The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis

Inclusion Criteria:

• 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 asdocumented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, orepisodes ≥ 6 minutes on event recorders or any other recording device.
• Competence to understand the study rationale, including potential risks and benefitsassociated with treatment, necessary for written informed consent.

Exclusion Criteria:

• CHA2DS2-VASc Score ≤1
• Other indications for oral anticoagulation treatment (pulmonary embolism < 6 months,deep vein thrombosis <3 months, mechanical heart valve prosthesis) irrespective ofwhether 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 surgicaltherapy
• 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 studyoutcomes