Abstract
BACKGROUND: Patients with diabetes mellitus (DM) or aspirin resistance are exposed to recurrent atherothrombotic events after acute coronary syndrome (ACS). Aspirin once-daily can allow the recovery of platelet cyclooxygenase activity before the next intake in these patients. Twice-daily administration provides more stable inhibition of platelet aggregation and may improve prognosis in these patients.AIM: To demonstrate the superiority of twice-daily aspirin compared to once daily in reducing major adverse cardiovascular events (MACE) in patients with DM or aspirin resistance after ACS.METHODS: The ANDAMAN trial is a randomized, multicenter study including patients (aged ≥18 years) with DM or with aspirin resistance defined as: i) index event occurring under aspirin; ii) body mass index ≥ 27 kg/m2); iii) increased waist circumference (≥ 88 cm for women or ≥ 102 cm for men). The patients will be recruited in 39 centers after an ACS (with or without ST elevation) with at least one significant coronary stenosis and will be randomized before hospital discharge between twice-daily versus once daily low-dose aspirin (100 mg bid versus od). The primary composite endpoint will be the occurrence of MACE including all-cause death, myocardial infarction, stroke, urgent coronary revascularization or acute arterial thrombotic event during a follow-up of 18 months. To achieve a 20% reduction in the relative risk of MACE in the twice-daily aspirin group, a total of 2,574 patients will be included in the trial. The main secondary endpoint will be major bleeding (type 3-5 following BARC classification).CONCLUSIONS:The trial will evaluate the prognostic impact of twice-daily aspirin for ACS patients with DM or aspirin resistance and may change the way aspirin is administered to these patients.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT02520921