INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

Summary

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.

Timeline

Start

2026-08-01

Primary completion

2028-12-31

Completion

2028-12-31

Publications

• Results Yang X, He X, Pan D, Xu Y, Peng H, Li K, Zhang M, Zhu Y, Chen Y, He B, Zhou H, Li J, Hou H, Sun H, Liu Y, Tang Y. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial. BMJ Open. 2024 Nov 5;14(11):e091059. doi: 10.1136/bmjopen-2024-091059.
• Results Huo X, Luo G, Sun D, Nguyen T, Abdalkader M, Chen W, Yao X, Yuan G, Yi T, Han H, Pan Y, Jovin TG, Liebeskind DS, Liu L, Zhao X, Ren Z, Wang Y, Wang Y, Yan B, Miao Z. Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial. Stroke Vasc Neurol. 2025 Aug 26;10(4):508-513. doi: 10.1136/svn-2024-003318.
• Results Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645.
• Results Renu A, de la Riva P, Delgado-Mederos R, Dorado L, Fernandez-Couto MD, Herrera-Isasi M, Lopez Hernandez N, Morales A, Morales-Caba L, Camps-Renom P, Singla A, Terceno M, Vega P, Amaro S, Blasco J, Laredo C, Leira EC, Oleaga L, Serena J, Urra X, Werner M, Hernandez Fernandez F, Valls J, Arenillas Lara JF, Freijo MDM, Perez de la Ossa N, San Roman L, Torres F, Castellanos M, Davalos A, Chamorro A; CHOICE 2 Investigators. Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol. Stroke Vasc Neurol. 2025 Dec 3:svn-2025-004279. doi: 10.1136/svn-2025-004279. Online ahead of print.

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