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

Prior treatment

• 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.
• Concurrent need for anticoagulation for any indication.
• Contraindication to study drugs.
• Indications to perform carotid revascularization surgery.
• Active or previous recurrent peptic ulcer and/or gastric/intestinal bleeding, or other types of bleeding such as cerebrovascular hemorrhage.

Other illness

• Known hypersensitivity to aspirin, clopidogrel or ticlopidine, or to any of the excipient.
• Severe renal impairment.
• Uncontrolled severe cardiac failure.
• History of asthma induced by the administration of acetylsalicylates or substances with a similar activity, especially nonsteroidal anti-inflammatory drugs.
• Bleeding diathesis; coagulation disorders such as hemophilia and thrombocytopenia.
• Severe hepatic impairment.

Other

• 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).

• Aged ≥18 years old
• Males and females
• Non-cardioembolic ischemic stroke within the previous 14 days
• Starting/prosecuting secondary prevention with single or double anti-platelet therapy after the index stroke
• 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)