NCT06768138

Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke

Intra-Arterial Thrombolysis After SUCCESSful Angiographic Recanalization in Acute Large Vessel Occlusion Stroke of the Anterior Circulation: the IA-SUCCESS Multicenter, Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prospective phase 3 multicenter with open label blinded endpoint (PROBE) superiority randomized controlled trial, with health-economics evaluation. The study strategy is to demonstrate the superiority of adjunct intra-arterial thrombolysis compared to no adjunct intra-arterial thrombolysis after successful angiographic reperfusion (eTICI 2b-2c-3) after intravenous alone, bridging therapy, or mechanical thrombectomy alone on 90-day functional outcome rate (shift of 90-day modified Rankin Scale toward a better functional outcome). Patients with anterior circulation large vessel occlusion stroke will be recruited in the angiosuite by neurologists and/or neuroradiologists in participating centres after acute reperfusion therapy (intravenous thrombolysis alone, bridging therapy, or mecanical thrombectomy alone). Patients 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 and the maximal allowed dose is 20mg. Intra-arterial Alteplase will be injected through the guiding catheter placed in the internal carotid artery during 15 minutes.The total intra-arterial dose must be injected in the absence of complications. Secondary objectives: 1. To assess the clinical and safety of adjunct intra-arterial thrombolysis. 2. To assess the cost-effectiveness of adjunct intra-arterial thrombolysis. 3. To assess the budget impact of new stroke management strategy in case of successful angiographic reperfusion.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
DRUG	Intra-arterial infusion of Alteplase	Patients 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

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-09-16
• Completion: 2029-07-01
• First posted: 2025-01-10
• Last updated: 2025-06-05

Locations

1 site across 1 country: France