Guillaume Cayla1, Thomas Cuisset2, Johanne Silvain3, Patrick Henry4, Florence Leclercq5, Didier Carrié6, Christophe Saint Etienne7, Loic Belle8, Grégoire Rangé9, Christophe Pouillot10, Olivier Varenne11, Eric Van Belle12, Ziad Boueri13, Pascal Motreff14, Simon Elhadad15, Nicolas Delarche16, Rami El Mahmoud17, Eric Vicaut18, Jean-Philippe Collet3, Gilles Montalescot19. 1. Service de Cardiologie, CHU Carémeau, Nîmes, France. 2. Departement de Cardiologie, Hôpital de la Timone, Marseille, France. 3. Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France. 4. Service de Cardiologie, Hôpital Lariboisière, Paris, France. 5. Departement de Cardiologie, CHU, Montpellier, France. 6. Service de Cardiologie, CHU, Toulouse, France. 7. Service de Cardiologie, CHU, Tours, France. 8. Service de Cardiologie, CH, Annecy, France. 9. Service de Cardiologie, Hôpital Louis Pasteur, Le Coudray, France. 10. Clinique Sainte Clotilde, Saint Denis, La Réunion, France. 11. Service de Cardiologie, Hôpital Cochin, Paris, France. 12. Service de Cardiologie CHRU, Lille, France. 13. Service de Cardiologie, CH, Bastia, France. 14. Service de Cardiologie, CHRU, Clermont-Ferrand, France. 15. Service de Cardiologie, CH, de Lagny, Marne-la-Vallée, France. 16. Hôpital François Mitterand, CH, Pau, France. 17. Hôpital Ambroise Paré, Boulogne-Billancourt, France. 18. Unité de Recherche Clinique Lariboisère, Hôpital Fernand Widal, Paris, France. 19. Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France. Electronic address: gilles.montalescot@psl.aphp.fr.
Abstract
BACKGROUND:Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio. STUDY DESIGN: The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy usingprasugrel 5 mg without monitoring and without adjustment (Conventional Treatment Arm) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome (ACS). ANTARCTIC is a multicenter, prospective, open-label study with 2 parallel arms. A total of 852 elderly patients (≥ 75 years) undergoing stent percutaneous coronary intervention for ACS are to be enrolled. The primary end point is the time to first occurrence of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, urgent revascularization, and bleeding complications (Bleeding Academic Research Consortium definition 2, 3, or 5). Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment. CONCLUSION: ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.
RCT Entities:
BACKGROUND: Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio. STUDY DESIGN: The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment (Conventional Treatment Arm) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome (ACS). ANTARCTIC is a multicenter, prospective, open-label study with 2 parallel arms. A total of 852 elderly patients (≥ 75 years) undergoing stent percutaneous coronary intervention for ACS are to be enrolled. The primary end point is the time to first occurrence of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, urgent revascularization, and bleeding complications (Bleeding Academic Research Consortium definition 2, 3, or 5). Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment. CONCLUSION: ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.
Authors: Jaya Chandrasekhar; Benjamin Hibbert; Michael Froeschl; Derek So; Roxana Mehran; Michel Le May Journal: Eur J Clin Pharmacol Date: 2015-10-09 Impact factor: 2.953