Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Intravenous administration of eptifibatide+Standard medical treatment
Control group:Intravenous administration of eptifibatide placebo+Standard medical 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. Preliminary diagnosis as acute ischemic stroke based on clinical symptoms or imaging examinations; 3. Confirmed as intracranial non-large vessel occlusive stroke by CTA/MRA/DSA; 4. ASPSECTS or PC-ASPECTS score on CT/MRI > 6; 5. Agreed and received intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours from last known well; 6. Still experiencing disabling stroke 4 hours after intravenous thrombolysis (definition of disabling stroke: NIHSS score >= 5); 7. Post-thrombolysis cranial imaging excludes intracranial hemorrhage; 8. Randomization occurs within 24 hours from the completion of intravenous thrombolysis; 9. The patient or the family member have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received or are scheduled to receive endovascular treatment; 2. Confirmed intracranial hemorrhage by cranial CT or MRI; 3. Pre-stroke mRS score >= 2; 4. Pregnant or lactating women; 5. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and antihypertensive medication is unable to control it; 6. Cerebral embolism or potential cerebral thrombus, with any of the following clear causes of cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, left atrial spontaneous echo contrast; 7. Genetic or acquired bleeding constitution, deficiency of anticoagulant factors; or current use of anticoagulant drugs with INR > 1.7; 8. Blood glucose 22.2 mmol/L, platelets 220 µmol/L) patients; 11. Severe liver function impairment, ALT > 3 times the upper limit of normal or AST > 3 times the upper limit of normal; 12. Any disease in the advanced stage with an expected life expectancy of < 6 months; 13. Expected not to be able to complete follow-up; 14. Intracranial aneurysm, arteriovenous malformation; 15. Brain tumors with a space-occupying effect on imaging; 16. Allergic to eptifibatide and contrast agents; 17. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score 0-1 at 90 days (%) ;The incidence of symptomatic intracranial hemorrhage within 48 hours after treatment ;90-day mortality ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Outcome Analaysis;COSMOS score;mRS score 0-2 at 90 days (%) ;mRS score shift analysis at 90 days;NIHSS score at 5-7 days or discharge if earlier;90-day EQ-5D scale score;The incidence of asymptomatic intracranial hemorrhage within 48 hours after treatment ;The incidence rate of non-intracranial hemorrhage complications ;The incidence rate of non-hemorrhagic serious adverse events ;Thrombocytopenia ; | — |
Countries
China
Contacts
Public ContactYangmei Chen; Wenjie Zi
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed