Acute ischemic stroke
Conditions
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older; 2.Any of the following presentations of AIS: (1) Within 24 hours of time last known well and ineligible for IVT or EVT. (2) More than 24 hours and less than 96 hours after time last known well but within 24 hours of ischemic stroke progression [worsening of >= 2 points on the National Institutes of Health Stroke Scale (NIHSS]; and ineligible for IVT or EVT. (3) Treated with IVT followed by early neurological deterioration (worse NIHSS by >= 4 points) within the first 24 hours after IVT. (4) Treated with IVT followed by no neurological improvement (decrease in the NIHSS score by = 5 immediately prior to trial entry, including at least one limb with NIHSS motor item score 2-4. 4.Without visible large or medium intracranial vessel occlusion on CT angiography, MR angiography, or digital subtraction angiography. (Qualifying mechanisms are: a) hypoperfusion caused by arterial stenosis; b) the initial occluded large or medium artery spontaneously recanalized or recanalized with IV tPA before the vascular imaging performed; c) multiple or single distal emboli from cardiac or other sources not in arterial branches too small to visualized on CTA or MRA; d) lacunar infarct due to small vessel occlusion); 5.Written informed consent obtained from patients or their legal representatives.
Exclusion criteria
Exclusion criteria: 1. CT or MR evidence of hemorrhage; 2. Pre-morbid disability with a pre-stroke modified Rankin scale (mRS) >= 2; 3. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%; 4. Planned treatment with dual antiplatelet therapy within 1week of the index stroke; 5. Any history of a primary intracerebral (parenchymal) hemorrhage; 6. Any history of other intracranial hemorrhage (subarachnoid, subdural, epidural); 7. Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation; 8. Major systemic hemorrhage within 30 days; 9. Active bleeding diathesis, including clinical laboratory evidence of coagulation abnormalities (platelet count 50 seconds or international normalized ratio > 1.7), or treatment with a direct oral anticoagulant within the prior 48h; 10. Any major surgery within 14 days of the index stroke; 11. Systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits; 12. Severe renal insufficiency (glomerular filtration rate 220 µmol/L [2.5 mg/dl]); 13. Known allergy or contraindication to tirofiban or aspirin; 14. Currently pregnant or lactating; 15. Any intracranial tumor (except small meningioma); 16. Any terminal illness with life expectancy less than 6 months; 17. Preexisting neurological or psychiatric disease that would confound the neurological functional outcome evaluations; 18. Unlikely to be available for 90-day follow-up; 19. Current participation in another treatment clinical trial.
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 1 at 90 days after randomization.;Incidence of symptomatic intracranial hemorrhage within 48 hours;mortality at 90 days; | — |
Countries
China
Contacts
Public ContactYang Qingwu
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed