Stroke, Acute IschemicSOLUTION-2NCT06374667
The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction
A study testing Y-3 ICO injection, Y-3 intravenous injection and Conventional treatment in people with Stroke, Acute Ischemic and Blood-Brain Barrier, run by yilong Wang at 6 sites in China.
Trial summary
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Ischemic, Blood-Brain Barrier
- What is being tested?
- Y-3 ICO injection, Y-3 intravenous injection and Conventional treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesChina
- Study dates
- 22 Apr 2024to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18≤Age≤80 years;
- First stroke or complete self-care before the onset of current stroke (mRS 0-1);
- Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);
- Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:
- 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;
- Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values <620×10^-6mm^2/s lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) <30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.
- NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.
- Informed consent signed
Who cannot join
- Complications with other cerebrovascular diseases meet one of the following conditions:
- Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;
- Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (>70%);
- Or imaging suggests that the area of cerebral infarction is involved bilaterally;
- The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.
- Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;
Show all 25Show fewer
- Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a > 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;
- Craniotomy decompression was planned before randomization;
- Refractory hypertension (systolic > 200mmHg or diastolic > 110mmHg) or hypotension (systolic < 70mmHg or diastolic < 50mmHg) that is difficult to control with medication;
- Abnormal blood glucose before randomization (random venous blood glucose < 2.8mmol/L or > 23mmol/L);
- Presence of significant abnormal liver function markers or renal function markers prior to randomization;
- Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL/min/1.73 m² (eGFR, calculated using the CKD-EPI formula)
- Acute ST-elevation myocardial infarction (MI) and/or decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months;
- Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural/extradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches；
- Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts < 100×10^9/L, and the presence of clotting disorders such as hemophilia；
- Presence of severe or very severe anemia (hemoglobin <60 g/L) at randomization；
- Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator;
- The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections;
- Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.);
- Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors;
- Known allergy to any component of investigational process therapy drugs and contrast agents;
- Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become pregnant;
- Subjects are unable to comply with trial protocols or follow-up requirements;
- Other circumstances deemed by the investigators to be unsuitable for enrollment (registration of reasons for inability to enroll is required);
- Have participated in other interventional clinical trials.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 5 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Yilong Wang, PhD，MD, yilong538@gmail.com
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Heibei
Yachen An, MD
- Withdrawn
Tangshan Municipal Worker's Hospital
Tangshan, Heibei
- Recruiting
Tianjin Huanhu hospital
Tianjin
Jialing Wu, MD
- Recruiting
The first affiliated hospital of Wannan Medical College
Wuhu, Anhui
Shoucai Zhao, MD
Zhenbao Li, MD
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Wei Hu, MD
About this study
Official title: The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction（SOLUTION-2）
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
Read the detailed description
The mortality rate of large hemispheric infarction(LHI) is up to 40%-60%, while current available treatment is limited. Mainstream therapeutics include endovascular reperfusion therapy and decompressive craniectomy. But endovascular-reperfusion has limits such as short time window and hemorrhagic transformation risk, while decompressive craniectomy can reduce mortality but not infarct volume. Curative effect of intravenous injection of neuroprotective drugs is severely limited because of the blood-brain barrier. Microchannels connecting the skull bone marrow and dura may be effective drug delivery shortcuts bypassing the blood-brain barrier. Cytoprotective drug Y-3 affects dual aspects of ischemic cascade by disrupting both function of the synaptic folding post-synaptic density protein 95 (PSD-95), as well as α2-γ⁃Aminobutyric acid type A receptor (α2-GABAAR) agonist. Phase I and Phase II clinical trials have confirmed the safety and efficacy of intravenous infusion of Y-3 in treating cerebral infarction, with the optimal dosage being 40mg. Preclinical testing proved that ICO injection of Y-3 solution 24h post rat permanent middle cerebral artery infarction reduced rat infarction volume and improved neurological function.
SOLUTION-2 is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study
The purpose of this study is to investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in acute LHI patients with contraindications of reperfusion therapy or poor outcomes.
Patients will be randomly assigned to one of the following 2 groups at 1:1 ratio.
ICO injection group: Y-3 ICO injection (dose was given as 32 ug/kg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines.
intravenous injection group: Y-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines.
Face to face interviews will be made on baseline, 4±1 days after randomization, 8±1 days after randomization, 14±1 days after randomization or discharge day, and 90 days , 1year± 14 days after randomization.
The primary efficacy outcomes is the modified Rankin Scale（mRS） 0-3 points at 90±7 days. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Being Tiantan hospital, Capital Medical University.
- Conditions
- Stroke, Acute Ischemic, Blood-Brain Barrier
- Being tested
- Y-3 ICO injection, Y-3 intravenous injection, Conventional treatment
- Keywords
- large hemispheric infarction, Y-3, postsynaptic density protein 95 inhibitor, BBB-bypassing route, brain drug delivery, intracalvariosseous 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 ICO injectionProcedure or surgery
Patients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days.
Y-3 intravenous injectionDrug
Patients included will be given Y-3 intravenous injection for 7 consecutive days.
Conventional treatmentOther
standard treatment and management according to related guidelines during the entire treatment period
| Study group | Role | What they receive |
|---|---|---|
| ICO injection group | Experimental | Y-3 ICO injection (dose was given as 32 ug/kg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines. Receives: Procedure: Y-3 ICO injection; Other: Conventional treatment |
| intravenous injection group | Active comparator | Y-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines. Receives: Drug: Y-3 intravenous injection; Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day favorable clinical outcome
Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±7 days after randomization
Secondary outcomes (7)
Change of infarct volume from baseline to 8-day
The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10^-6mm^2/s or on CTP image with rCBF<30%
Measured: baseline，8±1 days after randomization
Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) .
NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.
Measured: 8±1 days after randomization，14±1 days after randomization，90±7 days after randomization
Patients with symptoms improvement from baseline to 14-day
Symptoms improvement defined as the NIHSS scores improved by 4 points from baseline to 14-day
Measured: baseline，14±1 days after randomization
Rate of decompressive hemicraniectomy
Rate of decompressive hemicraniectomy
Measured: 90±7 days after randomization
Depression scale scores at 90-day
Depression scale scores including Stroke Aphasic Depression Questionnaire-Hospital Version(SADQ-H) and Aphasia Depression Rating Scale(ADRS)
Measured: 90±7 days after randomization
Proportion of combined adverse events at 90-day
Combined adverse events defined as mRS 4-5, decompressive craniotomy, vascular death
Measured: 90±7 days after randomization
90-day modified Rankin Scale
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start22 Apr 2024
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yilong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Yilong Wang, PhD，MD, Principal investigator, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374667
- Sponsor's protocol ID
- KY2024-071-02
- Acronym
- SOLUTION-2
- Status last verified
- Jan 2025
- First submitted
- 16 Apr 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang N, Zhang M, Yang M, Liu W, Liu W, Ou Y, Zhou M, Wang X, Sun Z, Pan Y, Wang Y, Wang Y. Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial. Stroke Vasc Neurol. 2026 Mar 4;11(1):130-135. doi: 10.1136/svn-2024-004011.
PubMed 40461153
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction（SOLUTION-2）
- ClinicalTrials.gov ID
- NCT06374667
- Acronym / sponsor ID
- SOLUTION-2 / KY2024-071-02
- Conditions
- Stroke, Acute Ischemic, Blood-Brain Barrier
- Keywords
- large hemispheric infarction, Y-3, postsynaptic density protein 95 inhibitor, BBB-bypassing route, brain drug delivery, intracalvariosseous injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- yilong WangUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
Detailed description
The mortality rate of large hemispheric infarction(LHI) is up to 40%-60%, while current available treatment is limited. Mainstream therapeutics include endovascular reperfusion therapy and decompressive craniectomy. But endovascular-reperfusion has limits such as short time window and hemorrhagic transformation risk, while decompressive craniectomy can reduce mortality but not infarct volume. Curative effect of intravenous injection of neuroprotective drugs is severely limited because of the blood-brain barrier. Microchannels connecting the skull bone marrow and dura may be effective drug delivery shortcuts bypassing the blood-brain barrier. Cytoprotective drug Y-3 affects dual aspects of ischemic cascade by disrupting both function of the synaptic folding post-synaptic density protein 95 (PSD-95), as well as α2-γ⁃Aminobutyric acid type A receptor (α2-GABAAR) agonist. Phase I and Phase II clinical trials have confirmed the safety and efficacy of intravenous infusion of Y-3 in treating cerebral infarction, with the optimal dosage being 40mg. Preclinical testing proved that ICO injection of Y-3 solution 24h post rat permanent middle cerebral artery infarction reduced rat infarction volume and improved neurological function.
