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Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients

NCT02610933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2019-01-28

No results posted yet for this study

Summary

This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a vitamin K antagonist.

The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification. The second question is whether addition of vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.

Conditions

  • Vascular Calcification

Interventions

DRUG

rivaroxaban

replacement of vitamin K antagonist by rivaroxaban

DIETARY_SUPPLEMENT

Vitamin K2

Vitamin K2 supplementation

Sponsors & Collaborators

  • Onze Lieve Vrouw Hospital

    lead OTHER

Principal Investigators

  • Rogier Caluwé, MD · Nephrology Department OLV Hospital Aalst Belgium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-01-23
Completion
2019-01-23

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02610933 on ClinicalTrials.gov