Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)
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| ClinicalTrials.gov Identifier: NCT02886962 |
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Recruitment Status :
Recruiting
First Posted : September 1, 2016
Last Update Posted : September 14, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Failure, Chronic | Biological: No oral anticoagulation Drug: Oral anticoagulation with vitamin K antagonists | Phase 4 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: No anticoagulation
No oral anticoagulation, and no monitoring of the INR.
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Biological: No oral anticoagulation
No oral anticoagulation, and no monitoring of the INR. |
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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 |
- 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 |
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)
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
| Contact: Thierry Hannedouche, MD | 0388116768 | thierry.hannedouche@chru-strasbourg.fr | |
| Contact: Thierry Krummel, MD | 0388116768 | thierry.krummel@chru-strasbourg.fr |
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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: | September 14, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Vitamin K Vitamins |
Micronutrients Physiological Effects of Drugs Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |