Oral Anticoagulation in Haemodialysis Patients

NCT02886962 | Terminated Phase 4

• 1 other identifier: 6396
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 25

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.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation

  2 years

Study Arms (2)

No anticoagulation

EXPERIMENTAL

No oral anticoagulation, and no monitoring of the INR.

Biological: No oral anticoagulation

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.

Drug: Oral anticoagulation with vitamin K antagonists

Interventions

No oral anticoagulation BIOLOGICAL

No oral anticoagulation, and no monitoring of the INR.

No anticoagulation

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

Oral anticoagulation with vitamin K antagonists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (25)

Service de Néphrologie et médecine interne

Amiens, 80000, France

Location

CHRU d'Angers - Service de Néphrologie

Angers, 49033, France

Location

Service Néphrologie, Dialyse, Transplantation

Caen, 14033, France

Location

Pathologie Rénale

Chambéry, 73000, France

Location

Service de Néphrologie

Cherbourg-Octeville, 50102, France

Location

Aural Colmar

Colmar, 68000, France

Location

Service de néphrologie

Colmar, 68000, France

Location

Service de néphrologie

Dijon, 21000, France

Location

Aurad Aquitaine

Gradignan, 33170, France

Location

Centre Hospitalier de Haguenau - service de Néphrologie

Haguenau, 67504, France

Location

AURAL Haguenau

Haguenau, France

Location

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Clinique Bouchard

Marseille, 13006, France

Location

Service de Néphrologie

Nancy, 54511, France

Location

ECHO de Nantes

Nantes, 44000, France

Location

Service de Néphrologie

Nantes, 44093, France

Location

AURA Paris Plaisance

Paris, 75014, France

Location

Hôpital Tenon - Service de Néphrologie

Paris, 75970, France

Location

Service de néphrologie

Rennes, 35033, France

Location

ECHO CA Laennec

Saint-Herblain, 44821, France

Location

NéphroCare Tassin-Charcot

Sainte-Foy-lès-Lyon, 69110, France

Location

AURAL st Anne

Strasbourg, 67000, France

Location

Service de Néphrologie

Strasbourg, 67000, France

Location

Centre Hospitalier Bretagne-Atlantique

Vannes, 56017, France

Location

Calydial CH Lucien Hussel

Vienne, 38209, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: July 12, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (25)