- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03799822
Oral Anticoagulation in Hemodialysis
Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Aalst, Belgium, 9300
- OLV Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inclusion in the trial with clinicaltrials.gov identifier NCT02610933
- signed informed consent for this extension trial
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
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treatment with a vitamin K antagonist
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Experimental: rivaroxaban
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
|
replacement of warfarin by rivaroxaban
|
Experimental: rivaroxaban + K2
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
|
replacement of warfarin by rivaroxaban
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
|
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
Time Frame: through study completion, on average 3 years
|
composite of fatal and non-fatal stroke and other cardiovascular events
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through study completion, on average 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death rate
Time Frame: through study completion, on average 3 years
|
cause of death
|
through study completion, on average 3 years
|
safety: incidence of life-threatening, major and minor bleeding
Time Frame: through study completion, on average 3 years
|
incidence of life-threatening, major and minor bleeding
|
through study completion, on average 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rogier Caluwe, MD, OLV Hospital Aalst, Belgium
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Protease Inhibitors
- Micronutrients
- Vitamins
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Rivaroxaban
Other Study ID Numbers
- OLV 2014/065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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