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    Summary
    EudraCT Number:2018-004202-25
    Sponsor's Protocol Code Number:PI18/01297
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-004202-25
    A.3Full title of the trial
    Usefulness of amiodarone for the Prevention of new onset Atrial Fibrillation after transcatheter aortic valve implantation: a randomized controlled trial
    Utilidad de la amiodarona en la prevención de la fibrilación auricular de nueva aparición después del implante de una válvula aórtica transcatéter: Ensayo clínico aleatorizado doble ciego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Usefulness of amiodarone for the Prevention of Atrial Fibrillation after implantation of a cardiac valve
    Utilidad de la amiodarona en la prevención de la fibrilación auricular después del implante de una válvula del corazón.
    A.4.1Sponsor's protocol code numberPI18/01297
    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 SponsorLuis Nombela Franco
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLuis Nombela Franco
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressC/Profesor Martín Lagos s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number0034629510139
    B.5.5Fax number003491330 35 15
    B.5.6E-mailluisnombela@yahoo.com
    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 AMIODARONA AUROVITAS
    D.2.1.1.2Name of the Marketing Authorisation holderAurovitas Spain, S.A.U.
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMIODARONE HYDROCHLORIDE
    D.3.9.1CAS number 19774-82-4
    D.3.9.4EV Substance CodeSUB00472MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atrial fibrillation
    fibrilación auricular
    E.1.1.1Medical condition in easily understood language
    atrial fibrillation
    fibrilación auricular
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    compare the incidence of new onset atrial fibrillation (NOAF) at 30 days after transcatheter aortic valve implantation (TAVI) on patients that recieve oral amiodarone versus placebo.
    Comparar la incidencia de FA de nueva aparición durante los 30 días después del TAVI entre los pacientes que recibieron amiodarona frente a los que no.
    E.2.2Secondary objectives of the trial
    -Evaluate the effect of the amiodarone in the incidence of NOAF 60 after TAVI .
    -Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI.
    -Compare all-cause mortality and CV mortality between groups.
    -Compare the combined end-point MACE (death, stroke or major or life-threatening bleeding according to VARC-2 criteria).
    -Assess the effectiveness of the amiodarone in the reduction of the hospital stay after the procedure.
    -Analyze the safety of the treatment with amiodarone in patients undergoing TAVI.
    -Assess the incidence of permanent pacemaker implantation in the both groups.
    -Compare EuroQoL 5D and Kansas City questionnaires between groups.
    -Compare the number of readmissions due to CV causes.
    -Evaluate the functional change according to the NYHA scale between both groups.
    -Value the change in capacity for the exercise, evaluated by the 6-minute walk test between groups.
    -Compare the events of acute renal failure between groups.
    -Valorar el efecto de la amiodarona en la incidencia de FA a los 60 días post-TAVI.
    -Analizar el efecto de la amiodarona en el momento de aparición y la carga de FA después del TAVI.
    -Comparar la mortalidad por todas las causas y la mortalidad CV entre grupos.
    -Comparar los eventos MACE (evento combinado de muerte, ictus y sangrados mayores o amenazantes según la escala VARC-2).
    -Valorar la eficacia de la amiodarona en la reducción de la estancia hospitalaria post-TAVI.
    -Analizar la seguridad del tratamiento con amiodarona en pacientes sometidos al TAVI.
    -Valorar la incidencia de implante de marcapasos.
    -Comparar la calidad de vida entre los ambos grupos.
    -Comparar el número de reingresos por causas cardiovasculares entre grupos.
    -Evaluar el cambio funcional según la escala NYHA respecto a la clase funcional basal entre ambos grupos.
    -Valorar el cambio en la capacidad para el ejercicio en ambos grupos.
    -Comparar los eventos de fracaso renal agudo durante entre grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy.
    2.Patients that will undergo TAVI due to aortic stenosis.
    3.Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.
    1. Hombres y mujeres mayores de 18 años. Mujeres en edad fértil deberán comprometerse al uso de métodos anticonceptivos de eficacia asegurada.
    2. Pacientes que van a ser sometidos a TAVI por estenosis aortica de forma programada: pacientes ambulatorios o pacientes hospitalizados en los que el procedimiento de TAVI pueda ser planificado al menos 1 semana (7 días) después de su discusión en el equipo médico.
    3. Ritmo sinusal demostrado por un ECG realizado en las 72 horas previas a la inclusión en el estudio.
    E.4Principal exclusion criteria
    1.Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test.
    2.Paroxysmal or persistent AF (documented record in electrocardiogram or ECG holter)
    3.Congestive heart failure with functional class NYHA IV despite optimal medical treatment.
    4.Sustained hypotension (TAS < 80mmHg)
    5.Severe mitral stenosis or regurgitation
    6.Treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an exclusion criteria.
    7.Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AV block.
    8.QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
    9.Clinical hypo- or hyperthyroidism.
    10.Allergy or adverse reaction known or suspected to the amiodarone.
    11.Denial of the patient or inability to give informed consent.
    1. Embarazo o lactancia. Mujeres en edad fértil que no tengan test de embarazo negativo.
    2. FA paroxística o persistente (antecedente descrito en la historia clínica o episodio documentado en electrocardiograma o holter ECG de 24 horas realizado en los 90 días previos a la inclusión).
