Anakinra After Endovascular Therapy for Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, PROBE trial compares high-dose Anakinra, low-dose Anakinra, and standard care in adults who had acute ischemic stroke and achieved successful recanalization after thrombectomy. Participants must be within 24 hours of symptom onset, have ICA or MCA M1/M2 occlusions, NIHSS 6-25, and pre-stroke mRS ≤1. The primary outcome is infarct core growth measured by MRI at 5-7 days. The study aims to determine safety and potential efficacy of Anakinra as an adjunct after reperfusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Unable to perform CTP or PWI;
* Acute or past intracerebral hemorrhage (ICH) (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma) confirmed by CT or MRI;
* Multiple arterial occlusion (e.g., bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
* Glomerular filtration rate (GFR) \<30 mL/min or serum creatinine level \>2.5 mg/dL;
* Suspected septic embolism or infective endocarditis;
* 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;
* 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;
* 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;
* 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;
* Participation in other interventional clinical trials within the previous 3 months.

Where it's running

• Beijing tiantan hospital
  Beijing, Beijing Municipality, China Recruiting
• Luoyang Yiluo Hospital
  Luoyang, Henan, China Recruiting
• People's Hospital of Queshan
  Panlong, Henan, China Recruiting
• Puyang Oilfield General Hospital
  Puyang, Henan, China Recruiting
• Linyi People's Hospital
  Linyi, Shandong, China Recruiting
• Weifang People's Hospital
  Weifang, Shandong, China Recruiting

Study contacts

• Principal investigator: Yunyun Xiong — Beijing Tiantan Hospital
• Study coordinator: Yunyun Xiong, professor
• Email: xiongyunyun@bjtth.org
• Phone: 86-10-59978350

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.