Perforating Artery InfarctionPhase 2/3CORALNCT07721545
Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction
A Phase 2/3 study testing Y-6 tablet in people with Perforating Artery Infarction and PAI, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Y-6 sublingual tablets work to improve functional outcomes in patients with acute perforating artery infarction. It will also learn about the safety of Y-6 sublingual tablets. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perforating Artery Infarction, PAI
- What is being tested?
- Y-6 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 944 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Jul 2028
- Phase
- Phase 2/3
- 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
- Male or female participants aged ≥18 and ≤80 years;
- Onset of stroke within 72 hours before the first administration of study treatment;
- Clinical symptoms and signs suggestive of an acute isolated perforating artery territory infarction (no cortical involvement, no multifocal involvement, NIHSS score between 4 and 15, and level of consciousness item 1a ≤1);
- Pre-stroke modified Rankin Scale (mRS) score ≤1 before the current stroke onset;
- Brain magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) showing an isolated infarction lesion in the perforating artery territory (including the basal ganglia, internal capsule, thalamus, pons, etc.) with a diameter <30 mm, and meeting at least one of the following criteria:
- The infarct lesion involves at least 3 DWI axial slices;
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- The maximum diameter of the lesion on DWI is ≥15 mm;
- The DWI lesion is connected to the ventral surface of the pons, located near the midline, unilateral, and does not cross the midline;
- No severe stenosis of the parent artery supplying the infarct territory (severe stenosis defined as >70% stenosis on magnetic resonance angiography [MRA], or >50% stenosis on computed tomography angiography [CTA] or digital subtraction angiography [DSA]);
- The participant or legally authorized representative voluntarily signs the informed consent form approved by the ethics committee.
Who cannot join
- Known allergy to any component of the investigational product or its excipients;
- Ischemic stroke caused by large artery atherosclerosis, cardioembolism, arterial dissection, or vasculitis identified at screening;
- History of intracranial hemorrhagic diseases within 3 months prior to screening, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
- History of other active or major neurological diseases, including recurrent seizures, intracranial tumors, vascular malformations (including arteriovenous malformations, arterial malformations, cavernous malformations), untreated aneurysms >3 mm in diameter, etc.;
- History of congestive heart failure, or acute myocardial infarction within 3 months prior to screening, or severe cardiac dysfunction (NYHA class III-IV);
- Significant head trauma, intracranial or spinal surgery, or severe physical trauma within 4 weeks prior to screening; major surgery within 3 months prior to screening; or planned endovascular treatment during the study period;
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- Severe hepatic or renal dysfunction at screening, or meeting any of the following criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN);
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² (calculated using the CKD-EPI equation based on serum creatinine; see Appendix 4);
- Coagulation disorders, bleeding tendency, or active systemic bleeding at screening, including but not limited to:
- Prothrombin time >1.5 × ULN;
- Platelet count <100 × 10⁹/L;
- Hemophilia, capillary fragility disorders, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.;
- Persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive treatment;
- Known acute gastrointestinal ulcer;
- History of asthma induced by salicylates or salicylate-containing substances (especially non-steroidal anti-inflammatory drugs [NSAIDs]);
- Continuous use of dual antiplatelet therapy within 5 days prior to screening, or administration of loading doses of clopidogrel (300 mg) or ticagrelor (180 mg) after current stroke onset and before screening, or use of antiplatelet agents other than aspirin, cilostazol, clopidogrel, or ticagrelor after current stroke onset and before screening;
- Received intravenous thrombolysis, thrombectomy, other endovascular treatment, or bridging therapy after current stroke onset; or received anticoagulants, batroxobin, defibrase, snake venom-derived preparations, or lumbrokinase therapy;
- Presence of a clear indication for anticoagulation (suspected cardioembolic stroke, such as atrial fibrillation, known prosthetic heart valve, atrial myxoma, endocarditis, etc.) or a clear indication for dual antiplatelet therapy (such as recent coronary artery stenting or intracranial artery stenting);
- Expected need for long-term use of NSAIDs other than the study medication;
- Life expectancy ≤12 months;
- Participation in any other interventional clinical trial within 3 months prior to screening or current participation in another clinical trial;
- Male participants (or their partners) or female participants who plan to conceive during the study period, or participants unwilling to use one or more non-drug contraceptive methods (such as complete abstinence, condoms, sterilization, etc.) throughout the study period;
- Pregnant or breastfeeding women;
- Any other condition considered by the investigator to potentially affect compliance or make the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing TianTan Hospital
Beijing, Beijing Municipality, 100070
lilong wang, 13911666571, yilong528@aliyun.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial of Y-6 Sublingual Tablets for the Treatment of Acute Perforator Artery Territory Infarction
The goal of this clinical trial is to learn if Y-6 sublingual tablets work to improve functional outcomes in patients with acute perforating artery infarction. It will also learn about the safety of Y-6 sublingual tablets.
The main questions it aims to answer are:
Read more
Does Y-6 sublingual tablets increase the proportion of participants who achieve a modified Rankin Scale (mRS) score of 0-1 at Day 90 after treatment? What medical problems do participants have when taking Y-6 sublingual tablets?
Researchers will compare different doses of Y-6 sublingual tablets and placebo to evaluate the effectiveness and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction.
Participants will:
Take Y-6 sublingual tablets or placebo according to the assigned treatment regimen.
Visit the clinic for assessments of neurological function, functional outcomes, and safety during the study period.
Complete clinical assessments, including neurological examinations, laboratory tests, and other safety evaluations.
Be followed for functional outcomes and safety events after treatment.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, seamless adaptive Phase II/III clinical trial to evaluate the efficacy and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction. The study consists of two stages. In Stage 1, participants will be randomly assigned to receive high-dose Y-6 sublingual tablets (2 tablets, containing a total of 12 mg of borneol and 50 mg of cilostazol), low-dose Y-6 sublingual tablets (1 tablet containing 6 mg of borneol and 25 mg of cilostazol plus 1 matching placebo tablet), or placebo (2 matching placebo tablets), in addition to standard antiplatelet therapy with aspirin (100mg). The purpose of Stage 1 is to evaluate the efficacy and safety of different doses of Y-6 sublingual tablets and select the recommended dose for Stage 2 based on interim analyses reviewed by an independent data monitoring committee (IDMC). In Stage 2, participants will be randomly assigned to receive the selected dose of Y-6 sublingual tablets or placebo, in addition to concomitant aspirin therapy, to confirm the efficacy and safety of Y-6 sublingual tablets. Participants will receive study treatment and be followed for efficacy and safety outcomes, including functional outcomes, adverse events, bleeding events, and other safety assessments
- Conditions
- Perforating Artery Infarction, PAI
- Being tested
- Y-6 tablet, Placebo
- Keywords
- Y-6, future-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-6 tabletDrug
Y-6 sublingual tablets (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.
PlaceboDrug
Placebo (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Y-6 tablet | Experimental | twice daily for 90 consecutive days Receives: Drug: Y-6 tablet |
| Placebo | Placebo comparator | twice daily for 90 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
Measured: Day 90(+7 days)
Secondary outcomes (17)
Distribution of mRS scores after treatment
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
Measured: Day 90(+7 days)
Proportion of participants with stroke-related disability after treatment
Stroke disability is defined as disability (modified Rankin Scale [mRS] score of 3-5), major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and vascular death, and all-cause mortality.
Measured: Day90 (+7 days)
Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point
The NIHSS total score ranges from 0 to 42, with higher scores indicating worse neurological outcomes.
Measured: Day90 (+7 days)
Proportion of participants achieving a Barthel Index score ≥95 after treatment
The Barthel Index (BI) is a measure of activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater independence, while lower scores indicate greater dependence on assistance for daily activities.
Measured: Day 90 (+7 days)
Proportion of participants with early neurological deterioration after treatment
Early neurological deterioration means within 7 days after stroke attack, an increase in NIHSS of ≥2 points or an increase in hemiparesis of ≥1 point or an increase in impaired consciousness of ≥1 point from baseline and excluding progression of disease due to intracranial hemorrhage by examination of cranial CT or MRI and exacerbation of disease due to other non-stroke causes, such as cardiac insufficiency, hepatic insufficiency, renal insufficiency, etc.
Measured: 72 hours (±12 hours) after treatment、Day 7 (±1 day)
Proportion of participants with ischemic stroke after treatment
Measured: Day90 (+7 days)
Incidence of moderate and severe bleeding events after treatment
Bleeding events will be classified according to the GUSTO bleeding criteria. Severe or life-threatening bleeding is defined as intracerebral hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment. Moderate bleeding is defined as bleeding requiring blood transfusion. Minor bleeding is defined as other bleeding events not requiring transfusion or causing hemodynamic compromise.
Measured: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of intracranial hemorrhage after treatment
Measured: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of any bleeding events after treatment
Measured: Day 30 (±3 days)、Day 90 (+7 days)
All-cause Mortality after treatment
Measured: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of platelet count ≤100 × 10⁹/L after treatment
Measured: Day 30 (±3 days）、Day 90(+7 days）
Incidence of new-onset moderate-to-severe headache after treatment
Headache severity will be assessed using the 11-point Numerical Rating Scale (11-NRS). The scale ranging from 0 to 10, where 0 indicates no headache and 10 indicates the worst imaginable headache. Higher scores indicate greater headache severity.
Measured: Day 30 (±3 days)、Day 90 (+7 days)
Incidence and severity of adverse events after treatment
Measured: Day 90 (+7days)
The Incidence of subject getting abnormal results of physical examinations after treatment
Measured: Day 90 (+7days)
The Incidence of subject getting abnormal results of vital signs after treatment
Measured: Day 90 (+7days)
The Incidence of subject getting abnormal results of laboratory tests after treatment
Measured: Day 90 (+7days)
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment
Measured: Day 90 (+7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforating Artery InfarctionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721545
- Sponsor's protocol ID
- Y-6-LC-05
- Acronym
- CORAL
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial of Y-6 Sublingual Tablets for the Treatment of Acute Perforator Artery Territory Infarction
- ClinicalTrials.gov ID
- NCT07721545
- Acronym / sponsor ID
- CORAL / Y-6-LC-05
- Conditions
- Perforating Artery Infarction, PAI
- Keywords
- Y-6, future-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 944 participants (estimated)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Jul 2026 (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.
The goal of this clinical trial is to learn if Y-6 sublingual tablets work to improve functional outcomes in patients with acute perforating artery infarction. It will also learn about the safety of Y-6 sublingual tablets.
The main questions it aims to answer are:
Does Y-6 sublingual tablets increase the proportion of participants who achieve a modified Rankin Scale (mRS) score of 0-1 at Day 90 after treatment? What medical problems do participants have when taking Y-6 sublingual tablets?
Researchers will compare different doses of Y-6 sublingual tablets and placebo to evaluate the effectiveness and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction.
Participants will:
Take Y-6 sublingual tablets or placebo according to the assigned treatment regimen.
Visit the clinic for assessments of neurological function, functional outcomes, and safety during the study period.
Complete clinical assessments, including neurological examinations, laboratory tests, and other safety evaluations.
Be followed for functional outcomes and safety events after treatment.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, seamless adaptive Phase II/III clinical trial to evaluate the efficacy and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction. The study consists of two stages. In Stage 1, participants will be randomly assigned to receive high-dose Y-6 sublingual tablets (2 tablets, containing a total of 12 mg of borneol and 50 mg of cilostazol), low-dose Y-6 sublingual tablets (1 tablet containing 6 mg of borneol and 25 mg of cilostazol plus 1 matching placebo tablet), or placebo (2 matching placebo tablets), in addition to standard antiplatelet therapy with aspirin (100mg). The purpose of Stage 1 is to evaluate the efficacy and safety of different doses of Y-6 sublingual tablets and select the recommended dose for Stage 2 based on interim analyses reviewed by an independent data monitoring committee (IDMC). In Stage 2, participants will be randomly assigned to receive the selected dose of Y-6 sublingual tablets or placebo, in addition to concomitant aspirin therapy, to confirm the efficacy and safety of Y-6 sublingual tablets. Participants will receive study treatment and be followed for efficacy and safety outcomes, including functional outcomes, adverse events, bleeding events, and other safety assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-6 tablet | Experimental | Drug: Y-6 tablettwice daily for 90 consecutive days |
| Placebo | Placebo comparator | Drug: Placebotwice daily for 90 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants aged ≥18 and ≤80 years;
- Onset of stroke within 72 hours before the first administration of study treatment;
- Clinical symptoms and signs suggestive of an acute isolated perforating artery territory infarction (no cortical involvement, no multifocal involvement, NIHSS score between 4 and 15, and level of consciousness item 1a ≤1);
- Pre-stroke modified Rankin Scale (mRS) score ≤1 before the current stroke onset;
- Brain magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) showing an isolated infarction lesion in the perforating artery territory (including the basal ganglia, internal capsule, thalamus, pons, etc.) with a diameter <30 mm, and meeting at least one of the following criteria:
Key exclusion criteria (25 listed)
- Known allergy to any component of the investigational product or its excipients;
- Ischemic stroke caused by large artery atherosclerosis, cardioembolism, arterial dissection, or vasculitis identified at screening;
- History of intracranial hemorrhagic diseases within 3 months prior to screening, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
- History of other active or major neurological diseases, including recurrent seizures, intracranial tumors, vascular malformations (including arteriovenous malformations, arterial malformations, cavernous malformations), untreated aneurysms >3 mm in diameter, etc.;
- History of congestive heart failure, or acute myocardial infarction within 3 months prior to screening, or severe cardiac dysfunction (NYHA class III-IV);
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-6 tabletY-6 sublingual tablets (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days. | Drug | Y-6 tablet |
| PlaceboPlacebo (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days. | Drug | Placebo |
Primary outcome
Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment
Time frame: Day 90(+7 days)
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
17 secondary outcomes
Distribution of mRS scores after treatment
Time frame: Day 90(+7 days)
Proportion of participants with stroke-related disability after treatment
Time frame: Day90 (+7 days)
Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point
Time frame: Day90 (+7 days)
Proportion of participants achieving a Barthel Index score ≥95 after treatment
Time frame: Day 90 (+7 days)
Proportion of participants with early neurological deterioration after treatment
Time frame: 72 hours (±12 hours) after treatment、Day 7 (±1 day)
Proportion of participants with ischemic stroke after treatment
Time frame: Day90 (+7 days)
Incidence of moderate and severe bleeding events after treatment
Time frame: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of intracranial hemorrhage after treatment
Time frame: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of any bleeding events after treatment
Time frame: Day 30 (±3 days)、Day 90 (+7 days)
All-cause Mortality after treatment
Time frame: Day 30 (±3 days)、Day 90 (+7 days)
Incidence of platelet count ≤100 × 10⁹/L after treatment
Time frame: Day 30 (±3 days）、Day 90(+7 days）
Incidence of new-onset moderate-to-severe headache after treatment
Time frame: Day 30 (±3 days)、Day 90 (+7 days)
Incidence and severity of adverse events after treatment
Time frame: Day 90 (+7days)
The Incidence of subject getting abnormal results of physical examinations after treatment
Time frame: Day 90 (+7days)
The Incidence of subject getting abnormal results of vital signs after treatment
Time frame: Day 90 (+7days)
The Incidence of subject getting abnormal results of laboratory tests after treatment
Time frame: Day 90 (+7days)
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment
Time frame: Day 90 (+7 days)
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 23 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Y-6 tablet in people with Perforating Artery Infarction and PAI, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site 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 10 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (13911666571, yilong528@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment (time frame: Day 90(+7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.