NCT02886962

Oral Anticoagulation in Haemodialysis Patients

Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	No oral anticoagulation	No oral anticoagulation, and no monitoring of the INR.
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

Timeline

• Start date: 2017-07-12
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-09-01
• Last updated: 2024-08-20

Locations

25 sites across 1 country: France