Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Intravenous eptifibatide plus oral aspirin/clopidogrel placebo treatment
Control group:Intravenous eptifibatide placebo plus oral aspirin/clopidogrel treatment
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old; 2)The time of arrival at the hospital is within 24 hours from the last known normal time; 3) Confirmed as intracranial non-large vessel occlusive stroke by CTA/MRA/DSA, and endovascular treatment is not planned; 4)NIHSS score of 6 on CT/MRI; 6) Signed written informed consent by the patient or family member.
Exclusion criteria
Exclusion criteria: 1) Intracranial hemorrhage confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI); 2) Pre-morbid modified Rankin Scale (mRS) score >=2; 3) Pregnant or lactating women; 4) Allergy or allergic predisposition to eptifibatide, contrast agents, aspirin, and clopidogrel, or patients with contraindications to the aforementioned medications; 5) Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with oral antihypertensive medications; 6) Hereditary or acquired hemorrhagic diathesis, deficiency of anticoagulation factors; or patients already on oral anticoagulants with INR >1.7; 7) Blood glucose 22.2 mmol/L (400 mg/dL), platelets 3 times upper limit of normal or AST >3 times upper limit of normal; chronic hemodialysis and severe renal impairment (glomerular filtration rate 220 µmol/L (2.5 mg/dL)); 10) Non-atherosclerotic lesions, including: arterial dissection, moyamoya disease, vasculitis, herpes zoster, varicella-zoster or other viral vasculopathy, neurosyphilis, any other intracranial infection, any vascular stenosis associated with cerebrospinal fluid pleocytosis, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign cerebrovascular disease of the central nervous system, postpartum angiopathy, suspected vasospasm, suspected thrombus recanalization; 11) Cardioembolic stroke or potential cardioembolic thromboembolism with any of the following definitive cardioembolic sources: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, left atrial spontaneous echo contrast; 12) History of any brain parenchymal or other intracranial subarachnoid, subdural, or epidural hemorrhage within the past 30 days; 13) Myocardial infarction within the past 30 days; 14) Planned major surgery within 90 days (including open femoral artery, aortic, carotid, subclavian, or intracranial artery bypass grafting, etc.) and cerebral angioplasty (balloon or stent placement); 15) Ejection fraction <40%, dysfunction of vital organs such as heart and lungs; 16) Current severe alcohol dependence or drug abuse; 17) Any terminal illness with expected life expectancy <6 months; 18) Expected inability to complete follow-up; 19) Intracranial aneurysm or arteriovenous malformation; 20) Brain tumor with mass effect on imaging; 21) Currently participating in other clinical trials that may affect study results or previously enrolled in this study; 22) Intravenous thrombolysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score 0 at 90 days (%) ;The incidence of symptomatic intracranial hemorrhage within 48 hours;90-day mortality ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Outcome Analaysis;COSMOS score;mRS score 0-1 at 90 days;mRS score shift analysis at 90 days;mRS score 0-2 at 90 days;NIHSS score at 5-7 days or discharge if earlier;90-day EQ-5D scale score;Major adverse cardiovascular and cerebrovascular events within 90 days (newly onset stroke, myocardial infarction, and cardiovascular-related mortality);Newly diagnosed stroke within 90 days (including ischemic and hemorrhagic);Newly onset acute ischemic stroke within 90 days;Newly onset hemorrhagic stroke within 90 days;Newly Diagnosed Myocardial Infarction Within 90 Days;Cardiovascular mortality rate within 90 days;Major cardiovascular and cerebrovascular adverse events within one year (newly onset stroke, myocardial infarction, cardiovascular-related mortality);The incidence of asymptomatic intracranial hemorrhage within 48 hours;Systemic Bleeding During Hospitalization (GUSTO Classification);Thrombocytopenia; | — |
Countries
China
Contacts
Public ContactYangmei Chen; Wenjie Zi
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed