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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 de novo atrial fibrillation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicholas Carlson
• Collaborator: Danish Heart Foundation
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• Patients ≥18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular 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:

• CHA2DS2-VASc Score ≤1

• Other indications for oral anticoagulation treatment (pulmonary embolism < 6 months, deep vein thrombosis <3 months, prior atrial fibrillation, 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