Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI (AMUNDSEN)
STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
About this trial
This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring STEMI, NSTEMI, PCI, STATIN, EVOLOCUMAB, Anti-PCSK9, LDL-C
Eligibility Criteria
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:
- Age≥18
- 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
- Statin at maximal tolerated dose, as part of the standard of care at randomization
- 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.
Sites / Locations
- ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Evolocumab + SOC
Standard of care (SOC)
Investigational Product is open label Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 12 months.
management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria