A Phase 4 interventional study of Rivaroxaban 10 MG Oral Tablet and MK-7 2000µg thrice weekly in Atrial Fibrillation, sponsored by Onze Lieve Vrouw Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Onze Lieve Vrouw Hospital · Phase 4, Interventional, and Prevention
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 132 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Onze Lieve Vrouw Hospital is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
Drug: Vitamin K Antagonist - Drug
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
Drug: Rivaroxaban 10 MG Oral Tablet
Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
Drug: Rivaroxaban 10 MG Oral Tablet · Dietary Supplement: MK-7 2000µg thrice weekly
replacement of warfarin by rivaroxaban
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
treatment with a vitamin K antagonist
composite of fatal and non-fatal stroke and other cardiovascular events
composite of fatal and non-fatal stroke and other cardiovascular events
Time frame: through study completion, on average 3 years
death rate
cause of death
Time frame: through study completion, on average 3 years
safety: incidence of life-threatening, major and minor bleeding
incidence of life-threatening, major and minor bleeding
Time frame: through study completion, on average 3 years
Ran from May 2017 to primary completion in Sep 2020, 40 months.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's 40 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivaroxaban
Onze Lieve Vrouw Hospital