Acute ischemic stroke
Conditions
Interventions
Experimental group:Tirofiban+Standard medical treatment
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old. 2. Preliminary diagnosis based on clinical symptoms or imaging examination indicates acute ischemic stroke. 3. Confirmed by cranial CT angiography (CTA)/magnetic resonance angiography (MRA)/digital subtraction angiography (DSA) as non-large vessel occlusive stroke within the cranium (large vessel occlusive stroke is defined as occlusion in the intracranial segment of the internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, and P1-P3 segments of the posterior cerebral artery). 4. Agreed and received intravenous alteplase or tenecteplase thrombolysis within 4.5 hours from symptom onset. 5. Still experiencing disabling stroke (disabling stroke is defined as NIHSS score > 5) 2 hours after the completion of intravenous thrombolysis. 6. Post-thrombolysis cranial imaging excludes intracranial hemorrhage. 7. Randomization occurs within 24 hours from the completion of intravenous thrombolysis. 8. Patient or family members have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Confirmed intracranial hemorrhage by cranial CT or MRI. 2. Pre-stroke mRS score = 2. 3. Pregnant or lactating women. 4. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and antihypertensive medication is unable to control it. 5. Cardiogenic stroke or potential cardiogenic thrombus with any of the following established 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. 6. Genetic or acquired bleeding disorders, deficiencies of anticoagulant factors, or current use of anticoagulant drugs with INR > 1.7. 7. Blood glucose 22.2 mmol/L, platelet count 220 µmol/L) patients. 10. Any disease with a life expectancy of < 6 months. 11. Anticipated inability to complete follow-up. 12. Intracranial aneurysm, arteriovenous malformation. 13. Intracranial space-occupying lesions. 14. Allergy to tirofiban or contrast agents. 15. Currently participating in another 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 after tirofiban administration.;mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Outcome Score;90 day mRS score 0-2 points (%);90 day mRS score shift analysis;Changes in NIHSS score 5-7 days after medication;90 day EQ-5D scale rating;The incidence of asymptomatic intracranial hemorrhage (aSICH) within 48 hours after use of tirofiban;The incidence of non intracranial hemorrhage complications CNKI;Thrombocytopenia; | — |
Countries
China
Contacts
Public ContactYang Qingwu
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed