NCT03799822

Oral Anticoagulation in Hemodialysis

Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Onze Lieve Vrouw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients. After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.

Detailed description

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients. After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Rivaroxaban 10 MG Oral Tablet	replacement of warfarin by rivaroxaban
DIETARY_SUPPLEMENT	MK-7 2000µg thrice weekly	dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
DRUG	Vitamin K Antagonist - Drug	treatment with a vitamin K antagonist

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-09-15
• Completion: 2020-10-01
• First posted: 2019-01-10
• Last updated: 2020-11-03

Locations

1 site across 1 country: Belgium