Acute ischemic stroke
Conditions
Interventions
Y-6 Sublingual Tablet Group (1 tab/dose, BID):Y-6 Sublingual Tablet (1 tab/dose, BID)
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 =80 years, regardless of gender; 2) Diagnosis of acute ischemic stroke within 24 hours of onset (onset to completion of reperfusion therapy); 3) First stroke or before stroke onset (mRS 0-1 points); 4) Image-confirmed acute intracranial large vessel occlusion (LVO), including occlusion of the intracranial segment of the internal carotid artery, the T-bifurcation, the middle cerebral artery M1 and/or M2 segments, and the anterior cerebral artery A1 and/or A2 segments; 5) ASPECTS = 6; 6) National Institutes of Health Stroke Scale (NIHSS) score: 6 < NIHSS = 25 after the onset of the event; 7) Patients who meet the indications for reperfusion therapy, including mechanical thrombolysis, bridging therapy (thrombolysis with intravenous r-tPA), etc., and for whom mechanical thrombolysis is planned; 8) Patients or their legal representatives voluntarily signed an informed consent approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1) Severe impairment of consciousness: =2 on the NIHSS 1a level of consciousness; 2) a previous history of definite intracranial hemorrhagic disease: including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extracranial hematoma 3) intracranial tumors, intracranial arteriovenous malformations or aneurysms; 4) bilateral anterior or posterior circulation ischemic stroke; 5) large vessel occlusion of rare or unknown etiology: e.g., entrapment, vasculitis, etc; 6) Fiber-lowering therapy such as dual antiplatelet agents, tirofiban, warfarin, new oral anticoagulants, argatroban, snake venom, defibrinolytic enzymes, and earthworm kinase after the onset of the disease; 7) Severe hepatic insufficiency or renal insufficiency and those receiving dialysis for various reasons prior to randomization (severe hepatic insufficiency is defined as an ALT value >3 times the upper limit of normal or an AST value >3 times the upper limit of normal; severe renal insufficiency is defined as a blood creatinine of >3.0 mg/dl (265.2 µmol/L)) or a creatinine clearance of 180 mmHg or diastolic blood pressure >110 mmHg) that is difficult to control with medications; 10) History of significant head trauma or stroke within 3 months prior to randomization; 11) intracranial or intraspinal surgery within 3 months prior to randomization; 12) history of major surgery or severe physical trauma within 1 month prior to randomization; 13) immediate known hemorrhagic retinopathy; 14) male subjects (or their partners) or female subjects who plan 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, ligation, etc.) during the trial; 15) Those with known contraindications to contrast agents or other contrast agents, cilostazol, dexamethasone allergy; 16) other surgical or interventional procedures planned within 3 months that may require termination of the trial drug; 17) Advanced stage of any disease with a life expectancy of <6 months; 18) Patients who have received an experimental drug or instrument within 3 months; 19) Other conditions that make participation in this clinical study inappropriate, such as inability to understand and/or comply with study procedures and/or follow-up visits due to psychiatric disorders, cognitive or mood disorders, or contraindications to thrombolysis, nuclear magnetic resonance imaging, or other conditions that, in the opinion of the investigator, may affect compliance or make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the proportion of modified-Rankin scale (mRS) score recovered to 0~1 score at 90±7 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the modified-Rankin scale (mRS) score at 90±7 days after randomization;To investigate the integrity of BBB evaluated by DCE at 96±7 hours after randomization;To investigate the changes of NIHSS score between baseline and within 2 hours after reperfusion therapy;To examine the changes of NIHSS score between baseline and at 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days and 28 ± 3 days after randomization;To investigate the proportion of subjects with early progression of stroke at 24 ± 2 hours and 96 ± 7 hours after randomization;To investigate the proportion of subjects with combined vascular events at 90 ± 7 days after randomization; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed