> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/y-6-sublingual-tablets-for-acute-penetrating-artery-8d79ed5e-7a5a-41e3-a68c-02f083a6a0f9
> Record changed: 2026-10-13

# Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction

NCT07721545

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Phase

Phase 2/Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Recruitment status

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Participants

944

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Lead sponsor

Neurodawn Pharmaceutical Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Start date

2026-08-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Title and summary

**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. 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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Acronym**

CORAL

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Short title**

Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Recruitment status**

Not yet recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Phase**

Phase 2/Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Dates

**Completion date**

2028-07-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**First posted**

2026-07-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Registry last updated**

2026-07-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Primary completion date**

2028-02-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Start date**

2026-08-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Size and sites

**Participants**

944

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Planned participants**

944

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Lead sponsor**

Neurodawn Pharmaceutical Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Identifiers

**Registry ID**

NCT07721545

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**ClinicalTrials.gov ID**

NCT07721545

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Outcomes

### Primary outcomes

1. Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment  
Timeframe: 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.

### Secondary outcomes

1. Distribution of mRS scores after treatment  
Timeframe: 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.
2. Proportion of participants with stroke-related disability after treatment  
Timeframe: Day90 (+7 days)  
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.
3. Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point  
Timeframe: Day90 (+7 days)  
The NIHSS total score ranges from 0 to 42, with higher scores indicating worse neurological outcomes.
4. Proportion of participants achieving a Barthel Index score ≥95 after treatment  
Timeframe: Day 90 (+7 days)  
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.
5. Proportion of participants with early neurological deterioration after treatment  
Timeframe: 72 hours (±12 hours) after treatment、Day 7 (±1 day)  
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.
6. Proportion of participants with ischemic stroke after treatment  
Timeframe: Day90 (+7 days)
7. Incidence of moderate and severe bleeding events after treatment  
Timeframe: Day 30 (±3 days)、Day 90 (+7 days)  
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.
8. Incidence of intracranial hemorrhage after treatment  
Timeframe: Day 30 (±3 days)、Day 90 (+7 days)
9. Incidence of any bleeding events after treatment  
Timeframe: Day 30 (±3 days)、Day 90 (+7 days)
10. All-cause Mortality after treatment  
Timeframe: Day 30 (±3 days)、Day 90 (+7 days)
11. Incidence of platelet count ≤100 × 10⁹/L after treatment  
Timeframe: Day 30 (±3 days）、Day 90(+7 days）
12. Incidence of new-onset moderate-to-severe headache after treatment  
Timeframe: Day 30 (±3 days)、Day 90 (+7 days)  
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.
13. Incidence and severity of adverse events after treatment  
Timeframe: Day 90 (+7days)
14. The Incidence of subject getting abnormal results of physical examinations after treatment  
Timeframe: Day 90 (+7days)
15. The Incidence of subject getting abnormal results of vital signs after treatment  
Timeframe: Day 90 (+7days)
16. The Incidence of subject getting abnormal results of laboratory tests after treatment  
Timeframe: Day 90 (+7days)
17. The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment  
Timeframe: Day 90 (+7 days)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### Inclusion criteria

1. Male or female participants aged ≥18 and ≤80 years;
2. Onset of stroke within 72 hours before the first administration of study treatment;
3. 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);
4. Pre-stroke modified Rankin Scale (mRS) score ≤1 before the current stroke onset;
5. 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:

  1. The infarct lesion involves at least 3 DWI axial slices;
  2. The maximum diameter of the lesion on DWI is ≥15 mm;
  3. The DWI lesion is connected to the ventral surface of the pons, located near the midline, unilateral, and does not cross the midline;
6. 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 \[DSA\]);
7. The participant or legally authorized representative voluntarily signs the informed consent form approved by the ethics committee.

### Exclusion criteria

1. Known allergy to any component of the investigational product or its excipients;
2. Ischemic stroke caused by large artery atherosclerosis, cardioembolism, arterial dissection, or vasculitis identified at screening;
3. History of intracranial hemorrhagic diseases within 3 months prior to screening, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
4. 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.;
5. History of congestive heart failure, or acute myocardial infarction within 3 months prior to screening, or severe cardiac dysfunction (NYHA class III-IV);
6. 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;
7. Severe hepatic or renal dysfunction at screening, or meeting any of the following criteria:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN);
  2. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² (calculated using the CKD-EPI equation based on serum creatinine; see Appendix 4);
8. Coagulation disorders, bleeding tendency, or active systemic bleeding at screening, including but not limited to:

  1. Prothrombin time >1.5 × ULN;
  2. Platelet count <100 × 10⁹/L;
  3. Hemophilia, capillary fragility disorders, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.;
9. Persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive treatment;
10. Known acute gastrointestinal ulcer;
11. History of asthma induced by salicylates or salicylate-containing substances (especially non-steroidal anti-inflammatory drugs \[NSAIDs\]);
12. 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;
13. 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;
14. 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);
15. Expected need for long-term use of NSAIDs other than the study medication;
16. Life expectancy ≤12 months;
17. Participation in any other interventional clinical trial within 3 months prior to screening or current participation in another clinical trial;
18. 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;
19. Pregnant or breastfeeding women;
20. Any other condition considered by the investigator to potentially affect compliance or make the participant unsuitable for participation in this study.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Sites

- Beijing TianTan HospitalBeijing, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07721545)

## Related records

### Drugs (1)

- [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md)

### Lead sponsors (1)

- [Neurodawn Pharmaceutical Co., Ltd.](https://trialight.com/data/company/neurodawn-pharmaceutical-co-ltd-5848e6af-bfeb-413b-9c14-1e56ffab2d36.md)

### Conditions (1)

- [Pai syndrome](https://trialight.com/data/condition/pai-syndrome-ca62b972-11f1-54a6-a99d-6da0b4c1edc1.md)

---

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