Overview

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.

Eligibility

Inclusion Criteria:

        Participant meeting all of the following criteria will be considered for enrolment into the
        study:
          1. Male or female
          2. 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
          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:
          1. Fibrinolysis treatment
          2. Planned CABG
          3. 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%
          4. Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active
             biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
          5. Active malignancy
          6. A comorbid condition with an estimated life expectancy of ≤ 12 months
          7. Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
          8. Known sensitivity to any of the products or components to be administered during study
          9. 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
         10. 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).
         11. 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.