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    Summary
    EudraCT Number:2017-001502-15
    Sponsor's Protocol Code Number:2016-01382
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-27
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001502-15
    A.3Full title of the trial
    Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts with Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Alirocumab on coronary plaque formation in patients with acute heart infarct. A serial, multivessel imaging study.
    Vergleich des Effektes von Alirocumab auf die koronare Plaquebildung bei Patienten mit akutem Herzinfarkt. Eine serielle Mehrgefäss-Bildgebungsuntersuchung.
    A.3.2Name or abbreviated title of the trial where available
    PACMAN-AMI
    A.4.1Sponsor's protocol code number2016-01382
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03067844
    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 SponsorInsel Gruppe AG - Inselspital
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAKH Vienna, Medical University of Vienna
    B.5.2Functional name of contact pointProf. Dr. Irene Lang
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post codeA-1090
    B.5.3.4CountryAustria
    B.5.4Telephone number4314040046140
    B.5.6E-mailirene.lang@meduniwien.ac.at
    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 Praluent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALIROCUMAB
    D.3.9.3Other descriptive nameALIROCUMAB
    D.3.9.4EV Substance CodeSUB170596
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients presenting with acute myocardial infarction (non-ST-elevation myocardial infarction or acute ST-elevation myocardial infarction) and with elevated cholesterol levels.
    E.1.1.1Medical condition in easily understood language
    Patients with acute heart infarct and elevated cholesterol (fat-like substance) levels.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028597
    E.1.2Term Myocardial infarction acute
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of the PCSK9 inhibitor alirocumab on the change in percent atheroma volume (PAV) at week 52 in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) in the infarct-related artery and receiving uidelinerecommended high-intensity statin therapy.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of the PCSK9 inhibitor alirocumab on the change in lipid core burden index (defined by NIRS), macrophage accumulation, and fibrous cap thickness of coronary plaques (defined by OCT) as compared with placebo in the non-infarct-related coronary arteries;
    To assess the effect of alirocumab on change in lipid levels
    (cholesterol, LDL-C, HDL-C, Lp(a), triglycerides, non-HDL-C, Apo B, Apo A-1, ratio Apo B/Apo A-1, Apo C-III), inflammatory biomarkers (hs-CRP, TNFa, IL-1b, IL-6, MPO, cystatine, SIRT1, SIRT6) and other selected biomarkers (hs-troponin T, NT-pro-BNP) and explore possible associations with changes in coronary plaque characteristics;
    To evaluate adverse events in patients treated with alirocumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Acute myocardial infarction: acute ST-segment elevation myocardial infarction (STEMI) with pain onset within ≤24h, or non-ST segment elevation myocardial infarction (NSTEMI), with at least one coronary segment (culprit lesion) requiring PCI;
    LDL-C ≥70 mg/dL (≥1.8 mmol/L) assessed prior to, or during PCI in patients who have been receiving any stable statin regimen within ≥ 4 weeks prior to enrollment; OR LDL-C ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been on stable statin regimen
    for ≥ 4 weeks prior to enrollment;
    At least two major native coronary arteries ("target vessels") each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure;
    Hemodynamic stability allowing the repetitive administration of nitroglycerine;
    Ability to understand the requirements of the study and to provide informed consent;
    Willingness to undergo follow-up intracoronary imaging
    E.4Principal exclusion criteria
    Left-main disease, defined as ≥50% reduction in lumen diameter of the left main coronary artery by angiographic visual estimation;
    Three-vessel disease;
    History of coronary artery bypass surgery;
    TIMI flow <2 of the infarct-related artery after PCI;
    Unstable clinical status (hemodynamic or electrical instability);
    Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation;
    Uncontrolled cardiac arrhythmia;
    Severe renal dysfunction;
    Active liver disease or hepatic dysfunction;
    Known intolerance to rosuvastatin OR known statin intolerance ;
    Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel;
    Known sensitivity to any substances to be administered, including known statin intolerance
    Patients who previously received alirocumab or other PCSK9 inhibitor;
    Patient who received cholesterol ester transfer protein inhibitors in the
    past 12 months prior to screening; Treatment with systemic steroids or
    systemic cyclosporine in the past 3 months;
    Known active infection or major hematologic, metabolic, or endocrine
    dysfunction;
    Planned surgery within 12 months;
    Patients who will not be available for study-required visits;
    Current enrollment in another investigational device or drug study;
    History of cancer within the past 5 years, except for adequately treated
    basal cell skin cancer, squamous cell skin cancer, or in situ cervical
    cancer;
    Estimated life expectancy less than 1 year;
    Female of childbearing potential (age <50 years and last menstruation
    within the last 12 months), who did not undergo tubal ligation,
    ovariectomy or hysterectomy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in percent atheroma volume (PAV)
    as determined by IVUS, between baseline and 52-week follow-up from
    matched regions of interest. This endpoint is used for the pre-specified
    sample size calculation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow up at week 52 (or as soon as possible, when the COVID-19 restrictions allow study visits).
    E.5.2Secondary end point(s)
    Change in lipid-core burden index (LCBItotal) as determined by NIRS, between baseline and 12-month follow-up from matched ROI;
    Change in maximum LCBI in any 4-mm segment (maxLCBI4mm) as determined by NIRS;
    Change in minimal and fibrous mean cap thickness as determined by OCT;
    Change in Average Angular Extension (AAE) of macrophages as determined by OCT, between baseline and 12-month follow-up from matched ROI;
    Change in normalized total atheroma volume (NTAV);
    Change in LDL-cholesterol, hs-CRP, hs-TnT and NT-pro-BNP as well as lipid and inflammatory markers between baseline (Week 0), Week 4, and Week 52;
    Association between levels of biomarkers and changes in plaque characteristics as described in the primary and secondary imaging endpoints;
    Death, cardiac death, myocardial infarction, any coronary revascularization, stroke, transient ischemic attack;
    Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), product complaints, laboratory data.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Followup at week 52 and week 4 (biomarkers)
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Austria
    Denmark
    Netherlands
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 126
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 294
    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)
    None
    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 Decision2017-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-13
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