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    Summary
    EudraCT Number:2019-003341-15
    Sponsor's Protocol Code Number:FFIS/2019/01/AS
    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:2022-06-06
    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 number2019-003341-15
    A.3Full title of the trial
    Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial.
    Aspirina versus Placebo para la Prevención de Preclampsia en Embarazos Gemelares: Estudio multicéntrico, randomizado, doble ciego y controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial.
    Aspirina versus Placebo para la Prevención de Preclampsia en Embarazos Gemelares: Estudio multicéntrico, randomizado, doble ciego y controlado con placebo.
    A.3.2Name or abbreviated title of the trial where available
    ASPRE-T
    ASPRE-T
    A.4.1Sponsor's protocol code numberFFIS/2019/01/AS
    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 SponsorFundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
    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 supportThe Fetal Medicine Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlataforma EECC IMIB
    B.5.2Functional name of contact pointMaria Muñoz
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Madrid-Cartagena s/n
    B.5.3.2Town/ cityEl Palmar - Murcia
    B.5.3.3Post code30120
    B.5.3.4CountrySpain
    B.5.4Telephone number34381290
    B.5.6E-mailmaria.munoz@imib.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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderRenaClinical Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAspirin
    D.3.4Pharmaceutical form Gastro-resistant 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
    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
    Pre-eclampsia
    Preeclampsia
    E.1.1.1Medical condition in easily understood language
    Pre-eclampsia
    Preeclampsia
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036485
    E.1.2Term Pre-eclampsia
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of low-dose aspirin on the incidence of pre-eclampsia with delivery <37 weeks’ gestation.
    Determinar el efecto de la aspirina a dosis bajas sobre la incidencia de preeclampisa prematura con parto <37 semanas de gestación.
    E.2.2Secondary objectives of the trial
    To determine the effect of low-dose aspirin on the incidence of:
    - Delivery with pre-eclampisa at <32 weeks, <34 weeks, <37 weeks and at any gestation.
    - Birth at <32 weeks, <34 weeks and <37 weeks.
    - Death of one twin and/or both twins before discharge from hospital.
    - Birthweight <3rd, <5th and <10th percentile for gestational age.
    - Placental abruption at <32 weeks, <34 weeks, <37 weeks and at any gestation.
    - Postpartum hemorrhage.
    - Neonatal morbidity.
    - Neonatal therapy.
    - Length of stay in neonatal intesive care unit.
    Determinar el efecto de la aspirina a dosis bajas sobre la incidencia de:
    - Parto con preeclampsia a las <32 semanas, <34 semanas, <37 semanas y en cualquier gestación.
    - Parto pre-término a las <32 semanas, <34 semanas y <37 semanas de gestación.
    - Muerte de uno y/o ambos gemelos.
    - Peso neonatal <percentil 3, 5 y 10.
    - Desprendimiento placentario en <32 semanas, <34 semanas, <37 semanas o en cualquier momento de la gestación.
    - Hemorragia postparto.
    - Morbilidad neonatal.
    - Necesidad de terapia neonatal.
    - Tiempo de estancia en la unidad de cuidados intensivos neonatal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >18 years.
    - Dichorionic diamniotic or Monochorionic diamniotic twin pregnancies.
    - Both livefetuses at 11+2 - 13+6 weeks of gestation.
    - Informed and written consent.
    - Edad >18 años.
    - Embarazos gemelares dicoriónicos o monocoriónicos diamnióticos.
    - Ambos fetos vivos a las 11+2 - 13+6 semanas de gestación.
    - Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    - Monoamniotic twins.
    - Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin.
    - Pregnancies complicated by major fetal abnormality or nuchal translucency thickness >3.5mm identified at the 11+2 - 13+6 weeks scan.
    - Monochorionic diamniotic twin pregnancies in which there are early signs of twin-to-twin transfusion syndrome or selective fetal growth restriction defined by a 20% discordance in crown-rump length at the 11+2 - 13+6 weeks’ scan.
