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)

Zapata‐Arriaza, Elena; Medina-Rodríguez, Manuel; Moniche, Francisco; Albóniga-Chindurza, Asier de; Aguilar-Pérez, Marta; Ainz-Gómez, Leire; Baena-Palomino, Pablo; Zamora, Aynara; Pardo‐Galiana, Blanca; Delgado, Fernando; Valverde Moyano, Roberto; Jiménez-Gómez, Elvira; Bravo-Rey, Isabel; Oteros-Fernández, Rafael; Escudero-Martínez, Irene; Vielba-Gómez, Isabel; Morales-Caba, Lluis; Díaz-Pérez, José; García-Molina, Estefanía; Mosteiro, Sonia; Castellanos-Rodrigo, María del Mar; Pascasio, Laura Amaya; Hidalgo, Carlos; Freijo-Guerrero, Maria del Mar; González-Díaz, Eva; Ramírez-Moreno, José M.; Fernández-Prudencio, Luis; Terceño Izaga, Mikel; Bashir Viturro, Saima; Gamero-García, Miguel Ángel; Jiménez-Jorge, Silvia; Rosso-Fernández, Clara; Montaner, Joan; González, Alejandro

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)

© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, p...

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Autores:	Zapata‐Arriaza, Elena, Medina-Rodríguez, Manuel, Moniche, Francisco, Albóniga-Chindurza, Asier de, Aguilar-Pérez, Marta, Ainz-Gómez, Leire, Baena-Palomino, Pablo, Zamora, Aynara, Pardo‐Galiana, Blanca, Delgado, Fernando, Valverde Moyano, Roberto, Jiménez-Gómez, Elvira, Bravo-Rey, Isabel, Oteros-Fernández, Rafael, Escudero-Martínez, Irene, Vielba-Gómez, Isabel, Morales-Caba, Lluis, Díaz-Pérez, José, García-Molina, Estefanía, Mosteiro, Sonia, Castellanos-Rodrigo, María del Mar, Pascasio, Laura Amaya, Hidalgo, Carlos, Freijo-Guerrero, Maria del Mar, González-Díaz, Eva, Ramírez-Moreno, José M., Fernández-Prudencio, Luis, Terceño Izaga, Mikel, Bashir Viturro, Saima, Gamero-García, Miguel Ángel, Jiménez-Jorge, Silvia, Rosso-Fernández, Clara, Montaner, Joan, González, Alejandro
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2024
País:	España
Institución:	Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:	DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:	oai:digital.csic.es:10261/360311
Acceso en línea:	http://hdl.handle.net/10261/360311
Access Level:	acceso abierto
Palabra clave:	Protocol Stroke Tandem occlusion Statistics Antiplatelet therapy

