Comparing Aspirin and Tirofiban for Treating Acute Ischemic Stroke with Tandem Lesions
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
This study is testing whether Tirofiban works better than Aspirin for treating patients with acute ischemic stroke caused by blockages in both the brain and neck arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 13 sites (Badalona, Barcelona and 12 other locations) |
| Trial ID | NCT05225961 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Tirofiban compared to Aspirin in patients experiencing acute ischemic stroke due to tandem lesions. Patients eligible for the study will have occlusions in both an intracranial vessel and the internal carotid artery, requiring thrombectomy and stent placement. The trial aims to evaluate the safety and efficacy of these antiplatelet medications during the acute phase of treatment, addressing the risks associated with current antithrombotic regimens. The study will enroll patients who meet specific criteria related to their stroke severity and age.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke from tandem lesions requiring thrombectomy and cervical stent placement.
Not a fit: Patients under 18 years of age or those with severe stroke as indicated by an ASPECTS score below 6 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and reduce complications for patients with acute ischemic stroke due to tandem lesions.
How similar studies have performed: While there is ongoing research in this area, the specific comparison of Tirofiban and Aspirin in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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 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.
Where this trial is running
Badalona, Barcelona and 12 other locations
- Germans Trias i Pujol Hospital — Badalona, Barcelona, Spain (Not_yet_recruiting)
- Complexo Hospitalario Universitario A Coruña — A Coruña, Spain (Recruiting)
- General Hospital Dr. Balmis (Alicante) — Alicante, Spain (Active_not_recruiting)
- Complejo Hospitalario Torrecárdenas — Almería, Spain (Recruiting)
- Complejo Hospital Universitario de Badajoz — Badajoz, Spain (Recruiting)
- Hospital Universitario de Cruces — Bilbao, Spain (Recruiting)
- Reina Sofía Hospital — Córdoba, Spain (Recruiting)
- Josep Trueta Hospital — Gerona, Spain (Recruiting)
- Ramón y Cajal Hospital — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca, Murcia — Murcia, Spain (Recruiting)
- Virgen del Rocío Hospital — Seville, Spain (Recruiting)
- Virgen Macarena Hospital — Seville, Spain (Recruiting)
- Hospital Universitario y Politécnico de La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Elena Zapata-Arrizada, PhD — Virgen del Rocío Hospital, Seville, Spain
- Study coordinator: Clara M Rosso-Fernández, PhD
- Email: claram.rosso.sspa@juntadeandalucia.es
- Phone: 0034 955012144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.