NCT07423975

Advancing Reperfusion Therapy for Ischemic Stroke: Safety and Efficacy of Anakinra for Futile Reperfusion Following Endovascular Treatment in Patients With Acute Ischemic Stroke

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	High-dose Anakinra	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.
DRUG	Low-dose Anakinra	100 mg subcutaneous Anakinra over 60 seconds within 0.5 hours after randomization, followed by 100 mg administered twice daily for 3 days.
OTHER	Standard medical treatment	Administration of standard medical treatment should be done according to routine clinical practice and current international guidelines.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China