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dc.title.none.fl_str_mv	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)
title	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)
spellingShingle	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) Zapata‐Arriaza, Elena Protocol Stroke Tandem occlusion Statistics Antiplatelet therapy
title_short	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)
title_full	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)
title_fullStr	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)
title_full_unstemmed	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)
title_sort	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)
dc.creator.none.fl_str_mv	Zapata‐Arriaza, Elena Medina-Rodríguez, Manuel Moniche, Francisco Albóniga-Chindurza, Asier de Aguilar-Pérez, Marta Ainz-Gómez, Leire Baena-Palomino, Pablo Zamora, Aynara Pardo‐Galiana, Blanca Delgado, Fernando Valverde Moyano, Roberto Jiménez-Gómez, Elvira Bravo-Rey, Isabel Oteros-Fernández, Rafael Escudero-Martínez, Irene Vielba-Gómez, Isabel Morales-Caba, Lluis Díaz-Pérez, José García-Molina, Estefanía Mosteiro, Sonia Castellanos-Rodrigo, María del Mar Pascasio, Laura Amaya Hidalgo, Carlos Freijo-Guerrero, Maria del Mar González-Díaz, Eva Ramírez-Moreno, José M. Fernández-Prudencio, Luis Terceño Izaga, Mikel Bashir Viturro, Saima Gamero-García, Miguel Ángel Jiménez-Jorge, Silvia Rosso-Fernández, Clara Montaner, Joan González, Alejandro
author	Zapata‐Arriaza, Elena
author_facet	Zapata‐Arriaza, Elena Medina-Rodríguez, Manuel Moniche, Francisco Albóniga-Chindurza, Asier de Aguilar-Pérez, Marta Ainz-Gómez, Leire Baena-Palomino, Pablo Zamora, Aynara Pardo‐Galiana, Blanca Delgado, Fernando Valverde Moyano, Roberto Jiménez-Gómez, Elvira Bravo-Rey, Isabel Oteros-Fernández, Rafael Escudero-Martínez, Irene Vielba-Gómez, Isabel Morales-Caba, Lluis Díaz-Pérez, José García-Molina, Estefanía Mosteiro, Sonia Castellanos-Rodrigo, María del Mar Pascasio, Laura Amaya Hidalgo, Carlos Freijo-Guerrero, Maria del Mar González-Díaz, Eva Ramírez-Moreno, José M. Fernández-Prudencio, Luis Terceño Izaga, Mikel Bashir Viturro, Saima Gamero-García, Miguel Ángel Jiménez-Jorge, Silvia Rosso-Fernández, Clara Montaner, Joan González, Alejandro
author_role	author
author2	Medina-Rodríguez, Manuel Moniche, Francisco Albóniga-Chindurza, Asier de Aguilar-Pérez, Marta Ainz-Gómez, Leire Baena-Palomino, Pablo Zamora, Aynara Pardo‐Galiana, Blanca Delgado, Fernando Valverde Moyano, Roberto Jiménez-Gómez, Elvira Bravo-Rey, Isabel Oteros-Fernández, Rafael Escudero-Martínez, Irene Vielba-Gómez, Isabel Morales-Caba, Lluis Díaz-Pérez, José García-Molina, Estefanía Mosteiro, Sonia Castellanos-Rodrigo, María del Mar Pascasio, Laura Amaya Hidalgo, Carlos Freijo-Guerrero, Maria del Mar González-Díaz, Eva Ramírez-Moreno, José M. Fernández-Prudencio, Luis Terceño Izaga, Mikel Bashir Viturro, Saima Gamero-García, Miguel Ángel Jiménez-Jorge, Silvia Rosso-Fernández, Clara Montaner, Joan González, Alejandro
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Instituto de Salud Carlos III European Commission Zapata‐Arriaza, Elena [0000-0002-1730-1999] Medina-Rodríguez, Manuel [0000-0002-2862-9586] Moniche, Francisco [0000-0001-8613-2909] Delgado, Fernando [0000-0003-2180-5273] Escudero-Martínez, Irene [0000-0003-1838-0235] Montaner, Joan [0000-0003-4845-2279] Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv	Protocol Stroke Tandem occlusion Statistics Antiplatelet therapy
topic	Protocol Stroke Tandem occlusion Statistics Antiplatelet therapy
description	© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
publishDate	2024
dc.date.none.fl_str_mv	2024 2024 2024
dc.type.none.fl_str_mv	info:eu-repo/semantics/article http://purl.org/coar/resource_type/c_6501 Publisher's version info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/10261/360311
url	http://hdl.handle.net/10261/360311
