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

Who is this study for? Adult patients with atrial fibrillation and chronic kidney disease
What treatments are being studied? Warfarin
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 atrial fibrillation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aalborg University Hosptial
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
RECRUITING
Copenhagen
Esbjerg and Grindsted Hospital
RECRUITING
Esbjerg
Department of Nephrology, Herlev Hospital
RECRUITING
Herlev
Department of nephrology, Nordsjaellands Hospital
RECRUITING
Hillerød
Holbaek Hospital
RECRUITING
Holbæk
Holstebro Hospital
RECRUITING
Holstebro
Lillebælt Hospital
RECRUITING
Kolding
Bornholms Hospital
RECRUITING
Rønne
Zealand University Hospital
RECRUITING
Roskilde
Hospital Sønderjylland
RECRUITING
Sønderborg
Viborg Regional Hospital
RECRUITING
Viborg
Contact Information
Primary
Nicholas Carlson, MD PhD
nicholas.carlson.01@regionh.dk
+45 35455827
Backup
Gunnar H Gislason, Prof MD PhD
Gunnar.Gislason@regionh.dk
+45 70 25 00 00
Time Frame
Start Date: 2019-10-09
Estimated Completion Date: 2027-01
Participants
Target number of participants: 718
Treatments
Active_comparator: Treatment with Warfarin
Warfarin with dosing targeting an international normalized ratio of 2-3.
No_intervention: No treatment
No treatment
Sponsors
Leads: Nicholas Carlson
Collaborators: Danish Heart Foundation

This content was sourced from clinicaltrials.gov