Oral Anticoagulation in Hemodialysis

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban 10 MG Oral Tablet; Drug: Vitamin K Antagonist - Drug; Dietary Supplement: MK-7 2000µg thrice weekly

• Registration Number: NCT03799822
• Lead Sponsor: Onze Lieve Vrouw Hospital

Brief 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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Primary Completion: 2020-09-15
• Status Verified: 2020-10
• Study Completion: 2020-10-01
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• inclusion in the trial with clinicaltrials.gov identifier NCT02610933
• signed informed consent for this extension trial

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rivaroxaban	Rivaroxaban 10 MG Oral Tablet	Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
rivaroxaban + K2	Rivaroxaban 10 MG Oral Tablet	Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
rivaroxaban + K2	MK-7 2000µg thrice weekly	Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
Control	Vitamin K Antagonist - Drug	Hemodialysis patients with non valvular atrial fibrillation receiving warfarin

Primary Outcome Measures

Name	Time	Method
composite of fatal and non-fatal stroke and other cardiovascular events	through study completion, on average 3 years	composite of fatal and non-fatal stroke and other cardiovascular events

Secondary Outcome Measures

Name	Time	Method
death rate	through study completion, on average 3 years	cause of death
safety: incidence of life-threatening, major and minor bleeding	through study completion, on average 3 years	incidence of life-threatening, major and minor bleeding

Trial Locations

Locations (1)

OLV Hospital; 🇧🇪 Aalst, Belgium