Acute ischemic stroke
Conditions
Interventions
Intervention group:100 Units (1 vial)/time/day fibrinogenase for injection were given for the first dose, and 300 Units (3 vials)/time/day once daily for later days, diluted in 250 mL of 0.9% sodium c
Control group:Placebo injection with the appearance consistent with that of fibrinogenase for injection, 1 vial/time/day for the first dose and 3 vials/time/day thereafter, diluted in 250 mL of 0.9% s
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years; 2. Clinically diagnosed with acute anterior circulation ischemic stroke; 3. Responsible occluded vessel located in the intracranial segment of the internal carotid artery, M1 or M2 segment of the middle cerebral artery; 4. Baseline NIHSS score before thrombectomy between 6-25 points; 5. Time from onset to arterial puncture within 24 hours; 6. Received mechanical thrombectomy, and successful recanalization after mechanical thrombectomy (eTICI 2b-3); 7. Study medication can be administered within 48 hours of onset; 8. Signed informed consent obtained from the patient or their legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Pre onset mRS score>=2 points; 2. Accept intravenous thrombolysis treatment or arterial thrombolysis treatment; 3. Perform emergency intracranial stent implantation surgery; 4. Head CT within 24 hours after thrombectomy confirms intracranial hemorrhage; During medication, dual antiplatelet therapy, oral anticoagulant therapy, or heparin drugs should be used; 6. Severe consciousness disorders, GCS1.7 or PT>15 seconds; 10. Acute bleeding tendency, presence of coagulation disorders, including platelet count less than 100 × 10 ^ ? or other diseases; 11. There has been gastrointestinal or urinary bleeding in the past 3 weeks; 12. Aortic arch dissection; 13. Patients with severe liver and kidney dysfunction, active pulmonary tuberculosis cavities, and peptic ulcers; The definition of severe liver dysfunction is ALT>3 times the upper limit of normal or AST>3 times the upper limit of normal; The definition of severe renal insufficiency is creatinine>2 times the upper limit of normal 14. Skin test positive for fibrinolytic enzyme drugs; 15. Pregnant or lactating women with positive pregnancy test results; 16. Have participated in other drugs or clinical trials within 30 days prior to randomization; 17. Due to mental illness, cognitive or emotional disorders, inability to understand and/or comply with research procedures and/or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional independence rate at 90 days after randomization (mRS score 0-2);Symptomatic intracranial hemorrhage (sICH) rate within 48 hours after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS score 0-1 at 90 days after randomization;Functional independence rate at 30 days after randomization (mRS score 0-2);Proportion of patients with mRS score 0-1 at 30 days after randomization;mRS score distribution at 90 days after randomization;mRS score distribution at 30 days after randomization;Neurological improvement rate (reduction of =4 points in NIHSS score from baseline to Day 8 after randomization);EQ-5D-5L score at 90 days after randomization;Composite vascular event rate within 90 days (recurrent ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death);All-cause mortality at 90 days;Any intracranial hemorrhage rate within 48 hours after randomization;All-cause mortality at 30 days;Drug-related adverse events during treatment;Death events during treatment: all-cause death, ischemic vascular death, hemorrhagic vascular death; | — |
Countries
China
Contacts
Public ContactHe Li
West China Hospital of Sichuan University
Outcome results
None listed