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Studies

Interventional Recruiting Phase 3

NCT06768138 on ClinicalTrials.gov

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

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

  • Sponsor: Centre Hospitalier Universitaire de Nancy
  • Enrollment: 626 (Estimated)
  • Study start: 2025-06-01 (Actual)
  • Primary completion: 2028-09-16 (Estimated)
  • Study completion: 2029-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Stroke, Acute Ischemic

Intervention / Treatment

  • Drug: Intra-arterial infusion of Alteplase

Primary Outcome Measures

  • The superiority of adjunct intra-arterial thrombolysis versus no adjunct intra-arterial thrombolysis (90 (±15) days)
    The primary endpoint is the severity of disability according to the distribution of scores on the modified Rankin Scale (mRS): mRS 0 to 6

Countries

France

Locations and Investigators

  • CHRU Nancy, Nancy, France (Recruiting)
    • Benjamin GORY, MD, PhD
    • Benjamin GORY, MD, PhD (Principal Investigator)