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).

Autor: Zapata-Arriaza E; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain. elena.zpt@gmail.com.; Interventional Neuroradiology Department, Virgen del Rocío University Hospital, Neurovascular Research Laboratory, Institute of Biomedicine of Seville (IBIS), Av Manuel Siurot sn, Seville, 41013, Spain. elena.zpt@gmail.com., Medina-Rodríguez M; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., Moniche Álvarez F; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., de Albóniga-Chindurza A; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., Aguilar-Pérez M; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Interventional Neuroradiology Department, Virgen del Rocío University Hospital, Neurovascular Research Laboratory, Institute of Biomedicine of Seville (IBIS), Av Manuel Siurot sn, Seville, 41013, Spain., Ainz-Gómez L; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., Baena-Palomino P; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., Zamora A; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain., Pardo-Galiana B; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen del Rocío University Hospital, Sevilla, Spain., Delgado-Acosta F; Interventional Neuroradiology Department, Reina Sofía University Hospital, Córdoba, Spain., Valverde Moyano R; Neurology Department, Reina Sofía University Hospital, Córdoba, Spain., Jiménez-Gómez E; Interventional Neuroradiology Department, Reina Sofía University Hospital, Córdoba, Spain., Bravo Rey I; Interventional Neuroradiology Department, Reina Sofía University Hospital, Córdoba, Spain., Oteros Fernández R; Interventional Neuroradiology Department, Reina Sofía University Hospital, Córdoba, Spain., Escudero-Martínez I; Neurology Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Vielba-Gomez I; Interventional Neuroradiology Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Morales Caba L; Interventional Neuroradiology Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Díaz Pérez J; Interventional Neuroradiology Department, Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain., García Molina E; Neurology Department, Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain., Mosteiro S; Interventional Neuroradiology Department, A Coruña University Hospital Complex, Coruña, Spain., Castellanos Rodrigo MDM; Neurology Department, A Coruña University Hospital Complex, A Coruña, Spain., Amaya Pascasio L; Neurology Department, Torrecardenas University Hospital, Almería, Spain., Hidalgo C; Interventional Neuroradiology Department, Torrecardenas University Hospital, Almería, Spain., Freijo Guerrero MDM; Neurology Department, Cruces University Hospital, Vizcaya, Spain., González Díaz E; Interventional Neuroradiology Department, Cruces University Hospital, Vizcaya, Spain., Ramírez Moreno JM; Neurology Department, Badajoz University Hospital, Badajoz, Spain., Fernández Prudencio L; Interventional Neuroradiology, Badajoz University Hospital, Badajoz, Spain., Terceño Izaga M; Department of Neurology, Doctor Josep Trueta Hospital, Girona, Spain.; Interventional Neuroradiology Unit, Doctor Josep Trueta Hospital, Girona, Spain., Bashir Viturro S; Department of Neurology, Doctor Josep Trueta Hospital, Girona, Spain.; Interventional Neuroradiology Unit, Doctor Josep Trueta Hospital, Girona, Spain., Gamero-García MÁ; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen Macarena University Hospital, Seville, Spain., Jiménez Jorge S; Clinical Research and Clinical Trials Unit (CTU), Virgen del Rocío Hospital, Seville, Spain., Rosso Fernández C; Clinical Research and Clinical Trials Unit (CTU), Virgen del Rocío Hospital, Seville, Spain., Montaner J; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Neurology Department, Virgen Macarena University Hospital, Seville, Spain., González García A; Stroke Unit, Neurovascular Research Program, Seville Biomedical Research Institute, Seville, Spain.; Interventional Neuroradiology Department, Virgen del Rocío University Hospital, Neurovascular Research Laboratory, Institute of Biomedicine of Seville (IBIS), Av Manuel Siurot sn, Seville, 41013, Spain.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Jan 09; Vol. 25 (1), pp. 35. Date of Electronic Publication: 2024 Jan 09.
DOI: 10.1186/s13063-023-07817-9
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje