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)

Elena Zapata‐Arriaza; Manuel Medina-Rodríguez; Francisco Moniche Álvarez; 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; R. Oteros Fernández; Irene Escudero‐Martínez; Isabel Vielba-Gómez; L. Morales Caba; Jose Díaz Pérez; Estefanía García Molina; Sonia Mosteiro; Mar Castellanos; Laura Amaya‐Pascasio; C. Hidalgo; María del Mar Freijo Guerrero; Eva C. González Díaz; J.M. Ramírez-Moreno; Luis Fernández Prudencio; Mikel Terceño Izaga; Saima Bashir; Miguel Ángel Gamero-García; Silvia Jiménez‐Jorge; Clara Rosso-Fernández; Joan Montaner; Alejandro González García

doi:10.6084/m9.figshare.24971306

January 1, 2024Open Access

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)

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Key Points

To establish the predefined statistical analysis framework and protocol details for evaluating intravenous tirofiban against aspirin in acute ischemic stroke patients with tandem lesions receiving endovascular therapy.
Multicenter, open-label, randomized controlled trial design (ATILA trial) comparing intravenous tirofiban to aspirin.
Target population comprises patients presenting with acute ischemic stroke caused by tandem arterial lesions undergoing endovascular recanalization.
Documentation formalizes statistical workflows, data safety monitoring board charters, and trial protocol revisions.
Provides standardized statistical procedures and hypothesis testing parameters without reporting primary endpoint event rates or numerical outcome measures.
Delineates pre-specified safety stopping rules, interim analysis plans, and covariate-adjusted models for comparing functional recovery between treatment arms.

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Implication

Randomized trial outlines the statistical analysis plan comparing tirofiban against aspirin in acute ischemic stroke with tandem lesions, highlighting standardized methodology for efficacy evaluation.

Abstract

Additional file 1: Supplementary Material 1. Minor Revision. Supplementary Material 2. DSMB. Supplementary Material 3. Full protocol.

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Zapata‐Arriaza et al. (2024) studied this question.

synapsesocial.com/papers/6a7d088176c74e41c946c976 https://doi.org/10.6084/m9.figshare.24971306

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