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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose Anakinra+standard medical treatment | Experimental | 100 mg loading dose Anakinra over 60 seconds within 0.5 hours after randomization, followed by consecutive 2mg/kg/h infusions over 24 hours. Standard treatment strategy will be in the discretion of site investigators according to guidelines. |
|
| Low-dose Anakinra+standard medical treatment | Experimental | 100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days. Standard treatment strategy will be in the discretion of site investigators according to guidelines. |
|
| Standard medical treatment | Other | All enrolled patients receive standard early management and secondary prevention treatment according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Anakinra | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days | 5-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunyun Xiong, professor | Contact | 86-10-59978350 | xiongyunyun@bjtth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yunyun Xiong | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tiantan hospital | Beijing | Beijing Municipality | 100070 | China |
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| Low-dose Anakinra | Drug | 100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days. |
|
| Standard medical treatment | Other | Administration of standard medical treatment should be done according to routine clinical practice and current international guidelines. |
|
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. |
| 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. | 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. | 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. | 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. | 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]). | 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 | 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) | 36 hours |
| Malignant stroke resulting in herniation and craniectomy within 7 days | Malignant stroke resulting in herniation and craniectomy within 7 days | 7 days |
| The proportion of all-cause mortality | All-cause mortality at 90 days | 90 days |
| The proportion of serious adverse events (SAEs) | Serious adverse events within 90 days | 90 days |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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