Acute ischemic stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age =18 years old; (2) within 24 hours of onset; (3) Acute ischemic stroke according to clinical symptoms or imaging examination; (4) mRS Score was 3-5, or NIHSS score =5 after onset. (5) CTA/MRA/DSA proved to be large vascular occlusive stroke. (Remarks: Great vessels were defined as ICA, vertebral artery (VA) segments V1-V4, basilar artery (BA), posterior cerebral artery (PCA) segment P1, anterior cerebral artery (ACA) segment A1, MCA M1, M2, including extracranial and intracranial segments); (6) Choose intravenous thrombolytic drug therapy or antiplatelet drug therapy; (7) Written informed consent signed by the patient or his family.
Exclusion criteria
Exclusion criteria: (1) Pre-onset mRS Score =2 points; (2) Pregnant or lactating women; (3) A history of intracranial hemorrhage or previous cerebral hemorrhage confirmed by CT or MRI; (4) Patients with allergies or allergies to ultrasonic microvesicles, clopidogrel, aspirin, alteplase, etc., and contraindications to the use of these drugs; (5) Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and oral antihypertensive drugs can not control; (6) Genetics or acquired bleeding constitution, lack of anticoagulation factors; Or have taken oral anticoagulants with INR>1.7; (7) Random blood glucose 22.2mmol/L (400mg/dl), platelets 3 times the upper limit of normal or AST > 3 times the upper limit of normal; Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220µmol/L (2.5mg/dl)); (10) Large vascular lesions not caused by atherosclerotic lesions, including: Arterial dissection, Moya-moya disease, vasculitis disease, herpes zoster, varicella zoster or other viral vascular disease, neurosyphilis, any other intracranial infection, any vascular stenosis associated with the proliferation of cerebrospinal fluid cells, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign vascular disease of the central nervous system, birth Postvascular disease, suspected vasospasm, suspected embolus recanalization; (11) Cardiogenic stroke or potential cardiogenic thrombosis, with any of the following definite causes of cardiac embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valves, endocarditis, intracardiac thrombosis or implants, dilated cardiomyopathy, left atrial spontaneous acoustic imaging; (12) History of parenchyma or other intracranial subarachnoid, subdural or epidural blood within the last 30 days; (13) myocardial infarction within the last 30 days; (14) Major surgery (including open femoral artery, aorta, carotid artery, subclavian artery or intracranial artery bypass surgery, etc.) and cerebrovascular angioplasty (balloon or stent implantation) scheduled within 90 days; (15) The heart, lungs and other important organs are not fully functional; (16) There is currently significant alcohol dependence or drug abuse; (17) Alzheimer's disease or mental illness interferes with reliable adherence to the follow-up plan; (18) Life expectancy of <6 months due to the advanced stage of any disease; (19) The follow-up is not expected to be completed; (20) Intracranial aneurysm, arteriovenous malformation; (21) Imaging of brain tumors with space-occupying effects. (22) Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients with excellent functional outcome, defined as a mRS score of 0 to 2 at 90 days after randomization.;Incidence of symptomatic intracranial hemorrhage within 48 hours after treatment.;mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 day mRS score 0-1 points (%);90 day mRS score;Changes in NIHSS score 24hours and 5-7 days after treatment;90 day EQ-5D-5L scale rating; | — |
Countries
CHINA
Contacts
The Second Affiliated Hospital, Army Medical Unive