INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

The NEWLINE trial is a multicenter, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether adjunctive low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Eligible participants achieving successful reperfusion (eTICI 2b-3) within 24 hours of symptom onset will be randomized 1:1 to receive intra-arterial alteplase plus standard care or standard care alone. The primary outcome is excellent functional outcome (modified Rankin Scale score 0-1) at 90 days.

NCT Number	NCT07727395
Lead Sponsor	115 People's Hospital Collaborators: Ho Chi Minh City Stroke Association
Conditions	Stroke, Acute Ischemic, Large Vessel Occlusion, Thrombectomy
Enrollment	416 participants
Start Date	2026-08-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-11