Pharmacokinetics of rivaroxaban: Genomic effects

  • Research type

    Research Study

  • Full title

    Pharmacokinetic effects of genomic polymorphism in the rivaroxaban metabolic pathway

  • IRAS ID

    170363

  • Contact name

    Kathryn Lang

  • Contact email

    kathryn.lang@nhs.net

  • Sponsor organisation

    King's College Hospital NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 5 months, 30 days

  • Research summary

    Rivaroxaban is an oral anticoagulant (blood-thinning drug) that is marketed as having predictable action in every patient and therefore requires no monitoring of the drug's effects. In some patients, when rivaroxaban levels are checked, they are found to be outside the reference ranges accepted as normal for the drug. Some patients will experience both rethrombosis (recurrence of a blood clot) and bleeding on the drug and in a small proportion, this is due to abnormally high or low levels of rivaroxaban. Rivaroxaban is metabolised (broken down by the body) via five main genetically controlled pathways - these are genetic pathways that have significant differences in and between people. These differences in the genes of the pathways may be the reason that some people over or under-metabolise the drug and could explain some of the differences we see in practice. We plan to test the genes of patients on rivaroxaban whose levels are abnormal and investigate to what extent these abnormalities are being caused by the natural genetic differences between people. In the future, we could then test a person's genes before starting on rivaroxaban to ensure the drug is suitable for them and then dose them accordingly.

  • REC name

    North East - York Research Ethics Committee

  • REC reference

    15/NE/0161

  • Date of REC Opinion

    1 May 2015

  • REC opinion

    Further Information Favourable Opinion