Ischemic stroke
Conditions
Interventions
experimental group:Intravenous injection of cyclosporine A before mechanical thrombectomy (Using the cyclosporine A solution of 250mg/5ml, Prepare injection as required 2.0mg/kg, i.e. 0.04ml/kg.)
control group:Intravenous injection of normal saline before mechanical thrombectomy (Use 0.9% sodium chloride solution and inject as per 0.04ml/kg).
Sponsors
Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-85 years; 2. Patients whose clinical symptoms and imaging diagnosis are consistent with acute ischemic stroke of anterior circulation; 3. Patients whose time from onset to arrival is between 4.5 and 12 hours (including those with sleep stroke and unclear specific onset time, the onset time is defined as the time when patients have cerebral infarction symptoms. If the onset time is not clear, the onset time is defined as the time before the onset of the disease when the patients have clear disease yet); 4. Patients with NIHSS > 5 (within one hour after admission); 5. Patients with pre-onset Mrs (modified Rankin scale) score = 1.8 and mismatch area volume > / = 15 ml.
Exclusion criteria
Exclusion criteria: 1. Lactating or pregnant women; 2. Patients with rapid improvement of neurological function or evidence of vascular recanalization before randomization; 3. It is difficult to analyze the patient's condition objectively because of the defects of psychiatry or nervous system; 4. Patients with known contraindications of cyclosporine A or history of cyclosporine A allergy, ricinus oil or polyoxyethylene allergy, and sensitivity to contrast medium, nickel and titanium; 5. Patients with uncontrollable abnormal blood glucose 22.0mmol/l (400mg / dl); 6. Patients with uncontrollable refractory hypertension (systolic blood pressure >= 185mmhg or diastolic blood pressure >= 110mmhg); 7. Patients with severe renal dysfunction: serum creatinine >= 133 µ mol / L, or patients who reported that they needed hemodialysis or peritoneal dialysis; 8. Patients with known liver diseases; 9. Patients with cardiogenic shock (systolic blood pressure 3 or prothrombin time > 3 times of normal level; or platelets < 40 x 10 ^ 9 / L; if new oral anticoagulants are taken within 48 hours, normal prothrombin time is required); 13. Patients with basic hemoglobin < 7 mmol / L; 14. Patients who are taking St. John's wort, stiripentol, bosentan, rosuvastatin or receiving sulfonylurea or nicorandil; 15. Patients who have received any intravenous thrombolysis or intra-arterial treatment since the onset of the disease; 16. Patients with immunosuppressive history in the past 6 months: self-reported tumor, lymphoma, hepatitis B, HIV positive serum test, etc; 17. Patients with a history of ischemic or hemorrhagic stroke in the past 3 months; 18. Patients with major operation or severe head injury in recent 3 months; 19. Patients with bleeding history or active bleeding in the past 30 days; 20. Patients who have participated in other clinical studies in the past 30 days; 21. Patients who received cyclosporine a treatment in the past 10 days; 22. Patients who use a stent retriever, a dedicated aspiration catheter or a combination of stent and aspiration; 23. Patients using intra-arterial thrombolysis; 24. Patients without pulsation of femoral artery; 25. Patients with life expectancy less than 90 days; 26. Patients who are homeless or have difficulty in long-term follow-up; 27. Imaging exclusion criteria: (1) Intracranial hemorrhage on CT; (2) Brain CT or MRI showed intracranial tumors (except for small meningiomas); (3) CT or MRI of the head showed significant space occupying effect leading to midline displacement; (4) CTA or MRA of the head or history suggest cerebral vasculitis or aortic dissection; (5) CTA or MRA of the head indicated occlusion of multiple blood vessels (bilateral anterior circulation or anterior circulation / vertebrobasilar system), or clinical evidence showed bilateral or multiple stroke; (6) CTA images showed that the patients were not suitable for thrombectomy, including the extreme tortuosity of blood vessels, which made it difficult to reach the lesion; (7) Carotid stent implantation may be necessary for dissection or thrombectomy due to high stenosis or occlusion of carotid artery; (8) Stent implantati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral infarction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume of newly discovered low density lesion;Patency of blood vessels at the operation site;Conversion rate of hematoma type haemorrhage;Conversion rate of PH-2 cerebral hemorrhage;Conversion rate of hematoma type haemorrhage;Conversion rate of PH-2 cerebral hemorrhage;Modified Rankin Score (mRS);National Institutes of Health Stroke Scale score (NIHSS);Modified Rankin Score (mRS);EQ-5D quality of life score;PHQ-4depression screening scale score;GAD-7 anxiety screening scale score;Recurrent ischemic stroke;Occurrence of serious adverse events;Death;Anaphylaxis;Acute renal damage;Hypertension crisis;Changes of blood routine and liver and kidney function;Glomerular filtration rate;Gastrointestinal reactions such as anorexia, nausea and vomiting.;Gingival hyperplasia with bleeding and pain;Seriously infect; | — |
Countries
China
Contacts
Public ContactJian-Ren Liu
Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed