Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI

  • STATUS
    Recruiting
  • End date
    Sep 29, 2023
  • participants needed
    1666
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 10 October 2021

Summary

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).

The objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up on the overall population.

Central randomization uses an IWRS. Stratification is by center and stratum with random block size, generated according to the procedures of the sponsor, by a statistician not involved in the study.

Description

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.

That's why the 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).

Details
Condition STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
Treatment Standard of Care (SOC), Evolocumab 140 mg/mL
Clinical Study IdentifierNCT04951856
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant meeting all of the following criteria will be considered for
enrolment into the
study
Male or female
Diagnosis of STEMI or NSTEMI
STEMI defined as
symptoms of acute MI of at least 30 min AND
within the previous 24 hours with new persistent ST-segment elevation 1 mm in 2 continuous ECG leads AND
an indication for primary PCI AND
> 55 years
NSTEMI defined as
Age18
a history of chest discomfort or ischemic symptoms of 10 minutes duration at rest 48 hours prior to entry into the study with no evidence of persistent ST-segment elevation and with an elevated troponin ( the upper limit of normal according to local laboratory norms), AND
indication for a coronary angiogram within 72hrs AND
indication for PCI AND
at least one the following high-risk characteristics: Diabetes Peripheral Artery Disease Multivessel ( 2 or LM) disease on the coronary angiogram History of MI or stroke without sequels prior to randomization eGFR: 15 to 45 mL/min/1.73 m2 calculated with MDRD formula at randomization 3. Statin at maximal tolerated dose, as part of the standard of care at randomization 4. Informed consent obtained in writing at enrolment into the study

Exclusion Criteria

Participant presenting with any of the following will not be included in the
study
Fibrinolysis treatment
Planned CABG
Ongoing hemodynamic instability defined as any of the following
Killip Class III or IV
Sustained and/or symptomatic hypotension (systolic blood pressure < 80 mm Hg)
Known left ventricular ejection fraction < 30%
Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
Active malignancy
A comorbid condition with an estimated life expectancy of 12 months
Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
Known sensitivity to any of the products or components to be administered during study
Female subject is pregnant, had a positive pregnancy test at inclusion, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 17 weeks after the last dose of IMP
Currently receiving treatment in any other investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies)
Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge
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