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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: (1) index event occurring under aspirin; (2) body mass index ≥27 kg/m 2); (3) 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 vs once daily low-dose aspirin (100 mg bid vs 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 registration

ClinicalTrials.gov Identifier: NCT02520921.

Details

Subject
Patients;
Acute coronary syndromes;
Aspirin;
Diabetes;
Stroke;
Cerebral infarction;
Stenosis;
Body size;
Diabetes mellitus;
Myocardial infarction;
Platelet aggregation;
Working groups;
Body mass index;
Platelets;
Ischemia;
Drug dosages;
Prostaglandin endoperoxide synthase
Location
France
Title
Twice-a-day administration of aspirin in patients with diabetes mellitus or aspirin resistance after acute coronary syndrome: Rationale and design of the randomized ANDAMAN trial
Author
Jean-Guillaume Dillinger 1   VIAFID ORCID Logo  ; Pezel, Théo 2 ; Batias, Laure 3 ; Angoulvant, Denis 4 ; Goralski, Marc 5 ; Ferrari, Emile 6 ; Cayla, Guillaume 7 ; Silvain, Johanne 8 ; Gilard, Martine 9 ; Lemesle, Gilles 10 ; Souteyrand, Géraud 11 ; Lim, Pascal 12 ; Roubille, François 13 ; Jean-Louis, Georges 14 ; Claire Bal dit Sollier 15 ; Petroni, Thibaut 16 ; Morel, Olivier 17 ; Delarche, Nicolas 18 ; Meier Elbaz 19 ; Puymirat, Etienne 20 ; Toupin, Solenn 2 ; Montalescot, Gilles 8 ; Drouet, Ludovic 15 ; Vicaut, Eric 21 ; Henry, Patrick 22 

1  Department of Cardiology, Université Paris Cité, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Inserm MASCOT - UMRS, Paris, France; MIRACL.ai Laboratory, Multimodality Imaging for Research and Artificial Intelligence Core Laboratory, University Hospital of Lariboisiere (AP-HP), Paris, France; Centre de Référence et d’Education des antithrombotiques d’Ile de France, CREATIF, Hôpital Lariboisière, Publique-Hôpitaux de Paris, Paris, France 
2  Department of Cardiology, Université Paris Cité, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Inserm MASCOT - UMRS, Paris, France; MIRACL.ai Laboratory, Multimodality Imaging for Research and Artificial Intelligence Core Laboratory, University Hospital of Lariboisiere (AP-HP), Paris, France 
3  Centre Hospitalier Métropole Savoie, Service de Cardiologie, Place Lucien Biset, Chambéry, France 
4  Cardiology Department, CHU Tours, INSERM Unité 1327 ISCHEMIA, Université de Tours, Tours, France 
5  Cardiology Department, CHU Orléans, Orléans, France 
6  Cardiology Department, Pasteur University Hospital, Nice, France 
7  Cardiology Department, Nimes University Hospital, Montpellier University, ACTION Group, Nimes, France 
8  Department of Cardiology, Sorbonne Université, ACTION Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France 
9  Chest Diseases, CHU_Brest, INSERM U1304, Univ_Brest, Brest, France 
10  Heart and Lung Institute, University hospital of Lille, CHU Lille, Institut Pasteur of Lille, Inserm U1011-EGID, FACT (French Alliance for Cardiovascular Trials), Paris, France 
11  Institut Pascal, Thérapies Guidées par l'Image, CNRS SIGMA UCA UMR 6602 University Hospital Gabriel Montpied, Clermont-Ferrand, France 
12  Service de Cardiologie, Univ Paris Est Créteil, INSERM, IMRB, AP-HP, Hôpital Universitaire Henri-Mondor, Créteil, France 
13  Cardiology Department, PhyMedExp, Université de Montpellier, INSERM, CNRS, INI-CRT, CHU de Montpellier, France 
14  Centre Hospitalier de Versailles, Service de cardiologie, cardiologie interventionnelle, Hôpital André Mignot, Le Chesnay-Rocquencourt, France 
15  Centre de Référence et d’Education des antithrombotiques d’Ile de France, CREATIF, Hôpital Lariboisière, Publique-Hôpitaux de Paris, Paris, France 
16  Cardiology Department, Clinique Pont de Chaume, Montauban, France 
17  Division of Cardiovascular Medicine, Nouvel Hôpital Civil, Strasbourg University Hospital, UR 3074 Translational CardioVascular Medicine CRBS, Strasbourg, France 
18  Cardiology Department, Hôpital François Mitterrand, Pau, France 
19  Center for Clinical Investigation (CIC1436)/CARDIOMET, Rangueil University Hospital, Toulouse, France 
20  Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Université de Paris Cité, Paris, France 
21  Unité de Recherche Clinique, ACTION Group, Hôpital Fernand Widal (AP-HP), Paris, France 
22  Department of Cardiology, Université Paris Cité, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Inserm MASCOT - UMRS, Paris, France 
Publication title
The American Heart Journal; Philadelphia
Volume
288
Pages
101-110
Publication year
2025
Publication date
Oct 2025
Section
Trial Designs
Publisher
Elsevier Limited
Place of publication
Philadelphia
Country of publication
United Kingdom
Publication subject
Medical Sciences--Cardiovascular Diseases
ISSN
00028703
e-ISSN
10976744
Source type
Scholarly Journal
Language of publication
English
Document type
Evidence Based Healthcare, Journal Article
DOI
https://doi.org/10.1016/j.ahj.2025.04.016
ProQuest document ID
3215511233
Document URL
https://www.proquest.com/scholarly-journals/twice-day-administration-aspirin-patients-with/docview/3215511233/se-2?accountid=208611
Copyright
©2025. The Author(s)
Last updated
2025-06-10
Database
2 databases
  • ProQuest One Academic
  • ProQuest One Academic