ACETYLSALICYLIC ACID for Non-cardioembolic ischemic stroke|Ischaemic stroke

Stratification factors

• Gender

Inclusion criteria

• {"criterion_text":"- Aged ≥18 years old\n- Males and females\n- Non-cardioembolic ischemic stroke within the previous 14 days\n- Starting/prosecuting secondary prevention with single or double anti-platelet therapy after the index stroke\n- Written informed consent (informed consent can be obtained on incapacitated patients in accordance with national legislation (versions “ex art. 82” of informed consent to study participation and data treatment consent)"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to aspirin, clopidogrel or ticlopidine, or to any of the excipient.\n- Severe renal impairment.\n- Uncontrolled severe cardiac failure.\n- Methotrexate used at doses equal to or greater than 15 mg/week. Combination with other potentially myelotoxic drugs. Subjects with or who have had leukopenia, thrombocytopenia, or agranulocytosis.\n- Concurrent need for anticoagulation for any indication.\n- Contraindication to study drugs.\n- Indications to perform carotid revascularization surgery.\n- Pregnancy and breastfeeding; WOCBP not using acceptable contraception during the trial period (combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral tubal occlusion. vasectomised partner, sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide).\n- History of asthma induced by the administration of acetylsalicylates or substances with a similar activity, especially nonsteroidal anti-inflammatory drugs.\n- Active or previous recurrent peptic ulcer and/or gastric/intestinal bleeding, or other types of bleeding such as cerebrovascular hemorrhage.\n- Bleeding diathesis; coagulation disorders such as hemophilia and thrombocytopenia.\n- Severe hepatic impairment."}

Primary endpoints

• {"endpoint_text":"- 12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.","definition_or_measurement_approach":"Time-to-first-event analysis over 12 months for the composite outcome of ischemic stroke, myocardial infarction, or cardiovascular death."}

Secondary endpoints

• {"endpoint_text":"- Adherence to treatment, tested at the 3-month and 12-month follow-up visit via: •\tRate of ‘good adherence’ (score ≥20) at the 5-item Medication Adherence Report Scale (MARS-5, total score 5–25). •\tRate of responder status (ASPI/ADP based on appropriate drug) at the follow-up aggregation test.","definition_or_measurement_approach":"Adherence measured at 3 and 12 months using MARS-5 (good adherence defined as score ≥20) and responder status assessed by platelet aggregation (ASPI/ADP) at follow-up."}
• {"endpoint_text":"- Good Functional status at 12 months, defined and adjudicated according to modified Rankin Scale 0-2.","definition_or_measurement_approach":"Functional outcome adjudicated using modified Rankin Scale; good status defined as mRS 0–2 at 12 months."}
• {"endpoint_text":"- 12-month single-items of the composite primary outcome.","definition_or_measurement_approach":"Incidence at 12 months of each individual component of the primary composite (ischemic stroke, myocardial infarction, cardiovascular death)."}
• {"endpoint_text":"- 12-month incidence of single-items of the composite safety outcome.","definition_or_measurement_approach":"Incidence at 12 months of individual components of the composite safety outcome (major and minor bleeding events)."}
• {"endpoint_text":"- Gender differences in the primary and secondary outcomes","definition_or_measurement_approach":"Analysis of outcomes stratified by gender to evaluate differences in primary and secondary endpoints."}
• {"endpoint_text":"- Prevalence in CYP2C192 and CYP2C1917 polymorphisms rate between responders and non-responders.","definition_or_measurement_approach":"Genetic polymorphism (CYP2C19*2 and CYP2C19*17) prevalence compared between responder and non-responder groups."}
• {"endpoint_text":"- 3-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.","definition_or_measurement_approach":"Time-to-first-event analysis over 3 months for the composite outcome of ischemic stroke, myocardial infarction, or cardiovascular death."}
• {"endpoint_text":"- 12-month incidence of major and minor bleeding (composite safety outcome).","definition_or_measurement_approach":"Incidence of major and minor bleeding events at 12 months as the composite safety outcome."}

Italy

Earliest CTIS Part Ii Submission Date

28-11-2025

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

140

Number Of Sites

3

Number Of Participants

1506

Primary sponsor

Full Name

Azienda Unita Sanitaria Locale Di Bologna

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy