Oral Anticoagulation in Hemodialysis

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban 10 MG Oral Tablet
* Dietary Supplement: MK-7 2000µg thrice weekly
* Drug: Vitamin K Antagonist - Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inclusion in the trial with clinicaltrials.gov identifier NCT02610933 signed informed consent for this extension trial Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Hemodialysis patients with non valvular atrial fibrillation receiving warfarin | Drug: Vitamin K Antagonist - Drug<br>* treatment with a vitamin K antagonist<br>|
| Experimental: rivaroxaban<br>Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od | Drug: Rivaroxaban 10 MG Oral Tablet<br>* replacement of warfarin by rivaroxaban<br>|
| Experimental: rivaroxaban + K2<br>Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements | Drug: Rivaroxaban 10 MG Oral Tablet<br>* replacement of warfarin by rivaroxaban<br>Dietary Supplement: MK-7 2000µg thrice weekly<br>* dietary supplement of vitamin K2 MK-7 2000µg thrice weekly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, rivaroxaban, vitamin K2