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    Summary
    EudraCT Number:2021-004865-11
    Sponsor's Protocol Code Number:IV-FLEC
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-17
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-004865-11
    A.3Full title of the trial
    Comparison of the effectiveness of IntraVenous FLECainide plus oral ranolazine
    versus intravenous flecainide alone in the cardioversion of recent onset atrial
    fibrillation – a randomized, prospective, multicentre, open study, the IV-FLEC study
    Σύγκριση της αποτελεσματικότητας της συνδυασμένης θεραπείας
    ενδοφλέβιας φλεκαϊνίδης με από του στόματος ρανολαζίνη έναντι της ενδοφλέβιας
    φλεκαϊνίδης για την ανάταξη κολπικής μαρμαρυγής προσφάτου ενάρξεως – μια
    τυχαιοποιημένη, προοπτική, πολυκεντρική, ανοιχτή μελέτη (IV-FLEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    IV-FLEC
    A.4.1Sponsor's protocol code numberIV-FLEC
    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 SponsorWin Medica Pharmaceuticals S.A.
    B.1.3.4CountryGreece
    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 supportWin Medica Pharmaceuticals S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWin Medica Pharmaceuticals S.A.
    B.5.2Functional name of contact pointGiota Koufaki
    B.5.3 Address:
    B.5.3.1Street AddressOedipus 1-3 & Attiki Odos Side 33-35
    B.5.3.2Town/ cityChalandri, Athens
    B.5.3.3Post code152 38
    B.5.3.4CountryGreece
    B.5.4Telephone number003021074 88 821133
    B.5.5Fax number003021074 88 827
    B.5.6E-mailg.koufaki@winmedica.gr
    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 FLECARDIA
    D.2.1.1.2Name of the Marketing Authorisation holderWin Medica S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameFLECARDIA
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLECAINIDE ACETATE
    D.3.9.1CAS number 54143-56-5
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Ranexa
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A
    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 nameRanexa
    D.3.4Pharmaceutical form Prolonged-release 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 INNRanolazine
    D.3.9.1CAS number 95635-55-5
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    Restoration of sinus rhythm in patients with recent AF onset
    Αποκατάσταση του φλεβοκομβικού ρυθμού σε ασθενείς με ΚΜ προσφάτου ενάρξεως
    E.1.1.1Medical condition in easily understood language
    Restoration of sinus rhythm in patients with recent AF onset
    Αποκατάσταση του φλεβοκομβικού ρυθμού σε ασθενείς με ΚΜ προσφάτου ενάρξεως
    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
    The aim of the study is to compare the effectiveness of the combined
    antiarrhythmic therapy with flecainide IV and ranolazine PO versus monotherapy with flecainide IV, in the restoration of sinus rhythm in patients with recent AF
    (<48 hours), which are suitable for drug reassignment and meet the
    inclusion and exclusion criteria.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients can only be included in the study if they meet all of the following
    Criteria:
    1. Patients aged ≥18 years
    2. Patients with electrocardiographically confirmed AF, with recent onset
    (self-reported onset of arrhythmia within 48 hours of starting medication
    reorganization).
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the
    have the following criteria:
    1. Coronary heart disease and / or significant structural heart disease
    2. Cardiogenic shock
    3. Heart failure, or reduced systolic function left ventricle (ejection fraction <55%)
    4. Hypotension (systolic blood pressure <100mmHg)
    5. Previous treatment with ranolazine within previous 48 hours.
    6. Atrial fibrillation disorder [(2nd degree atrioventricular block, biceps block (RBBB + LAH or RBBB + LPH), or left arm block (LBBB)}, or absent sinus syndrome
    pacemaker,
    7. Hemodynamically intolerant AF
    8. Creatinine clearance less than or equal to 30ml / min
    9. Moderate or severe hepatic impairment
    10. Extended QTc interval (corrected QT> 460ms)
    11. Recent treatment with antiarrhythmic drugs category Ic within the previous 24 hours or with amiodarone within the previous 6 months
    12. Co-administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, klarithromycin, telithromycin, nefazodone)
    13. Known Brugada syndrome
    14. Pregnant or breastfeeding women
    15. Hypersensitivity to flecainide (flecainide acetate) or to
    ranolazine or any of the excipients
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of AF patients referred
    sinus rhythm within 3 hours after the start of the combined antiarrhythmic
    treatment with flecainide IV and PC ranolazine PC versus flecainide IV monotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to the end of trial.
    E.5.2Secondary end point(s)
    1. Comparison of the mean (standard deviation) time from the start of treatment to restoration of sinus rhythm in the combined antiarrhythmic group
    treatment with flecainide IV and ranolazine PO versus flecainide IV monotherapy.

    2. Percentage of patients with sinus rhythm recovery 6 hours after onset
    combined antiarrhythmic therapy with flecainide IV and ranolazine PO versus
    monotherapy with flecainide IV
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to the end of trial.
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 Yes
    E.8.1.7.1Other trial design description
    prospective, multi-site study
    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 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 concerned12
    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
    End of data collection - October 31st, 2022
    LVLS
    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 months5
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The trial includes patients that have been diagnosed with Atrial Fibrillation (VV) of recent onset (within 48 hours).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    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)
    At the end of patients' participation in the study, study doctor will suggest the treatment that he/she deems appropriate for the patient and he/she should follow.
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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