ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem Lesion
NCT ID: NCT05225961
Last Updated: 2024-03-07
Study Results
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Basic Information
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RECRUITING
PHASE4
240 participants
INTERVENTIONAL
2022-05-01
2025-12-31
Brief Summary
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Therefore, the use of a single antiplatelet agent could be a reasonable alternative. To establish the best protocol for mono-antiaggregant therapy in the acute phase of TL, the investigators propose to carry out a prospective multicenter randomized clinical trial.
1. All patients with ischemic stroke secondary to TL in the anterior circulation candidates for mechanical thrombectomy in whom cervical endoprosthesis will be placed in the acute phase, will be included, randomized to two groups: 500 mg of intravenous (iv) Aspirin vs Low dose regimen of Tirofiban iv.
2. Carotid reocclusion rates and sICH rates will be evaluated within the first 24 hours after mechanical thrombectomy . As a secondary objective, the functional prognosis at 3 months in both groups will be analyzed, as well as a panel of biomarkers predictors of reocclusion in both groups. Establishing an antiplatelet management protocol in the acute phase in these patients would be an innovative strategy not developed by any other group worldwide, and would place us at the forefront of research in the field. Likewise, developing a clinical-biological predictive model of carotid reocclusion will allow us to establish risk patients in which to plan alternative treatments. Reference hospitals in the treatment of ischemic stroke at the national level with sufficient experience in the management of this pathology will participate in the project.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tirofiban
An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 10 ml (500 micrograms) of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters).
Tirofiban
An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 500 micrograms of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Tirofiban infusion started in the neuroradiology room should be maintained until a control brain computerized tomography (CT) scan is performed at 20 hours (+/-2 hours). Once the absence of parenchymal hematoma is demonstrated in control CT, loading doses of acetylsalicylic acid and clopidogrel will be intravenously administered in the Tirofiban group, and the perfusion must be maintained simultaneously of Tirofiban and oral double antiplatelet therapy for four hours, after which the administration of the experimental drug should be discontinued.
Acetylsalicylic acid
A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. One vial of ASPIRINA ® in not more than 250 ml in 0.9% sodium chloride solution, 5% and 10% glucose solution, Ringer's solution or lactated Ringer's. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial.
Acetylsalicylic acid
A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. It will not be necessary to maintain aspirin infusion. In the Acetylsalicylic acid group, a head computerized tomography scan will also be performed at 20 (+/- 2 hours) after the endovascular procedure. Once the absence of parenchymal hematoma is demonstrated, a load of clopidogrel and 100 mg of Acetylsalicylic acid will be administered. Oral antiplatelet medication can be administered orally if the patient has a good level of consciousness and is not associated with dysphagia; or by placing a nasogastric tube.
Interventions
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Tirofiban
An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 500 micrograms of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Tirofiban infusion started in the neuroradiology room should be maintained until a control brain computerized tomography (CT) scan is performed at 20 hours (+/-2 hours). Once the absence of parenchymal hematoma is demonstrated in control CT, loading doses of acetylsalicylic acid and clopidogrel will be intravenously administered in the Tirofiban group, and the perfusion must be maintained simultaneously of Tirofiban and oral double antiplatelet therapy for four hours, after which the administration of the experimental drug should be discontinued.
Acetylsalicylic acid
A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. It will not be necessary to maintain aspirin infusion. In the Acetylsalicylic acid group, a head computerized tomography scan will also be performed at 20 (+/- 2 hours) after the endovascular procedure. Once the absence of parenchymal hematoma is demonstrated, a load of clopidogrel and 100 mg of Acetylsalicylic acid will be administered. Oral antiplatelet medication can be administered orally if the patient has a good level of consciousness and is not associated with dysphagia; or by placing a nasogastric tube.
Eligibility Criteria
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Inclusion Criteria
* The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
* ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥6.
* Greater than or equal to 18 years of age.
* Signed informed consent.
Exclusion Criteria
* Patients with ASPECTS \<6.
* Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
* Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
* Candidate patients for carotid puncture.
* Previous treatment with double antiplatelet therapy for another cause prior to inclusion.
* Severe comorbidity and / or reduced life expectancy.
* Modified Rankin scale (mRS)\> 2.
* Severe allergy to contrast medium.
* Pregnant.
* Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection.
* Documented allergy to acetylsalicylic acid or Tirofiban.
* Personal history of platelet penia (Platelets \<100,000)
* Concomitant anticoagulant treatment with presence of International Normalized Ratio (INR) \> 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant \<48 hours ago)
* Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
18 Years
100 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Elena Zapata-Arrizada, PhD
Role: PRINCIPAL_INVESTIGATOR
Virgen del Rocío Hospital, Seville, Spain
Locations
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Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, , Spain
General Hospital Dr. Balmis (Alicante)
Alicante, , Spain
Complejo Hospitalario Torrecárdenas
Almería, , Spain
Complejo Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Universitario de Cruces
Bilbao, , Spain
Reina Sofía Hospital
Córdoba, , Spain
Josep Trueta Hospital
Girona, , Spain
Ramón y Cajal Hospital
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia
Murcia, , Spain
Virgen del Rocío Hospital
Seville, , Spain
Virgen Macarena Hospital
Seville, , Spain
Hospital Universitario y Politécnico de La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Zapata-Arriaza E, Medina-Rodriguez M, Moniche Alvarez F, de Alboniga-Chindurza A, Aguilar-Perez M, Ainz-Gomez L, Baena-Palomino P, Zamora A, Pardo-Galiana B, Delgado-Acosta F, Valverde Moyano R, Jimenez-Gomez E, Bravo Rey I, Oteros Fernandez R, Escudero-Martinez I, Vielba-Gomez I, Morales Caba L, Diaz Perez J, Garcia Molina E, Mosteiro S, Castellanos Rodrigo MDM, Amaya Pascasio L, Hidalgo C, Freijo Guerrero MDM, Gonzalez Diaz E, Ramirez Moreno JM, Fernandez Prudencio L, Terceno Izaga M, Bashir Viturro S, Gamero-Garcia MA, Jimenez Jorge S, Rosso Fernandez C, Montaner J, Gonzalez Garcia A. 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). Trials. 2024 Jan 9;25(1):35. doi: 10.1186/s13063-023-07817-9.
Other Identifiers
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ATILA-ictus-2021
Identifier Type: -
Identifier Source: org_study_id
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