RecruitingPhase 4NCT03862859

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

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


Sponsor

Nicholas Carlson

Enrollment

718 participants

Start Date

Oct 9, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing the safety and effectiveness of warfarin (a traditional blood thinner) versus newer types of blood thinners (direct oral anticoagulants, or DOACs) in dialysis patients with atrial fibrillation (an irregular heartbeat), because the best treatment for this specific group of patients is currently unknown. **You may be eligible if...** - You are 18 or older - You are on chronic dialysis because your kidneys have failed (end-stage renal disease) - You have been diagnosed with atrial fibrillation (an irregular heartbeat), either ongoing or in episodes, confirmed by an ECG or heart monitor - You understand the study and can give written consent **You may NOT be eligible if...** - Your stroke risk score (CHA2DS2-VASc) is very low (score of 1 or less) - You have another reason requiring blood thinners (such as a mechanical heart valve, recent blood clot, or pulmonary embolism) - You are already on two antiplatelet (clot-preventing) drugs at the same time - You have had an active cancer or cancer treatment in the past year - You have had a recent stomach ulcer or digestive bleed, esophageal varices, or a genetic blood clotting disorder - You are lactose intolerant (due to excipients in the study medication) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWarfarin

Dose adjusted Warfarin targeting an international normalized ratio of 2-3.


Locations(13)

Aalborg University Hosptial

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Department of Nephrology, Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

Esbjerg and Grindsted Hospital

Esbjerg, Denmark

Department of Nephrology, Herlev Hospital

Herlev, Denmark

Department of nephrology, Nordsjaellands Hospital

Hillerød, Denmark

Holbaek Hospital

Holbæk, Denmark

Holstebro Hospital

Holstebro, Denmark

Lillebælt Hospital

Kolding, Denmark

Zealand University Hospital

Roskilde, Denmark

Bornholms Hospital

Rønne, Denmark

Hospital Sønderjylland

Sønderborg, Denmark

Viborg Regional Hospital

Viborg, Denmark

View Full Details on ClinicalTrials.gov

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NCT03862859


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