Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment

Who is this study for? Patients with Acute Ischemic Stroke
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Patients with tandem lesions (TL) are defined as patients with an acute ischemic stroke (AIS) with occlusion of an intracranial vessel of the anterior circulation and an occlusion or severe stenosis (70-99%) of the origin of the ipsilateral internal carotid artery (ICA). The greatest current limitation in the management of this type of lesion is the use of antithrombotic medication (double antiaggregation) in the acute phase that is required in case of placing extracranial stent to stabilize the atheroma plaque. In relation to this antiplatelet regimen, the latest clinical practice guidelines warn about the risk of combining intravenous fibrinolysis with antiplatelet medication in the acute phase, since it seems to increase the risk of symptomatic intracranial hemorrhage (sICH). However, the non-stabilization of the carotid atheroma plaque is associated with higher rates of cervical reocclusion, poorer functional prognosis, and higher mortality. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.

• 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.

Locations
Other Locations
Spain
Complexo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
General Hospital Dr. Balmis (Alicante)
ACTIVE_NOT_RECRUITING
Alicante
Complejo Hospitalario Torrecárdenas
RECRUITING
Almería
Complejo Hospital Universitario de Badajoz
RECRUITING
Badajoz
Germans Trias i Pujol Hospital
NOT_YET_RECRUITING
Badalona
Hospital Universitario de Cruces
RECRUITING
Bilbao
Reina Sofía Hospital
RECRUITING
Córdoba
Josep Trueta Hospital
RECRUITING
Girona
Ramón y Cajal Hospital
RECRUITING
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia
RECRUITING
Murcia
Virgen del Rocío Hospital
RECRUITING
Seville
Virgen Macarena Hospital
RECRUITING
Seville
Hospital Universitario y Politécnico de La Fe
RECRUITING
Valencia
Contact Information
Primary
Clara M Rosso-Fernández, PhD
claram.rosso.sspa@juntadeandalucia.es
0034 955012144
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 240
Treatments
Experimental: 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).
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

This content was sourced from clinicaltrials.gov