Influence of vitamin K deficiency on response to novel anticoagulants

  • Research type

    Research Study

  • Full title

    Investigation of the effect of vitamin K deficiency upon anticoagulant response to novel oral anticoagulants (direct thrombin inhibitors and FXa inhibitors) ex-vivo

  • IRAS ID

    208502

  • Contact name

    Farhad Kamali

  • Contact email

    farhad.kamali@newcastle.ac.uk

  • Sponsor organisation

    Newcastle upon Tyne Hosptials NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    Anticoagulation with warfarin has long been established for treatment and prevention of clotting disorders. Its action is exagerated by vitamin K deficiency. Novel oral anticoagulants have been licensed and are available for use according to their licensed indications. Whilst clinical trials suggest that the novel oral anticoagulants are safe, the impact of dietary vitamin K status on anticoagulation response has not been studied. There is evidence that vitamin K deficiency in rats enhances anticoagulant response to the direct thrombin inhibitor Ximelagatran. We have investigated the possible effect of dietary vitamin K deficiency on anticoagulation response in man by comparing response of clotting factors to the factor Xa inhibitor, rivaroxaban, in the laboratory ex-vivo using blood samples obtained from people with a normal or deficient vitamin K diet, and noted anticoagulant response to be exaggerated in vitamin K deficient older people compared with younger people replete in vitamin K. We wish to assess whether this observation is also the case for the other factor Xa inhibitors apixaban and edoxaban, and for the direct thrombin inhibitor dabigatran.

  • REC name

    West of Scotland REC 5

  • REC reference

    16/WS/0184

  • Date of REC Opinion

    11 Oct 2016

  • REC opinion

    Further Information Favourable Opinion