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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

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    Summary
    EudraCT Number:2014-003599-21
    Sponsor's Protocol Code Number:MEIXO-VALV-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-003599-21
    A.3Full title of the trial
    Platelet reactivity after TAVI: A multicenter randomized clinical trial
    Evalaución de la REACtividad plaquetaria Tras la implAntacion de Valvula aortIca percutanea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platelet reactivity after TAVI: A Multicenter pilot study
    Reactividad plaquetaria tras TAVI: Un estudio multicentrico
    A.3.2Name or abbreviated title of the trial where available
    REAC-TAVI
    REAC-TAVI
    A.4.1Sponsor's protocol code numberMEIXO-VALV-002
    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 SponsorSociedad Española de Cardiología
    B.1.3.4CountrySpain
    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 supportFundacion Biomedica Galicia Sur
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiovascular Research Unit Vigo
    B.5.2Functional name of contact pointUNICA Vigo
    B.5.3 Address:
    B.5.3.1Street AddressHospital Rebullon. lelvel -1. Puxeiros s/n
    B.5.3.2Town/ cityMos
    B.5.3.3Post code36415
    B.5.3.4CountrySpain
    B.5.4Telephone number34986811758
    B.5.5Fax number34986911727
    B.5.6E-mailcarlos.maria.diaz.lopez@sergas.es
    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 BRILIQUE
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTicagrelor
    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 DUOPLAVIN
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma BristolNON-BREAKING HYPHEN (8209) Myers Squibb SNC 174
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    Study platelet reactivity in patients with Aortic Stenosis (AS) selected for TAVI and to assess the effectiviness of ticagrelor as antiplatelet monotherapy for the supression of high platelet reactivity after TAVI, compared with current standard DAPT with ASA plus clopidogrel.
    Estudio de la reactividad plaquetaria en pacientes con estenosis aórtica (AS) seleccionados para TAVI y evaluar la effectiviness de ticagrelor en monoterapia antiplaquetario para la supresión de la alta reactividad plaquetaria después de TAVI, en comparación con DAPT estándar actual con AAS más clopidogrel.
    E.1.1.1Medical condition in easily understood language
    Comparing to treatments (ASA plus clopidogrel versus ticagrelor) after implantantation of a percutaneous aortic valve implantation.
    Comparar dos tratamientos (AAS más clopidogrel en comparación con ticagrelor) después implantantation de un implante de válvula aórtica percutánea.
    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 evaluate the effectiviness of ticagrelor compared to clopidogrel and aspirin for the supression of res¡dual platelet reactivity by VeryNow P2Y12 assay 90 days after TAVI
    Evaluar la efectividad de ticagrelor en comparación con clopidogrel y aspirina para la supresión de la reactividad plaquetaria res¡dual mediante ensayo P2Y12 VeryNow 90 días después de TAVI
    E.2.2Secondary objectives of the trial
    Compare the proportion of patients with high on treatment platelet reactivity before TAVI and after 6hrs, 24 hrs, 5 days, 30 days, and 90 days of antiplatelet treatment initiation post-TAVI.
    Comparar la proporción de pacientes con alta reactividad plaquetaria en el tratamiento antes y después de TAVI 6hrs, 24 horas, 5 días, 30 días, y 90 días de inicio del tratamiento antiplaquetario después de TAVI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures.
    2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
    3. Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
    4. Patients who are not participating in any other clinical trial or research study (registries allowed).
    1. Consentimiento informado firmado y fechado antes de recibir cualquier procedimiento específico del estudio.
    2. Pacientes mayores de 18 años con capacidad de comprender y aceptar la participación en el ensayo clínico.
    3. Pacientes con estenosis aórtica severa sintomática degenerativa aceptados para TAVI por el Hearteam de cada centro.
    4. Los pacientes que no participan en ningún otro ensayo clínico o estudio de investigación (registros permitidos).
    E.4Principal exclusion criteria
    1. Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
    2. Patients under chronic oral anticoagulation
    3.Patients with proven allergy to aspirin, clopidogrel or ticagrelor
    4.Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
    Known pregnancy or breast-feeding
    5. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not azitromicine), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, and more than a daily liter of grapefruit juice.
