Evaluating Warfarin for Stroke Prevention in Dialysis Patients with Atrial Fibrillation
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
This study is testing if starting Warfarin can safely help dialysis patients with atrial fibrillation reduce their risk of stroke.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 718 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 13 sites (Aalborg and 12 other locations) |
| Trial ID | NCT03862859 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of initiating Warfarin treatment for stroke risk reduction in patients with end-stage renal disease on dialysis who have atrial fibrillation. It aims to provide conclusive evidence regarding the appropriateness of oral anticoagulation in this population, which has been largely excluded from previous randomized controlled trials. The study will enroll 718 patients, randomly assigning them to receive either Warfarin or no treatment, while assessing tolerability and safety outcomes. The results are expected to influence clinical management and guidelines for treating atrial fibrillation in dialysis patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older on chronic dialysis with atrial fibrillation.
Not a fit: Patients with a CHA2DS2-VASc Score of 1 or less or those with other indications for anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stroke prevention strategies for patients with atrial fibrillation undergoing dialysis.
How similar studies have performed: While there is limited evidence from randomized trials in this specific population, observational studies suggest potential benefits, making this approach novel and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aalborg and 12 other locations
- Aalborg University Hosptial — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Department of Nephrology, Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Esbjerg and Grindsted Hospital — Esbjerg, Denmark (Recruiting)
- Department of Nephrology, Herlev Hospital — Herlev, Denmark (Recruiting)
- Department of nephrology, Nordsjaellands Hospital — Hillerød, Denmark (Recruiting)
- Holbaek Hospital — Holbæk, Denmark (Recruiting)
- Holstebro Hospital — Holstebro, Denmark (Recruiting)
- Lillebælt Hospital — Kolding, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
- Bornholms Hospital — Rønne, Denmark (Recruiting)
- Hospital Sønderjylland — Sønderborg, Denmark (Recruiting)
- Viborg Regional Hospital — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Nicholas Carlson, MD PhD — Department of Nephrology, Copenhagen University Hospital Rigshospitalet
- Study coordinator: Nicholas Carlson, MD PhD
- Email: nicholas.carlson.01@regionh.dk
- Phone: +45 35455827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.