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: Elena Zapata-Arriaza, Manuel Medina-Rodríguez, Francisco Moniche Álvarez, Asier de Albóniga-Chindurza, Marta Aguilar-Pérez, Leire Ainz-Gómez, Pablo Baena-Palomino, Aynara Zamora, Blanca Pardo-Galiana, Fernando Delgado-Acosta, Roberto Valverde Moyano, Elvira Jiménez-Gómez, Isabel Bravo Rey, Rafael Oteros Fernández, Irene Escudero-Martínez, Isabel Vielba-Gomez, Lluis Morales Caba, Jose Díaz Pérez, Estefania García Molina, Sonia Mosteiro, María del Mar Castellanos Rodrigo, Laura Amaya Pascasio, Carlos Hidalgo, María del Mar Freijo Guerrero, Eva González Díaz, Jose María Ramírez Moreno, Luis Fernández Prudencio, Mikel Terceño Izaga, Saima Bashir Viturro, Miguel Ángel Gamero-García, Silvia Jiménez Jorge, Clara Rosso Fernández, Joan Montaner, Alejandro González García
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07817-9
Popis: 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. Trial registration The trial is registered as NCT05225961. February, 7th, 2022.
Databáze: Directory of Open Access Journals
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