Stroke AcutePhase 2ARTS-SAFENCT07423975
Advancing Reperfusion Therapy for Ischemic Stroke: Safety and Efficacy of Anakinra for Futile Reperfusion Following Endovascular Treatment in Patients With Acute Ischemic Stroke
A Phase 2 study testing High-dose Anakinra, Low-dose Anakinra and Standard medical treatment in people with Stroke Acute and Endovascular Treatment, run by Beijing Tiantan Hospital at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Acute, Endovascular Treatment
- What is being tested?
- High-dose Anakinra, Low-dose Anakinra and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 6 sitesChina
- Study dates
- 8 Apr 2026to 30 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing tiantan hospital
Beijing, Beijing Municipality, 100070
Yunyun Xiong, professor, 86-10-59978350, xiongyunyun@bjtth.org
- Recruiting
Linyi People's Hospital
Linyi, Shandong, 276003
Hao Wang, MD, 13518690201, neurology_hao@163.com
- Recruiting
Luoyang Yiluo Hospital
Luoyang, Henan
Yajun Yang, 0379-82888808, sqyyj7119@163.com
- Recruiting
People's Hospital of Queshan
Panlong, Henan
Jianxin Xu, 0396-7068021, 249957242@qq.com
- Recruiting
Puyang Oilfield General Hospital
Puyang, Henan
Yutie Zhao, 0393-4821096, 454981103@qq.com
- Recruiting
Weifang People's Hospital
Weifang, Shandong
Li Zhou, 963360, weifangzhou003@163.com
About this study
Official title: Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Safety and Efficacy of Anakinra for Futile Reperfusion Following Endovascular Treatment in Patients With Acute Ischemic Stroke (SAFE)
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.
Read the detailed description
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.
- Conditions
- Stroke Acute, Endovascular Treatment
- Being tested
- High-dose Anakinra, Low-dose Anakinra, Standard medical treatment
- Keywords
- acute ischemic stroke, endovascular treatment, successful recanalization, Anakinra
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Standard medical treatmentOther
Administration of standard medical treatment should be done according to routine clinical practice and current international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ischaemic lesion volume from baseline to 7±2 days or discharge from the hospital
Measured: 7±2 days or discharge from the hospital
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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
Measured: 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)
Measured: 36 hours
The rate of malignant stroke resulting in herniation or craniectomy within 7 days
Malignant stroke resulting in herniation or craniectomy within 7 days
Measured: 7 days
The proportion of all-cause mortality
All-cause mortality at 90 days
Measured: 90 days
The proportion of serious adverse events (SAEs)
Serious adverse events within 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start8 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Yunyun Xiong, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423975
- Sponsor's protocol ID
- 2025-B15
- Acronym
- ARTS-SAFE
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No