Clinical trial NCT02886962: Oral Anticoagulation in Haemodialysis Patients
Official title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years)
* 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:

* Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
* 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)

Primary outcomes:
measure: Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service de Néphrologie et médecine interne
city: Angers
country: France
facility: CHRU d'Angers - Service de Néphrologie
city: Caen
country: France
facility: Service Néphrologie, Dialyse, Transplantation
city: Chambéry
country: France
facility: Pathologie Rénale
city: Cherbourg-Octeville
country: France
facility: Service de Néphrologie
city: Colmar
country: France
facility: Aural Colmar
city: Colmar
country: France
facility: Service de néphrologie
city: Dijon
country: France
facility: Service de néphrologie
city: Gradignan
country: France
facility: Aurad Aquitaine
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau - service de Néphrologie
city: Haguenau
country: France
facility: AURAL Haguenau
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Marseille
country: France
facility: Clinique Bouchard
city: Nancy
country: France
facility: Service de Néphrologie
city: Nantes
country: France
facility: ECHO de Nantes
city: Nantes
country: France
facility: Service de Néphrologie
city: Paris
country: France
facility: AURA Paris Plaisance
city: Paris
country: France
facility: Hôpital Tenon - Service de Néphrologie
city: Rennes
country: France
facility: Service de néphrologie
city: Saint-Herblain
country: France
facility: ECHO CA Laennec
city: Sainte-Foy-lès-Lyon
country: France
facility: NéphroCare Tassin-Charcot
city: Strasbourg
country: France
facility: AURAL st Anne
city: Strasbourg
country: France
facility: Service de Néphrologie
city: Vannes
country: France
facility: Centre Hospitalier Bretagne-Atlantique
city: Vienne
country: France
facility: Calydial CH Lucien Hussel
Study officials:
References: