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    Summary
    EudraCT Number:2021-005272-19
    Sponsor's Protocol Code Number:20190184
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2021-005272-19
    A.3Full title of the trial
    EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Early Evolocumab Administration on Cardiovascular Events after Acute Myocardial Infarction
    A.3.2Name or abbreviated title of the trial where available
    EVOLVE-MI: EVOLocumab Very Early after Myocardial Infarction
    A.4.1Sponsor's protocol code number20190184
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen AB
    B.5.2Functional name of contact pointMedical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressGustav IIIs Boulevard 54
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-169 27
    B.5.3.4CountrySweden
    B.5.4Telephone number+4686951100
    B.5.6E-mailmedinfo.sweden@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Repatha 140 mg Solution for Injection in Pre-filled Pen
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEvolocumab, prefilled autoinjector pen (AI/pen)
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia
    E.1.1.1Medical condition in easily understood language
    Abnormal amounts of lipids in the blood
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effectiveness of treatment with evolocumab plus routine lipid management compared with routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization and all-cause death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI).
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting on percent reduction of low-density lipoprotein cholesterol (LDL-C) at 12 weeks and 52 weeks following initiation.
    To evaluate the effectiveness of treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and cardiovascular death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI).
    To evaluate the effect of treatment with evolocumab plus routine lipid management vs routine lipid management alone on the risk of:
    - first myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the study only if all of the following criteria apply:
    - Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
    OR
    - Subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.

    - Age ≥ 18 years (eg, if no upper age limit).
    - Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease.
    E.4Principal exclusion criteria
    Disease Related
    - Patients requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
    - Patients with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension,
    stress induced cardiomyopathy).).

    Other Medical Conditions
    - History or evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator(s), Amgen physician or designee would pose a risk to the patient’s safety or interfere with the study assessments, procedures, completion, or result in a life expectancy of less than 1 year.

    Prior/Concomitant Therapy
    - Previously received or receiving any therapy to inhibit PCSK9 in the following timeframe:
    • Evolocumab, alirocumab, or any other monoclonal antibody against PCSK9 within 3 months prior to screening.
    • Inclisiran within 6 months prior to screening.

    Prior/Concurrent Clinical Study Experience
    Currently receiving treatment in another investigational (not approved for any use in the country the subject is to be randomized) device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

    Other Exclusions
    - Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 15 weeks after the last dose of investigational product.
    - Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product.
    - Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product.
    - Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
    - Subject has known sensitivity to any of the products or components to be administered during dosing.
    - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.

    History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    E.5 End points
    E.5.1Primary end point(s)
    Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3.5 years
    E.5.2Secondary end point(s)
    • Percent LDL-C change from baseline to 12 weeks and 52 week in a subset of approximately 300 selected subjects.
    • Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death.
    • Time to the first occurrence of the composite of myocardial infarction, ischemic stroke, revascularization procedure, and all-cause death.
    • Total myocardial infarctions
    • Total arterial revascularization procedures
    • Total ischemia-driven coronary revascularization procedures
    • Total ischemic strokes
    • Cardiovascular death
    • All-cause death
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and each scheduled yearly visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Standard of care
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, antibody testing), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1780
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state700
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 6000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects may be eligible for continued treatment with Amgen investigational product(s) by an extension protocol or as provided for by the local country's regulatory mechanism. However, Amgen reserves the unilateral right, at its sole discretion, to determine whether to supply Amgen investigational product(s) and by what mechanism, after the termination of the study and before the product(s) is/are available commercially.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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