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    Summary
    EudraCT Number:2013-003778-29
    Sponsor's Protocol Code Number:CTU/2013/064
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-06
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-003778-29
    A.3Full title of the trial
    Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Screening and prevention of pre-eclampsia (high blood pressure): Randomised trial of aspirin versus placebo
    A.3.2Name or abbreviated title of the trial where available
    ASPRE (Version 1)
    A.4.1Sponsor's protocol code numberCTU/2013/064
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN13633058
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1140-4837
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London Clinical Trials Unit
    B.5.2Functional name of contact pointSusan Tebbs
    B.5.3 Address:
    B.5.3.1Street Address175-176 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076795691
    B.5.6E-mailsusan.tebbs@ucl.ac.uk
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Aspirin
    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 Coated 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 INNAcetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameAcetylsalicylic acid: Rhodine
    D.3.9.4EV Substance CodeAS1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Raised blood pressure in pregnancy as a result of abnormal function of the placenta
    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 18.0
    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 examine if the use of low-dose aspirin starting at 11-14 weeks gestation in women at increased risk for pre-eclampsia (high blood pressure) can reduce the incidence and severity of this complication.
    E.2.2Secondary objectives of the trial
    To examine if the use of low-dose aspirin can reduce the incidence of early delivery due to complications from high blood pressure, growth restricted babies, stillbirth or neonatal complications related to high blood pressure, rate of neonatal admission, the incidence of placental separation and spontaneous preterm delivery before 34 weeks and 37 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years
    • Singleton pregnancies
    • Live fetus at 11-13 weeks of gestation
    • High-risk for preterm preeclampsia will be defined at 11-13 weeks by the algorithm combining maternal history, biophysical findings (mean arterial blood pressure and uterine artery Dopplers) and biochemical factors (PAPP-A and PlGF)
    • English, Italian, Spanish and French speaking (otherwise NHS Trust interpreters, in the UK will be used)
    • Informed and written consent
    E.4Principal exclusion criteria
    • Multiple pregnancies
    • Pregnancies complicated by major fetal abnormality identified at the 11-13
    weeks assessment
    • Women taking low-dose aspirin regularly (administration must have ceased >28 days prior to randomisation)
    • Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
    • Bleeding disorders such as Von Willebrand’s disease
    • Peptic ulceration
    • Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory
    medication
    • Age < 18 years
    • Concurrent participation in another drug trial or at any time within the previous 28 days
    • Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of preterm pre-eclampsia (< 37 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. In addition, the obstetric records of women with pre-existing or pregnancy associated hypertension will be examined to determine if the condition is pre-eclampsia requiring delivery before 37 weeks' gestation.
    E.5.2Secondary end point(s)
    Secondary end points:
    1. Incidence of early preeclampsia (<34 weeks) and total preeclampsia (at any gestation);
    2. Birth weight below the 3rd, 5th and 10th centile;
    3. Stillbirth or neonatal death due to any cause;
    4. Stillbirth or neonatal death ascribed to preeclampsia
    or fetal growth restriction;
    5. Stillbirth or neonatal death in association with maternal or neonatal bleeding;
    6. Rate of neonatal intensive care unit admission;
    7. Composite measure of neonatal mortality and morbidity;
    8. Placental abruption (clinically or on placental examination);
    9. Spontaneous preterm delivery <34 weeks and <37 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. In addition, the obstetric records of all women with pre-existing or pregnancy associated hypertension will be examined to determine if the condition is pre-eclampsia requiring delivery before 34 weeks' gestation.

    Neonatal outcomes will be collected from the Special Care Baby Unit/Neonatal Intensive Care Unit.
    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 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 concerned9
    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 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
    The end of the study for individual participants will be defined as 30 days after delivery of the baby or 30 days after the EDD date, whichever is the latter. The end of the study as a whole will be defined as the point at which the last participant (n=1,684) has fulfilled the above definition and details of their complete pregnancy outcome have been collected.
    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 months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1684
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state1260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1684
    F.4.2.2In the whole clinical trial 1684
    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)
    Not appropriate as intervention is being studied only in pregnancy.
    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 Decision2014-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-03
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