.1159/000356320. Epub 2013 Dec 12.

    PubMed 24356194

  • Fisher M; Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003 Jun;34(6):1539-46. doi: 10.1161/01.STR.0000072983.64326.53. Epub 2003 May 15.

    PubMed 12750546

  • Hackett ML, Kohler S, O'Brien JT, Mead GE. Neuropsychiatric outcomes of stroke. Lancet Neurol. 2014 May;13(5):525-34. doi: 10.1016/S1474-4422(14)70016-X. Epub 2014 Mar 28.

    PubMed 24685278

  • Ferro JM, Caeiro L, Figueira ML. Neuropsychiatric sequelae of stroke. Nat Rev Neurol. 2016 May;12(5):269-80. doi: 10.1038/nrneurol.2016.46. Epub 2016 Apr 11.

    PubMed 27063107

  • Murrough JW, Abdallah CG, Mathew SJ. Targeting glutamate signalling in depression: progress and prospects. Nat Rev Drug Discov. 2017 Jul;16(7):472-486. doi: 10.1038/nrd.2017.16. Epub 2017 Mar 17.

    PubMed 28303025

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Y-3 Injection/Y-3 blank injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment . (time frame: 90th day of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429384, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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