Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
50 participants
INTERVENTIONAL
2017-07-12
2023-12-01
Brief Summary
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The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No anticoagulation
No oral anticoagulation, and no monitoring of the INR.
No oral anticoagulation
No oral anticoagulation, and no monitoring of the INR.
Oral anticoagulation with vitamin K antagonists
VKA use as recommended in the guidelines with INR target range between 2 and 3. Daily administration or thrice weekly at the end of dialysis sessions upon Nephrologist's choice.
Antiplatelet therapy will be provided only if recent acute coronary syndrome (\< 6 months) or active coronary stent. Aspirin should be preferred in dialysis patients as clopidogrel has an unpredictable reduced activity and there is no safety data on combination of VKA with prasugrel or ticagrelor in this population.
Oral anticoagulation with vitamin K antagonists
Vitamin K antagonist prescription with INR target between 2 and 3 as recommended in the guidelines.
Administration once daily or at the end of each dialysis session, according to the nephrologist choice.
INR monitoring at least once per week
Interventions
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No oral anticoagulation
No oral anticoagulation, and no monitoring of the INR.
Oral anticoagulation with vitamin K antagonists
Vitamin K antagonist prescription with INR target between 2 and 3 as recommended in the guidelines.
Administration once daily or at the end of each dialysis session, according to the nephrologist choice.
INR monitoring at least once per week
Eligibility Criteria
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Inclusion Criteria
* Patient on hemodialysis treatment for at least 1 month
* Patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal).
* Patient with a CHADS2VASC score ≥2
* Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (\>2) history of falls.
* Patient capable of understanding information about the study and of giving his/her consent
* Patient informed of the preliminary medical exam results
* Patient with healthcare insurance
* Written consent signed
Exclusion Criteria
* Life expectancy \< 6 months (e.g., terminal cancer)
* Live donor transplantation scheduled within 6 months
* Pregnancy (β-HCG blood-based assay)or nursing (lactating) women
* Women of child bearing potential, unless they are using an effective method of birth control
* Patient under legal guardianship
* Patients under law protection
* Known hypersensibility to coumadin or indoine derivatives or to any excipients (CI to oral AVK)
* Severe liver failure (CI to oral AVK)
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service de Néphrologie et médecine interne
Amiens, , France
CHRU d'Angers - Service de Néphrologie
Angers, , France
Service Néphrologie, Dialyse, Transplantation
Caen, , France
Pathologie Rénale
Chambéry, , France
Service de Néphrologie
Cherbourg-Octeville, , France
Aural Colmar
Colmar, , France
Service de néphrologie
Colmar, , France
Service de néphrologie
Dijon, , France
Aurad Aquitaine
Gradignan, , France
Centre Hospitalier de Haguenau - service de Néphrologie
Haguenau, , France
AURAL Haguenau
Haguenau, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Clinique Bouchard
Marseille, , France
Service de Néphrologie
Nancy, , France
ECHO de Nantes
Nantes, , France
Service de Néphrologie
Nantes, , France
AURA Paris Plaisance
Paris, , France
Hôpital Tenon - Service de Néphrologie
Paris, , France
Service de néphrologie
Rennes, , France
ECHO CA Laennec
Saint-Herblain, , France
NéphroCare Tassin-Charcot
Sainte-Foy-lès-Lyon, , France
AURAL st Anne
Strasbourg, , France
Service de Néphrologie
Strasbourg, , France
Centre Hospitalier Bretagne-Atlantique
Vannes, , France
Calydial CH Lucien Hussel
Vienne, , France
Countries
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Other Identifiers
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6396
Identifier Type: -
Identifier Source: org_study_id
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