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Oral Anticoagulation in Hemodialysis

NCT ID: NCT03799822

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Hemodialysis patients with non valvular atrial fibrillation receiving warfarin

Group Type ACTIVE_COMPARATOR

Vitamin K Antagonist - Drug

Intervention Type DRUG

treatment with a vitamin K antagonist

rivaroxaban

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

Group Type EXPERIMENTAL

Rivaroxaban 10 MG Oral Tablet

Intervention Type DRUG

replacement of warfarin by rivaroxaban

rivaroxaban + K2

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

Group Type EXPERIMENTAL

Rivaroxaban 10 MG Oral Tablet

Intervention Type DRUG

replacement of warfarin by rivaroxaban

MK-7 2000µg thrice weekly

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Rivaroxaban 10 MG Oral Tablet

replacement of warfarin by rivaroxaban

Intervention Type DRUG

MK-7 2000µg thrice weekly

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin K Antagonist - Drug

treatment with a vitamin K antagonist

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rogier Caluwe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rogier Caluwe, MD

Role: PRINCIPAL_INVESTIGATOR

OLV Hospital Aalst, Belgium

Locations

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OLV Hospital

Aalst, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 38189593 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33753537 (View on PubMed)

Other Identifiers

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OLV 2014/065

Identifier Type: -

Identifier Source: org_study_id