AVKDIAL: Oral Anticoagulation in Haemodialysis Patients

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02886962

Collaborator

(none)

Enrollment

Locations

Arms

65.7

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jul 12, 2017

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service de Néphrologie et médecine interne	Amiens	France	80000
2	CHRU d'Angers - Service de Néphrologie	Angers	France	49033
3	Service Néphrologie, Dialyse, Transplantation	Caen	France	14033
4	Pathologie Rénale	Chambéry	France	73000
5	Service de Néphrologie	Cherbourg-Octeville	France	50102
6	Aural Colmar	Colmar	France	68000
7	Service de néphrologie	Colmar	France	68000
8	Service de néphrologie	Dijon	France	21000
9	Aurad Aquitaine	Gradignan	France	33170
10	Centre Hospitalier de Haguenau - service de Néphrologie	Haguenau	France	67504
11	AURAL Haguenau	Haguenau	France
12	Centre Hospitalier Emile Roux	Le Puy-en-Velay	France	43000
13	Clinique Bouchard	Marseille	France	13006
14	Service de Néphrologie	Nancy	France	54511
15	ECHO de Nantes	Nantes	France	44000
16	Service de Néphrologie	Nantes	France	44093
17	AURA Paris Plaisance	Paris	France	75014
18	Hôpital Tenon - Service de Néphrologie	Paris	France	75970
19	Service de néphrologie	Rennes	France	35033
20	ECHO CA Laennec	Saint-Herblain	France	44821
21	NéphroCare Tassin-Charcot	Sainte-Foy-lès-Lyon	France	69110
22	AURAL st Anne	Strasbourg	France	67000
23	Service de Néphrologie	Strasbourg	France	67000
24	Centre Hospitalier Bretagne-Atlantique	Vannes	France	56017
25	Calydial CH Lucien Hussel	Vienne	France	38209

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT02886962

Other Study ID Numbers:

6396

First Posted:

Sep 1, 2016

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Kidney Failure, Chronic

Vitamin K

Study Results

No Results Posted as of Aug 23, 2022