Stroke is a leading cause of disability and mortality worldwide. Despite the clinical benefit of mechanical thrombectomy, 1 out of 2 patients treated are functionally independent at 90 days. Achieving the best possible angiographic reperfusion is a key determinant of clinical outcome in acute ischemic stroke patients with anterior circulation large vessel occlusion. Mechanical thrombectomy is standard treatment for large vessel occlusion stroke patients within 24. In the setting of successful (eTICI ≥2b), adjunct intra-arterial thrombolysis may be a promising therapeutic option allowing recanalization of distal arterial occlusions (not accessible to mechanical devices) and improvement of upstream brain reperfusion by targeting microvascular obstruction.
The IA-SUCCESS randomized trial aims to assess the clinical and safety of adjunct intra-arterial thrombolysis vs. no adjunct intra-arterial thrombolysis after successful angiographic reperfusion in patients with acute anterior circulation large vessel occlusion stroke.
Age ≥ 18 years
Pre-stroke mRS 0-2
Acute ischemic stroke with anterior circulation large vessel occlusion defined as intracranial internal carotid artery, M1, or M2 occlusion proven on CT or MRI
NIHSS score ≥ 5 at admission
Person who do not speak French
Contraindications for intra-arterial thrombolysis: Platelet count <100 000/mm3, INR >1.7, AOD use <48h or biological confirmation of activity and effective heparin treatment
Bleeding-risk complications during the mechanical thrombectomy procedure (e.g carotid dissection, complicated femoral approach)
Bleeding-risk complications consecutive to a fall associated with stroke
Parallel
Intra-arterial infusion of Alteplase
DrugPatients enrolled in the experimental arm will receive intra-arterial thrombolysis with Alteplase. The dose of Intra-arterial Alteplase is 0.225 mg/kg body weight with a maximal dose of 20 mg
The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis
The primary endpoint is the severity of disability according to the distribution of scores on the modified Rankin Scale (mRS): mRS 0 to 6
To assess the efficacy of adjunct intra-arterial thrombolysis
Distribution of the mRS score (0 to 6)
To assess the efficacy of adjunct intra-arterial thrombolysis
Excellent functional outcome (mRS 0-1)
To assess the efficacy of adjunct intra-arterial thrombolysis
Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1)
To assess the safety of adjunct intra-arterial thrombolysis
Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on imaging follow-up, according to the Heidelberg classification (imaging core laboratory).
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