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    Summary
    EudraCT Number:2019-001425-26
    Sponsor's Protocol Code Number:REDOX19032019
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-001425-26
    A.3Full title of the trial
    Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation
    Rotterdam Edoxaban Klepblad evaluatie bij patienten na een percutane aortaklep vervanging
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of heartvalve leaflet thickening whilst using edoxaban after catheter based aortic valve replacement
    Onderzoek naar verdikking van de hartklepbladen bij het gebruik van edoxaban na een kathetergebonden aortaklepvervanging.
    A.3.2Name or abbreviated title of the trial where available
    REDOX-TAVI
    REDOX-TAVI
    A.4.1Sponsor's protocol code numberREDOX19032019
    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 SponsorThoraxcentrum Erasmus MC
    B.1.3.4CountryNetherlands
    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 supportDaiichi Sankyo Europe GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThoraxcentrum Erasmus MC
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molenwaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310107035260
    B.5.6E-mailn.vanmieghem@erasmusmc.nl
    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 Lixiana
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.11 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
    aortic stenosis
    aortastenose
    E.1.1.1Medical condition in easily understood language
    narrowing of the aortic heart valve
    vernauwing van de aortaklep
    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
    To investigate whether edoxaban affects the incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months treatment.
    E.2.2Secondary objectives of the trial
    To investigate whether treatment with edoxaban affects transprosthetic gradients (i.e. change in transprosthetic gradient between TTE at discharge and at 1 year) after TAVI.

    To investigate the safety of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on net adverse clinical outcomes after 1 month, 3 months and one year; i.e.: the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) and every endpoint separately including any neurological event (minor/disabling stroke and TIA)

    To investigate the effect of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on major bleeding at 1 month, 3 months and one year
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients completed successful elective TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
    o Correct positioning of a single prosthetic heart valve into the proper anatomical location
    o Device success, defined by
     Mean aortic valve gradient < 20 mmHg
     Peak transvalvular velocity <3.0 m/s
     Aortic valve regurgitation of 2 or less
    • No periprocedural complications
    o No overt stroke
    o No uncontrolled bleeding
    o No major vascular complication defined by the VARC-2 consensus
    • No formal indication for oral anticoagulation
    o Prevention of thromboembolic complications in patients with atrial fibrillation
    o Prevention for recurrent venous thromboembolism
    o Prevention for recurrent pulmonary embolism
    E.4Principal exclusion criteria
    • History of life-threatening or major bleeding event ≥ BARC 3b definitions within the last year
    • Other conditions with a high risk of bleeding
    o Active peptic ulcer or upper gastrointestinal bleeding within last 3 months prior to enrolment
    o Malignancy with high risk of bleeding
    o Recent unresolved brain of spinal injury
    o Spinal or ophthalmic surgery within last 3 months prior to enrolment
    o Intracranial haemorrhage
    o Esophagal varices
    o Atriovenous malformations with high risk of bleeding
    o Vascular aneurysms
    o Major intraspinal or intracerebral vascular abnormalities
    • Hypersensitivity or contraindications to edoxaban
    • Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to randomization.
    • Concomitant percutaneous coronary intervention (PCI) during the TAVI procedure, requiring DAPT after the procedure.
    • Renal impairment defined as by dialysis-dependency or GFR < 30 mL/min at time of enrollment
    • Active bleeding or bleeding diasthesis including thrombocytopenia (platelet count < 50.000 cells/UL), thrombobasthenia, haemophilia or von Willebrand disease
    • Patients unable to adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condtition or life-threatening disease
    • Pregnant or breast-feeding subjects
    • Current participation in clinical trials that potentially interfere with the current study
    E.5 End points
    E.5.1Primary end point(s)
    incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    three months
    E.5.2Secondary end point(s)
    occurrence of reduced THV leaflet motion by MSCT at 3 months of follow up.
    transprosthetic gradients (i.e. change in transprosthetic gradient between TTE at discharge and at 1 year) after TAVI
    the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) and every endpoint separately including any neurological event (minor/disabling stroke and TIA)
    To investigate the effect of edoxaban treatment in patients undergoing TAVI -with no formal OAC indication- on major bleeding at 1 month, 3 months and one year
    E.5.2.1Timepoint(s) of evaluation of this end point
    one month, 3 months and 12 months
    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 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 No
    E.8.1.1Randomised No
    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 No
    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
    The trial will end when 100 subjects have reached the primary endpoint (which is 3 months after TAVI).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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