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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Unita Sanitaria Locale Di Bologna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-01-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate that a tailored prescription of antiplatelet drugs can cut the rate of 12-month major cardiovascular events compared to usual care

Secondary objectives 5

1. adverse events, including major and minor bleeding
2. to evaluate adherence to treatment
3. to explore gender-based differences
4. to evaluate the rate of CYP2C192 and CYP2C1917 polymorphisms
5. rate of 3-month major cardiovascular events compared to usual care

Conditions and MedDRA coding

Non-cardioembolic ischemic stroke

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Aged ≥18 years old
2. Males and females
3. Non-cardioembolic ischemic stroke within the previous 14 days
4. Starting/prosecuting secondary prevention with single or double anti-platelet therapy after the index stroke
5. 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 12

1. Known hypersensitivity to aspirin, clopidogrel or ticlopidine, or to any of the excipient.
2. Concurrent need for anticoagulation for any indication.
3. Contraindication to study drugs.
4. Indications to perform carotid revascularization surgery.
5. 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).
6. History of asthma induced by the administration of acetylsalicylates or substances with a similar activity, especially nonsteroidal anti-inflammatory drugs.
7. Active or previous recurrent peptic ulcer and/or gastric/intestinal bleeding, or other types of bleeding such as cerebrovascular hemorrhage.
8. Bleeding diathesis; coagulation disorders such as hemophilia and thrombocytopenia.
9. Severe hepatic impairment.
10. Severe renal impairment.
11. Uncontrolled severe cardiac failure.
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.

Secondary endpoints 8

1. 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.
2. Good Functional status at 12 months, defined and adjudicated according to modified Rankin Scale 0-2.
3. 12-month single-items of the composite primary outcome.
4. 12-month incidence of single-items of the composite safety outcome.
5. Gender differences in the primary and secondary outcomes
6. Prevalence in CYP2C192 and CYP2C1917 polymorphisms rate between responders and non-responders.
7. 3-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.
8. 12-month incidence of major and minor bleeding (composite safety outcome).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Unita Sanitaria Locale Di Bologna

Sponsor organisation

Azienda Unita Sanitaria Locale Di Bologna

Address

Largo Bartolo Nigrisoli 2

City

Bologna

Postcode

40133

Country

Italy

Scientific contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Public contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Principal Investigator

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications