1 Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
2 Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia.
Int J Stroke. 2017 Oct;12(8):906-909. doi: 10.1177/1747493017710340. Epub 2017 Jun 1.
Rationale In acute ischemic stroke patients with large vessel occlusion, although reperfusion within 6 h after stroke onset using combined intravenous alteplase and mechanical thrombectomy (bridging therapy) can improve functional outcome, still approximately 50% patients suffer disability which may result from reperfusion injury. Proof-of-concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in acute ischemic stroke patients as a single therapy beyond 4.5 h of disease onset, or in combination with alteplase within 4.5 h of disease onset. Aim To assess whether the treatment of fingolimod combined with bridging therapy in large vessel occlusion acute ischemic stroke patients is effective and safe. Design and sample size estimates Fingolimod with Alteplase bridging with Mechanical Thrombectomy in Acute Ischemic Stroke (FAMTAIS) study is a randomized, open-label, multiple central trial. This study includes 98 patients with anterior circulation large vessel occlusion acute ischemic stroke who are eligible for bridging therapy, providing 80% power to reject the null hypothesis that, combined with fingolimod, the bridging therapy has an at least 15% higher penumbra tissue salvage index than receiving bridging therapy alone. Study outcomes The primary outcome is the penumbra tissue salvage index. Key secondary outcomes focus on: infarct growth and extent of clinical improvement from day 1 to day 7, frequency of parenchymal hemorrhage at day 1. Discussion If the hypothesis of FAMTAIS is confirmed, combination of fingolimod with bridging therapy is effective in attenuating reperfusion injury in patients with large vessel occlusion treated with 6 h of stroke onset.
在发病 6 小时内接受溶栓联合机械取栓治疗（桥接治疗）的急性大动脉闭塞性脑梗死患者，其功能结局可以得到改善，但仍有约 50%的患者遗留残疾，这可能与再灌注损伤相关。临床前研究已经证实，鞘氨醇-1-磷酸受体调节剂芬戈莫德在发病超过 4.5 小时或发病 4.5 小时内与阿替普酶联合应用时，可减轻脑内炎症反应，改善急性脑梗死患者的临床结局。目的：评估鞘氨醇-1-磷酸受体调节剂芬戈莫德联合桥接治疗对发病 6 小时内的急性大动脉闭塞性脑梗死患者的有效性和安全性。设计和样本量估计：急性大动脉闭塞性脑梗死患者接受桥接治疗时联合使用芬戈莫德的疗效和安全性研究（FAMTAIS 研究）是一项多中心、随机、开放标签临床试验。该研究纳入了 98 例适合接受桥接治疗的前循环大动脉闭塞性急性脑梗死患者，该研究有 80%的把握度可以拒绝无效假设，即与桥接治疗相比，联合使用芬戈莫德可使半暗带组织挽救指数至少提高 15%。研究结局：主要结局是半暗带组织挽救指数。关键次要结局指标包括：梗死灶体积和第 1 天至第 7 天的临床改善程度、第 1 天实质内出血的发生率。讨论：如果 FAMTAIS 研究的假设得到证实，那么对于接受发病 6 小时内治疗的急性大动脉闭塞性脑梗死患者，使用芬戈莫德联合桥接治疗可以减轻再灌注损伤。
