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)

被引：0

作者：

Zapata-Arriaza, Elena ^{[1
,2
]}

Medina-Rodriguez, Manuel ^{[1
,3
]}

Moniche alvarez, Francisco ^{[3
]}

de Alboniga-Chindurza, Asier ^{[1
,3
]}

Aguilar-Perez, Marta ^{[1
,2
]}

Ainz-Gomez, Leire ^{[1
,3
]}

Baena-Palomino, Pablo ^{[1
,3
]}

Zamora, Aynara ^{[1
]}

Pardo-Galiana, Blanca ^{[1
,3
]}

Delgado-Acosta, Fernando ^{[4
]}

Valverde Moyano, Roberto ^{[5
]}

Jimenez-Gomez, Elvira ^{[4
]}

Bravo Rey, Isabel ^{[4
]}

Oteros Fernandez, Rafael ^{[4
]}

Escudero-Martinez, Irene ^{[6
]}

Vielba-Gomez, Isabel ^{[7
]}

Morales Caba, Lluis ^{[7
]}

Diaz Perez, Jose ^{[8
]}

Garcia Molina, Estefania ^{[9
]}

Mosteiro, Sonia ^{[10
]}

Castellanos Rodrigo, Maria del Mar ^{[11
]}

Amaya Pascasio, Laura ^{[12
]}

Hidalgo, Carlos ^{[13
]}

Freijo Guerrero, Maria del Mar ^{[14
]}

Gonzalez Diaz, Eva ^{[15
]}

Ramirez Moreno, Jose Maria ^{[16
]}

Fernandez Prudencio, Luis ^{[17
]}

Terceno Izaga, Mikel ^{[18
,19
]}

Bashir Viturro, Saima ^{[18
,19
]}

Gamero-Garcia, Miguel angel ^{[1
,20
]}

Jimenez Jorge, Silvia ^{[21
]}

Rosso Fernandez, Clara ^{[21
]}

Montaner, Joan ^{[1
,20
]}

Gonzalez Garcia, Alejandro ^{[1
,2
]}

机构：

[1] Seville Biomed Res Inst, Neurovasc Res Program, Stroke Unit, Seville, Spain

[2] Virgen del Rocio Univ Hosp, Intervent Neurorradiol Dept, Neurovasc Res Lab, Inst Biomed Seville IBIS, Av Manuel Siurot Sn, Seville 41013, Spain

[3] Virgen del Rocio Univ Hosp, Neurol Dept, Seville, Spain

[4] Reina Sofia Univ Hosp, Intervent Neuroradiol Dept, Cordoba, Spain

[5] Reina Sofia Univ Hosp, Neurol Dept, Cordoba, Spain

[6] La Fe Univ & Polytech Hosp, Neurol Dept, Valencia, Spain

[7] La Fe Univ & Polytech Hosp, Intervent Neuroradiol Dept, Valencia, Spain

[8] Virgen de la Arrixaca Univ Clin Hosp, Intervent Neuroradiol Dept, Murcia, Spain

[9] Virgen de la Arrixaca Univ Clin Hosp, Neurol Dept, Murcia, Spain

[10] A Coruna Univ Hosp Complex, Intervent Neuroradiol Dept, Coruna, Spain

[11] A Coruna Univ Hosp Complex, Neurol Dept, La Coruna, Spain

[12] Torrecardenas Univ Hosp, Neurol Dept, Almeria, Spain

[13] Torrecardenas Univ Hosp, Intervent Neuroradiol Dept, Almeria, Spain

[14] Cruces Univ Hosp, Neurol Dept, Vizcaya, Spain

[15] Cruces Univ Hosp, Intervent Neuroradiol Dept, Vizcaya, Spain

[16] Badajoz Univ Hosp, Neurol Dept, Badajoz, Spain

[17] Badajoz Univ Hosp, Intervent Neuroradiol, Badajoz, Spain

[18] Doctor Josep Trueta Hosp, Dept Neurol, Girona, Spain

[19] Doctor Josep Trueta Hosp, Intervent Neuroradiol Unit, Girona, Spain

[20] Virgen Macarena Univ Hosp, Neurol Dept, Seville, Spain

[21] Virgen del Rocio Hosp, Clin Res & Clin Trials Unit CTU, Seville, Spain

来源：

TRIALS | 2024年 / 25卷 / 01期

关键词：

Protocol; Stroke; Tandem occlusion; Statistics; Antiplatelet therapy; DOSE TIROFIBAN; THROMBECTOMY; OCCLUSION; OUTCOMES; THROMBOLYSIS; MANAGEMENT;

D O I：

10.1186/s13063-023-07817-9

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

RationaleIn-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.AimsTo 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 estimatesTwo hundred forty patients will be enrolled, 120 in every treatment arm.Methods and designA 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 outcomesPrimary 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.DiscussionThis will be the first clinical trial to assess the best antiplatelet therapy to avoid in-stent thrombosis after MT in patients with TL.Trial registrationThe trial is registered as NCT05225961. February, 7th, 2022.

引用

页数：12

共 26 条

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