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    Summary
    EudraCT Number:2014-005407-24
    Sponsor's Protocol Code Number:KKIKEM
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-005407-24
    A.3Full title of the trial
    Effect of early administration of eplerenone in patients after acute myocardial infarction
    Efekt časného podání eplerenonu u pacientů po akutním infarktu myokardu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REMODEL-AMI
    REMODEL-AMI
    A.4.1Sponsor's protocol code numberKKIKEM
    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 SponsorIKEM
    B.1.3.4CountryCzech Republic
    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 supportIKEM PRAGUE
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIKEM
    B.5.2Functional name of contact pointALES HERMAN
    B.5.3 Address:
    B.5.3.1Street AddressVIDENSKA 1958/9
    B.5.3.2Town/ cityPRAGUE
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number0042236054001
    B.5.6E-mailales.herman@ikem.cz
    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 EPLERENON SANDOZ 50mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameEPLERENON SANDOZ 50 MG
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 Eplerenon Sandoz 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameEPLERENON-SANDOZ 25 MG
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Verify the efficacy of early administration of eplerenone in relation to the development of pathological remodeling of the myocardium in patients after myocardial infarction.
    E.1.1.1Medical condition in easily understood language
    Loss of the cardiac muscle during acute myocardial infarction (AMI) results in the development of undesirable remodeling of left ventricle (LV) that results in development of chronic heart failure.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    With use of cardiac magnetic resonance (CMR) demonstrate the benefit of early treatment with eplerenone in reducing pathological remodeling of the left ventricle (LV) in patients with acute myocardial infarction (AMI).
    E.2.2Secondary objectives of the trial
    Pathological remodeling factors, such as a serum biomarker or indirect indicators arrhythmogenesis In relation to active treatment with eplerenone will be studied.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years old
    2. Have an ischemic symptom of >20 min within 24 hours before randomization
    3. At least one of the following indicator of AMI:
    · ST-segment elevation ≥0.2 mV in at least 2 contiguous precordial leads
    · ST-segment elevation ≥0.1 mV in at least 2 contiguous limb leads
    · New or undated left bundle branch block
    · Q waves in at least 2 contiguous precordial leads (excluding V1 and avr) not known to be old
    · Troponin levels ≥3 times the upper local limit of normal and in case of NSTEMI, a Thrombolysis In Myocardial Infarction19 score ≥3
    4. Written informed consent provided by the patient
    E.4Principal exclusion criteria
    • Cardiopulmonary instability
    • Killip score≥3
    • persistent atrial fibrillation with planned rate control therapy
    • serum creatinine> 220 umol / L for men and> 177 umol / L for women
    • serum potassium> 5.0 mmol / L
    • anticipated early aorto-coronary bypass or valve surgery
    • anticipated early pacemaker implantation or cardioverter-defibrillator
    • contraindications to perform MR (implanted pacemaker, defibrillator, or neurostimulator; the presence of foreign material in the body of uncertain origin or with known incompatibility with MR tomograph; implantation of coronary stents other than the Promus Element-Boston Scientific, Orsiro-Biotronic, RESOLUT Integrity Medtronic; extreme overweight; the claustrophobia)
    • age <18 years
    • pregnancy, lactation
    • premenopausal women who are not willing to use an effective form of contraception
    • absence of consent to inclusion in the study
    • clinically relevant polymorbidity
    • assumption noncompliance
    • Hypersensitivity to the active substance or to any of the excipients
    • Patients with moderate to severe renal insufficiency (creatinine clearance <50 ml / min or serum creatinine levels above 220 umol / L in men and over 170 umol / L in women
    • Patients with severe hepatic insufficiency (class C according to Child-Pugh).
    • Patients receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP3A4 (eg. Itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
    • Simultaneous treatment of mild to moderate CYP3A4 inhibitors, eg. Amiodarone, diltiazem and verapamil
    • diagnosing heart failure in the past
    • In the past identified LV EF below 40%
    E.5 End points
    E.5.1Primary end point(s)
    The effect of early administration of eplerenone will lead to:
    • Reduction of the LV fibrosis assessed by CMR method MOLLI
    • Influence of LVEDV, LVESV, EF asssessed by MR
    • Decrease of the serum concentration of galectin-3
    • Reduction of ventricular ectopic assessed by 24 h ECG Holter

    Predictive factor for LV pathological remodeling is:
    • The rate of early microvascular obstruction assessed by MRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ambulatory monitoring in the 1st and 6th month •
    Standard 12-lead ECG during AMI, before the discharge of the patient at the end of the first week after AMI, in the 1st and 6th month
    • Left ventriculography performed during acute coronary angiography
    • Echocardiographic examination within 48 hours of AMI (in case that left ventriculography is not performed, echocardiographic examination will be performed before randomization), before discharge of the patient at the end of the first week after AMI and at 6 months
    •CMRduring the first week of AMI (minimum 96 hours after AMI) and at 6 months
    • Serum biomarkers (BNP, Galectin-3, cortisol, aldosterone, plasma renin activity) - before randomization, before discharge, as well as in the 1st and 6th month
    E.5.2Secondary end point(s)
    The effect of early administration of eplerenone will lead to:
    • Decline in serum concentrations of BNP
    • Shortening of QRS interval duration
    • Favorable impact on ECG markers related to arrhythmogenesis

    Predictive factors for LV pathological remodeling LK are:
    • The period of ischemia
    • The size of infarct on assessed on initial MRI scans
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Signal-averaged ECG in the first week of AIM (at least 72 hours after AMI) and at 6 months
    • Ultra-high-frequency (UHF) ECG in the first week after AIM (at least 72 hours after AIM) and at 6 months
    • ECG Holter / 24 hours in the first week after AMI (at least 72 hours after AMI) and at 6 months
    • Consumption levels of troponin T (hsTnT) - during AMI, 8 hours and 48 hours after AMI, in the 1st and 6th month
    • Iontogram (K +, Na +, Cl-), urea, creatinine - before randomization, every day during hospitalization for AMI, in the 1st, 3rd and 6th month
    • Blood pressure measurement during AMI, then daily during the stay in the intensive care unit, in the 1st and 6th month
    • A pregnancy test prior to enrollment
    • Objectified drug compliance in the 6th month
    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 Yes
    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) 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LAST FOLLOW-UP AT 6 MONTHS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state150
    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 Decision2015-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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