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Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)

Primary Purpose

Kidney Failure, Chronic

Status
Active
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
No oral anticoagulation
Oral anticoagulation with vitamin K antagonists
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Service de Néphrologie et médecine interne
  • CHRU d'Angers - Service de Néphrologie
  • Service Néphrologie, Dialyse, Transplantation
  • Pathologie Rénale
  • Service de Néphrologie
  • Aural Colmar
  • Service de néphrologie
  • Service de néphrologie
  • Aurad Aquitaine
  • Centre Hospitalier de Haguenau - service de Néphrologie
  • AURAL Haguenau
  • Centre Hospitalier Emile Roux
  • Clinique Bouchard
  • Service de Néphrologie
  • ECHO de Nantes
  • Service de Néphrologie
  • AURA Paris Plaisance
  • Hôpital Tenon - Service de Néphrologie
  • Service de néphrologie
  • ECHO CA Laennec
  • NéphroCare Tassin-Charcot
  • AURAL st Anne
  • Service de Néphrologie
  • Centre Hospitalier Bretagne-Atlantique
  • Calydial CH Lucien Hussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No anticoagulation

Oral anticoagulation with vitamin K antagonists

Arm Description

No oral anticoagulation, and no monitoring of the INR.

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.

Outcomes

Primary Outcome Measures

Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation

Secondary Outcome Measures

Full Information

First Posted
August 29, 2016
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02886962
Brief Title
Oral Anticoagulation in Haemodialysis Patients
Acronym
AVKDIAL
Official Title
Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No anticoagulation
Arm Type
Experimental
Arm Description
No oral anticoagulation, and no monitoring of the INR.
Arm Title
Oral anticoagulation with vitamin K antagonists
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
No oral anticoagulation
Intervention Description
No oral anticoagulation, and no monitoring of the INR.
Intervention Type
Drug
Intervention Name(s)
Oral anticoagulation with vitamin K antagonists
Intervention Description
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 Measure Information:
Title
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Service de Néphrologie et médecine interne
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CHRU d'Angers - Service de Néphrologie
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Service Néphrologie, Dialyse, Transplantation
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Pathologie Rénale
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
Service de Néphrologie
City
Cherbourg-Octeville
ZIP/Postal Code
50102
Country
France
Facility Name
Aural Colmar
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Service de néphrologie
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Service de néphrologie
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Aurad Aquitaine
City
Gradignan
ZIP/Postal Code
33170
Country
France
Facility Name
Centre Hospitalier de Haguenau - service de Néphrologie
City
Haguenau
ZIP/Postal Code
67504
Country
France
Facility Name
AURAL Haguenau
City
Haguenau
Country
France
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Facility Name
Clinique Bouchard
City
Marseille
ZIP/Postal Code
13006
Country
France
Facility Name
Service de Néphrologie
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
ECHO de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service de Néphrologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
AURA Paris Plaisance
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Tenon - Service de Néphrologie
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Service de néphrologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
ECHO CA Laennec
City
Saint-Herblain
ZIP/Postal Code
44821
Country
France
Facility Name
NéphroCare Tassin-Charcot
City
Sainte-Foy-lès-Lyon
ZIP/Postal Code
69110
Country
France
Facility Name
AURAL st Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Service de Néphrologie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier Bretagne-Atlantique
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
Calydial CH Lucien Hussel
City
Vienne
ZIP/Postal Code
38209
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Anticoagulation in Haemodialysis Patients

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