Oral Anticoagulation in Hemodialysis

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799822
• Other study ID #: OLV 2014/065
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 1, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• inclusion in the trial with clinicaltrials.gov identifier NCT02610933

• signed informed consent for this extension trial

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban 10 MG Oral Tablet
replacement of warfarin by rivaroxaban

Dietary Supplement:
• MK-7 2000µg thrice weekly
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly

Drug:
• Vitamin K Antagonist - Drug
treatment with a vitamin K antagonist

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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