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The New Horizons Study

  • Research type

    Research Study

  • Full title

    Can edoxaban and rivaroxaban be prescribed for breastfeeding mothers?

  • IRAS ID

    1005067

  • Contact name

    Roopen Arya

  • Contact email

    roopen.arya@nhs.net

  • Sponsor organisation

    King's College Hospital Foundation NHS Trust

  • Eudract number

    2001-000000-00

  • ISRCTN Number

    ISRCTN57583139

  • Research summary

    Women are at increased risk of bloods clots, in the veins of the legs and the blood vessels of the lungs, after having a baby for up to 6 weeks. Women who are identified at high risk of developing these blood clots are given anticoagulant treatment at a low dose to try and prevent them. Currently, the only treatments we know to be safe in breastfeeding women is an injectable medication (low molecular weight heparin) or a tablet which needs frequent blood testing (warfarin). Both options have pros and cons associated with them, making life difficult for women. In recent years new anticoagulant tablets have become available, called direct oral anticoagulants (DOACs) however little information exists on how much of these new medications distribute into breastmilk. This research study builds on our previous work and will:
    - look at how 2 of these new medicines (rivaroxaban and edoxaban) gets into breastmilk of women who have recently had their child, and
    - assess whether it would be safe for women to breastfeed safely, when on these medications.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    22/NW/0273

  • Date of REC Opinion

    7 Oct 2022

  • REC opinion

    Further Information Favourable Opinion

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