DAN-WAR-D Danish Warfarin-Dialysis Study Anticoagulation for prevention of stroke in patients with end-stage renal disease on dialysis with atrial fibrillation: A national randomized trial

DAN-WAR-D Danish Warfarin-Dialysis Study Safety and efficacy of warfarin in patients with atrial fibrillation on dialysis - A nationwide parallel-group open randomized clinical trial - DAN-WAR-D - Danish Warfarin-Dialysis Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000484-86-DK

Enrollment

800

Registered

2018-10-16

Start date

2019-01-16

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, end-stage renal disease, and stroke MedDRA version: 20.1 Level: LLT Classification code 10016149 Term: Failure kidney System Organ Class: 100000004857 MedDRA version: 20.0 Level: LLT Classification code 10016566 Term: Fibrillation atrial System Organ Class: 100000004849 MedDRA version: 22.1 Level: LLT Classification code 10057613 Term: Thromboembolic stroke System Organ Class: 100000004852

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: WARFARIN CAS Number: 81-81-2 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.5-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 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. 2. Competence to understand the study rational, including potential risks and benefits associated with treatment, necessary for written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600

Exclusion criteria

Exclusion criteria: 1. CHA2DS2-VASc Score =1 2. Other indications for oral anticoagulation treatment (pulmonary embolism 1) 13. Bacterial endocarditis 1.5) 180/110mmhg) < 30 days 22. Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1µIU/mL) <30 days 23. Pregnancy or lactation 24. Participation in other ongoing intervention trials adjudged to influence study outcomes

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the following parallel-group open randomized clinical trial presents a nationwide study aimed at investigating the benefit, tolerability, and safety of initiating warfarin versus no treatment in patients with atrial fibrillation on dialysis. The anticipated results from this project will provide conclusive evidence as to the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation with direct effects on clinical management and international guidelines pertaining to these patients.;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy outcome: Ischemic stroke or death due to ischemic or unspecified stroke Primary safety outcome: Major bleeding defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients, i.e. major intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular with compartment syndrome, or gastrointestinal bleeding. ;Timepoint(s) of evaluation of this end point: Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.	—

Measure

Time frame

Main Objective: The main objective of the following parallel-group open randomized clinical trial presents a nationwide study aimed at investigating the benefit, tolerability, and safety of initiating warfarin versus no treatment in patients with atrial fibrillation on dialysis. The anticipated results from this project will provide conclusive evidence as to the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation with direct effects on clinical management and international guidelines pertaining to these patients.;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy outcome: Ischemic stroke or death due to ischemic or unspecified stroke Primary safety outcome: Major bleeding defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients, i.e. major intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular with compartment syndrome, or gastrointestinal bleeding. ;Timepoint(s) of evaluation of this end point: Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes; non-fatal and fatal ischemic stroke, non-fatal and fatal hemorrhagic stroke, non-fatal and fatal ischemic or hemorrhagic stroke, discontinuation of the allocated randomized therapy, calciphylaxis, arteriovenous fistula thrombosis, fatal or non-fatal acute myocardial infarction, hospitalization due to left-sided heart failure, peripheral artery disease, arteriovenous fistula thrombosis, osteoporosis, all-cause mortality, and the combination of any non-fatal stroke and all-cause mortality, and the combination of any non-fatal stroke, any non-fatal major bleeding, and all-cause mortality. Tertiary outcomes: Alopecia and dermal necrosis. Additionally, the time in therapeutic range adjudged by international normalized ratios will be evaluated amongst patients treated with warfarin. ;Timepoint(s) of evaluation of this end point: Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.	—

Measure

Time frame

Secondary end point(s): Secondary outcomes; non-fatal and fatal ischemic stroke, non-fatal and fatal hemorrhagic stroke, non-fatal and fatal ischemic or hemorrhagic stroke, discontinuation of the allocated randomized therapy, calciphylaxis, arteriovenous fistula thrombosis, fatal or non-fatal acute myocardial infarction, hospitalization due to left-sided heart failure, peripheral artery disease, arteriovenous fistula thrombosis, osteoporosis, all-cause mortality, and the combination of any non-fatal stroke and all-cause mortality, and the combination of any non-fatal stroke, any non-fatal major bleeding, and all-cause mortality. Tertiary outcomes: Alopecia and dermal necrosis. Additionally, the time in therapeutic range adjudged by international normalized ratios will be evaluated amongst patients treated with warfarin. ;Timepoint(s) of evaluation of this end point: Study end will be defined as one year after ultimate randomization. A preplanned analysis of outcome by allocated treatment is proposed at study end.

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Countries

Denmark

Contacts

Public ContactDepartment of Nephrology

Rigshospitalet

+4535453545

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026