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

Launched by NICHOLAS CARLSON · Mar 1, 2019

Keywords

ClinConnect Summary

The Danish Warfarin-Dialysis Study is looking at how safe and effective the blood-thinning medication Warfarin is for patients with atrial fibrillation (a heart rhythm disorder) who are undergoing dialysis due to end-stage kidney disease. The main goal is to see if starting Warfarin can help reduce the risk of strokes in these patients. The study is currently recruiting participants aged 18 and older who are on chronic dialysis and have specific types of atrial fibrillation.

To be eligible for this study, participants must not have serious health issues that would prevent them from safely using Warfarin, such as recent bleeding or certain heart conditions. If someone joins the study, they can expect to be monitored closely for their safety and how well the treatment works. It’s important for potential participants to understand the risks and benefits of using Warfarin, as well as the commitment involved in being part of a clinical trial.

Gender

ALL

Eligibility 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