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    Summary
    EudraCT Number:2019-000661-20
    Sponsor's Protocol Code Number:ICO
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-04
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2019-000661-20
    A.3Full title of the trial
    Ivabradine to prevent anthracycline-induced cardiotoxicity: a prospective randomized open label clinical trial.
    Ivabradino įtaka kardiotoksinės chemoterapijos indukuotos ankstyvosios miokardo pažaidos išsivystymui: kontroliuojamas atsitiktinės imties tyrimas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cancer treatment with anthracyclines may cause heart damage and can lead to heart failure. There are drugs which may protect against cardiotoxic effects of anthracyclines, but they are untolerated due to hypotension. Ivabradine is heart rate lowering drug without effect on blood pressure which was approved for treatment of angina pectoris and heart failure. The aim of this study is to investigate protective effects of ivabradine in cancer patients undergoing anthracycline-based chemotherapy.
    Chemoterapija antraciklinais sukelia širdies raumens pažeidimą. Siekiant to išvengti yra skiriami vaistai, bet jie nepakankamai veiksmingi ir turi nepageidaujamų reiškinių. Ivabradinas yra vaistas, skirtas krūtinės angina ir lėtiniu širdies nepakankamumu sergantiems pacientams, kuris mažina pulsą nemažindamas kraujospūdžio. Tyrimo tikslas yra nustatyti, ar ivabradinas saugus ir veiksmingas vėžiu sergantiems ir antraciklinais gydomiems pacientams.
    A.3.2Name or abbreviated title of the trial where available
    ICO
    ICO
    A.4.1Sponsor's protocol code numberICO
    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 SponsorVilnius University Hospital Santaros klinikos
    B.1.3.4CountryLithuania
    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 supportSociety of cardiovascular medicine
    B.4.2CountryLithuania
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVilnius University hospital Sanatros klinikos
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressSanatriskiu 2
    B.5.3.2Town/ cityVilnius
    B.5.3.3Post codeLT-08661
    B.5.3.4CountryLithuania
    B.5.4Telephone number+37068223328
    B.5.6E-mailegle.ciburiene@santa.lt
    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 Ivabradine Anpharm 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holder"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIvabradine 5 mg
    D.3.9.1CAS number 148849-67-6
    D.3.9.3Other descriptive nameIVABRADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB22933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Ivabradine Anpharm 7,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holder"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameIvabradine Anpharm 7,5 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIvabradine Anpharm 7,5 mg
    D.3.9.1CAS number 148849-67-6
    D.3.9.3Other descriptive nameIVABRADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB22933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancers treated with anthracyclines: leukemias, limphomas, breast, stomach, uterine, ovarian, lung.
    Vėžiniai susirgimai gydomi antraciklinų grupės preparatais: leukemijos, limfomos, krūties, skrandžio, gimdos, kiaušidžių, plaučių.
    E.1.1.1Medical condition in easily understood language
    Cancer: blood, lymphnode, breast, stomach, uterine, ovarian, lung.
    Vėžys: kraujo, limfmazgių, krūties, skrandžio, gimdos, kiaušidžių, plaučių.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.
    Tyrimo tikslas yra įvertinti kardioprotekcines ivabradino savybes antraciklinais gydomiems pacientams.
    E.2.2Secondary objectives of the trial
    1. Incidence of anthracyclines induced cardiotoxicity and heart failure.
    2. Incidence of major cardiovascular outcomes.
    1. Kardiotoksinės antraciklinių chemoterapijos sukelto širdies pažeidimo ir širdies nepakankamumo išsivystymo dažnis.
    2. Didžiųjų nepageidaujamų kardiovaskulinių reiškinių dažnis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Chemotherapy with anthracyclines;
    • Age 18-80 years;
    • Heart rate ≥ 70 times per minute;
    • Written informed consent.
    • Pacientai, gydomi antraciklinais;
    • Amžius 18-80 m.;
    • Pulsas ≥ 70 k./min.;
    • Pacientai turi norėti ir sugebėti užpildyti informuoto asmens sutikimo formą (lengvai bendrauti su tyrėju ir neturėti psichikos sutrikimų).
    E.4Principal exclusion criteria
    • Contraindications for ivabradine administration;
    • heart rate <70 times per minute;
    • Incapability to complete informed consent;
    • Severe valve disease;
    • Left ventricle ejection fraction ≤ 30 proc.;
    • Poor echogenicity.
    • Kontraindikacijos ivabradino skyrimui.
    • Pulsas < 70 k./min.;
    • Nesugebėjimas užpildyti informuoto asmens sutikimo formos;
    • Vožtuvų stenozė arba nesandarumas, didesnis nei vidutinio laipsnio;
    • Kairiojo skilvelio išstūmio frakcija ≤ 30 proc.;
    • Nepakankamai gera analizei širdies echoskopijos vaizdų kokybė.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction of ≥ 3%.
    2. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.
    3. Incidence of left ventricular systolic and diastolic dysfunction.
    1. Įvertinti miokardo bendrosios išilginės deformacijos kitimo dinamiką gydymo antraciklinais metu.
    2. Įvertinti miokardo pažaidą (vertinant didelio jautrumo troponino I (TnI) koncentracijos bei plazmos smegenų tipo natriuretinio propeptido (NT-proBNP) koncentracijos kitimus) gydymo antraciklainais metu.
    3. Įvertinti kardiotoksinę chemoterapiją bei ivabradiną gaunančių pacientų kairiojo skilvelio sistolinės bei diastolinės funkcijų pokyčius gydymo antraciklainais metu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines.
    Po 1, 3, 6 ir 7 mėnesių nuo antraciklinių chemoterapijos pradžios.
    E.5.2Secondary end point(s)
    1. Incidence of symptomatic heart failure.
    2. Incidence of adverse effects of ivabradine.
    3. Change in left ventricle and right ventricle dimensions by 2D and 3D echocardiography.
    4. Subgroup analysis by gender, age, type of cancer, cardiovascular risk factors.
    1. Simptominio širdies nepakankamumo išsivystymo dažnis.
    2. Kairiojo ir dešiniojo skilvelio dydžio kitimų dinamika 2D ir 3D echokardioskopijos metu.
    3. Subgrupių analizė pagal lytį, amžių, vėžio tipą ir kardiovaskulinius rizikos veiksnius.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial.
    Tyrimo pabaigoje.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    įprastinis gydymas
    Usual care
    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 No
    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
    LVLS
    Paskutinio paciento paskutinis vizitas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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) No
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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)
    Usual care.
    Įprastinis stebėjimas ir gydymas.
    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 Decision2019-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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