    3. Insuficiencia cardíaca congestiva con clase funcional NYHA IV a pesar del tratamiento médico.
    4. Hipotensión sostenida (TAS < 80 mmHg).
    5. Insuficiencia o estenosis mitral severa.
    21
    6. Tratamiento con fármacos antiarrítmicos (incluida la amiodarona) 3 meses antes del procedimiento. No se considera criterio de exclusión el tratamiento con betabloqueantes o calcioantagonistas dihidropirimidínicos.
    7. Bradicardia sinusal (<50 lpm), intervalo PR > 240 mseg o bloqueo AV de segundo o tercer grado en un ECG realizado en las 72 horas antes de la inclusión, sin marcapasos definitivo implantado.
    8. Duración del intervalo QT mayor de 480 mseg un ECG realizado en las 72 horas antes de la inclusión, sin marcapasos definitivo implantado.
    9. Hipo o hipertiroidismo clínico. No se excluyen pacientes con hipotiroidismo en tratamiento sustitutivo con niveles de TSH normal.
    10. Alergia o reacción adversa conocida o sospechada a la amiodarona.
    11. Negativa del paciente o incapacidad de otorgar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.
    Se considera como variable principal de valoración la aparición de fibrilación auricular detectada durante la monitorización electrocardiográfica en el ingreso a partir del implante de TAVI o en el Holter ECG de 30 días. Se define FA como una absoluta irregularidad de los intervalos RR, en ausencia de bloqueo AV completo, con ausencia de ondas p en el ECG de superficie (en caso de que se distinga la onda p la longitud de ciclo de la actividad auricular deberá ser variable y usualmente < 200 mseg), con una duración de 30 segundos o más (16).
    Se ha seleccionado como medida principal de eficacia de la amiodarona la reducción del riesgo de FA de nueva aparición durante los primeros 30 días después del implante de TAVI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30-day after the TAVI procedure
    días después del implante de TAVI
    E.5.2Secondary end point(s)
    1.NOAF incidence at 60-day after TAVI.
    2.Time until atrial fibrillation appearance
    3.AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm.
    4.Need for a permanent pacemaker implantation during the hospitalization, and at 30-, 60-day and 1-year follow-up
    5.Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate at 30-, 60-day, 6 months and 1-year follow-up.
    6. The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
    7. hospital stay after the procedure in patients undergoing TAVI.
    8. EuroQOL 5D and Heart Failure Questionnaire (Kansas City) at 30 and 60 days and at 12 months after the procedure .
    9.readmissions due to cardiovascular causes.
    10.change of functional status according to the NYHA scale with respect to the baseline functional class at month, at 2, 6 and 12 months.
    11.change in capacity for the exercise, evaluated by the 6-minute walk test, 30 days, 60 days and one year of follow-up, compared to baseline.
    12.acute renal failure during admission and 30 days postprocedure.
    1.incidencia de FA a los 60 días post-TAVI.
    2.momento de aparición de la FA.
    3.carga de FA después del TAVI.
    4.implante de marcapasos during the hospitalization, a los 30, 60 días y 1 año post-TAVI.
    5.muerte, ictus y sangrados mayores o amenazantes at 30-, 60-días, 6 meses and 1 año post-TAVI.
    6.Eventos adversos desde inicio del tratamiento hasta la última visita del seguimiento.
    7.estancia hospitalaria post-TAVI.
    8.Calidad de vida (EuroQOL 5D and Heart Failure Questionnaire (Kansas City)) a los 30 y 60 días y 1 año post-TAVI.
    9.reingresos por causas cardiovasculares
    10.estado funcional según la escala NYHA respecto a la clase funcional basal al mes, a los 2, 6 y 12 meses post-TAVI.
    11.capacidad para el ejercicio en ambos grupos mediante el test de la marcha de 6 minutos a los 30, 60 días y al año post-TAVI comprado con el basal.
    12.fracaso renal agudo durante el ingreso y a los 30 días post-TAVI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 60-day after TAVI.
    2.Time until atrial fibrillation appearance
    4. during the hospitalization, and at 30-, 60-day and 1-year follow-up
    5. at 30-, 60-day, 6 months and 1-year follow-up.
    6.since tretament start until last follow-up visit.
    7.hospital discharge.
    8.at 30 and 60 days and at 12 months after the procedure .
    10.baseline, at 1, 2, 6 and 12 months.
    11.30 days, 60 days and one year of follow-up, compared to baseline.
    12.during admission and 30 days postprocedure.
    1.60 días post-TAVI.
    2.momento de aparición de la FA.
    4.a los 30, 60 días y 1 año post-TAVI.
    5.a los 30-, 60-días, 6 meses and 1 año post-TAVI.
    6.Eventos adversos desde inicio del tratamiento hasta la última visita del seguimiento.
    7.alta hopistalaria.
    8.a los 30 y 60 días y 1 año post-TAVI.
    10.basal, al mes, a los 2, 6 y 12 meses post-TAVI.
    11.a los 30, 60 días y al año post-TAVI comprado con el basal.
    12.durante el ingreso y a los 30 días post-TAVI.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned6
    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
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 20
    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 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 state120
    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
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
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