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
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 incon...
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Open |
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| author | Christian Torp-Pedersen Rikke Borg Ditte Hansen Lars Køber Morten Schou Gunnar Gislason Theis Lange Jonas Bjerring Olesen Jens Dam Jensen Iain Bressendorff Morten Lindhardt Mads Hornum Erik L Grove Marianne Rix Anne-Lise Kamper Christian Daugaard Peters Jan Dominik Kampmann Dea Haagensen Kofod Kristine Lindhard Frank Holden Mose Ellen Linnea Freese Ballegaard Finn Thomsen Nielsen Ida Nørager Tietze Lene Boesby Marianne Camilla Bertelsen Julie Maria Bøggild Brøsen Donata Cibulskyte-Ninkovic Jesper Moesgaard Rantanen Alice Skovhede Nielsen Johanne Kodal Breinholt Peter Vilhelm Clausen Casper Niels Furbo Bang Nicholas Carlson |
| author_facet | Christian Torp-Pedersen Rikke Borg Ditte Hansen Lars Køber Morten Schou Gunnar Gislason Theis Lange Jonas Bjerring Olesen Jens Dam Jensen Iain Bressendorff Morten Lindhardt Mads Hornum Erik L Grove Marianne Rix Anne-Lise Kamper Christian Daugaard Peters Jan Dominik Kampmann Dea Haagensen Kofod Kristine Lindhard Frank Holden Mose Ellen Linnea Freese Ballegaard Finn Thomsen Nielsen Ida Nørager Tietze Lene Boesby Marianne Camilla Bertelsen Julie Maria Bøggild Brøsen Donata Cibulskyte-Ninkovic Jesper Moesgaard Rantanen Alice Skovhede Nielsen Johanne Kodal Breinholt Peter Vilhelm Clausen Casper Niels Furbo Bang Nicholas Carlson |
| author_sort | Christian Torp-Pedersen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T13:58:24Z |
| format | Article |
| id | doaj.art-bab64788782d4769b515dc81aeed052a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-07T13:58:24Z |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-bab64788782d4769b515dc81aeed052a2024-03-07T08:10:08ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-081961Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trialChristian Torp-Pedersen0Rikke Borg1Ditte Hansen2Lars Køber3Morten Schou4Gunnar Gislason5Theis Lange6Jonas Bjerring Olesen7Jens Dam Jensen8Iain Bressendorff9Morten Lindhardt10Mads Hornum11Erik L Grove12Marianne Rix13Anne-Lise Kamper14Christian Daugaard Peters15Jan Dominik Kampmann16Dea Haagensen Kofod17Kristine Lindhard18Frank Holden Mose19Ellen Linnea Freese Ballegaard20Finn Thomsen Nielsen21Ida Nørager Tietze22Lene Boesby23Marianne Camilla Bertelsen24Julie Maria Bøggild Brøsen25Donata Cibulskyte-Ninkovic26Jesper Moesgaard Rantanen27Alice Skovhede Nielsen28Johanne Kodal Breinholt29Peter Vilhelm Clausen30Casper Niels Furbo Bang31Nicholas Carlson32Department of Cardiology, Copenhagen University Hospital - North Zealand, Hillerød, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, DenmarkSection of Biostatistics, University of Copenhagen, Kobenhavns, DenmarkDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, DenmarkDepartment of Renal Medicine, Aarhus University Hospital, Aarhus N, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDept. of Clinical Medicine, Aarhus University, Aarhus N, DenmarkInternal medicine, Hospital of Southern Jutland Sonderborg Branch, Sonderborg, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, DenmarkDepartment of Nephrology, Gødstrup Regional Hospital, Herning, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Medicine, Viborg Regional Hospital, Viborg, DenmarkDepartment of Medicine, Zealand University Hospital, Roskilde, DenmarkDepartment of Endocrinology and Nephrology, Copenhagen University Hospital - North Zealand, Hillerød, DenmarkDepartment of Endocrinology and Nephrology, Copenhagen University Hospital - North Zealand, Hillerød, DenmarkDepartment of Nephrology, Lillebaelt Hospital, Kolding, DenmarkDepartment of Nephrology, Aalborg University Hospital, Aalborg, DenmarkDepartment of Medicine, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, DenmarkDepartment of Clinical Biochemistry, Esbjerg Hospital, University Hospital of Southern Denmark, Esbjerg, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital - Frederiksberg and Bispebjerg, Copenhagen, DenmarkDepartment of Nephrology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkIntroduction 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.https://bmjopen.bmj.com/content/14/2/e081961.full |
| spellingShingle | Christian Torp-Pedersen Rikke Borg Ditte Hansen Lars Køber Morten Schou Gunnar Gislason Theis Lange Jonas Bjerring Olesen Jens Dam Jensen Iain Bressendorff Morten Lindhardt Mads Hornum Erik L Grove Marianne Rix Anne-Lise Kamper Christian Daugaard Peters Jan Dominik Kampmann Dea Haagensen Kofod Kristine Lindhard Frank Holden Mose Ellen Linnea Freese Ballegaard Finn Thomsen Nielsen Ida Nørager Tietze Lene Boesby Marianne Camilla Bertelsen Julie Maria Bøggild Brøsen Donata Cibulskyte-Ninkovic Jesper Moesgaard Rantanen Alice Skovhede Nielsen Johanne Kodal Breinholt Peter Vilhelm Clausen Casper Niels Furbo Bang Nicholas Carlson 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/2/e081961.full |
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