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 - Publisher Copyright: © 2024 BMJ Publishing Group. All rights reserved.

PY - 2024

Y1 - 2024

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 - Anticoagulation

KW - Clinical Trial

KW - Dialysis

KW - End stage renal failure

KW - Thromboembolism

U2 - 10.1136/bmjopen-2023-081961

DO - 10.1136/bmjopen-2023-081961

M3 - Journal article

C2 - 38413147

AN - SCOPUS:85186740220

VL - 14

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

M1 - e081961

ER -