    6. Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
    7. Patients with documented moderate or severe hepatic insufficiency
    8. Any condition that may put the patient at risk or influence the outcome of the trial
    9. Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
    1. Accidentes cerebrovasculares <14 días antes de la TAVI, la enfermedad no revascularizado severa de las arterias coronarias o de la carótida (estenosis> 70%) o la esperanza de vida <12 meses.
    2. Los pacientes bajo anticoagulación oral crónica.
    3.Pacientes con alergia demostrada a la aspirina, clopidogrel o ticagrelor.
    4.Pacientes que después de una TAVI no puede someterse a un régimen de terapia individual o de doble antiagregación durante 3 meses por indicación médica.
    5.Embarazo conocido o periodo de lactancia
    6.Terapia oral o intravenosa concomitante con inhibidores potentes del citocromo P450 3A (CYP3A) que no puede ser suspendida durante el curso del estudio. Los medicamentos considerados como inhibidores son, entre otros : ketoconazol, itraconazol, voriconazol, telitromicina, claritromicina (o eritromicina, pero no azitromicine), nefazodona, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, y más de un litro diario de zumo de pomelo.
    6. Trombocitopenia (<50.000 plaquetas U / L) documentada y clínicamente relevante.
    7. Pacientes con insuficiencia hepática moderada o grave.
    8. Cualquier condición que puede poner al paciente en riesgo o influir en el resultado del estudio.
    9. Los pacientes aleatorizados previamente en un ensayo clínico con un producto en investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoint: Achievement of residual platelet reactivity with Verify Now P2Y12 of PRU <208 in ? 70 % of patients treated with ticagrelor (or a net difference between groups of 40 %) after three months of antiplatelet initiation following TAVI procedure.
    Variable primaria de eficacia : Evaluación de la reactividad plaquetaria residual con Verify now P2Y12 de PRU <208 en ? 70% , de pacientes tratados con ticagrelor (diferencia entre los grupos de 40%) después de tres meses del el inicio con tratamiento antiplaquetario posterior al procedimiento TAVI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after TAVI
    90 días posteriores al procedimiento TAVI.
    E.5.2Secondary end point(s)
    Proportion of patients with high on treatment platelet reactivity as measured by Verify Now P2Y12 assay after 6 hours of antiplatelet treatment iniciated post TAVI, achieving the lower prevalence of high on treatment pletelet reactivity patients in the group treated with ticagrelor compared with clopidogrel (net difference between groups of 30%).
    Proporción de pacientes con alta reactividad plaquetaria en el tratamiento según lo estimado a traves por el dispositivo Verify Now P2Y12 tras 6 horas de tratamiento antiplaquetario posterior al precedimiento TAVI para lograr la menor prevalencia en tratamiento de los pacientes con alta reactividad plaquetaria en el grupo tratado con ticagrelor en comparación conel grupo tratado con Aspirina y clopidogrel (diferencia neta entre grupos de 30%).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluate patients with high on treatment platelet reactivity at 6 hours, 24 hours, 5 days, 30 days and 90 days after TAVI.
    Evaluación a las 6 horas , 24 horas, 5 días, 30 días y 90 días posterior al tratamiento TAVI.
    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 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) 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 No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    aspirina y clopidogrel
    aspirin plus clopidogrel
    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 concerned7
    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: Patients who have completed all testing procedures as defined in the protocol, including post-treatment measurements. Last visit of last patient and close of CRF.
    Pacientes que hayan completado todos los procedimientos del ensayo tal como se definen en el protocolo, incluyendo las determinaciones postratamiento. La última visita del último paciente al centro y el crd electrónico.
    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 months7
    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: 60
    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
    Elderly population age range over 75 years old
    Población anciana pacientes con edad superior a 75 años.
    F.4 Planned number of subjects to be included
    F.4.1In the member state124
    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)
    The patient will be follow up by practical clinical routine.
    El paciente seguira la practica clínica habitual.
    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 Decision2015-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
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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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