Key result
IA-SUCCESS trial tests whether intra-arterial alteplase improves 90-day functional outcomes in acute ischemic stroke.
Why the study?
Does intra-arterial thrombolysis with alteplase improve functional outcome in patients with acute ischaemic stroke due to anterior circulation large-vessel occlusion who have successful angiographic recanalisation?
RCT (n=626)
Open-label, blinded-endpoint
1:1
Yes
Does intra-arterial thrombolysis with alteplase improve functional outcome in patients with acute ischaemic stroke due to anterior circulation large-vessel occlusion who have successful angiographic recanalisation?
The IA-SUCCESS trial protocol outlines a study to evaluate whether intra-arterial alteplase improves functional outcomes in European patients with acute ischaemic stroke following successful angiographic recanalisation.
BACKGROUND: 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. 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.
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Gory et al. (2026) conducted an RCT in Acute ischaemic stroke due to anterior circulation large-vessel occlusion (n=626). Intra-arterial thrombolysis with alteplase vs. No intra-arterial thrombolysis was evaluated on Functional outcome on the modified Rankin Scale at 90 (±15) days. The IA-SUCCESS trial is a phase 3 randomized protocol designed to evaluate whether intra-arterial alteplase improves 90-day functional outcomes in 626 patients with acute ischemic stroke.
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