The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to explore the safety and efficacy of different dose of Anakinra compared to standard medical care for patients with acute ischemic stroke who have achieved successful recanalization after endovascular thrombectomy.
Adult acute ischemic stroke patients who have achieved successful recanalization (defined as expanded thrombolysis in cerebral infarction \[eTICI\] 2b50-3) after endovascular thrombectomy within 24 hours of symptom onset will be enrolled in this trial. The enrolled patients have stroke due to Internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 occlusions confirmed by CTA/MRA and with baseline National Institutes of Health Stroke Scale (NIHSS) score of 6-25. The eligible patients will be randomly assigned to receive high-dose Anakinra, low-dose Anakinra or standard medical treatment. The primary outcome is Infarct core growth reduction via MRI at 5-7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
159
100 mg loading dose Anakinra over 60 seconds within 0.5 hours after randomization, followed by consecutive 2 mg/kg/h infusions over 24 hours.
100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days.
Administration of standard medical treatment should be done according to routine clinical practice and current international guidelines.
Beijing tiantan hospital
Beijing, Beijing Municipality, China
Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days
Time frame: 5-7 days
Ordinal distribution of modified Rankin Scale (mRS) at 90 days
Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days
The proportion of patients with an mRS score of 5-6 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Time frame: 90 days
The rate of early neurological improvement at 72 hours
The rate of early neurological improvement at 72 hours after randomization (defined as a National Institute of Health Stroke Scale \[NIHSS\] score ≤1 or ≥8 points improvement compared with the baseline). NIHSS is scores range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 72 hours
The median value of change in the National Institute of Health Stroke Scale (NIHSS) score at 7 days
The median value of change in the National Institute of Health Stroke Scale (NIHSS) score at 7 days. NIHSS is scores range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 7 days
The proportion of complete recanalization at 24 hours after randomization
Complete recanalization is defined as an Arterial Occlusion Lesion scale \[AOL\] score of 3 (scale range, 0 \[no recanalization\] to 3 \[complete recanalization\]).
Time frame: 24 hours
The proportion of improvement on reperfusion at 24 hours after randomization
Improvement on reperfusion is defined as \>90% reduction in Tmax \> 6s lesion volume
Time frame: 24 hours
The proportion of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36 hours (as defined by Safe Implementation of Thrombolysis in Stroke Monitoring Study \[SITS-MOST\] criteria)
Time frame: 36 hours
Malignant stroke resulting in herniation and craniectomy within 7 days
Malignant stroke resulting in herniation and craniectomy within 7 days
Time frame: 7 days
The proportion of all-cause mortality
All-cause mortality at 90 days
Time frame: 90 days
The proportion of serious adverse events (SAEs)
Serious adverse events within 90 days
Time frame: 90 days
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