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Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)

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ClinicalTrials.gov Identifier: NCT02886962
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Biological: No oral anticoagulation Drug: Oral anticoagulation with vitamin K antagonists Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 855 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Arm Intervention/treatment
Experimental: No anticoagulation
No oral anticoagulation, and no monitoring of the INR.
Biological: No oral anticoagulation
No oral anticoagulation, and no monitoring of the INR.

Active Comparator: 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.

Drug: 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





Primary Outcome Measures :
  1. Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886962


Contacts
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Contact: Thierry Hannedouche, MD 0388116768 thierry.hannedouche@chru-strasbourg.fr
Contact: Thierry Krummel, MD 0388116768 thierry.krummel@chru-strasbourg.fr

Locations
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France
Service de Néphrologie et médecine interne Not yet recruiting
Amiens, France, 80000
Contact: Gabriel CHOUKROUN, MD         
CHRU d'Angers - Service de Néphrologie Not yet recruiting
Angers, France, 49033
Contact: Virginie Besson, MD         
Service Néphrologie, Dialyse, Transplantation Not yet recruiting
Caen, France, 14033
Contact: Patrick HENRI, MD         
Pathologie Rénale Recruiting
Chambéry, France, 73000
Contact: Laure Croze, MD    0479965084      
Service de Néphrologie Not yet recruiting
Cherbourg-Octeville, France, 50102
Contact: Guillaume QUEFFEULOU, MD         
Aural Colmar Recruiting
Colmar, France, 68000
Contact: Claire BORNI DUVAL, MD       c.borni-duval@aural.asso.fr   
Service de néphrologie Not yet recruiting
Colmar, France, 68000
Contact: Alexandre KLEIN, MD         
Service de néphrologie Not yet recruiting
Dijon, France, 21000
Contact: Emmanuelle KOHLER, MD         
Aurad Aquitaine Not yet recruiting
Gradignan, France, 33170
Contact: Catherine LASSEUR, MD         
Centre Hospitalier de Haguenau - service de Néphrologie Not yet recruiting
Haguenau, France, 67504
Contact: Yves DIMITROV, MD         
AURAL Haguenau Recruiting
Haguenau, France
Contact: Yves DIMITROV       yves.dimitrov@ch-haguenau.fr   
Centre Hospitalier Emile Roux Recruiting
Le Puy-en-Velay, France, 43000
Contact: Marc BOUILLER       marc.bouiller@ch-lepuy.fr   
Clinique Bouchard Recruiting
Marseille, France, 13006
Contact: Jérome SAMPOL, MD         
Service de Néphrologie Not yet recruiting
Nancy, France, 54511
Contact: Luc Frimat, MD         
ECHO de Nantes Recruiting
Nantes, France, 44000
Contact: Angelo TESTA, MD         
Service de Néphrologie Recruiting
Nantes, France, 44093
Contact: Caroline GOURRAUD-VERCEL, MD         
AURA Paris Plaisance Recruiting
Paris, France, 75014
Contact: Maxime TOUZOT, MD         
Hôpital Tenon - Service de Néphrologie Recruiting
Paris, France, 75970
Contact: Hafedh FESSI, MD         
Service de néphrologie Recruiting
Rennes, France, 35033
Contact: Cécile VIGNEAU, MD         
ECHO CA Laennec Recruiting
Saint-Herblain, France, 44821
Contact: Dan HRISTEA, MD         
NéphroCare Tassin-Charcot Not yet recruiting
Sainte-Foy-lès-Lyon, France, 69110
Contact: Guillaume JEAN, MD         
AURAL st Anne Recruiting
Strasbourg, France, 67000
Contact: Clotilde MULLER       Clotilde-muller@hotmail.fr   
Service de Néphrologie Recruiting
Strasbourg, France, 67000
Contact: Thierry Hannedouche, MD         
Centre Hospitalier Bretagne-Atlantique Not yet recruiting
Vannes, France, 56017
Contact: Pierre Yves DURAND, MD         
Calydial CH Lucien Hussel Not yet recruiting
Vienne, France, 38209
Contact: Agnès CAILLETTE BEAUDOIN, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02886962     History of Changes
Other Study ID Numbers: 6396
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Vitamin K
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants