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Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study
- Source :
- American Heart Journal, American Heart Journal, Elsevier, 2020, 225, pp.27-37. ⟨10.1016/j.ahj.2020.04.017⟩, American Heart Journal, 2020, 225, pp.27-37. ⟨10.1016/j.ahj.2020.04.017⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
Abstract
- International audience; 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.
- Subjects :
- medicine.medical_specialty
Ticlopidine
medicine.medical_treatment
Myocardial Infarction
Coronary Disease
030204 cardiovascular system & hematology
Coronary Angiography
Loading dose
Coronary artery disease
03 medical and health sciences
0302 clinical medicine
Percutaneous Coronary Intervention
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
Internal medicine
medicine
Humans
030212 general & internal medicine
Myocardial infarction
cardiovascular diseases
Aged
Aspirin
business.industry
Percutaneous coronary intervention
medicine.disease
Clopidogrel
3. Good health
Conventional PCI
Cardiology
Purinergic P2Y Receptor Antagonists
[SDV.IB]Life Sciences [q-bio]/Bioengineering
Cardiology and Cardiovascular Medicine
business
Ticagrelor
Platelet Aggregation Inhibitors
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 00028703 and 10976744
- Database :
- OpenAIRE
- Journal :
- American Heart Journal, American Heart Journal, Elsevier, 2020, 225, pp.27-37. ⟨10.1016/j.ahj.2020.04.017⟩, American Heart Journal, 2020, 225, pp.27-37. ⟨10.1016/j.ahj.2020.04.017⟩
- Accession number :
- edsair.doi.dedup.....3339f7b1c15097f63e9156b8279faee3