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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No anticoagulation | Experimental | No oral anticoagulation, and no monitoring of the INR. |
|
| Oral anticoagulation with vitamin K antagonists | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No oral anticoagulation | Biological | No oral anticoagulation, and no monitoring of the INR. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Néphrologie et médecine interne | Amiens | 80000 | France | |||
| CHRU d'Angers - Service de Néphrologie |
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| Oral anticoagulation with vitamin K antagonists | Drug | 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 |
|
| Angers |
| 49033 |
| France |
| Service Néphrologie, Dialyse, Transplantation | Caen | 14033 | France |
| Pathologie Rénale | Chambéry | 73000 | France |
| Service de Néphrologie | Cherbourg-Octeville | 50102 | France |
| Aural Colmar | Colmar | 68000 | France |
| Service de néphrologie | Colmar | 68000 | France |
| Service de néphrologie | Dijon | 21000 | France |
| Aurad Aquitaine | Gradignan | 33170 | France |
| Centre Hospitalier de Haguenau - service de Néphrologie | Haguenau | 67504 | France |
| AURAL Haguenau | Haguenau | France |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | 43000 | France |
| Clinique Bouchard | Marseille | 13006 | France |
| Service de Néphrologie | Nancy | 54511 | France |
| ECHO de Nantes | Nantes | 44000 | France |
| Service de Néphrologie | Nantes | 44093 | France |
| AURA Paris Plaisance | Paris | 75014 | France |
| Hôpital Tenon - Service de Néphrologie | Paris | 75970 | France |
| Service de néphrologie | Rennes | 35033 | France |
| ECHO CA Laennec | Saint-Herblain | 44821 | France |
| NéphroCare Tassin-Charcot | Sainte-Foy-lès-Lyon | 69110 | France |
| AURAL st Anne | Strasbourg | 67000 | France |
| Service de Néphrologie | Strasbourg | 67000 | France |
| Centre Hospitalier Bretagne-Atlantique | Vannes | 56017 | France |
| Calydial CH Lucien Hussel | Vienne | 38209 | France |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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