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OpenTrials
Completed

NCT Number: NCT03799822

Oral Anticoagulation in Hemodialysis

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OLV Hospital

Aalst, 9300, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Rivaroxaban 10 MG Oral Tablet

Drug

replacement of warfarin by rivaroxaban

MK-7 2000µg thrice weekly

Dietary Supplement

dietary supplement of vitamin K2 MK-7 2000µg thrice weekly

Vitamin K Antagonist - Drug

Drug

treatment with a vitamin K antagonist

Primary outcomes

  1. 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

Secondary outcomes

  1. death rate

    Time frame: through study completion, on average 3 years

    cause of death

  2. 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

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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