Zapata-Arriaza, ElenaMedina-Rodríguez, MMoniche Álvarez, FranciscoAlbóniga-Chindurza, Asier deAguilar-Pérez, MartaAinz-Gómez, LeireBaena-Palomino, PabloZamora, AynaraPardo-Galiana, BlancaDelgado-Acosta, FernandoValverde Moyano, RobertoJiménez-Gómez, ElviraBravo Rey, IsabelOteros Fernández, RafaelEscudero-Martínez, IreneVielba-Gómez, IsabelMorales Caba, LluísDíaz Pérez, JoséGarcía Molina, EstefaníaMosteiro, SoniaCastellanos, María del MarAmaya Pascasio, LauraHidalgo, CarlosFreijo Guerrero, María del MarGonzález Díaz, EvaRamírez Moreno, José MaríaFernández Prudencio, LuisTerceño Izaga, MikelBashir Viturro, SaimaGamero-García, Miguel ÁngelJiménez Jorge, SilviaRosso Fernández, ClaraMontaner, JoanGonzález-García, Alejandro2024-06-202024-06-202024-01-09Zapata-Arriaza E, Medina-Rodríguez M, Moniche Álvarez F, de Albóniga-Chindurza A, Aguilar-Pérez M, Ainz-Gómez L, Baena-Palomino P, Zamora A, Pardo-Galiana B, Delgado-Acosta F, Valverde Moyano R, Jiménez-Gómez E, Bravo Rey I, Oteros Fernández R, Escudero-Martínez I, Vielba-Gomez I, Morales Caba L, Díaz Pérez J, García Molina E, Mosteiro S, Castellanos Rodrigo MDM, Amaya Pascasio L, Hidalgo C, Freijo Guerrero MDM, González Díaz E, Ramírez Moreno JM, Fernández Prudencio L, Terceño Izaga M, Bashir Viturro S, Gamero-García MÁ, Jiménez Jorge S, Rosso Fernández C, Montaner J, González García A. Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial). Trials. 2024 Jan 9;25(1):35.1745-6215http://hdl.handle.net/2183/37205Study protocol[Abstract] Rationale: In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated. Aims: To assess efficacy and safety of intravenous tirofiban versus intravenous aspirin in patients undergoing MT plus carotid stenting in the setting of AIS due to TL. Sample size estimates: Two hundred forty patients will be enrolled, 120 in every treatment arm. Methods and design: A multicenter, prospective, randomized, controlled (aspirin group), assessor-blinded clinical trial will be conducted. Patients fulfilling the inclusion criteria will be randomized at MT onset to the experimental or control group (1:1). Intravenous aspirin will be administered at a 500-mg single dose and tirofiban at a 500-mcg bolus followed by a 200-mcg/h infusion during the first 24 h. All patients will be followed for up to 3 months. Study outcomes: Primary efficacy outcome will be the proportion of patients with carotid in-stent thrombosis within the first 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage. Discussion: This will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.engCreative Commons Attribution 4.0 International License (CC-BY 4.0)http://creativecommons.org/licenses/by/3.0/es/Antiplatelet therapyProtocolStatisticsStrokeTandem occlusionjournal articleopen access10.1186/s13063-023-07817-9