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Trial protocol for intra-arterial alteplase in anterior circulation large-vessel occlusion ischaemic strokeTrial Plans to Test Intra-arterial Alteplase for Ischaemic Stroke

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Key Takeaway
Note that this is a protocol publication; no clinical outcomes or safety data are currently available.

This Phase 3 randomized controlled trial was designed to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischaemic stroke caused by anterior circulation large-vessel occlusion (LVO). The study population included patients within 24 h of stroke onset who achieved successful angiographic reperfusion. The multicentre study was conducted in France.

The intervention group received intra-arterial thrombolysis with alteplase (0.225 mg kg-1 and a maximum of 20 mg) injected into the ipsilateral internal carotid artery. The comparator group received no intra-arterial thrombolysis. The primary outcome was functional outcome on the modified Rankin Scale at 90 (±15) days.

Secondary outcomes included clinical outcomes at 24 (±6) h, 5-7 days, 90 (±15) days, and 12 (±1) months, as well as mortality at 90 (±15) days and intracranial haemorrhage. Follow-up was planned for up to 12 (±1) months.

Because this is a protocol publication, no results regarding efficacy or safety are reported. Safety data including adverse events, serious adverse events, and discontinuations were not reported. The trial aims to provide high-quality randomized data on the clinical outcomes of intra-arterial alteplase in European patients with anterior circulation LVO.

How this fits prior evidence

How this fits prior evidence: This protocol addresses a gap regarding the specific use of intra-arterial alteplase for anterior circulation large-vessel occlusion. It relates to previous findings where adjunctive intra-arterial alteplase with thrombectomy increased excellent functional outcome to 57.5% at 90 days, and where extended-window alteplase improved function but increased hemorrhage risk.

Researchers are preparing a large multicenter trial in France to study a specific treatment for ischemic stroke. The study focuses on patients who have experienced a major blockage in the arteries supplying blood to the brain within 24 hours of their symptoms starting.

The trial will compare two different approaches. One group will receive intra-arterial thrombolysis, where the medication alteplase is injected directly into the affected artery. The other group will not receive this specific intra-arterial treatment. The goal is to see if this direct delivery improves physical function and survival rates.

Because this is a protocol study, no results have been collected or shared yet. The trial is designed to provide high-quality data on whether this method is safe and effective for patients in Europe. Since the study is still in the planning phase, these findings cannot be used to change current medical treatments at this time.

What this means for you:
This is a planned study; no results are available yet to determine if this treatment is effective or safe.

Common questions

What is the goal of this study?

The trial aims to provide high-quality randomized data on the clinical efficacy and safety of intra-arterial alteplase. It specifically looks at patients with ischemic stroke caused by large-vessel occlusion in the anterior circulation within 24 hours of onset.

Is this treatment currently proven to work?

Because this is a protocol study, no results have been reported yet. The trial is designed to gather data on whether intra-arterial thrombolysis provides better outcomes compared to standard care for these specific stroke patients.

Who is eligible for this specific study?

The study targets patients with acute ischemic stroke due to anterior circulation large-vessel occlusion (LVO) within 24 hours of onset who have achieved successful angiographic reperfusion. The trial will involve a total of 626 participants.

Study Details

Study typeRct
Sample sizen = 626
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
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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