Acute ischemic stroke
Conditions
Interventions
Y-6 Sublingual Tablet Low Dose Group (25 mg/dose, bid):Y-6 Sublingual Tablet (25 mg/dose, bid)
Y-6 Sublingual Tablet High Dose Group (50 mg/dose, bid):Y-6 Sublingual Tablet (50 mg/dose, bid)
Cilostazol low dose group(25 mg/dose, bid):Cilostazol tablets (25 mg/dose, bid)
Cilostazol high dose group(50 mg/dose, bid):Cilostazol tablets (50 mg/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 and 80, Sex gender; 2) diagnosis of acute ischemic stroke within 24 hours of onset (onset of endovascular treatment); 3) first stroke or stroke (mRS 0-1 point); 4) acute intracranial large vessel occlusion confirmed by imaging, Including intracranial segment of internal carotid artery, T-shaped bifurcation, M1 and / or M2 segment of middle cerebral artery, and A1 and / or A2 segment occlusion of anterior cerebral artery; 5) ASPECTS 6 at screening; 6) after this onset, NUS Stroke Scale score: 6 <NIHSS 25 points; 7) patients who met the indications of reperfusion therapy for mechanical thrombectomy and planned for endovascular treatment; 8) voluntarily signed informed consent approved by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1) Severe consciousness disorder during screening: NIHSS 1a level of consciousness 2 points; 2) clear history of intracranial hemorrhage during screening: including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subdural / external hematoma; 3) clear diagnosis of intracranial tumor, intracranial arteriovenous malformation or aneurysm during screening; 4) clear diagnosis of bilateral anterior circulation or posterior circulation ischemic stroke during screening; 5) occlusion of rare or unknown etiology during screening: such as dissection, Vasculitis, etc.; 6) after the onset of tirofiban, warfarin, new oral anticoagulants, agatban, snake venom, descending inase, lummikinase and other descending fiber treatment, Or platelet count 3 times the upper normal limit or AST value> 3 times the upper normal limit; Severe renal insufficiency refers to blood creatinine> 3.0 mg/dl (265.2 µmol/L) or creatinine clearance 180 mmHg or diastolic BP> 110 mmHg); 10) significant history of head trauma or stroke within 1 month prior to randomization; 11) intracranial or intraspinal surgery within 3 months prior to randomization; 12) history of major surgical or severe physical trauma within 1 month prior to randomization; 13) to known hemorrhagic retinopathy; 14) male subjects (or their partner) or complete abstinence, condom, ligation, etc.) throughout the trial and during the 3 months after the study; 15) known contraindications of contrast or other contrast agents, Cilostazol and right; 16) other surgical procedures or interventional therapy planned within 3 months may require termination of trial drug; 17) any advanced life expectancy of <3 months; 18) patients receiving investigational drug or investigational instrument within 3 months; 19) other investigators who consider the subject otherwise compliant or inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomization 90±7 days Proportion of mRS recovering to a score of 0-1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Randomization 90±7 days mRS score;Randomization 24±2 hours, 7±2 days, 28+3 days Change from baseline in NIHSS score;Proportion of early stroke progression at 24±2 hours of randomization;Proportion of combined vascular events at 90±7 days of randomization; | — |
Countries
China
Contacts
Public ContactYilong Wang
Beijing Tiantan Hospital
Outcome results
None listed