Actively Recruiting
The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Led by Nicholas Carlson · Updated on 2024-02-26
718
Participants Needed
13
Research Sites
377 weeks
Total Duration
On this page
Sponsors
N
Nicholas Carlson
Lead Sponsor
D
Danish Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older on chronic dialysis due to end-stage renal disease
- Non-valvular paroxysmal, persistent, or permanent atrial fibrillation, or untreated prevalent atrial fibrillation documented by ECG, Holter monitor, or event recorder
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- CHA2DS2-VASc score of 1 or less
- Other reasons for oral anticoagulation such as recent pulmonary embolism, deep vein thrombosis, or mechanical heart valve
- Current dual antiplatelet treatment
- Recent or ongoing cancer treatment except for non-melanoma skin cancer
- Recent gastrointestinal ulcer or esophageal varices
- Autoimmune or genetic clotting disorders
- Pending spinal tap
- Cerebrovascular malformations or arterial aneurysms
- Ulcers or wounds of Wagner grade greater than 1
- Recent bacterial endocarditis
- Active bleeding that prevents anticoagulation
- Recent non-elective or non-ambulatory surgery
- Recent cerebral hemorrhage
- Low platelet count within 30 days
- Severe liver insufficiency within 30 days
- Known intolerance to Warfarin
- Use of St. John's Wort
- Uncontrolled high blood pressure within 30 days
- Uncontrolled hyperthyroidism within 30 days
- Pregnancy or breastfeeding
- Participation in other clinical trials affecting study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Aalborg University Hosptial
Aalborg, Denmark, 9100
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2
Aarhus University Hospital
Aarhus, Denmark, 8200
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3
Department of Nephrology, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
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4
Esbjerg and Grindsted Hospital
Esbjerg, Denmark, 6700
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5
Department of Nephrology, Herlev Hospital
Herlev, Denmark, 2730
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6
Department of nephrology, Nordsjaellands Hospital
Hillerød, Denmark, 3400
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7
Holbaek Hospital
Holbæk, Denmark, 4300
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8
Holstebro Hospital
Holstebro, Denmark, 7500
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9
Lillebælt Hospital
Kolding, Denmark
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10
Zealand University Hospital
Roskilde, Denmark, 4000
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11
Bornholms Hospital
Rønne, Denmark, 3700
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12
Hospital Sønderjylland
Sønderborg, Denmark, 6400
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13
Viborg Regional Hospital
Viborg, Denmark, 8800
Actively Recruiting
Research Team
N
Nicholas Carlson, MD PhD
CONTACT
G
Gunnar H Gislason, Prof MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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