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AMUNDSEN

Evolocumab or Normal strategies to reach guidelines LDL objectives in patients with acute myocardial infarction treated by percutaneous coronary intervention

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objectif

A phase IV, multicentric, randomized, real-world pragmatic study that compares a strategy of early LDL reduction with anti-PCSK9 in patients defined as extreme high risk by 2019 ESC/EAS guidelines vs. Standard of Care as defined by the guidelines but also constrained by current drug availabilities in the different participating countries.

date de réalisation

2021

nombre de patients

1666

nombre de centres participants

International multicentric trial

type de financement

Private (Fonds de Dotation ACTION & Amgen)

Référence

EUDRACT : 2021-000573-80

Acute Myocardial Infarction Upbound to PCI Immediately (STEMI) or in the Next Three Days (NSTEMI), and Randomized to Subcutaneous Evolocumab or Normal Strategies to Reach Guidelines LDL Objectives in the Real-world - The AMUNDSEN-real Study

Previous randomized studies and several meta-analyses have shown a positive effect of high-dose statins pretreatment on peri-procedural Myocardial Infarction (MI) incidence with favorable trends on mortality in both Acute Coronary Syndrome (ACS) and stable Coronary Artery Disease patients.
Numerous epidemiological studies, Mendelian randomization studies, and Randomized Controled Trials have consistently demonstrated a log-linear relationship between the absolute changes in plasma LDL-C and the risk of Cardio-Vascular (CV) disease. The effect of LDL-C on the risk of a new CV event appears to be determined by the absolute magnitude, the duration of exposure to LDL-C and possibly the time to reach the recommended target of low LDL in ACS patients.
There are good reasons to believe that the Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors could provide additional benefits when used early in MI patients treated with PCI revascularization.

Study Description

hypothesis of AMUNDSEN study is to demonstrate the superiority of a strategy using evolocumab before PCI in STEMI or NSTEMI patients versus standard of care (SOC) as described in the 2019 European Society of Cardiology / European Atherosclerosis Society (ESC/EAS) guidelines on dyslipidemia, to reach a Low-Density Lipoprotein Cholesterol (LDL-C) reduction of ≥ 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL) at the end of the study (LDL targets of the 2019 ESC/EAS guidelines).
The primary objective of ARCACHON trial is to demonstrate the non-inferiority of a strategy of clinical follow-up (without non-invasive stress testing) in asymptomatic patients with a history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing by the primary endpoint as the composite of: all-cause death, myocardial infarction, stroke or any cardiovascular event leading to unplanned hospitalization.
AMUNDSEN-real is a phase IV, international (7 European countries), multicenter, controlled, open label study randomized, in 2 parallel groups of patients with a diagnosis of STEMI or NSTEMI with an indication for PCI, using the PROBE study design (Prospective Randomised Open, Blinded Endpoint).

source clinicaltrials.gov

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