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

Prior treatment

• Any non-elective and/or non-ambulant surgery \<7 days

Other illness

• 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

Lab values

• Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
• Thrombocytopenia (platelet count \<100 × 109/L) \<30 days.

Other

• 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

• 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.