SOLUTION-2 is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study
The purpose of this study is to investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in acute LHI patients with contraindications of reperfusion therapy or poor outcomes.
Patients will be randomly assigned to one of the following 2 groups at 1:1 ratio.
ICO injection group: Y-3 ICO injection (dose was given as 32 ug/kg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines.
intravenous injection group: Y-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines.
Face to face interviews will be made on baseline, 4±1 days after randomization, 8±1 days after randomization, 14±1 days after randomization or discharge day, and 90 days , 1year± 14 days after randomization.
The primary efficacy outcomes is the modified Rankin Scale（mRS） 0-3 points at 90±7 days. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Being Tiantan hospital, Capital Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICO injection group | Experimental | Procedure: Y-3 ICO injection, Other: Conventional treatmentY-3 ICO injection (dose was given as 32 ug/kg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines. |
| intravenous injection group | Active comparator | Drug: Y-3 intravenous injection, Other: Conventional treatmentY-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18≤Age≤80 years;
- First stroke or complete self-care before the onset of current stroke (mRS 0-1);
- Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);
- Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:
- NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.
Key exclusion criteria (25 listed)
- Complications with other cerebrovascular diseases meet one of the following conditions:
- Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;
- Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a > 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;
- Craniotomy decompression was planned before randomization;
- Refractory hypertension (systolic > 200mmHg or diastolic > 110mmHg) or hypotension (systolic < 70mmHg or diastolic < 50mmHg) that is difficult to control with medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-3 ICO injectionPatients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days. | Procedure or surgery | ICO injection group |
| Y-3 intravenous injectionPatients included will be given Y-3 intravenous injection for 7 consecutive days. | Drug | intravenous injection group |
| Conventional treatmentstandard treatment and management according to related guidelines during the entire treatment period | Other | ICO injection group, intravenous injection group |
Primary outcome
90-day favorable clinical outcome
Time frame: 90±7 days after randomization
Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
7 secondary outcomes
Change of infarct volume from baseline to 8-day
Time frame: baseline，8±1 days after randomization
Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) .
Time frame: 8±1 days after randomization，14±1 days after randomization，90±7 days after randomization
Patients with symptoms improvement from baseline to 14-day
Time frame: baseline，14±1 days after randomization
Rate of decompressive hemicraniectomy
Time frame: 90±7 days after randomization
Depression scale scores at 90-day
Time frame: 90±7 days after randomization
Proportion of combined adverse events at 90-day
Time frame: 90±7 days after randomization
90-day modified Rankin Scale
Time frame: 90±7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 40461153Wang N, Zhang M, Yang M, Liu W, Liu W, Ou Y, Zhou M, Wang X, Sun Z, Pan Y, Wang Y, Wang Y. Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial. Stroke Vasc Neurol. 2026 Mar 4;11(1):130-135. doi: 10.1136/svn-2024-004011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yilong Wang, PhD，MD principal investigator
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-3 ICO injection, Y-3 intravenous injection and Conventional treatment in people with Stroke, Acute Ischemic and Blood-Brain Barrier, run by yilong Wang at 6 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 8 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wang, PhD+MD (18842627325/13261655100, yilong528@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day favorable clinical outcome (time frame: 90±7 days after randomization). 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 NCT06374667, which also lists 1 linked publication.
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 28 Jan 2025.