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Набира участници Фаза 4 2025-523065-16-00

Tailored antiplatelet secondary prevention in non-cardioembolic ischemic stroke: a phase IV gender-stratified randomized controlled trial (TAILOR trial)

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Non-cardioembolic ischemic stroke

Спонсор: Azienda Unita Sanitaria Locale Di Bologna

Налично на: БГ
Обобщение
Trial status: Authorised Adherence to treatment, tested at the 3-month and 12-month follow-up visit via: • Rate of ‘good adherence’ (score ≥20) at the 5-item Medication Adherence Report Scale (MARS-5, total score 5–25). • Rate of responder status (ASPI/ADP based on appropriate drug) at the follow-up aggregation test., Good Functional status at 12 months, defined and adjudicated according to modified Rankin Scale 0-2., 12-month single-items of the composite primary outcome., 12-month incidence of single-items of the composite safety outcome., Gender differences in the primary and secondary outcomes, Prevalence in CYP2C192 and CYP2C1917 polymorphisms rate between responders and non-responders., 3-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death., 12-month incidence of major and minor bleeding (composite safety outcome). 12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.
Описание
Adherence to treatment, tested at the 3-month and 12-month follow-up visit via: • Rate of ‘good adherence’ (score ≥20) at the 5-item Medication Adherence Report Scale (MARS-5, total score 5–25). • Rate of responder status (ASPI/ADP based on appropriate drug) at the follow-up aggregation test., Good Functional status at 12 months, defined and adjudicated according to modified Rankin Scale 0-2., 12-month single-items of the composite primary outcome., 12-month incidence of single-items of the composite safety outcome., Gender differences in the primary and secondary outcomes, Prevalence in CYP2C192 and CYP2C1917 polymorphisms rate between responders and non-responders., 3-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death., 12-month incidence of major and minor bleeding (composite safety outcome).
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 1506 participants
Интервенции
Acido Acetilsalicilico Aurobindo 100 mg compresse gastroresistenti
Drug
TICLOPIDINA MYLAN GENERICS 250 mg compresse rivestite
Drug
Clopidogrel Zentiva 75 mg film-coated tablets
Drug
Места на провеждане 1
Италия (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.01.2026
Регистрационен номер
2025-523065-16-00
Източник
euclinicaltrials.eu
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