The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicholas Carlson
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
CHA2DS2-VASc Score ≤1
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
Trial design
Treatments tested in this trial
- Warfarin
Treatment groups
718 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nicholas Carlson
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Danish Heart Foundation
Collaborator
Source ClinicalTrials.gov