American heart journal · 2025
Evolocumab before percutaneous coronary intervention for acute myocardial infarction: Design of the AMUNDSEN trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Montalescot Gilles, Bolognese Leonardo, Bartus Stanislaw, Cequier-Fillat Angel, Thiele Holger, Mach François, Jukema J Wouter, Ferrari Emile, Souteyrand Géraud, Bouleti Claire, Range Grégoire, Chioccioli Marco, Picchi Andréa, Batias-Moreau Laure, Esposito Giovanni, Braik Nassim, Redjimi Nassim, Duband Benjamin, Guedeney Paul, Zeitouni Michel, Brochard Karine, Silvain Johanne, Vicaut Eric, AMUNDSEN investigators of the ACTION Study Group
Аннотация
RATIONALE: PCSK9 inhibitors are currently recommended as third-line therapy for post-myocardial infarction (MI) patients, added to high-dose statin, ezetimibe, and potentially bempedoic acid when the LDL-C target of <55 mg/dL is not achieved. These guideline-driven indications result in delayed initiation of PCSK9 inhibitors, potentially missing the opportunity for benefit during the acute phase. Recent studies have demonstrated that early PCSK9 inhibition promotes anti-inflammatory effects and plaque stabilization, suggesting a potential role early in MI management.
METHODS: The AMUNDSEN trial is a randomized, international, phase IV study using a PROBE (Prospective Randomized Open, Blinded Endpoint) design to evaluate the effects of early PCSK9 inhibition in high-risk acute MI patients undergoing percutaneous coronary intervention (PCI). A total of 2,166 patients were enrolled, including those with ST-elevation MI undergoing primary PCI and those with non-ST-elevation MI with an indication for PCI, all presenting with at least 1 high-risk clinical characteristic. Patients were randomized to receive either immediate evolocumab prior to PCI alongside standard care or standard care alone. The primary objective is to achieve both a ≥ 50% reduction in LDL-C from baseline and a target LDL-C < 55 mg/dL at 12 months. The main clinical objective is to assess the composite of all-cause death or unplanned hospitalization for a cardiovascular (CV) reason at 12 months.
CURRENT STATUS: Enrollment and randomization are complete. Lipid and clinical follow-up are ongoing. Results from this study will clarify the lipid-lowering efficacy and clinical impact of early evolocumab initiation in the acute MI setting.
CONCLUSION: The AMUNDSEN trial will provide critical insights into the potential benefits of early PCSK9 inhibition in high-risk MI patients undergoing PCI.
CLINICAL TRIAL REGISTRATION: NCT (clinicaltrials.gov): 04951856 - EUCT number: 2024-518195-31-00.
METHODS: The AMUNDSEN trial is a randomized, international, phase IV study using a PROBE (Prospective Randomized Open, Blinded Endpoint) design to evaluate the effects of early PCSK9 inhibition in high-risk acute MI patients undergoing percutaneous coronary intervention (PCI). A total of 2,166 patients were enrolled, including those with ST-elevation MI undergoing primary PCI and those with non-ST-elevation MI with an indication for PCI, all presenting with at least 1 high-risk clinical characteristic. Patients were randomized to receive either immediate evolocumab prior to PCI alongside standard care or standard care alone. The primary objective is to achieve both a ≥ 50% reduction in LDL-C from baseline and a target LDL-C < 55 mg/dL at 12 months. The main clinical objective is to assess the composite of all-cause death or unplanned hospitalization for a cardiovascular (CV) reason at 12 months.
CURRENT STATUS: Enrollment and randomization are complete. Lipid and clinical follow-up are ongoing. Results from this study will clarify the lipid-lowering efficacy and clinical impact of early evolocumab initiation in the acute MI setting.
CONCLUSION: The AMUNDSEN trial will provide critical insights into the potential benefits of early PCSK9 inhibition in high-risk MI patients undergoing PCI.
CLINICAL TRIAL REGISTRATION: NCT (clinicaltrials.gov): 04951856 - EUCT number: 2024-518195-31-00.
Предметные рубрики MeSH
HumansPercutaneous Coronary InterventionAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLPCSK9 InhibitorsFemaleMaleMyocardial InfarctionProspective StudiesMiddle AgedAgedST Elevation Myocardial InfarctionClinical Trials, Phase IV as TopicMulticenter Studies as TopicRandomized Controlled Trials as TopicProprotein Convertase 9