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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2018-000811-26
    Sponsor's Protocol Code Number:STOPPRE
    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:2018-07-09
    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 number2018-000811-26
    A.3Full title of the trial
    A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.
    Ensayo clínico fase III, aleatorizado, abierto, multicéntrico y de grupos paralelos para la detección, en segundo trimestre del embarazo, de los falsos positivos del cribado de preeclampsia de primer trimestre (StopPRE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.
    Ensayo clínico fase III, aleatorizado, abierto, multicéntrico y de grupos paralelos para la detección, en segundo trimestre del embarazo, de los falsos positivos del cribado de preeclampsia de primer trimestre (StopPRE)
    A.4.1Sponsor's protocol code numberSTOPPRE
    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 SponsorVall D'Hebron Institut de Recerca (VHIR)
    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 supportCare Institute of Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall D'hebron Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointARO
    B.5.3 Address:
    B.5.3.1Street AddressPg. Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number349348930004113
    B.5.6E-mailaro@vhir.org
    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 TROMALYT
    D.2.1.1.2Name of the Marketing Authorisation holderTROMALYT
    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 nameTromalyt
    D.3.2Product code 59.210
    D.3.4Pharmaceutical form Oral drops
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    First-trimester pre-eclampsia patients
    Pacientes con preeclampsia de primer trimestre
    E.1.1.1Medical condition in easily understood language
    First-trimester pre-eclampsia patients
    Pacientes con preeclampsia de primer trimestre
    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 demostrate no increasement of incidence of preterm pre-emclampsia, comparing with a control-group patients who are taking the treatment as usual, when sFlt-1/PlGF ratio is less than 38 and patients are under 24-27 weeks of pregnancy.
    Demostrar que en aquellas pacientes con ratio sFlt-1/PlGF <38 a las 24-27+6 SG, la suspensión del AAS no incrementa la incidencia de PE pretérmino respecto al grupo control, que mantendrá la toma de AAS.
    E.2.2Secondary objectives of the trial
    - To demostrate that determination of sFlt-1/PlGF ratio, between 24-27+6 weeks of pregnancy, achieves to detect false positives using first-trimester pre-emclapsia screening.
    - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, whether you suspend the treatment with ASA, it is not increase the maternal morbility or mortality.
    - To demostrate that patients within sFlt-1/PlGF ratio less than 38, between 24-27+6 weeks of prenancy, the suspension of ASA reduces the incidence of minor maternal hemorrhages.
    -To demostrate that in high-risk pre-eclampsia patients, the detection of sFlt-1/PlGF ratio less than 38 between 24-27+6 weeks of prenancy, assumes a relief for those patients who get stress as the cognisance of high-risk group assignment for patients
    - To know the outcome of all patients with high-risk pre-eclampsia.
    • Demostrar que la determinación del ratio sFlt-1/PlGF a las 24-27+6 SG consigue detectar los falsos positivos del cribado de PE de primer trimestre.
    • Demostrar que en aquellas pacientes con ratio sFlt-1/PlGF <38 a las 24-27+6 SG, la suspensión del AAS no incrementa la morbilidad ni la mortalidad materna.
    • Demostrar que en aquellas pacientes con ratio sFlt-1/PlGF <38 a las 24-27+6 SG, la suspensión del AAS reduce la incidencia de hemorragias maternas menores.
    • Demostrar que la obtención de un ratio sFlt-1/PlGF <38 a las 24-27+6 SG, en pacientes de alto riesgo de PE de primer trimestre supone un alivio del estrés materno por dejar de pertenecer a un grupo de alto riesgo.
    • Conocer el desenlace de todas las pacientes con alto riesgo de PE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years old
    - Gestational period less than 28+0 weeks
    - Unique gestation
    - High-risk of pre-eclampsia for the first-trimester screening, defined through a validated multivariate algorithm for the population under study
    - AAS initiation taken ≤ 16 + 6 weeks of pregnancy
    - Ratio sFlt1 / PlGF determined between the weeks of pregnancy 24-27 + 6
    - Voluntary signature of the informed consent
    • Pacientes mayores de 18 años.
    • Edad gestacional < 28+0 semanas
    • Gestación única
    • Alto riesgo de preeclampsia en el cribado de primer trimestre, definido a través de un algoritmo multivariante validado para la población objeto de estudio
    • Toma AAS iniciada ≤ 16 + 6 Semanas de gestación
    • Ratio sFlt1/PlGF determinado entre las semanas de gestación 24-27+6
    • Firma voluntaria del consentimiento informado
    E.4Principal exclusion criteria
    - Multiple gestation
    - Dead and/or multiple malformation fetus, including also any genetical and/or cromosomical disseas affected by the fetus.
    - Von Willebrand dissease.
    - ASA intolerance and /or allergy
    - Peptic ulcer
    - Patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion.
    - AAS compliance <50% up to the current visit
    - Antiphospholipid syndrome
    - No signature of the informed consent
    • Gestación múltiple
    • Feto muerto o polimalformado o afecto de enfermedad genética o cromosómica conocida
    • Enfermedad de Von Willebrand
    • Alergia o intolerancia al AAS
    • Úlcera péptica
    • Pacientes incapaces de entender el protocolo del estudio o cualquier otra condición que en opinión del investigador pueda comprometer el cumplimiento del protocolo.
