Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial.
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Ballegaard Ellen Linnea Freese, Lindhard Kristine, Lindhardt Morten, Peters Christian Daugaard, Thomsen Nielsen Finn, Tietze Ida Nørager, Borg Rikke, Boesby Lene, Bertelsen Marianne Camilla, Brøsen Julie Maria Bøggild, Cibulskyte-Ninkovic Donata, Rantanen Jesper Moesgaard, Mose Frank Holden, Kampmann Jan Dominik, Nielsen Alice Skovhede, Breinholt Johanne Kodal, Kofod Dea Haagensen, Bressendorff Iain, Clausen Peter Vilhelm, Lange Theis, Køber Lars, Kamper Anne-Lise, Bang Casper Niels Furbo, Torp-Pedersen Christian, Hansen Ditte, Grove Erik L, Gislason Gunnar, Dam Jensen Jens, Olesen Jonas Bjerring, Hornum Mads, Rix Marianne, Schou Morten, Carlson Nicholas
Аннотация
METHODS AND ANALYSIS: The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0-3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient.
ETHICS AND DISSEMINATION: The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals.
TRIAL REGISTRATION NUMBERS: NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.