Status:
RECRUITING
The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Lead Sponsor:
Nicholas Carlson
Collaborating Sponsors:
Danish Heart Foundation
Conditions:
Atrial Fibrillation and Flutter
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ov...
Detailed Description
Data pertaining to the tolerability, safety, and benefit of initiating anticoagulation for stroke risk reduction in patients with end-stage renal disease and atrial fibrillation remains conflicting an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Cerebral hemorrhage \<4 weeks
- Thrombocytopenia (platelet count \<100 × 109/L) \<30 days.
- Severe liver insufficiency (spontaneous international normalized ratio \>1.5) \<30 days.
- Known intolerance to warfarin
- Use of hypericum perforatum / St. John's Wort
- Uncontrolled hypertension (repeat blood pressure \>180/110 mmhg) \< 30 days
- Uncontrolled hyperthyroidism (thyroid-stimulating hormone \<0.1μIU/mL) \<30 days
- Pregnancy or lactation
- Participation in other ongoing intervention trials adjudged to influence study outcomes
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT03862859
Start Date
October 9 2019
End Date
January 1 2027
Last Update
February 26 2024
Active Locations (13)
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1
Aalborg University Hosptial
Aalborg, Denmark, 9100
2
Aarhus University Hospital
Aarhus, Denmark, 8200
3
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
4
Esbjerg and Grindsted Hospital
Esbjerg, Denmark, 6700