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Oral Anticoagulation in Hemodialysis

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Rivaroxaban 10 MG Oral Tablet
MK-7 2000µg thrice weekly
Vitamin K Antagonist - Drug
Sponsored by
Onze Lieve Vrouw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring hemodialysis, rivaroxaban, vitamin K2

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • OLV Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

rivaroxaban

rivaroxaban + K2

Arm Description

Hemodialysis patients with non valvular atrial fibrillation receiving warfarin

Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od

Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements

Outcomes

Primary Outcome Measures

composite of fatal and non-fatal stroke and other cardiovascular events
composite of fatal and non-fatal stroke and other cardiovascular events

Secondary Outcome Measures

death rate
cause of death
safety: incidence of life-threatening, major and minor bleeding
incidence of life-threatening, major and minor bleeding

Full Information

First Posted
January 7, 2019
Last Updated
November 2, 2020
Sponsor
Onze Lieve Vrouw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03799822
Brief Title
Oral Anticoagulation in Hemodialysis
Official Title
Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouw Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
hemodialysis, rivaroxaban, vitamin K2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
Arm Title
rivaroxaban
Arm Type
Experimental
Arm Description
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
Arm Title
rivaroxaban + K2
Arm Type
Experimental
Arm Description
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 10 MG Oral Tablet
Intervention Description
replacement of warfarin by rivaroxaban
Intervention Type
Dietary Supplement
Intervention Name(s)
MK-7 2000µg thrice weekly
Intervention Description
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
Intervention Type
Drug
Intervention Name(s)
Vitamin K Antagonist - Drug
Intervention Description
treatment with a vitamin K antagonist
Primary Outcome Measure Information:
Title
composite of fatal and non-fatal stroke and other cardiovascular events
Description
composite of fatal and non-fatal stroke and other cardiovascular events
Time Frame
through study completion, on average 3 years
Secondary Outcome Measure Information:
Title
death rate
Description
cause of death
Time Frame
through study completion, on average 3 years
Title
safety: incidence of life-threatening, major and minor bleeding
Description
incidence of life-threatening, major and minor bleeding
Time Frame
through study completion, on average 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inclusion in the trial with clinicaltrials.gov identifier NCT02610933 signed informed consent for this extension trial Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogier Caluwe, MD
Organizational Affiliation
OLV Hospital Aalst, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
33753537
Citation
De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22.
Results Reference
derived

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Oral Anticoagulation in Hemodialysis

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