BACKGROUND: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. METHODS: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). CONCLUSION: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.

3rd Faculty of Medicine Charles University and Cardiocentre Kralovske Vinohrady Prague Czech Republic

AP HP Hôpitaux de l'Est Parisien Hôpital Saint Antoine Department of Cardiology Sorbonne Université INSERM UMR S_938 Centre de Recherche Saint Antoine Paris France

Cardiology department Nîmes university Hospital Montpellier University ACTION study group Nîmes France

CH Auxerre Département de Cardiologie Auxerre France

CH d'Antibes Juan Les Pins Département de Cardiologie Antibes Juan Les Pins France

CH de Bastia Département de Cardiologie Bastia France

CH de Chartres Département de Cardiologie Chartes France

CH de Versailles Service de Cardiologie Hôpital A Mignot Le Chesnay France

CHU Ambroise Paré Université Versailles Saint Quentin ACTION study Group INSERM U1018 CESP Boulogne France Service de Cardiologie

CHU de Caen Département de Cardiologie; Caen France

CHU de Poitiers Service de Cardiologie Poitiers France

CHU de Toulouse Département de Cardiologie Toulouse France

CHU Trousseau Tours Département de Cardiologie Tours France

Clinique Sainte Clotilde La Réunion Département de Cardiologie La Réunion France

Department of Cardiology Inserm U942 Lariboisière Hospital Assistance Publique Hôpitaux de Paris University of Paris Paris France

FACT DHU FIRE Hôpital Bichat AP HP Université de Paris Inserm U 1148 Paris France

GCS de Cardiologie de la Côte Basque CH Bayonne Bayonne France

Grand Hôpital de l'Est Francilien site Marne La Vallée Département de Cardiologie Marne La Vallée France

Hôpital Privé Dijon Bourgogne Cardiologie Interventionelle GCIDB VALMY Dijon France

Institut Mutualiste Montsouris Département de Cardiologie Paris France

Les Grands Prés Cardiac Rehabilitation center Villeneuve St Denis France

Sorbonne Université ACTION Study Group INSERM UMRS1166 Hôpital Pitié Salpêtrière Paris France

Unité de Recherche Clinique ACTION Study Group Hôpital Fernand Widal Paris France; SAMM Statistique Analyse et Modélisation Multidisciplinaire EA 4543 Université Paris 1 Panthéon Sorbonne Paris France

Univ Rennes CHU Rennes Inserm LTSI U1099 Rennes France

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ClinicalTrials.gov
NCT02617290