Oral Anticoagulation in Hemodialysis

Onze Lieve Vrouw Hospital

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Vitamin K Antagonist - Drug; Dietary Supplement: MK-7 2000µg thrice weekly; Drug: Rivaroxaban 10 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03799822

OLV 2014/065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Control

Active Comparator group

Description:

Hemodialysis patients with non valvular atrial fibrillation receiving warfarin

Treatment:

Drug: Vitamin K Antagonist - Drug

rivaroxaban

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban 10 MG Oral Tablet

rivaroxaban + K2

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban 10 MG Oral Tablet

Dietary Supplement: MK-7 2000µg thrice weekly