NCT07423975

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Mar 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 14, 2026

Last Update Submit

February 14, 2026

Conditions

Stroke AcuteEndovascular Treatment

Keywords

acute ischemic strokeendovascular treatmentsuccessful recanalizationAnakinra

Outcome Measures

Primary Outcomes (1)

  • Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days

    5-7 days

Secondary Outcomes (12)

  • Ordinal distribution of modified Rankin Scale (mRS) at 90 days

    90 days

  • The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days

    90 days

  • The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days

    90 days

  • The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days

    90 days

  • The rate of early neurological improvement at 72 hours

    72 hours

  • +7 more secondary outcomes

Study Arms (3)

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.

Drug: High-dose Anakinra

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.

Drug: Low-dose Anakinra

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.

Other: Standard medical treatment

Interventions

High-dose AnakinraDRUG

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.

High-dose Anakinra+standard medical treatment
Low-dose AnakinraDRUG

100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days.

Low-dose Anakinra+standard medical treatment
Standard medical treatmentOTHER

Administration of standard medical treatment should be done according to routine clinical practice and current international guidelines.

Standard medical treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yunyun Xiong

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Xiong, professor

CONTACT

86-10-59978350xiongyunyun@bjtth.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

CN(1)