Tailored antiplatelet secondary prevention in non-cardioembolic ischemic stroke: a phase IV gender-stratified randomized controlled trial (TAILOR trial)
Phase 4 – monitoring after market approval
Conditions:
Non-cardioembolic ischemic stroke
Sponsor: Azienda Unita Sanitaria Locale Di Bologna
trial.available_in:
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Overview
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.
Description
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).
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 1506 participants
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