Oral Anticoagulation in Hemodialysis

Conditions

Atrial Fibrillation

Keywords

hemodialysis, rivaroxaban, vitamin K2

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.

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.

An S. De Vriese, Rogier Caluwé, Hans Van Der Meersch, K. De Boeck, Dirk De Bacquer

Journal of the American Society of Nephrology2021-03-22170 citations

10.1681/asn.2020111566

Interventions

DRUGRivaroxaban 10 MG Oral Tablet

replacement of warfarin by rivaroxaban

DIETARY_SUPPLEMENTMK-7 2000µg thrice weekly

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

DRUGVitamin K Antagonist - Drug

treatment with a vitamin K antagonist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed