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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Participation in other interventional clinical trials within the previous 3 months.
研究组 & 干预措施
High-dose Anakinra+standard medical treatment
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.
干预措施: High-dose Anakinra (Drug)
Low-dose Anakinra+standard medical treatment
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.
干预措施: Low-dose Anakinra (Drug)
Standard medical treatment
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.
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Infarct core growth reduction via magnetic resonance imaging (MRI) at 5-7 days
时间窗: 5-7 days
次要结局
- 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)
- The median value of change in the National Institute of Health Stroke Scale (NIHSS) score at 7 days(7 days)
- The proportion of complete recanalization at 24 hours after randomization(24 hours)
- The proportion of improvement on reperfusion at 24 hours after randomization(24 hours)
- The proportion of symptomatic intracranial hemorrhage(36 hours)
- Malignant stroke resulting in herniation and craniectomy within 7 days(7 days)
- The proportion of all-cause mortality(90 days)
- The proportion of serious adverse events (SAEs)(90 days)
研究者
Yunyun Xiong
Professor
Beijing Tiantan Hospital