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    Summary
    EudraCT Number:2020-000619-58
    Sponsor's Protocol Code Number:19CH214
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-000619-58
    A.3Full title of the trial
    A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism

    Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
    A.3.2Name or abbreviated title of the trial where available
    PARTUM
    A.4.1Sponsor's protocol code number19CH214
    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 SponsorCHU SAINT-ETIENNE
    B.1.3.4CountryFrance
    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 supportCalgary University
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Saint-Etienne
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Bâtiment Recherche - Hôpital Nord
    B.5.3.2Town/ citySaint-Etienne
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number+330477829458
    B.5.5Fax number+330477127820
    B.5.6E-mailflorence.rancon@chu-st-etienne.fr
    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 Acethylsalicylic acid
    D.2.1.1.2Name of the Marketing Authorisation holderAPOTEX Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAcethylsalicylic acid
    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
    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
    Post-Partum Venous thromboembolism prophylaxis
    E.1.1.1Medical condition in easily understood language
    Post-Partum Venous thromboembolism prophylaxis
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the pilot trial is to determine the mean recruitment rate per
    centre per month, calculated over 6 months.
    E.2.2Secondary objectives of the trial
    Evaluation of :
    1. Consent rates for eligible women who are approached
    2. Rate of study withdrawal or loss to follow-up
    3. Compliance rate with the study drug
    4. Time required to obtain REB/EC approvals and contract agreements at each site
    5. A more precise estimate of the VTE event rate
    6. More precise estimate of the major and clinically relevant non-major bleeding event
    rates
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Trial inclusion criteria includes one (or more) first order criterion or two (or more) second order criterion. A patient is still eligible if they have multiple criteria met, at the discretion of their physician and/or local investigator.
    ONE (or more) First Order Criterion:
    1. Known inherited thrombophilia diagnosed prior to enrolment. The necessary laboratory results must be available to confirm the diagnosis. Women with one of the following thrombophilias will be eligible for the trial, regardless of family history of VTE:
    i) Heterozygous factor V Leiden (genotyping result required), or
    ii) Heterozygous prothrombin gene variant (genotyping result required), or
    iii) Protein C deficiency (two abnormal and no normal tests based on local laboratory cutoffs), or
    iv) Protein S deficiency (two abnormal and no normal tests, one of which is done outside of pregnancy/postpartum OR two abnormal tests in
    pregnancy/postpartum and one abnormal test and no normal tests in a first degree relative, based on local laboratory cutoffs), or
    2. Antepartum immobilization (strict bedrest) for ≥7 days. Immobilization is defined as bed rest with 90% of waking hours spent in bed at any time during the antepartum period
    TWO (or more) Second Order Criteria:
    1. Pre-pregnancy BMI ≥30 kg/m2 (when possible, a documented pre-pregnancy height and weight will be used when available)
    2. Smoking ≥5 cigarettes/day pre-pregnancy (smoking history is based on prepregnancy history, irrespective of whether they continue or stop smoking during their pregnancy)
    3. Previous clinical history of superficial vein thrombosis
    4. Pre-eclampsia (SBP ≥140 and/or DBP ≥90 mmHg on at least one occasion and proteinuria of ≥0.3 grams/24 hours or ≥30 mg/mmol on a random urine sample diagnosed during pregnancy)
    5. Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
    6. Emergency cesarean birth (emergency = not previously planned)
    7. Small-for-gestational-age infant at time of delivery (<3rd percentile adjusted for gestational age and sex using the standardized international INTERGROWTH chart)
    8. Postpartum infection (symptoms/signs of infection and documented fever andlaboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory cutoffs)
    9. Postpartum hemorrhage (>1000 mL of blood loss, regardless of delivery mode)
    E.4Principal exclusion criteria
    Women will be excluded from the trial if they have a known increased risk of VTE where there is sufficiently high risk and/or adequate evidence to determine that LMWH or ASA is indicated, based on their physician and/or local investigator, with examples listed below.
    The trial exclusion criteria are as listed:
    1. More than 48 hours since delivery of the placenta at the time of randomization
    2. Received more than 2 doses of LMWH since delivery of the placenta*
    3. Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or local investigator. May include but is not limited to:
    a. Documented history of provoked or unprovoked VTE
    b. Mechanical heart valve(s)
    c. Known antiphospholipid syndrome (APS) (according to the revised Sapporo/Sydney criteria)55
    d. Known high-risk inherited thrombophilia
    i) Antithrombin deficiency (two abnormal and no normal tests based on local laboratory cutoffs)
    ii) Homozygous factor V Leiden (genotyping result required)
    iii) Homozygous prothrombin gene mutation (genotyping result required)
    iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation (genotyping result required)
    v) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden, prothrombin gene mutation, protein C deficiency, protein S deficiency, as previously defined.
    4. Need for postpartum ASA as judged by their physician and/or local investigator. May include but is not limited to:
    a. Documented history of myocardial infarction
    b. Documented history of ischemic stroke or transient ischemic attack (TIA)
    5. Contraindication to ASA including**:
    a. History of known ASA allergy
    b. Documented history of a gastrointestinal ulcer
    c. Known platelet count <50 x 109/L at any time during the current pregnancy or postpartum
    d. Active bleeding at any site, excluding normal vaginal bleeding, at the time of randomization
    e. Most recent known hemoglobin ≤70 g/L documented during the current pregnancy or postpartum
    f. Known severe hypertension (SBP >200 mmHg and/or DBP >120 mmHg) during the current pregnancy or postpartum
    6. <18 years of age
    7. Unable or refused consent
    *Pneumatic compression devices or graduated compression stockings are not a contraindication to enrolment but will be recorded.
    **Postpartum non-steroidal anti-inflammatories (NSAID) use is not a contraindication to enrolment but will be recorded.
    E.5 End points
    E.5.1Primary end point(s)
    Subject recruitment rate/centre/month. Target : 4 subjects/centre/month
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Proportion of eligible patients who provide consent. Target : More than 30%
    Withdrawals/loss to follow-up. Target : Less than 15%
    Proportion of sites with >18 months to REB and contract approval from the time of delivery of all study documents. Target : Less than 25%
    Level of compliance with study drug >80% taken. taget More than 70%
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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: 48
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state48
    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
    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 Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-02
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