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.
Intra-arterial thrombolysis (IAT) following successful mechanical thrombectomy (MT) in patients with anterior circulation large-vessel occlusion (LVO) improves cerebral tissue reperfusion and consequently clinical outcome, but has to be validated in non-Asian populations. We hypothesised that IAT with alteplase versus no IAT leads to a better clinical outcome in patients with anterior circulation LVO stroke who have successful angiographic recanalisation.
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.
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.
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.
ClinicalTrials.gov NCT06768138.
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.
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.
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.
ClinicalTrials.gov NCT06768138.
Authors
Gory Gory, Richard Richard, Pop Pop, Wolff Wolff, Cherifi Cherifi, Bretzner Bretzner, Henon Henon, Marnat Marnat, Sibon Sibon, Gentric Gentric, Timsit Timsit, Di Caterino Di Caterino, Charbonnier Charbonnier, Caroff Caroff, Denier Denier, Consoli Consoli, Lapergue Lapergue, Allard Allard, Gerschenfeld Gerschenfeld, Dumas Dumas, Lamy Lamy, Richter Richter, Castagnet Castagnet, Veunac Veunac, Bourgeois-Beauvais Bourgeois-Beauvais, Desilles Desilles, Seners Seners, Naggara Naggara, Januel Januel, Fontaine Fontaine, Boulouis Boulouis, Pasi Pasi, Dargazanli Dargazanli, Arquizan Arquizan, Heck Heck, Garambois Garambois, Comby Comby, Bejot Bejot, Zhu Zhu, Liao Liao, Loukoul Loukoul, Derelle Derelle, Anxionnat Anxionnat, Kamga Kamga, Hachit Hachit, Guillemin Guillemin, Turc Turc, Hossu Hossu
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