Tests warfarin for stroke prevention in dialysis patients with atrial fibrillation
Tests warfarin, a blood thinner, in adults with kidney failure on dialysis and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, Esbjerg, Herlev, Herning, Hillerød, Holbæk, Kolding, Roenne, Roskilde, Sønderborg, and Viborg, DenmarkSee the 13 sites
- Phase
- Phase 4
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Sydvestjysk SygehusEsbjerg, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
- Regionshospitalet GodstrupHerning, DenmarkTaking people
- Nordsjaellands HospitalHillerød, DenmarkTaking people
- Holbaek SygehusHolbæk, DenmarkTaking people
- Lillebaelt HospitalKolding, DenmarkTaking people
- Department of Medicine, Bornholm HospitalRoenne, DenmarkTaking people
- Zealand University HospitalRoskilde, DenmarkTaking people
- Soenderborg SygehusSønderborg, DenmarkTaking people
- Viborg Regional HospitalViborg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nicholas Carlson
- Trial code
- NCT03862859EU 2022-502500-75-00
- Record updated
- 19 May 2026
- Original description
The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.Read full original descriptionShow less
The Danish Warfarin-Dialysis Study: Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis - A Nationwide Parallel-group Open Randomized Clinical Trial
The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.
Inclusion: Patients ≥18 years on chronic dialysis due to end-stage renal disease; 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: Any non-elective and/or non-ambulant surgery <7 days; 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; 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; Autoimmune og genetic coagulation disorders; Active bleeding contraindicating anticoagulation; Cerebral hemorrhage <4 weeks; Severe liver insufficiency (spontaneous international normalized ratio >1.5) <30 days; Uncontrolled hypertension (repeat blood pressure >180/110 mmhg) < 30 days; Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption; Thrombocytopenia (platelet count <100 × 109/L) <30 days; CHA2DS2-VASc Score ≤1; Ongoing dual antiplatelet treatment; Esophageal varices; Pending spinal tap; Cerebrovascular malformations; Arterial aneurysms; Ulcers or wounds (Wagner grad >1); Bacterial endocarditis < 3 months; Known intolerance to warfarin; Use of hypericum perforatum / St. John's Wort; Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1μIU/mL) <30 days; Pregnancy or lactation; Participation in other ongoing intervention trials adjudged to influence study outcomes.