• Kentaro Suzuki, Kazumi Kimura, Masataka Takeuchi, Masafumi Morimoto, Ryuzaburo Kanazawa, Yuki Kamiya, Keigo Shigeta, Norihiro Ishii, Yohei Takayama, Yorio Koguchi, Tomoji Takigawa, Mikito Hayakawa, Takahiro Ota, Seiji Okubo, Hiromichi Naito, Kazunori Akaji, Noriyuki Kato, Masato Inoue, Teruyuki Hirano, Kazunori Miki, Toshihiro Ueda, Yasuyuki Iguchi, Shigeru Fujimoto, Toshiaki Otsuka, and Yuji Matsumaru.
• Department of Neurology, Nippon Medical School, Tokyo, Japan.
• Int J Stroke. 2019 Oct 1; 14 (7): 752-755.

RationaleBridging 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.AimThis 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 DesignThis 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 OutcomeThe 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.DiscussionThis 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 RegistrationUMIN000021488.

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