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Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02886962
Recruitment Status : Active, not recruiting
First Posted : September 1, 2016
Last Update Posted : August 23, 2022
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)
Actual Enrollment : 50 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

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 ]

Information from the National Library of Medicine

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

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

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Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02886962    
Other Study ID Numbers: 6396
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022
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
Vitamin K
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action