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
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