Health TrialsbyHealthPanel

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

ConditionsAtrial Fibrillation and FlutterStrokeMajor BleedEnd-stage Renal Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Warfarin

    Drug

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

Treatment groups

718 Participants
are divided into 2 treatment groups
Group A: Treatment with WarfarinActive comparator 1 intervention
Group B: No treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary efficacy outcome - Number of participants with transient ischemic attack, fatal and non-fatal ischaemic or unspecific stroke

Any transient ischemic attack, fatal and non-fatal ischaemic or unspecific stroke or death attributable to either ischemic or undefined stroke

Time frame
From randomization to end of observation - up to 4 years
2

Primary safety outcome - Number of participants with fatal or non-fatal major bleeding

Any major bleeding as defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients

Time frame
From randomization to end of observation - up to 4 years

Secondary outcomes

1

Number of participants with ischemic or unspecified stroke

Any non-fatal or fatal ischemic stroke or unspecified stroke event

Time frame
From time of randomization to end of observation - up to 4 years
2

Number of participants with ischemic stroke

Any non-fatal or fatal ischemic stroke event

Time frame
From time of randomization to end of observation - up to 4 years
3

Number of participants with hemorrhagic stroke

Any non-fatal or fatal hemorrhagic stroke event

Time frame
From time of randomization to end of observation - up to 4 years
4

Number of participants with ischemic or hemorrhagic stroke

Any non-fatal or fatal ischemic or hemorrhagic stroke event

Time frame
From time of randomization to end of observation - up to 4 years

Other outcomes

1

Discontinuation of the allocated randomized therapy

Number of participants discontinuing the allocated randomized therapy irrespective of cause

Time frame
From time of randomization to end of observation - up to 4 years
2

Number of participants with peripheral artery disease

Any diagnosis of previously unverified peripheral artery disease

Time frame
From time of randomization to end of observation - up to 4 years
3

Number of participants with fatal or non-fatal acute myocardial infarction

Any non-fatal or fatal acute myocardial infarction event

Time frame
From randomization to end of observation - up to 4 years
4

Number of participants with calciphylaxis

Development of calciphylaxis as defined by clinical diagnosis

Time frame
From time of randomization to end of observation - up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicholas Carlson

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Danish Heart Foundation

Collaborator

Source ClinicalTrials.gov
Apply now