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    Summary
    EudraCT Number:2021-005788-34
    Sponsor's Protocol Code Number:NL79578.100.21
    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:2022-03-31
    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 number2021-005788-34
    A.3Full title of the trial
    Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect
    Plaatjes inhibitie versus directe orale anticoagulatie bij patiënten die percutane sluiting van een patent foramen ovale of atriaal septum defect ondergaan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect
    Plaatjesremming versus directe antistollingsmedicatie bij patiënten die sluiting van een patent foramen ovale of atriaal septum defect ondergaan
    A.3.2Name or abbreviated title of the trial where available
    POPular CLOSE
    A.4.1Sponsor's protocol code numberNL79578.100.21
    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 SponsorSt. Antonius Hospital
    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 supportSt. Antonius Onderzoeksfonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Antonius Hospital
    B.5.2Functional name of contact pointResearch & Innovation Cardiology
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310880900
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 RoleComparator
    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 Acetylsalicylylzuur Cardio (and others)
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN B.V. (and others)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atrial septal defect or patent foramen ovale indicated for percutaneous closure with an occluder device.
    Atriaal septum defect of patent foramen ovale met een indicatie om percutaan te sluiten met een implantaat
    E.1.1.1Medical condition in easily understood language
    Atrial septal defect or patent foramen ovale indicated for percutaneous closure with an occluder device.
    Atriaal septum defect of patent foramen ovale met een indicatie om via de lies (percutaan) te sluiten met een implantaat
    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 goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot study.

    Doel van het onderzoek is het evalueren van de effectiviteit van een post-procedureel antitrombotisch beleid bestaande uit rivaroxaban op het onderdrukken van coagulatie activatie in vergelijking tot het huidige standaardbeleid bestaande uit duale antiplaatjestherapie.
    E.2.2Secondary objectives of the trial
    In addition to the hemostasis parameters, secondary (clinical) endpoints during 12-month follow-up will include:
    • Rate of device-related thrombus (DRT)
    • Rate of stroke, TIA, systemic embolism, pulmonary embolism and (cardiovascular) death
    • Rate of minor and major bleeding
    • Incomplete device endothelialization
    Naast variabelen op het gebied van hemostase, zullen de volgende klinische eindpunten gedurende 12 maanden worden verzameld:
    • Device-gerelateerd trombus (DRT)
    • Beroerte, TIA, systemische embolie, longembolie en(cardiovasculaire) dood
    • Kleine (minor) en grote (major) bloeding
    • Incomplete endothelialisatie van het implantaat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The subject is aged 18 years or older
    - The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician
    - The subject is able to understand and is willing to provide written informed consent to participate in the trial
    - De proefpersoon is 18 jaar of ouder
    - De proefpersoon is ingepland voor percutane sluiting van een PFO of ASD, waarbij de indicatie is gesteld door de behandelend arts
    - De proefpersoon is in staat om proefpersoneninformatie te begrijpen en bereid om informed consent ten behoeve van deelname te tekenen.
    E.4Principal exclusion criteria
    - Unable or unwilling to return for required follow-up visits
    - High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical
    - Mechanical heart valves or valvular disease requiring surgery or interventional procedure
    - Ongoing major bleeding or complicated or recent (<72 hours) major surgery
    - Severe thrombocytopenia (<50.000/ml)
    - Mitral valve regurgitation grade 3 or more
    - Aortic valve stenosis (AVA<1.0cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more
    - Left ventricular ejection fraction <30%
    - Life expectancy of less than 1 year
    - Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation)
    - Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting)
    - Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion
    - Pregnant or planning to become pregnant during the time of the study
    - Estimated glomerular filtration rate <50 ml/min/1.73m2
    - Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs).
    - Niet in staat of niet bereid om langs te komen voor onderzoeksvisites
    - Hoge waarschijnlijkheid dat proefpersoon niet beschikbaar is voor follow-up of aanwezigheid van een psycho-sociale conditie die studiedeelname onpraktisch maakt
    - Mechanische hartkleppen of hartklepziekte die chirurgie of een interventie behoeft
    - Actuele grote bloeding of gecompliceerde danwel recente (<72u) grote chirurgie
    - Ernstige trombocytopenie (<50.000/mL)
    - Mitraalklepinsufficiëntie graad 3 of meer
    - Aortaklepstenose (AVA<1.0 cm2 of Pmax > 50 mmHg) of aortaklepinsufficiëntie graad 3 of meer
    - Linker ventriculaire ejectiefractie < 30%
    - Levensverwachting kleiner dan 1 jaar
    - Elke indicatie voor chronische orale antistollingsmedicatie anders dan aanwezigheid/sluiting van een PFO/ASD (zoals atriumfibrilleren)
    - Elke indicatie voor chronische antiplaatjestherapie anders dan aanwezigheid/sluiting van een PFO/ASD (zoals recente stentplaatsing)
    - Contra-indicatie voor het gebruik van rivaroxaban of DAPT (zoals voorgeschiedenis van intracraniële bloeding), naar de mening van onderzoeksteam
    - Zwanger, of met actieve kinderwens gedurende de studieperiode
    - Geschatte glomerulaire filtratie ratio < 50 ml/min/1.73m2
    - Gebruik van medicatie die een significante interactie heeft met rivaroxaban; medicatie die cytochroom P450 3A4 of P-glycoproteïne inhibeert (zoals ketoconazol, HIV protease inhibitors, clarithromycine, erythromycine, fluconazol) of cytochroom P450 3A4 induceert (zoals rifampicine en verscheidene anti-epileptica)
    E.5 End points
    E.5.1Primary end point(s)
    This study will capture the following hemostatic endpoints:

    • Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex)
    • Platelet activation (e.g. P-selectin, CD40 ligand)
    • Von Willebrand Factor Antigen (VWF Ag)
    • Beta-thrombglobulin (beta-TG)
    • Plasminogen activator inhibitor-1 (PAI-1)
    • D-dimer
    • Thrombin Generation Test
    • Anti Xa activity
    De studie onderzoekt de volgende hemostatische eindpunten:
    - Coagulatie activatie (prothrombine fragment 1+2, thrombine antithrombine III complex)
    - Plaatjesactivatie (P-selectine, CD40 ligand)
    - Von Willebrand Factor antigeen
    - Beta-thromboglobuline
    - Plasminogeen activator inhibitor-1
    - D-dimeer
    - Trombine generatie test
    - Anti Xa activiteit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Platelet function and thrombin generation testing will be performed in blood samples collected prior to the procedure, 7 days after the procedure and 3 months following the procedure. Blood samples will be obtained from venipuncture.
    Plaatjesactivatie en trombinegeneratiebepaling zullen worden verricht in bloedsamples die zijn verzameld vóór de procedure, 7 dagen na de procedure en 3 maanden na de procedure. Bloedsamples worden verzameld door middel van venapunctie.
    E.5.2Secondary end point(s)
    In addition to the primary hemostatic endpoints, secondary endpoints include clinical event rates of:

    • Ischemic stroke
    • Hemorrhagic stroke
    • Transient ischemic attack (TIA)
    • Systemic embolism (SE)
    • Pulmonary embolism (PE)
    • Device-related thrombus (DRT)
    • Major bleeding (according to BARC criteria), both procedural up to 7 days and total
    • Minor bleeding (according to BARC criteria), both procedural up to 7 days and total
    • All-cause and cardiovascular death
    • Incomplete device endothelialization
    • Composite of ischemic endpoints (ischemic stroke, TIA, SE, PE and DRT)
    • Composite of bleeding endpoints (major and minor bleeding and hemorrhagic stroke)
    Naast variabelen op het gebied van hemostase, zullen de volgende klinische eindpunten worden verzameld:
    - Ischemische beroerte
    - Hemorrhagische beroerte
    - Transient ischemic attack (TIA)
    - Systemische embolie (SE)
    - Longembolie (LE)
    - Device-related thrombus (DRT)
    - Major bloeding (volgens BARC criteria), zowel procedureel tot 7 dagen als totaal
    - Minor bloeding (volgens BARC criteria), zowel procedureel tot 7 dagen als totaal
    - Overlijden (alle oorzaken en cardiovasculair)
    - Incomplete endothelializatie
    - Composiet van ischemische eindpunten (beroerte, TIA, SE, LE, DRT)
    - Composiet van bloedingseindpunten (major en minor bloeding en hemorrhagische beroerte)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Occurrence of clinical endpoints will be assessed during 3-month and 12-month follow up visits.
    Het optreden van klinische eindpunten zal worden geëvalueerd tijdens de 3-maanden en 12-maanden visite.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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 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
    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 months
    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) Yes
    F.1.2.1Number of subjects for this age range: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 state52
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-04
    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
    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.

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