Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.

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 suggest that PCI related myocardial infarction (MI) 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 (DAPT) by aspirin and clopidogrel in this setting. Methods ALPHEUS (Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting) (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, 1900 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 DAPT with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic endpoint is PCI-related myocardial infarction (MI 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 (BARC 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 endpoint for mortality. RCT# NCT02617290