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Efficacy and safety of ultrasound microbubble combined with drugs in the treatment of acute ischemic large vascular occlusive stroke

Efficacy and safety of ultrasound microbubble combined with drugs in the treatment of acute ischemic large vascular occlusive stroke

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092271
Enrollment
Unknown
Registered
2024-11-13
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Sponsors

Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

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

MeasureTime 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

MeasureTime 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

Public ContactQingwu Yang

The Second Affiliated Hospital, Army Medical Unive

yangqwmlys@hotmail.com+86 136 5763 8868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026