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DAN-WAR-D - Danish Warfarin-Dialysis Study: Safety and efficacy of warfarin in patients with atrial fibrillation on dialysis -A nationwide parallel-group open randomized clinical trial
EU CTIS ID: 2022-502500-75-00
What this study is testing
To investigate the safety and efficacy of warfarin in patients with atrial fibrillation on dialysis
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >=18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular paroxysmal, persistent or permanent atrial fibrillation OR non-treated (>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.
You likely can't join if
- CHA2DS2-VASc Score ≤1
- Cerebrovascular malformations
- Arterial aneurisms
- Ulcers or wounds (Wagner grad >1)
- Bacterial endocarditis < 3 months
- Active bleeding contraindicating anticoagulation
See the full eligibility criteria
- >=18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular paroxysmal, persistent or permanent atrial fibrillation OR non-treated (>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.
- CHA2DS2-VASc Score ≤1
- Cerebrovascular malformations
- Arterial aneurisms
- 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
- 2. Other indications for oral anticoagulation treatment (pulmonary embolism < 6months, deep vein thrombosis <3months, previous pulmonary embolism and/or deep vein thrombosis with life-long indication for oral anticoagulation, prior atrial fibrillation with proven non-tolerance of oral anticoagulation interruption, mechanical heart valve prosthesis) - irrespective of whether treatment is implemented
- Use of hypericum perforatum / St. John’s Wort
- Uncontrolled hypertension (repeat blood pressure >180/110mmhg) < 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.