ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem Lesion

PHASE4RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Acute Ischemic Stroke
Interventions
DRUG

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.

DRUG

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 In case of exceeding this time, the patient will be withdrawn from the trial.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.

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Germans Trias i Pujol Hospital, Badalona

RECRUITING

Complexo Hospitalario Universitario A Coruña, A Coruña

ACTIVE_NOT_RECRUITING

General Hospital Dr. Balmis (Alicante), Alicante

RECRUITING

Complejo Hospitalario Torrecárdenas, Almería

RECRUITING

Complejo Hospital Universitario de Badajoz, Badajoz

RECRUITING

Hospital Universitario de Cruces, Bilbao

RECRUITING

Reina Sofía Hospital, Córdoba

RECRUITING

Josep Trueta Hospital, Girona

RECRUITING

Ramón y Cajal Hospital, Madrid

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Murcia

RECRUITING

Virgen del Rocío Hospital, Seville

RECRUITING

Virgen Macarena Hospital, Seville

RECRUITING

Hospital Universitario y Politécnico de La Fe, Valencia

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER