Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001564-26
    Sponsor's Protocol Code Number:TRIMETA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-02-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-001564-26
    A.3Full title of the trial
    Evaluation of the cardioprotective metabolic effect of trimetazidine in patients with myocardial ischaemia
    Valutazione dell’effetto metabolico cardioprotettivo della Trimetazidina in pazienti con ischemia miocardica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the cardioprotective metabolic effect of trimetazidine in patients with myocardial ischaemia
    Valutazione dell’effetto metabolico cardioprotettivo della Trimetazidina in pazienti con ischemia miocardica
    A.3.2Name or abbreviated title of the trial where available
    TRIMETA
    TRIMETA
    A.4.1Sponsor's protocol code numberTRIMETA
    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 SponsorFONDAZIONE TOSCANA GABRIELE MONASTERIO
    B.1.3.4CountryItaly
    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 supportFondazione Toscana Gabriele Monasterio
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Toscana Gabriele Monasterio
    B.5.2Functional name of contact pointU.O.C. Farmacia Ospedaliera
    B.5.3 Address:
    B.5.3.1Street AddressVia Aurelia Sud
    B.5.3.2Town/ cityMassa
    B.5.3.3Post code54100
    B.5.3.4CountryItaly
    B.5.4Telephone number0585493507
    B.5.5Fax number0585493508
    B.5.6E-mailfarmacisti@ftgm.it
    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 VASTAREL - 20 MG COMPRESSE RIVESTITE 60 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIST.FARM.BIOL.STRODER S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTrimetazidina
    D.3.2Product code [Trimetazidina]
    D.3.4Pharmaceutical form 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 INNTRIMETAZIDINA
    D.3.9.2Current sponsor codetrimetazidina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients with clinical diagnosis of Inducible Myocardial Ischemia (exercise stress test positive for electrocardiographic criteria and /or symptoms)
    Pazienti con diagnosi clinica di cardiopatia ischemica (test da sforzo positivo per criteri elettrocardiografici e/o
    sintomi)
    E.1.1.1Medical condition in easily understood language
    Patients with Inducible Myocardial Ischemia
    Pazienti con cardiopatia ischemica
    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 10023033
    E.1.2Term Ischemia myocardial
    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 estimate the cardioprotective metabolic effect of trimetazidine in patients with myocardial ischemia using 18FDG-PET/CT imaging.
    Quantizzare l’effetto metabolico cardioprotettivo della trimetazidina in pazienti con ischemia miocardica mediante imaging PET/TC con 18FDG.
    E.2.2Secondary objectives of the trial
    To establish the best timing for identification of the ischemic event using 18FDG-PET imaging.
    To evaluate the pharmacological efficacy of trimetazidine in preventing anginal attacks in the study population.
    To evaluate the pharmacological effect of trimetazidine in varying the intake of nitrates with a short half-life (mg) in the study population.
    Stabilire il timing migliore per l’identificazione dell’evento ischemico mediante imaging PET con 18FDG.
    Valutare l’efficacia farmacologica della trimetazidina nel prevenire gli attacchi anginosi nella popolazione in studio.
    Valutare l’effetto farmacologica della trimetazidina nel variare l'assunzione di nitrati a breve emivita (mg) nella popolazione in studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females of any ethnicity;
    Age > 50 years;
    Clinical diagnosis of Inducible Myocardial Ischemia (exercise stress test positive for electrocardiographic criteria and /or symptoms);
    Known mono or bi-vessel coronary artery disease on coronary CT scan;
    Second level imaging tests to define the site and extent of the myocardial ischemia.
    Maschi e femmine di qualsiasi etnia;
    Età >50 anni;
    Diagnosi clinica di cardiopatia ischemica (test da sforzo positivo per criteri elettrocardiografici e/o sintomi);
    Coronaropatia nota mono o bivasale alla TC coronarica;
    Test di secondo livello per la definizione della sede ed estensione dell’ischemia miocardica.
    E.4Principal exclusion criteria
    Patients with overt diabetes;
    Previous myocardial infarction;
    Intraventricular conduction disorders on basal ECG;
    Previous coronary surgery revascularisation;
    Presence of heart failure (bi-ventricular function conserved);
    GFR <30mL/min;
    Hypersensitivity to the trimetazidine or to any of the excipients of Vastarel 20mg;
    Pregnancy, breastfeeding, fertile sexually active women in absence of highly effective contraception with low user dependency from screening through one menstrual cycle after the last dose of study medication, which include: i. Abstinence; ii .Sex only with persons of the same sex; iii. Monogamous
    relationship with vasectomized partner; iv. Intrauterine device; v. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); vi. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); vii. Intrauterine hormone-releasing system. Those contraceptive measures will not be performed in surgically sterile women (tubal occlusion, bilateral salpingectomy bilateral oophorectomy) or in post-menopausal women, defined as 12 months of amenorrhea without any other clinical cause with elevated FSH values in accordance with the post-menopausal interval. Patients who practice true abstinence or who exclusively have same sex partners need not use contraception, provided it is in line with their referred and usual lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Should any such patient stop practicing abstinence, they must use contraception as described above. Verification of pregnancy status in potentially fertile women will be performed with the evaluation of serum human corionic gonadotropin at the screening visit and repeated at study terminaton);
    Diagnosis of neurocognitive disease (Parkinson’s disease/dementia, parkinsonian symptoms, tremor, restless legs syndrome and other related
    movement disorders);
    Participation to a clinical study with an investigational drug within 30 days from the screening or 5 half lives of the study drug (the longer of the two either).
    Pazienti con diabete conclamato;
    Pregresso infarto miocardico;
    Disturbi di conduzione intraventricolare all’ECG;
    Pregressa rivascolarizzazione coronarica chirurgica;
    Presenza di scompenso cardiaco (funzione biventricolare conservata);
    GFR <30mL/min;
    Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti della specialità Vastarel 20mg;
    Stato di gravidanza e allattamento, donne fertili sessualmente attive in assenza di metodi contraccettivi altamente efficaci, con bassa dipendenza dall’utilizzatore, dallo screening fino a un ciclo mestruale dopo l’ultima dose del farmaco in studio, che comprendono: i. Astinenza; ii. Rapporti sessuali solo con persone dello stesso sesso; iii. Relazione monogama con partner vasectomizzato; iv. Dispositivo intrauterino; v. Contraccezione ormonale combinata contenente estrogeni e progestinici associata all’inibizione dell’ovulazione (orale, intravaginale, transdermica); vi. Contraccezione ormonale a base di soli progestinici associata all’inibizione dell’ovulazione (orale, iniettabile, impiantabile); vii. Sistema intrauterino a rilascio di ormoni. Le misure contraccettive altamente efficaci indicate in precedenza non sono previste per le pazienti chirurgicamente sterili (per es. occlusione delle tube, isterectomia, salpingectomia bilaterale, ovariectomia bilaterale) o in post-menopausa definita come 12 mesi di amenorrea spontanea senza una diversa causa clinica e livelli elevati di FSH in accordo all'intervallo previsto per la post-menopausa. Per i pazienti che praticano una vera astinenza o che hanno esclusivamente partner dello stesso sesso non è necessario l’uso della contraccezione, a condizione che ciò sia in linea con il loro stile di vita
    preferito e abituale. L’astinenza periodica (ad es. metodo del calendario, dell’ovulazione, sintotermico o post-ovulazione) e il coito interrotto non sono metodi di contraccezione accettabili. Nel caso in cui tale paziente cessi di praticare l’astinenza, deve utilizzare i metodi contraccettivi come descritto in precedenza. Lo stato di gravidanza in donne potenzialmente fertili sarà verificato mediante dosaggio ematico della gonadotropina corionica umana al momento dello screening e ripetuto a fine studio;
    Diagnosi di malattia neurocognitiva (morbo di Parkinson/demenza, sintomi parkinsoniani, tremore, sindrome delle gambe senza riposo e altri disturbi del movimento correlati);
    Partecipazione ad uno studio in cui sia stato somministrato un farmaco sperimentale entro 30 giorni dallo screening o 5 emivite del farmaco in studio a seconda di quale fra i due periodi sia il più lungo.
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative changes in the extension of the ischemic area assessed through regional glucose metabolism before and after treatment with trimetazidine
    Variazioni quantitative dell’estensione dell’area ischemica valutata attraverso il metabolismo glucidico regionale prima e dopo trattamento con trimetazidina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 days
    15 giorni
    E.5.2Secondary end point(s)
    To qualitatively and quantitatively assess the dynamics and extent of myocardial uptake of the radiopharmaceutical in patients with inducible myocardial ischemia in order to establish the optimum timing for metabolic identification of myocardial ischemia;; Number of anginal attacks reported by the patient in the week preceding the visit; Estimated intake of short half-life nitrates (mg) in the week prior to the visit reported by the patient
    Valutare qualitativamente e quantitativamente la dinamica e l’entità della captazione miocardica del radiofarmaco in pazienti con cardiopatia ischemica al fine di stabilire il timing ottimale per l’identificazione metabolica di ischemia miocardica.; Numero di attacchi anginosi nella settimana precedente la visita riferiti dal paziente; Stima dell’assunzione di nitrati a breve emivita (mg) nella settimana precedente la visita riferiti dal paziente
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 days; 15 days; 15 days
    15 giorni; 15 giorni; 15 giorni
    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) 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 No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.6 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 Information not present in EudraCT
    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
    LVLS
    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 months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    not applicable
    Non applicabile
    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 Decision2022-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 07:04:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA