Yang Bin, Bai Xuesong, Yi Tingyu, Wang Haibo, Liu Yifeng, Ma Lin, Liu Sheng, Wu Shaoguang, Zhang Liyong, Peng Ya, Nogueira Raul G, Chen Wenhuo, Jiao Liqun
Department of Neurosurgery, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China.
Department of Neurointervention, Zhangzhou Municipal Hospital, Zhangzhou, China.
Int J Stroke. 2025 Jan 23:17474930251313940. doi: 10.1177/17474930251313940.
The Chemical Optimization of Cerebral Embolectomy (CHOICE) trial suggested that the administration of intra-arterial alteplase after successful endovascular thrombectomy (EVT) may improve neurological outcomes in patients with acute ischemic stroke due to large-vessel occlusion (AIS-LVO) in the anterior circulation. However, the use of adjunctive intra-arterial alteplase following successful EVT in acute posterior circulation stroke remains unexplored.
This study aims to investigate the efficacy and safety of intra-arterial alteplase after successful EVT for AIS-LVO in the posterior circulation.
To detect an estimated 15% difference in the primary outcome between the two groups, a total of 376 patients will be enrolled. This sample size allows for 80% power and a 5% significance level, with an interim analysis planned after half of the sample (188 patients) has completed a 90-day follow-up.
The Intra-arterial Alteplase Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke in the Posterior Circulation (IAT-TOP) trial is a multicenter, prospective, randomized clinical trial using an open-label treatment design with blinded endpoint assessment (PROBE) conducted in China. Patients with acute basilar artery occlusion will be randomly assigned in a 1:1 ratio to receive either intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) or standard care following successful thrombectomy (defined as expanded thrombolysis in cerebral infarction [eTICI] ⩾ 2b50).
The primary outcome is the modified Rankin Scale (mRS) score of 0-2 at 90 days. Key secondary outcomes include changes in eTICI scores after intra-arterial thrombolysis (in the experimental group), mRS 0-3 at 90 days, ordinal shift analysis of mRS at 90 days, early neurological improvement at 48 h, and improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 48 h and 7 days or discharge. Safety outcomes include symptomatic intracranial hemorrhage (sICH) rates at 48 h, 90-day mortality, non-intracranial hemorrhagic complications, and non-hemorrhagic serious adverse events.
The IAT-TOP trial will provide crucial evidence regarding the potential benefits of adjunctive intra-arterial alteplase in patients with AIS-LVO in the posterior circulation following successful thrombectomy.
ClinicalTrials.gov NCT05897554.
脑动脉取栓术的化学优化（CHOICE）试验表明，成功进行血管内血栓切除术（EVT）后给予动脉内阿替普酶可能改善前循环大血管闭塞性急性缺血性卒中（AIS-LVO）患者的神经功能结局。然而，在急性后循环卒中成功进行EVT后使用辅助动脉内阿替普酶的情况仍未得到探索。
本研究旨在探讨成功进行EVT后动脉内阿替普酶治疗后循环AIS-LVO的疗效和安全性。
为检测两组主要结局估计15%的差异，将共纳入376例患者。该样本量具有80%的检验效能和5%的显著性水平，计划在一半样本（188例患者）完成90天随访后进行中期分析。
后循环急性缺血性卒中成功血栓切除术后动脉内阿替普酶溶栓（IAT-TOP）试验是一项在中国进行的多中心、前瞻性、随机临床试验，采用开放标签治疗设计和盲法终点评估（PROBE）。急性基底动脉闭塞患者将按1:1比例随机分配，在成功血栓切除术后（定义为脑梗死扩展溶栓[eTICI]⩾2b50）接受动脉内阿替普酶（0.225mg/kg；最大剂量22.5mg）或标准治疗。
主要结局是90天时改良Rankin量表（mRS）评分为0-2分。关键次要结局包括动脉内溶栓后（实验组）eTICI评分的变化、90天时mRS 0-3分、90天时mRS的序贯移位分析、48小时时早期神经功能改善以及48小时、7天或出院时美国国立卫生研究院卒中量表（NIHSS）评分的改善。安全性结局包括48小时时症状性颅内出血（sICH）发生率、90天死亡率、非颅内出血并发症以及非出血性严重不良事件。
IAT-TOP试验将为辅助动脉内阿替普酶对后循环AIS-LVO患者成功血栓切除术后潜在益处提供关键证据。
ClinicalTrials.gov NCT05897554。
