Evaluating Warfarin for Stroke Prevention in Dialysis Patients with Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Nephrology, Herlev Hospital
  Herlev, Herlev, Denmark Recruiting
• Department of nephrology, Nordsjaellands Hospital
  Hillerød, Hillerød, Denmark Recruiting
• 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

Study contacts

• Principal investigator: Nicholas Carlson, MD PhD — Department of Nephrology, Copenhagen University Hospital Rigshospitalet
• Study coordinator: Nicholas Carlson, MD PhD Ass. Prof
• Email: nicholas.carlson.01@regionh.dk
• Phone: +45 35455927

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.