Acute Perforator Artery Territory Infarction
Conditions
Interventions
Phase 1 Control group:Y-6 Placebo
Phase 1 Y-6 high-dose group:Y-6 sublingual tablets, 2 pieces
Phase 1 Y-6 low-dose group:One Y-6 sublingual tablet and one Y-6 placebo
Phase 2 Y-6 X-dose group:Y-6 sublingual tablets
Phase 2 Control group:Y-6 placebo
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 and =80 years; male or female; 2.Onset within 72 hours (time from onset to first administration of study drug); 3.Clinical symptoms and signs suggestive of an isolated acute infarct in the territory of a perforating artery (no evidence of cortical involvement, no evidence of multifocal involvement; NIHSS score 4–15, with a score of =1 on the level of consciousness item 1a); 4.Pre-stroke modified Rankin Scale (mRS) score =1; 5.Brain diffusion-weighted imaging (DWI) shows an isolated infarct lesion (diameter 70% stenosis on MRA, or >50% stenosis on CTA/DSA); 7.Trial participant or their legal guardian voluntarily signs the informed consent form approved by the ethics committee;
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug components or excipients; 2. Ischemic stroke caused by large-artery atherosclerosis, cardiac sources, arterial dissection, or vasculitis at the time of screening; 3. History of intracranial hemorrhagic disease within 3 months prior to screening, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.; 4. History of other active, major neurological disorders (e.g., 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 or severe cardiac insufficiency (NYHA Class III-IV) within 3 months prior to screening; 6. Significant head trauma, intracranial or intraspinal surgery, or severe physical trauma within 4 weeks prior to screening; or major surgery within 3 months or planned endovascular treatment during the study period; 7. Severe hepatic or renal dysfunction at the time of screening, or meeting any of the following criteria: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); (2) Estimated glomerular filtration rate (eGFR) 1.5 times the ULN; platelet count = 180 mmHg or diastolic blood pressure >= 110 mmHg despite blood pressure control; 10. History of acute gastrointestinal ulcer; 11. History of asthma induced by salicylates or salicylate-containing substances (particularly non-steroidal anti-inflammatory drugs); 12. Continuous use of dual antiplatelet therapy within the 5 days prior to screening; receipt of a loading dose of clopidogrel (300 mg) or ticagrelor (180 mg) between the onset of the current event and screening; or receipt of antiplatelet therapy other than aspirin, cilostazol, clopidogrel, or ticagrelor between the onset of the current event and screening; 13. Receipt of intravenous thrombolysis, endovascular treatment (such as thrombectomy), or bridging therapy following the onset of the current event; or receipt of anticoagulation or fibrinogen-lowering therapy (e.g., batroxobin, defibrase, snake venom preparations, lumbrokinase); 14. Clear indication for anticoagulation (suspected cardioembolism, such as in the presence of atrial fibrillation, known prosthetic heart valve, atrial myxoma, endocarditis, etc.) or clear indication for dual antiplatelet therapy (e.g., recent coronary or cerebral artery stenting); 15. Anticipated need for long-term use of non-steroidal anti-inflammatory drugs other than the study drug; 16. Life expectancy <= 12 months; 17. Participation in any other interventional clinical trial within 3 months prior to screening, or current participation in any other clinical trial; 18. Male participants (or their partners) or female participants planning to conceive during the study period, or participants unwilling to use one or more non-pharmacological contraceptive measures (e.g., complete abstinence, condoms, steril
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score;mRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score;Proportion of ischemic strokes;Proportion of patients experiencing early neurological deterioration;Safety;Side effects;Barthel Index;Proportion of stroke-related disability;mRS; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed