Intra-Arterial thrombolysis after SUCCESSful angiographic recanalization in acute large-vessel occlusion stroke of the anterior circulation (IA-SUCCESS): a multicentre, randomised, clinical trial protocol.
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Gory Benjamin, Richard Sébastien, Pop Raoul, Wolff Valérie, Cherifi Aboubaker, Bretzner Martin, Henon Hilde, Marnat Gaultier, Sibon Igor, Gentric Jean-Christophe, Timsit Serge, Di Caterino Fortunato, Charbonnier Guillaume, Caroff Jildaz, Denier Christian, Consoli Arturo, Lapergue Bertrand, Allard Julien, Gerschenfeld Gaspard, Dumas Victor, Lamy Matthias, Richter Sebastian Johan, Castagnet Hélène, Veunac Louis, Bourgeois-Beauvais Quentin, Desilles Jean-Philippe, Seners Pierre, Naggara Olivier, Januel Anne-Christine, Fontaine Louis, Boulouis Grégoire, Pasi Marco, Dargazanli Cyril, Arquizan Caroline, Heck Olivier, Garambois Katia, Comby Pierre-Olivier, Bejot Yannick, Zhu François, Liao Liang, Loukoul Wassim Abou, Derelle Anne-Laure, Anxionnat René, Kamga Marius Mkounga, Hachit Hamza, Guillemin Francis, Turc Guillaume, Hossu Gabriela
Аннотация
STUDY DESIGN: Intra-Arterial thrombolysis after SUCCESSful angiographic recanalization in acute large-vessel occlusion stroke of the anterior circulation (IA-SUCCESS) trial is a phase 3 investigator-initiated, multicentre, randomised, open-label, blinded-endpoint (PROBE) clinical trial with a health economic evaluation conducted in France. Patients with acute ischaemic stroke due to anterior circulation LVO within 24 h of stroke onset and successful angiographic reperfusion (defined as extended Thrombolysis in Cerebral Infarction score 2b-3) after intravenous thrombolysis alone, MT alone or both will be randomised in two balanced parallel groups (1:1) to receive either IAT with alteplase (0.225 mg kg-1 and a maximum of 20 mg) injected in the ipsilateral internal carotid artery or no IAT. A total of 626 patients will be included.
STUDY ENDPOINTS: The primary outcome is the functional outcome on the modified Rankin Scale at 90 (±15) days. Standard secondary clinical outcomes are assessed at 24 (±6) h, 5-7 days, 90 (±15) days and 12 (±1) months. Safety outcomes include mortality at 90 (±15) days and intracranial haemorrhage.
SUMMARY: The IA-SUCCESS trial will provide high-quality randomised data on the clinical efficacy and safety of intra-arterial alteplase following successful angiographic recanalisation in European patients with ischaemic stroke due to anterior circulation LVO intended for MT.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06768138.