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Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study
J. Silvain, G. Cayla, F. Beygui, G. Range, B. Lattuca, JP. Collet, JG. Dillinger, Z. Boueri, P. Brunel, C. Pouillot, F. Boccara, L. Christiaens, JN. Labeque, T. Lhermusier, JL. Georges, A. Bellemain-Appaix, H. Le Breton, M. Hauguel-Moreau, C....
Language English Country United States
Document type Clinical Trial Protocol, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest)
from 2002-01-01 to 2 months ago
Health Management Database (ProQuest)
from 2002-01-01 to 2 months ago
Public Health Database (ProQuest)
from 2002-01-01 to 2 months ago
- MeSH
- Purinergic P2Y Receptor Antagonists therapeutic use MeSH
- Myocardial Infarction etiology prevention & control MeSH
- Platelet Aggregation Inhibitors therapeutic use MeSH
- Clopidogrel therapeutic use MeSH
- Coronary Angiography MeSH
- Percutaneous Coronary Intervention adverse effects MeSH
- Coronary Disease therapy MeSH
- Humans MeSH
- Aged MeSH
- Ticlopidine therapeutic use MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Clinical Trial Protocol MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
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.
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 de Caen Département de Cardiologie
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
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
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
References provided by Crossref.org
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