The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
NCT ID: NCT03862859
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
718 participants
INTERVENTIONAL
2019-10-09
2027-01-31
Brief Summary
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Detailed Description
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The study is planned as a multicentre, randomized, open label, parallel group trial with planned inclusion of a total of 718 patients (359 patients per arm). Dialysis-treated patients with end-stage renal disease with paroxysmal, persistent, or permanent atrial fibrillation will be enrolled and randomized to either treatment with warfarin or no treatment. Randomization with be attained using a 1:1 allocation as per a computer-generated randomization schedule stratified by gender, age by decade, and center using permuted blocks of random sizes. Study participants will be allocated to treatment in accordance with the randomization for the full duration of the trial i.e. at a minimum one year following randomization, and followed with regular monitoring for the the primary efficacy outcome of ischemic stroke or death due to ischemic or unspecified stroke and the primary safety outcome of major bleeding defined in accordance with the International Society on Thrombosis and Hemostasis definition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Treatment with Warfarin
Warfarin with dosing targeting an international normalized ratio of 2-3.
Warfarin
Dose adjusted Warfarin targeting an international normalized ratio of 2-3.
No treatment
No treatment
No interventions assigned to this group
Interventions
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Warfarin
Dose adjusted Warfarin targeting an international normalized ratio of 2-3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for \>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.
* Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.
Exclusion Criteria
* Other indications for oral anticoagulation treatment (pulmonary embolism \< 6 months, deep vein thrombosis \<3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented
* Ongoing dual antiplatelet treatment
* Malignancy (with exception of non-melanoma skin cancer) with recent \< 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and/or scheduled surgical therapy
* Endoscopy with gastrointestinal ulcer \<1 month
* Esophageal varices
* Autoimmune og genetic coagulation disorders
* Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
* Pending spinal tap
* Cerebrovascular malformations
* Arterial aneurysms
* Ulcers or wounds (Wagner grad \>1)
* Bacterial endocarditis \< 3 months
* Active bleeding contraindicating anticoagulation
* Any non-elective and/or non-ambulant surgery \<7 days
* Cerebral hemorrhage \<4 weeks
* Thrombocytopenia (platelet count \<100 × 109/L) \<30 days.
* Severe liver insufficiency (spontaneous international normalized ratio \>1.5) \<30 days.
* Known intolerance to warfarin
* Use of hypericum perforatum / St. John's Wort
* Uncontrolled hypertension (repeat blood pressure \>180/110 mmhg) \< 30 days
* Uncontrolled hyperthyroidism (thyroid-stimulating hormone \<0.1μIU/mL) \<30 days
* Pregnancy or lactation
* Participation in other ongoing intervention trials adjudged to influence study outcomes
18 Years
ALL
No
Sponsors
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Danish Heart Foundation
OTHER
Nicholas Carlson
OTHER
Responsible Party
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Nicholas Carlson
Principal Investigator
Principal Investigators
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Nicholas Carlson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Gunnar H Gislason, Prof MD PhD
Role: STUDY_CHAIR
Danish Heart Foundation
Anne-Lise Kamper, MD DMSc
Role: STUDY_CHAIR
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Christian Torp-Pedersen, Prof MD DMSc
Role: STUDY_CHAIR
Department of Cardiology, North Zealand Hospital
Jonas B Olesen, MD PhD
Role: STUDY_CHAIR
Department of Cardiology, Copenhagen University Hospital Gentofte
Casper Bang, MD PhD
Role: STUDY_CHAIR
Department of Cardiology, Frederiksberg and Bispebjerg Hospital
Thomas A Gerds, Prof
Role: STUDY_CHAIR
Danish Heart Foundation
Ditte Hansen, MD PhD
Role: STUDY_CHAIR
Department of Nephrology, Copenhagen University Hospital Herlev
Morten Schou, Prof MD PhD
Role: STUDY_CHAIR
Department of Cardiology, Copenhagen University Hospital Herlev
Mads Hornum, Prof MD PhD
Role: STUDY_CHAIR
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Erik Grove, MD PhD
Role: STUDY_CHAIR
Department of Cardiology, Aarhus University Hospital
Jens D Jensen, MD PhD
Role: STUDY_CHAIR
Department of Nephrology, Aarhus University Hospital
Ellen Linnea F Ballegaard, MD
Role: STUDY_CHAIR
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Locations
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Aalborg University Hosptial
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Copenhagen, , Denmark
Esbjerg and Grindsted Hospital
Esbjerg, , Denmark
Department of Nephrology, Herlev Hospital
Herlev, , Denmark
Department of nephrology, Nordsjaellands Hospital
Hillerød, , Denmark
Holbaek Hospital
Holbæk, , Denmark
Holstebro Hospital
Holstebro, , Denmark
Lillebælt Hospital
Kolding, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Bornholms Hospital
Rønne, , Denmark
Hospital Sønderjylland
Sønderborg, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Ballegaard ELF, Lindhard K, Lindhardt M, Peters CD, Thomsen Nielsen F, Tietze IN, Borg R, Boesby L, Bertelsen MC, Brosen JMB, Cibulskyte-Ninkovic D, Rantanen JM, Mose FH, Kampmann JD, Nielsen AS, Breinholt JK, Kofod DH, Bressendorff I, Clausen PV, Lange T, Kober L, Kamper AL, Bang CNF, Torp-Pedersen C, Hansen D, Grove EL, Gislason G, Dam Jensen J, Olesen JB, Hornum M, Rix M, Schou M, Carlson N. 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. 2024 Feb 26;14(2):e081961. doi: 10.1136/bmjopen-2023-081961.
Other Identifiers
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2018-000484-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DANWARD 1.26
Identifier Type: -
Identifier Source: org_study_id
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