Advancing Reperfusion Therapy for Ischemic Stroke: Safety and Efficacy of Anakinra for Futile Reperfusion Following Endovascular Treatment in Patients With Acute Ischemic Stroke

Prior treatment

• Participation in other interventional clinical trials within the previous 3 months.

Other illness

• Allergy to Anakinra;
• NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate;
• Acute or past intracerebral hemorrhage (ICH) (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) confirmed by CT or MRI;
• History of malignancy other than basal cell carcinoma of the skin;
• History or evidence of active or latent tuberculosis infection, or presence of tuberculosis risk factors including but not limited to: close contact with active tuberculosis patients within the past 12 months;
• Any terminal illness such that the patient would not be expected to survive more than 1 year;
• Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;

Lab values

• Glomerular filtration rate (GFR) \<30 mL/min or serum creatinine level \>2.5 mg/dL;
• Neutropenia (ANC \<1.5 × 109/L);
• Known active or recurrent liver disease (including cirrhosis, hepatitis B and C; positive or indeterminate laboratory results), or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times ULN;

Other

• Unable to perform CTP or PWI;
• Multiple arterial occlusion (e.g., bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
• Suspected septic embolism or infective endocarditis;
• Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
• Unlikely to adhere to the trial protocol or follow-up;

• Age between 18-80 years old (both inclusive);
• Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
• Pre-stroke modified Rankin scale (mRS) score ≤1;
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive);
• Internal carotid artery (ICA) or middle cerebral artery (MCA) M1/M2 occlusions confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke;
• Successful recanalization (eTICI 2b50-3) after endovascular treatment;
• Written informed consent from patients or their legally authorized representatives.