NCT03799822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started May 2017

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

January 7, 2019

Last Update Submit

November 2, 2020

Conditions

Atrial Fibrillation

Keywords

hemodialysisrivaroxabanvitamin K2

Outcome Measures

Primary Outcomes (1)

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

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

    through study completion, on average 3 years

Secondary Outcomes (2)

  • death rate

    through study completion, on average 3 years

  • safety: incidence of life-threatening, major and minor bleeding

    through study completion, on average 3 years

Study Arms (3)

Control

ACTIVE COMPARATOR

Hemodialysis patients with non valvular atrial fibrillation receiving warfarin

Drug: Vitamin K Antagonist - Drug

rivaroxaban

EXPERIMENTAL

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

Drug: Rivaroxaban 10 MG Oral Tablet

rivaroxaban + K2

EXPERIMENTAL

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

Drug: Rivaroxaban 10 MG Oral TabletDietary Supplement: MK-7 2000µg thrice weekly

Interventions

Rivaroxaban 10 MG Oral TabletDRUG

replacement of warfarin by rivaroxaban

rivaroxabanrivaroxaban + K2
MK-7 2000µg thrice weeklyDIETARY_SUPPLEMENT

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

rivaroxaban + K2
Vitamin K Antagonist - DrugDRUG

treatment with a vitamin K antagonist

Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent for this extension trial

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (2)

  • Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

    PMID: 38189593DERIVED

  • 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.

    PMID: 33753537DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

RivaroxabanTablets

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Rogier Caluwe, MD

    OLV Hospital Aalst, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 10, 2019

Study Start

May 1, 2017

Primary Completion

September 15, 2020

Study Completion

October 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

BE(1)