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Tests treatment safety and results for Atrial Fibrillation and Flutter
Official title The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
ClinicalTrials.gov ID: NCT03862859
What this study is testing
What is Warfarin?
Warfarin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation and flutter.
Also referred to as Coumadin, Marevan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed...
You likely can't join if
- CHA2DS2-VASc Score ≤1
- Other indications for oral anticoagulation treatment (pulmonary embolism \< 6 months, deep vein thrombosis \<3 months, mechanical heart valve...
- Ongoing dual antiplatelet treatment
- Malignancy (with exception of non-melanoma skin cancer) with recent \< 1 year, ongoing, or planned curative, or palliative chemo- , radiation-...
- Endoscopy with gastrointestinal ulcer \<1 month
- Esophageal varices
See the full eligibility 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...
- Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Herlev, Denmark
- Hillerød, Hillerød, Denmark
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Esbjerg, Denmark
- Holbæk, Denmark
- Holstebro, Denmark
- Kolding, Denmark
- Roskilde, Denmark
- Rønne, Denmark
- Sønderborg, Denmark
- Viborg, Denmark
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Herlev, Denmark; Hillerød, Hillerød, Denmark; Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Esbjerg, Denmark and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.