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Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.
- Source :
-
American heart journal [Am Heart J] 2020 Jul; Vol. 225, pp. 27-37. Date of Electronic Publication: 2020 Apr 29. - Publication Year :
- 2020
-
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 P2Y <subscript>12</subscript> 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.<br />Methods: Assessment of Loading with the P2Y <subscript>12</subscript> 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).<br />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.<br /> (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Humans
Coronary Angiography
Randomized Controlled Trials as Topic
Clinical Trials, Phase III as Topic
Multicenter Studies as Topic
Clopidogrel therapeutic use
Coronary Disease therapy
Myocardial Infarction etiology
Myocardial Infarction prevention & control
Percutaneous Coronary Intervention adverse effects
Platelet Aggregation Inhibitors therapeutic use
Purinergic P2Y Receptor Antagonists therapeutic use
Ticlopidine therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 225
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 32473356
- Full Text :
- https://doi.org/10.1016/j.ahj.2020.04.017