Oral Anticoagulation in Haemodialysis Patients

Phase 4

Terminated

• Conditions: Kidney Failure, Chronic
• Interventions: Biological: No oral anticoagulation; Drug: Oral anticoagulation with vitamin K antagonists

• Registration Number: NCT02886962
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Study Start: 2017-07-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No anticoagulation	No oral anticoagulation	No oral anticoagulation, and no monitoring of the INR.
Oral anticoagulation with vitamin K antagonists	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation	2 years

Trial Locations

Locations (20)

Service de Néphrologie et médecine interne; 🇫🇷 Amiens, France

Hôpital Tenon - Service de Néphrologie; 🇫🇷 Paris, France

ECHO de Nantes; 🇫🇷 Nantes, France

AURA Paris Plaisance; 🇫🇷 Paris, France

ECHO CA Laennec; 🇫🇷 Saint-Herblain, France

NéphroCare Tassin-Charcot; 🇫🇷 Sainte-Foy-lès-Lyon, France

AURAL st Anne; 🇫🇷 Strasbourg, France

Centre Hospitalier Bretagne-Atlantique; 🇫🇷 Vannes, France

Calydial CH Lucien Hussel; 🇫🇷 Vienne, France

Service Néphrologie, Dialyse, Transplantation; 🇫🇷 Caen, France

CHRU d'Angers - Service de Néphrologie; 🇫🇷 Angers, France

Pathologie Rénale; 🇫🇷 Chambéry, France

Service de Néphrologie; 🇫🇷 Strasbourg, France

Aural Colmar; 🇫🇷 Colmar, France

Aurad Aquitaine; 🇫🇷 Gradignan, France

Centre Hospitalier de Haguenau - service de Néphrologie; 🇫🇷 Haguenau, France

AURAL Haguenau; 🇫🇷 Haguenau, France

Clinique Bouchard; 🇫🇷 Marseille, France

Service de néphrologie; 🇫🇷 Rennes, France

Centre Hospitalier Emile Roux; 🇫🇷 Le Puy-en-Velay, France