TY - JOUR
T1 - Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis
T2 - the Danish Warfarin-Dialysis (DANWARD) trial
AU - Ballegaard, Ellen Linnea Freese
AU - Lindhard, Kristine
AU - Lindhardt, Morten
AU - Peters, Christian Daugaard
AU - Thomsen Nielsen, Finn
AU - Tietze, Ida Nørager
AU - Borg, Rikke
AU - Boesby, Lene
AU - Bertelsen, Marianne Camilla
AU - Brøsen, Julie Maria Bøggild
AU - Cibulskyte-Ninkovic, Donata
AU - Rantanen, Jesper Moesgaard
AU - Mose, Frank Holden
AU - Kampmann, Jan Dominik
AU - Nielsen, Alice Skovhede
AU - Breinholt, Johanne Kodal
AU - Kofod, Dea Haagensen
AU - Bressendorff, Iain
AU - Clausen, Peter Vilhelm
AU - Lange, Theis
AU - Køber, Lars
AU - Kamper, Anne-Lise
AU - Bang, Casper Niels Furbo
AU - Torp-Pedersen, Christian
AU - Hansen, Ditte
AU - Grove, Erik L
AU - Gislason, Gunnar
AU - Dam Jensen, Jens
AU - Olesen, Jonas Bjerring
AU - Hornum, Mads
AU - Rix, Marianne
AU - Schou, Morten
AU - Carlson, Nicholas
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/2/26
Y1 - 2024/2/26
N2 - INTRODUCTION: Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit.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.
AB - INTRODUCTION: Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit.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.
KW - Humans
KW - Warfarin/therapeutic use
KW - Atrial Fibrillation/complications
KW - Renal Dialysis
KW - Anticoagulants/adverse effects
KW - Stroke/prevention & control
KW - Denmark
KW - Treatment Outcome
KW - Randomized Controlled Trials as Topic
U2 - 10.1136/bmjopen-2023-081961
DO - 10.1136/bmjopen-2023-081961
M3 - Protocol
C2 - 38413147
SN - 2044-6055
VL - 14
JO - BMJ open
JF - BMJ open
IS - 2
M1 - e081961
ER -