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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 E, Medina-Rodríguez M, Moniche Álvarez F et al. Trials. 2024 Jan 9;25(1):35. doi: 10.1186/s13063-023-07817-9. PMID: 38195586

https://pubmed.ncbi.nlm.nih.gov/38195586/

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 reoc‑ clusion is yet to be elucidated. Aims To assess efcacy and safety of intravenous tirofban 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 fulflling 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 tirofban at a 500-mcg bolus followed by a 200-mcg/h infusion during the frst 24 h. All patients will be followed for up to 3 months

Study outcomes Primary efcacy outcome will be the proportion of patients with carotid in-stent thrombosis within the frst 24 h after MT. Primary safety outcome will be the rate of symptomatic intracranial hemorrhage.
Discussion This will be the frst clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.

Funding: This project was funded by the Instituto de Salud Carlos III (ISCIII) throughvthe project PI21/01322 and co-funded by the European Union. The SpanishvClinical Research Network (SCReNCode: 21.033) also contributed to the study.vThe ITRIBiS project (Improving Translational Research Potential at the Institutevof Biomedicine of Seville) has the registration number REGPOT-2013-1. M.vMedina-Rodríguez was granted a Rio Hortega contract (CM21/00096). Thevproject was included in the Cooperative Cerebrovascular Disease Research Network (INVICTUS) (RD16/0019/0015).