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

RecruitingPhase 4Ages 18 Years - anyAllNicholas Carlson
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Warfarin
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Where

13 sites
Department of Nephrology, Herlev Hospital
Herlev, Denmark
Department of nephrology, Nordsjaellands Hospital
Hillerød, Denmark
Aalborg University Hosptial
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Esbjerg and Grindsted Hospital
Esbjerg, Denmark
Holbaek Hospital
Holbæk, Denmark
Holstebro Hospital
Holstebro, Denmark

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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