    • Cumplimiento AAS < 50% hasta la visita actual
    • Síndrome antifosfolípidos
    • No firmar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    - Preterm preeclampsia rate (< 37 weeks) within the two arms of the high-risk group under sFlt1/PlGF ratio less than 38 between 24-27+6 weeks of pregnancy.
    - Tasa de preeclampsia pretérmino (< 37 semanas) en las dos ramas del grupo de alto riesgo y ratio sFlt1/PlGF < 38 en las semanas 24-27+6 de gestación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - At the end of the study period (24-27+6 - 37 weeks of pregnancy)
    - Al final del tiempo del ensayo (semanas 24-27+6 - 37 de gestación)
    E.5.2Secondary end point(s)
    - Prevalence of early, preterm and late pre-eclampsia at high-risk group and ratio ≥ 38
    - Rate of adherence to the treatment assignated to high-risk screening group of patients
    - Stress perception by 'Perceived Stress Scale (PSS) of Cohen, S., Kamarck, T., & Mermelstein, R. This scale is evaluated the last month, having 14 items with an outcome defined by an scale of 5 points. It will be done in both groups of study. Seeing questionaries at anexo section.
    - Hemorrhagea along gestation at both groups of study (studying symptoms such as epistaxis, gingivorrhagia and genital bleeding)
    - Rate of maternal issues in both groups (sFlt1/PlGF ratio < 38 and sFlt1/PlGF ratio≥ 38) such as placental detachment, caesarea detected by abnormal cardiotocography, fetus death, undertaking more than 2 antidepressants, eclampsia, diseminated intravascular coagulation, maternal mortality, postpartum hemorraghea, accurate lung oedema, brain vascular hemorraghea, stroke, sepsis, income to intensive care and second-surgery needed.
    - Neonatal complications in both groups such as early partum, income at intensive care, Acute respiratory distress, Grade II-IV intravascular hemorraghea, patent ductus arteriosus, renal disfuntion, Necrotizing enterocolitis, intestinal perforation, sepsis, retinopathy of prematurity, Bronchopulmonary dysplasia, Periventricular leukomalacia, intrauterine growth restriction, postnatal administration of sulphactants or inotropics drugs and/or death.
    • Prevalencia de PE precoz, pretérmino y tardía en el grupo con cribado de alto riesgo y ratio ≥ 38
    • Tasa de cumplimiento del tratamiento asignado en las pacientes con cribado de alto riesgo.
    • Estudio del estrés percibido mediante el cuestionario Perceived Stress Scale (PSS) de Cohen, S., Kamarck, T., & Mermelstein, R. Esta escala evalúa el nivel de estrés percibido durante el último mes, consta de 14 ítems con un formato de respuesta de una escala de cinco puntos. Se pasará en ambos grupos. Ver cuestionario en la sección anexos.
    • Hemorragia durante la gestación en ambos grupos (epistaxis, gingivorragia y sangrado genital).
    • Tasa de complicaciones maternas en ambos grupos (< 38 y ≥ 38) (Desprendimiento de placenta, cesárea por cardiotocografía anormal, muerte fetal, necesidad de ≥2 fármacos antihipertensivos, eclampsia, coagulación intravascular diseminada, mortalidad materna, hemorragia postparto, edema agudo de pulmón, hemorragia vascular cerebral, embolia, sepsis, ingreso en la UCI y necesidad de segunda cirugía).
    • Complicaciones neonatales en ambos grupos (Parto prematuro, admisión UCI, distrés respiratorio, hemorragia intraventricular grado III-IV, conducto arterioso persistente, disfunción renal, enterocolitis necrotizante, perforación intestinal, sepsis, retinopatía del prematuro, displasia broncopulmonar, leucomalacia periventricular, retardo del crecimiento intrauterino, administración postnatal de surfactante o fármacos inotrópicos y / o la muerte)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Along the study period.
    - Along the study period.
    - 24-27+6, 28-31+6 weeks of pregnancy
    - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy
    - 24-27+6, 28-31+6, 32-35+6, 36 y 37 weeks of pregnancy
    - 4 months after the birth of the baby
    - A lo largo del tiempo del estudio.
    - A lo largo del tiempo del estudio.
    - semanas 24-27+6, 28-31+6 de gestación.
    - semanas 24-27+6, 28-31+6, 32-35+6, 36 y 37 de gestación.
    - semanas 24-27+6, 28-31+6, 32-35+6, 36 y 37 de gestación.
    - 4 meses después del nacimiento del bebé
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pacientes con continuación del medicamento (AAS 150mg/24hrs hasta semana 36)
    Patients whom continue the treatment (ASA as a medical product)
    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 concerned9
    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
    4 months after the birth of the baby
    4 meses después del nacimiento del bebé
    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 months0
    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) Yes
    F.1.2.1Number of subjects for this age range: 1134
    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 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 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 state1080
    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)
    According to hospital-procedure guideline of each centre.
    De acuerdo con el protocolo de cada centro.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-06
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