A Phase 4 interventional study of rivaroxaban and Vitamin K2 in Vascular Calcification, sponsored by Onze Lieve Vrouw Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by Onze Lieve Vrouw Hospital · Phase 4, Interventional, and Prevention
This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a vitamin K antagonist.
The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification. The second question is whether addition of vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.
The present study targets dialysis patients with non-valvular atrial fibrillation requiring treatment with vitamin K antagonists. It addresses the question whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification (VC). The second research question is whether addition of vitamin K2 to rivaroxaban can further beneficially affect the progression of VC. Two non-invasive methods are used to evaluate the impact of interventions on the progression of VC: i.e. coronary artery calcification (CAC) and pulse wave velocity (PWV) measurements. The detection of CAC is predictive for the presence of obstructive coronary artery disease and future coronary events. VC and stiffening of the central elastic-type arteries are independent predictors of cardiovascular morbidity and mortality in hemodialysis patients.
83 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 117 is above the median of 60 across 55 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Onze Lieve Vrouw Hospital is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Vitamin K antagonist treatment targeting an international normalized ratio of 2 to 3 for 18 months
Rivaroxaban 10 mg tablet by mouth once daily for 18 months
Drug: rivaroxaban
Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months
Drug: rivaroxaban · Dietary Supplement: Vitamin K2
replacement of vitamin K antagonist by rivaroxaban
Vitamin K2 supplementation
Also known as: MK-7
absolute and relative change in coronary artery calcification score
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
Time frame: 18 months
absolute and relative change in thoracic aortic calcification score
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
Time frame: 18 months
absolute and relative change in pulse wave velocity
Time frame: 18 months
absolute and relative change in aortic valve calcification score
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
Time frame: 18 months
absolute and relative change in mitral valve calcification score
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
Time frame: 18 months
mortality from any cause
Time frame: 18 months
myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause
Time frame: 18 months
Stroke, defined as sudden onset of focal neurological deficit consistent with the territory of a major cerebral artery and categorised as ischaemic, haemorrhagic, or unspecified.
Time frame: 18 months
Systemic embolism, defined as an acute vascular occlusion of a limb or organ documented by imaging, surgery, or autopsy.
Time frame: 18 months
Major bleeding, defined as a requirement for transfusion of two or more units of blood or a decrease in haemoglobin of 2 g/dL or more.
Time frame: 18 months
Life-threatening bleeding, defined as fatal bleeding, symptomatic intracranial bleeding, a decrease in haemoglobin of 5 g/dL or more, or a requirement for transfusion of four or more units of blood, inotropic agents, or surgery.
Time frame: 18 months
The record gives a start of Nov 2015, a primary completion of Jan 2019 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rivaroxaban · Vitamin K 2
Onze Lieve Vrouw Hospital