Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.
Am Heart J
; 225: 27-37, 2020 07.
Article
em En
| MEDLINE
| ID: mdl-32473356
ABSTRACT
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ticlopidina
/
Inibidores da Agregação Plaquetária
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Doença das Coronárias
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Antagonistas do Receptor Purinérgico P2Y
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Intervenção Coronária Percutânea
/
Clopidogrel
/
Infarto do Miocárdio
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Aged
/
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article