    - Those who lack capacity and who are unable to provide informed consent to take part.
    - Women taking low-dose aspirin regularly (administration must have ceased >7 days prior to randomization).
    - Participation in another drug trial within the previous 7 days.
    - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopeniaor concurrent anticoagulant therapy.
    - Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages;ď‚·Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment.
    - Hypersensitivity to salicylic acid compoundsor prostaglandin synthetase inhibitors or to any excipients.
    - Patients on long term non-steroidal anti-inflammatory medication.
    - Not fluent in local language and absence of interprete.
    - Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
    - Gemelos monoamnióticos.
    - Embarazos de trillizos que se habían sometido a reducción de embriones a gemelos o con un gemelo desaparecido.
    - Embarazos complicados por una anomalía fetal importante o un grosor de la translucidez nucal >3,5mm a las 11+2 - 13+6 semanas.
    - Embarazos gemelares monocoriónicos diamnióticos en los que hay signos tempranos de síndrome de transfusión gemelo a gemelo o sFGR definidos por una discordancia del 20% en la CRL en la exploración de las 11 + 2-13 + 6 semanas;•Mujeres severamente enfermas o problemas mentales.
    - Participación en otro ensayo de medicamentos dentro de los 7 días anteriores.
    - Diátesis hemorrágica; trastornos de la coagulación como hemofilia y trombocitopenia o terapia anticoagulante concurrente.
    - Úlcera péptica activa o antecedente recurrente y/o hemorragia gástrica/intestinal u otros tipos de hemorragia como hemorragias cerebrovasculares.
    - Pacientes que padecen gota conocida, insuficiencia hepática grave o insuficiencia renal grave.
    - Hipersensibilidad a los compuestos del ácido salicílico o inhibidores de la prostaglandina sintetasa o cualquier excipiente.
    - Pacientes con medicación antiinflamatoria no esteroidea a largo plazo.
    - No habla con fluidez el idioma local y no cuenta con un intérprete.
    -Cualquier otra razón que los investigadores clínicos crean que evitará que el posible participante cumpla con el protocolo del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the effect of low-dose aspirin on theincidence of preterm preeclampsiawith delivery <37 weeks’ gestation.
    Determinar el efecto de la aspirina en dosis bajas sobre la incidencia de preeclampsia prematura con parto <37 semanas de gestación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    200 days.
    200 días.
    E.5.2Secondary end point(s)
    To determine the effect of low-dose aspirin on the incidence of:
    - Delivery with pre-eclampisa at <32 weeks, <34 weeks, <37 weeks and at any gestation.
    - Birth at <32 weeks, <34 weeks and <37 weeks.
    - Death of one twin and/or both twins before discharge from hospital.
    - Birthweight <3rd, <5th and <10th percentile for gestational age.
    - Placental abruption at <32 weeks, <34 weeks, <37 weeks and at any gestation.
    - Postpartum hemorrhage.
    Determinar el efecto de la aspirina a dosis bajas sobre la incidencia de:
    - Parto con preeclampsia a las <32 semanas, <34 semanas, <37 semanas y en cualquier gestación.
    - Parto pre-término a las <32 semanas, <34 semanas y <37 semanas de gestación.
    - Muerte de uno y/o ambos gemelos.
    - Peso neonatal <percentil 3, 5 y 10.
    - Desprendimiento placentario en <32 semanas, <34 semanas, <37 semanas o en cualquier momento de la gestación.
    - Hemorragia postparto.
    - Morbilidad neonatal.
    - Necesidad de terapia neonatal.
    - Tiempo de estancia en la unidad de cuidados intensivos neonatal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    200 days.
    200 días.
    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 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 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Israel
    Austria
    Poland
    Bulgaria
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Hungary
    Ireland
    Portugal
    United Kingdom
    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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 192
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 Yes
    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 state195
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 827
    F.4.2.2In the whole clinical trial 2400
    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.
    No.
    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 Decision2022-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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