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

NCT03862859 | Recruiting Phase 4 DMC

• 2 other identifiers: DANWARD 1.262018-000484-86
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Atrial Fibrillation and Flutter; Stroke; Major Bleed; End-stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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

  From randomization to end of observation - up to 4 years

• 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

  From randomization to end of observation - up to 4 years

Secondary Outcomes (7)

• Number of participants with ischemic or unspecified stroke

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

• Number of participants with ischemic stroke

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

• Number of participants with hemorrhagic stroke

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

• Number of participants with ischemic or hemorrhagic stroke

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

• Number of deaths

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

Other Outcomes (7)

• Discontinuation of the allocated randomized therapy

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

• Number of participants with peripheral artery disease

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

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

  From randomization to end of observation - up to 4 years

Study Arms (2)

Treatment with Warfarin

ACTIVE COMPARATOR

Warfarin with dosing targeting an international normalized ratio of 2-3.

Drug: Warfarin

No treatment

NO INTERVENTION

No treatment

Interventions

Warfarin DRUG

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

Also known as: Coumadin, Marevan, Jantoven

Treatment with Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Endoscopy with gastrointestinal ulcer \<1 month
• Esophageal varices
• Autoimmune og genetic coagulation disorders
• Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
• Pending spinal tap
• Cerebrovascular malformations
• Arterial aneurysms
• Ulcers or wounds (Wagner grad \>1)
• Bacterial endocarditis \< 3 months
• Active bleeding contraindicating anticoagulation
• Any non-elective and/or non-ambulant surgery \<7 days

Sponsors & Collaborators

• Nicholas Carlson: lead
• Danish Heart Foundation: collaborator

Study Sites (13)

Aalborg University Hosptial

Aalborg, 9100, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Department of Nephrology, Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Esbjerg and Grindsted Hospital

Esbjerg, 6700, Denmark

RECRUITING

Department of Nephrology, Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Department of nephrology, Nordsjaellands Hospital

Hillerød, 3400, Denmark

RECRUITING

Holbaek Hospital

Holbæk, 4300, Denmark

RECRUITING

Holstebro Hospital

Holstebro, 7500, Denmark

RECRUITING

Lillebælt Hospital

Kolding, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Bornholms Hospital

Rønne, 3700, Denmark

RECRUITING

Hospital Sønderjylland

Sønderborg, 6400, Denmark

RECRUITING

Viborg Regional Hospital

Viborg, 8800, Denmark

RECRUITING

Related Publications (1)

• Ballegaard ELF, Lindhard K, Lindhardt M, Peters CD, Thomsen Nielsen F, Tietze IN, Borg R, Boesby L, Bertelsen MC, Brosen JMB, Cibulskyte-Ninkovic D, Rantanen JM, Mose FH, Kampmann JD, Nielsen AS, Breinholt JK, Kofod DH, Bressendorff I, Clausen PV, Lange T, Kober L, Kamper AL, Bang CNF, Torp-Pedersen C, Hansen D, Grove EL, Gislason G, Dam Jensen J, Olesen JB, Hornum M, Rix M, Schou M, Carlson N. Protocol for a randomised controlled trial comparing warfarin with no oral anticoagulation in patients with atrial fibrillation on chronic dialysis: the Danish Warfarin-Dialysis (DANWARD) trial. BMJ Open. 2024 Feb 26;14(2):e081961. doi: 10.1136/bmjopen-2023-081961.

  PMID: 38413147 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Kidney Failure, Chronic

Interventions

Warfarin; Vitamin B 6

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines

Study Officials

• Nicholas Carlson, MD PhD

  Department of Nephrology, Copenhagen University Hospital Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Gunnar H Gislason, Prof MD PhD

  Danish Heart Foundation

  STUDY CHAIR

• Anne-Lise Kamper, MD DMSc

  Department of Nephrology, Copenhagen University Hospital Rigshospitalet

  STUDY CHAIR

• Christian Torp-Pedersen, Prof MD DMSc

  Department of Cardiology, North Zealand Hospital

  STUDY CHAIR

• Jonas B Olesen, MD PhD

  Department of Cardiology, Copenhagen University Hospital Gentofte

  STUDY CHAIR

• Casper Bang, MD PhD

  Department of Cardiology, Frederiksberg and Bispebjerg Hospital

  STUDY CHAIR

• Thomas A Gerds, Prof

  Danish Heart Foundation

  STUDY CHAIR

• Ditte Hansen, MD PhD

  Department of Nephrology, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Morten Schou, Prof MD PhD

  Department of Cardiology, Copenhagen University Hospital Herlev

  STUDY CHAIR

• Mads Hornum, Prof MD PhD

  Department of Nephrology, Copenhagen University Hospital Rigshospitalet

  STUDY CHAIR

• Erik Grove, MD PhD

  Department of Cardiology, Aarhus University Hospital

  STUDY CHAIR

• Jens D Jensen, MD PhD

  Department of Nephrology, Aarhus University Hospital

  STUDY CHAIR

• Ellen Linnea F Ballegaard, MD

  Department of Nephrology, Copenhagen University Hospital Rigshospitalet

  STUDY CHAIR

Central Study Contacts

Nicholas Carlson, MD PhD

CONTACT

+45 35455827; nicholas.carlson.01@regionh.dk

Gunnar H Gislason, Prof MD PhD

CONTACT

+45 70 25 00 00; Gunnar.Gislason@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A multicentre, randomized, open label, parallel group study.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 5, 2019
• Study Start: October 9, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 12 months of study completion
• Access Criteria: Data access requests will be reviewed, requestors will be required to sign a Data Access Agreement.

Locations

DK (13)