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    Summary
    EudraCT Number:2013-003125-28
    Sponsor's Protocol Code Number:POPTAV001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-07
    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 number2013-003125-28
    A.3Full title of the trial
    Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation
    Antiplaatjestherapie bij transkatheter aortaklep implantatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation
    Bloedverdunning bij patiënten die een aortaklepvervanging ondergaan
    A.3.2Name or abbreviated title of the trial where available
    POPular-TAVI
    POPular-TAVI
    A.4.1Sponsor's protocol code numberPOPTAV001
    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 Hospital
    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 pointVincent J. Nijenhuis
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310306098055
    B.5.5Fax number00310306034420
    B.5.6E-mailv.nijenhuis@antoniusziekenhuis.nl
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.2Current sponsor codeclopidogrel
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 for which a transcatheter aortic valve implantation (TAVI) is performed.
    Aortastenose waarvoor een transkatheter aortaklepimplantatie is verricht.
    E.1.1.1Medical condition in easily understood language
    Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.
    Aortakleplijden waarvoor een transkatheter aortaklepimplantatie is verricht.
    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
    1. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients without an indication for oral anticoagulation (OAC) after TAVI (Cohort A);
    2. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients with an indication for OAC after TAVI (Cohort B);
    1. Het bepalen van de veiligheid en effectiviteit van het omitteren van clopidogrel in patiënten zonder een indicatie voor OAC na TAVI (Cohort A);
    2. Het bepalen van de veiligheid en effectiviteit van het omitteren van clopidogrel in patiënten met een indicatie voor OAC na TAVI (Cohort A);
    E.2.2Secondary objectives of the trial
    1. To investigate the safety and efficacy of the studied antithrombotic treatment regimens after TAVI compared with the common practiced antithrombotic treatment after surgical aortic valve replacement (SAVR) (Cohort C);
    2. Furthermore we obtain to investigate the effect of omission of clopidogrel on cognitive and functional parameters, quality of life and costs.
    1. Het bepalen van de veiligheid en effectiviteit van de bestudeerde antitrombotische behandelingen na TAVI in vergelijk met de reguliere behandeling na chirurgische aortaklepvervanging (SAVR) (Cohort C);
    2. Het bepalen van het effect van het omitteren van clopidogrel op cognitieve en functionele parameters, kwaliteit van leven, en kosten.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients undergoing surgical aortic valve replacement (Cohort C). Registry cohort; same safety and efficacy endpoints as Cohort A and B.
    E.3Principal inclusion criteria
    Cohort A
    1. Heart team agrees on indication and treatment proposal;
    2. Patient has provided written informed consent;

    Cohort B
    1. Heart team agrees on indication and treatment proposal;
    2. Need for long-term oral anticoagulation;
    3. Patient has provided written informed consent.

    Cohort C
    1. Heart team agrees on indication and treatment proposal;
    2. Patient has provided written informed consent.
    Cohort A
    1. Hartteam bereikt consensus over de indicatie en behandelstrategie;
    2. Patiënt heeft informed consent getekend.

    Cohort B
    1. Hartteam bereikt consensus over de indicatie en behandelstrategie;
    2. Nood aan lange termijn orale anticoagulantia;
    3. Patiënt heeft informed consent getekend.

    Cohort C
    1. Hartteam bereikt consensus over de indicatie en behandelstrategie;
    2. Patiënt heeft informed consent getekend.
    E.4Principal exclusion criteria
    Cohort A
    1. Need for long-term oral anticoagulation;
    2. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    3. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    4. Allergy or intolerance to aspirin or clopidogrel.

    Cohort B
    1. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    2. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    3. Allergy or intolerance to clopidogrel.

    Cohort C
    1. Patient is younger than 65 years old;
    2. Combination surgical procedure.
    Cohort A
    1. Nood aan lange termijn orale anticoagulantia;
    2. Drug-eluting stent implantatie binnen 3 maanden voorafgaand aan de TAVI procedure;
    3. Bare-metal stent implantatie binnen 1 maand voorafgaand aan de TAVI procedure;
    4. Allergie of intolerantie voor aspirine of clopidogrel.

    Cohort B
    1. Drug-eluting stent implantatie binnen 3 maanden voorafgaand aan de TAVI procedure;
    2. Bare-metal stent implantatie binnen 1 maand voorafgaand aan de TAVI procedure;
    3. Allergie of intolerantie voor clopidogrel.

    Cohort C
    1. Patient is jonger dan 65 jaar;
    2. Combinatie chirurgische behandeling.
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety outcome is defined as all bleeding. Co-primary safety outcome is defined as all non-procedure related bleeding.
    Primaire veiligheidseindpunt is gedefinieerd als alle bloedingen. Co-primaire veiligheidseindpunt is gedefinieerd als alle non-procedure gerelateerde bloedingen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days and 12 months
    E.5.2Secondary end point(s)
    Secondary efficacy outcome is a composite of cardiovascular mortality, major bleeding, life threatening/disabling bleeding, all-cause stroke, and myocardial infarction. Co-secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, all-cause stroke, and myocardial infarction.
    Secundaire effectiviteitseindpunt is een composiet van cardiovasculaire mortaliteit, majeure bloeding, levensbedreigende/invaliderende bloeding, cerebrovasculair accident, en myocardinfarct. Co-secundaire effectiviteitseindpunt is een composiet van cardiovasculaire mortaliteit, non-procedure gerlateerde bloeding, cerebrovasculair accident, en myocardinfarct.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days 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 Yes
    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) 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 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 concerned8
    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 Yes
    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 months3
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2200
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    High surgical risk or inoperable patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state2200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2200
    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 Decision2013-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-29
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