ATILA Project: Aspirin vs Tirofiban in endovascular treatment for patients with acute ischemic stroke due to Tandem Lession.

Phase 1

• Conditions: Acute Ischemic Stroke; MedDRA version: 20.0Level: HLTClassification code 10008192Term: Cerebrovascular and spinal necrosis and vascular insufficiencySystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLGTClassification code 10003216Term: Arteriosclerosis, stenosis, vascular insufficiency and necrosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003874-30-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI).

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• Patients under 18 years of age.
• 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 INR (International Normalized Ratio) > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified