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

Conditions

Non-cardioembolic ischemic stroke

Brief summary

12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.

Detailed 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).

Related papers

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Interventions

DRUGTICLOPIDINA MYLAN GENERICS 250 mg compresse rivestite

DRUGClopidogrel Zentiva 75 mg film-coated tablets

DRUGAcido Acetilsalicilico Aurobindo 100 mg compresse gastroresistenti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Outcome results

None listed