Oral Anticoagulation in Haemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Biological: No oral anticoagulation
* Drug: Oral anticoagulation with vitamin K antagonists


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No anticoagulation<br>No oral anticoagulation, and no monitoring of the INR. | Biological: No oral anticoagulation<br>* No oral anticoagulation, and no monitoring of the INR.<br>|
| Active Comparator: Oral anticoagulation with vitamin K antagonists<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation |  | 2 years |