Acute Large-Vessel Occlusive Stroke
Conditions
Interventions
Bevifibatide treatment group:bevifibatide citrate injection
Sponsors
The First Affiliated Hospital of University of South China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients must be at least 18 years old. Those over 80 years old are required to have a pre-stroke mRS score of 0–1. 2) Acute ischemic stroke within 24 hours of symptom onset. 3) Baseline NIHSS score of <= 25. 4) CTA/MRA/DSA confirms occlusion of the internal carotid artery, M1 segment of the middle cerebral artery, vertebral-basilar artery. 5) During endovascular thrombectomy, DSA imaging confirms large artery atherosclerotic disease or arterial dissection, and the operator determines that antiplatelet aggregation therapy is required during the procedure. 6) The patient or their family member must sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Intracranial hemorrhage confirmed by CT or MRI. 2) Baseline ASPECTS score of 0–2 or infarct core volume >= 100 ml. 3) Baseline imaging showing significant mass effect such as disappearance of the ventricles, midline shift, or herniation. 4) Tortuous vessels with anticipated inability of the thrombectomy device to reach the occlusion site. 5) Presence of atrial fibrillation, valvular heart disease, ventricular aneurysm, myocardial infarction within 3 months of symptom onset, severe heart failure, or other conditions that can support the diagnosis of cardioembolic stroke. 6) Any of the following laboratory findings: INR (International Normalized Ratio) >2.0, PT (Prothrombin Time) >1.3 times the normal value, platelet count <100×10^9/L, Hb (hemoglobin level) <10 g/dl. 7) Underwent any major surgical procedure within 6 weeks prior to stroke onset. 8) History of bleeding disorders, severe cardiac, hepatic, or renal disease, or sepsis. 9) Currently participating in another drug clinical trial. 10) Terminal illness with an expected survival of <6 months. 11) Contraindications for the use of bevifibatide citrate injection. 12) Other conditions that are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours;A favorable functional outcome at 90 days after onset, defined as a modified Rankin Scale (mRS) score of 0–2.; | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality at 90 days after onset;The proportion of patients with a mRS score of 0-3 at 90 days after onset;The rate of successful reperfusion on the last DSA angiography (defined as an eTICI score of =2b);The proportion of patients with a mRS score of 0-1 at 90 days after onset;The proportion of patients with a mRS score of 0-2 at 90 days after onset;Time from puncture to recanalization or procedure termination;Incidence of any intracranial hemorrhage (ICH) within 48 hours; | — |
Countries
China
Contacts
Public ContactRuan Zhongfan
The First Affiliated Hospital of University of South China
Outcome results
None listed