Acute ischemic stroke
Conditions
Interventions
Y-6 sublingual tablet group (25 mg/dose, bid):Y-6 sublingual tablet (25 mg/dose, bid)
Y-6 Placebo group:Y-6 Placebo
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=35 years and = 6 at screening; 6. National Institutes of Health Stroke Scale score: 6 < NIHSS <= 25 after this onset; 7. Patients who meet the indications for endovascular therapy at screening and are scheduled for endovascular therapy; 8. Obtained voluntary signed informed consent from the patients or their legal representatives approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the components of the study drug and its excipients; 2. Severe impairment of consciousness at screening: 1a level of consciousness >= 2 points on the NIHSS; 3. A history of previously diagnosed intracranial hemorrhagic conditions clearly known at screening: including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma; 4. A history of previously diagnosed intracranial tumors, intracranial arteriovenous malformations, or aneurysms is known at the time of screening; 5. A previous diagnosis of congestive heart failure clearly known at the time of screening; 6. A definite diagnosis of bilateral anterior or posterior circulation ischemic stroke, or large vessel occlusion of unknown etiology at the time of screening; 7. Treatment with warfarin, new oral anticoagulants, argatroban, snake venom, hypofibrinogenin, earth kinase, and bacitracin after onset of disease and prior to screening; 8. Those with a previous diagnosis of severe hematologic (platelet count 3 times the upper limit of normal, or AST value >3 times the upper limit of normal; blood creatinine >3.0 mg/dl (265.2 µmol/L) or creatinine clearance 180 mmHg or diastolic blood pressure >110 mmHg) that is difficult to control with medications; 11. History of significant head trauma or stroke within 1 month prior to randomization; 12. Intracranial or intraspinal surgery within 3 months prior to randomization; 13. History of major surgery or severe physical trauma within 1 month prior to randomization; 14. Male subjects (or their partners) or female subjects who have plans to have children throughout the trial and within 3 months of study completion or subjects who are unwilling to use one or more non-pharmacological contraceptive methods (e.g., total abstinence, condoms, sterilization, etc.) during the trial; 15. Prior allergy or contraindication to known contrast agents; 16. Other surgical or interventional procedures planned within 3 months that may require termination of study medication; 17. Those with a life expectancy of <3 months; 18. Who have participated in any other clinical trial within 3 months; 19. Other conditions that, in the opinion of the investigator, may affect compliance or make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mRS recovering to a score of 0-1 on day 90 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score on day 90 of treatment;Change from baseline in NIHSS score within day 1, 7 days, and 28 days of treatment;Proportion of early stroke progression within day 1 of treatment;Proportion of combined vascular events within 90 days of treatment;Incidence and severity of adverse events during treatment in each group;Changes in the indicators of laboratory tests in each group;Changes in vital signs before and after treatment in each group;Changes in physical examination before and after treatment in each group;Rate of symptomatic intracranial hemorrhage on day 28 of treatment in each group (Heidelberg hemorrhage staging);Incidence of any bleeding event in each group (GUSTO bleeding staging criteria);Vascular mortality by group;Overall mortality rate by group;Incidence of platelet counts =100×10^9 /L in each group; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed