Can a dissolving tablet improve recovery after a common stroke?
NCT ID NCT07721545
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial tests whether Y-6 sublingual tablets can help people recover from a specific type of stroke called acute perforator artery infarction. About 944 adults who have had a stroke within the past 72 hours will receive either Y-6 or a placebo twice daily for 90 days. Researchers will measure functional outcomes, such as the ability to perform daily activities, and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called Y-6, given as a sublingual tablet
- What this could lead to
- If effective, Y-6 could offer a new treatment option for a common type of stroke, potentially reducing long-term disability.
- What could go wrong
- This is an early-to-mid-stage trial, so the drug may not prove more effective than placebo. Safety and optimal dosing are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 944 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing TianTan Hospital
Beijing, Beijing Municipality, 100070, China