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	#PLACEHOLDER_PARENT_METADATA_VALUE# info:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI21%2F01322 Zapata‐Arriaza, Elena; Medina-Rodríguez, Manuel; Moniche, Francisco; Albóniga-Chindurza, Asier de; Aguilar-Pérez, Marta; Ainz-Gómez, Leire; Baena-Palomino, Pablo; Zamora, Aynara; Pardo‐Galiana, Blanca; Delgado, Fernando; Valverde Moyano, Roberto; Jiménez-Gómez, Elvira; Bravo-Rey, Isabel; Oteros-Fernández, Rafael; Escudero-Martínez, Irene; Vielba-Gómez, Isabel; Morales-Caba, Lluis; Díaz-Pérez, José; García-Molina, Estefanía; Mosteiro, Sonia; Castellanos-Rodrigo, María del Mar; Pascasio, Laura Amaya; Hidalgo, Carlos; Freijo-Guerrero, Maria del Mar; González-Díaz, Eva; Ramírez-Moreno, José M.; Fernández-Prudencio, Luis; Terceño Izaga, Mikel; Bashir Viturro, Saima; Gamero-García, Miguel Ángel; Jiménez-Jorge, Silvia; Rosso-Fernández, Clara; Montaner, Joan; González, Alejandro; 2024; Additional file 1 of 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) [Dataset]; Figshare; https://doi.org/10.6084/m9.figshare.24971306.v1 The underlying dataset has been published as supplementary material of the article in the publisher platform at https://doi.org/10.1186/s13063-023-07817-9 https://doi.org/10.1186/s13063-023-07817-9 Sí
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	BioMed Central Springer Nature
publisher.none.fl_str_mv	BioMed Central Springer Nature
dc.source.none.fl_str_mv	reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str	Consejo Superior de Investigaciones Científicas (CSIC)
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spelling	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)Zapata‐Arriaza, ElenaMedina-Rodríguez, ManuelMoniche, FranciscoAlbóniga-Chindurza, Asier deAguilar-Pérez, MartaAinz-Gómez, LeireBaena-Palomino, PabloZamora, AynaraPardo‐Galiana, BlancaDelgado, FernandoValverde Moyano, RobertoJiménez-Gómez, ElviraBravo-Rey, IsabelOteros-Fernández, RafaelEscudero-Martínez, IreneVielba-Gómez, IsabelMorales-Caba, LluisDíaz-Pérez, JoséGarcía-Molina, EstefaníaMosteiro, SoniaCastellanos-Rodrigo, María del MarPascasio, Laura AmayaHidalgo, CarlosFreijo-Guerrero, Maria del MarGonzález-Díaz, EvaRamírez-Moreno, José M.Fernández-Prudencio, LuisTerceño Izaga, MikelBashir Viturro, SaimaGamero-García, Miguel ÁngelJiménez-Jorge, SilviaRosso-Fernández, ClaraMontaner, JoanGonzález, AlejandroProtocolStrokeTandem occlusionStatisticsAntiplatelet therapy© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.[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.[Trial registration] The trial is registered as NCT05225961. February, 7th, 2022.This project was funded by the Instituto de Salud Carlos III (ISCIII) through the project PI21/01322 and co-funded by the European Union. The Spanish Clinical Research Network (SCReNCode: 21.033) also contributed to the study. The ITRIBiS project (Improving Translational Research Potential at the Institute of Biomedicine of Seville) has the registration number REGPOT-2013-1. M. Medina-Rodríguez was granted a Rio Hortega contract (CM21/00096). The project was included in the Cooperative Cerebrovascular Disease Research Network (INVICTUS) (RD16/0019/0015).Peer reviewedBioMed CentralSpringer NatureInstituto de Salud Carlos IIIEuropean CommissionZapata‐Arriaza, Elena [0000-0002-1730-1999]Medina-Rodríguez, Manuel [0000-0002-2862-9586]Moniche, Francisco [0000-0001-8613-2909]Delgado, Fernando [0000-0003-2180-5273]Escudero-Martínez, Irene [0000-0003-1838-0235]Montaner, Joan [0000-0003-4845-2279]Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202420242024info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/10261/360311reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Inglés#PLACEHOLDER_PARENT_METADATA_VALUE#info:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI21%2F01322Zapata‐Arriaza, Elena; Medina-Rodríguez, Manuel; Moniche, Francisco; Albóniga-Chindurza, Asier de; Aguilar-Pérez, Marta; Ainz-Gómez, Leire; Baena-Palomino, Pablo; Zamora, Aynara; Pardo‐Galiana, Blanca; Delgado, Fernando; Valverde Moyano, Roberto; Jiménez-Gómez, Elvira; Bravo-Rey, Isabel; Oteros-Fernández, Rafael; Escudero-Martínez, Irene; Vielba-Gómez, Isabel; Morales-Caba, Lluis; Díaz-Pérez, José; García-Molina, Estefanía; Mosteiro, Sonia; Castellanos-Rodrigo, María del Mar; Pascasio, Laura Amaya; Hidalgo, Carlos; Freijo-Guerrero, Maria del Mar; González-Díaz, Eva; Ramírez-Moreno, José M.; Fernández-Prudencio, Luis; Terceño Izaga, Mikel; Bashir Viturro, Saima; Gamero-García, Miguel Ángel; Jiménez-Jorge, Silvia; Rosso-Fernández, Clara; Montaner, Joan; González, Alejandro; 2024; Additional file 1 of 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) [Dataset]; Figshare; https://doi.org/10.6084/m9.figshare.24971306.v1The underlying dataset has been published as supplementary material of the article in the publisher platform at https://doi.org/10.1186/s13063-023-07817-9https://doi.org/10.1186/s13063-023-07817-9Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/3603112026-05-22T06:33:51Z
score	15.811543

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)

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