acute ischemic stroke
Conditions
Interventions
Experimental group:Randomized to receive tirofiban with loading dose: 0.4 µg/kg/min intravenous micropump tirofiban for 30 minutes, and then continue at a rate of 0.1 µg/kg/min for 24 hours. Tirofiban
Control group:Guidelines recommended the best antiplatelet drug therapy after randomization.
Sponsors
The Second Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Acute ischemic stroke based on clinical symptoms or imaging examination; 3. Onset to randomization within one week; 4. NIHSS score >= 4 points before enrollment; 5. ASPECTS score > 6 points; 6. Signed written informed consent by the patient or family member.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage confirmed by CT or MRI of the head; 2. mRS score >= 2 points before onset; 3. Pregnant or lactating women; 4. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and antihypertensive drugs cannot be controlled; 5. Planned or have undergone endovascular treatment in the acute phase; 6. Glycoprotein IIb/IIIa receptor antagonists have been used before enrollment in this disease; 7. Cardiac stroke or underlying cardiogenic thrombosis with any of the following definite causes of cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valve, endocarditis, intracardiac thrombosis or implant, dilated cardiomyopathy, left atrial spontaneous acoustic development; 8. Blood glucose 22.2 mmol/L, platelet count 1.7; 10. History of bleeding (digestive and urinary system bleeding) in the past 1 month; 11. Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220 µmol/L); 12. Life expectancy < 6 months due to advanced disease; 13. Expected inability to complete follow-up; 14. Intracranial aneurysm, arteriovenous malformation; 15. Intracranial space-occupying lesions; 16. Allergy to tirofiban and contrast agents; 17. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mRS score 0-1 points;Incidence of symptomatic intracranial hemorrhage (SICH) within 48 hours after medication;90-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement in 90-day mRS score (shift analysis);90-day mRS score 0-2 points;90-day mRS score 0-3 points;Changes in NIHSS score 5-7 days after medication;90-day EQ-5D scale score;Incidence of asymptomatic intracranial hemorrhage (aSICH) within 48 hours;Incidence of non-intracranial hemorrhage complications (including gastrointestinal bleeding, urethral bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma, etc.);Incidence of non-hemorrhagic serious adverse events (including cerebral herniation, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, and psychiatric symptoms);Thrombocytopenia (defined as a platelet count of 90*10^9/L < re-checked blood routine within 48 hours after medication); | — |
Countries
China
Contacts
Public ContactYang Qingwu
The Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed