Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Oral anticoagulation with vitamin K antagonists; Biological: No oral anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02886962

6396

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

No anticoagulation

Experimental group

Description:

No oral anticoagulation, and no monitoring of the INR.

Treatment:

Biological: No oral anticoagulation

Oral anticoagulation with vitamin K antagonists

Active Comparator group

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.

Treatment:

Drug: Oral anticoagulation with vitamin K antagonists