Oral Anticoagulation in Hemodialysis

November 2, 2020 updated by: Rogier Caluwe, Onze Lieve Vrouw Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
Drug: Vitamin K Antagonist - Drug
treatment with a vitamin K antagonist
Experimental: rivaroxaban
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
Drug: Rivaroxaban 10 MG Oral Tablet
replacement of warfarin by rivaroxaban
Experimental: rivaroxaban + K2
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of fatal and non-fatal stroke and other cardiovascular events
Time Frame: through study completion, on average 3 years
composite of fatal and non-fatal stroke and other cardiovascular events
through study completion, on average 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death rate
Time Frame: through study completion, on average 3 years
cause of death
through study completion, on average 3 years
safety: incidence of life-threatening, major and minor bleeding
Time Frame: through study completion, on average 3 years
incidence of life-threatening, major and minor bleeding
through study completion, on average 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Rogier Caluwe, MD, OLV Hospital Aalst, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

September 15, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLV 2014/065

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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