Rationale

Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear.

Aim

This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy.

Methods and design

This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy.

Study outcome

The primary efficacy endpoint is a modified Rankin Scale score of 0–2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h.

Discussion

This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities.

Trial registration

UMIN000021488.

中文翻译：

---

ICA和M1闭塞的急性卒中患者行血管内或不接受静脉内纤溶酶原激活剂的血管内治疗的随机研究（SKIP研究）

基本原理

据报道，采用血管内治疗（EVT）和静脉溶栓治疗（IVT）的桥接疗法可改善前循环大血管闭塞的急性卒中患者的预后。虽然IVT可能会增加再灌注率，但出血并发症的风险会增加。尚无IVT（直接EVT）的EVT与桥接治疗在急性卒中中是否同样有效尚不清楚。

目的

这项针对ICA和M1闭塞的急性卒中进行或不进行静脉内使用纤溶酶原激活剂的血管内治疗的随机研究旨在阐明与桥接治疗相比直接EVT的疗效和安全性。

方法与设计

这是研究者发起的，多中心，前瞻性，随机，开放治疗，盲目的临床试验。目标患者人数为200，其中包括100例接受直接EVT的患者和100例接受桥接疗法的患者。

研究成果

主要功效终点是在90天时改良的Rankin量表评分为0–2。安全预后指标是24小时内是否有颅内出血。

讨论

该试验可能有助于确定是否应建议在发病后4.5 h内将直接EVT推荐作为缺血性卒中患者的常规临床策略。然后，直接EVT将成为具有血管内设施的中风中心治疗的选择。

试用注册

UMIN000021488。