Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients

Vascular Calcification Clinical Trial

Official title:

The Effect of Replacement of Vitamin K Antagonist by Rivaroxaban With or Without Vitamin K2 Supplementation on Vascular Calcifications in Chronic Hemodialysis Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610933
• Other study ID #: 2014/065
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: January 23, 2019

Study information

• Verified date: January 2019
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 23, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• end stage renal failure treated with chronic hemodialysis

• atrial fibrillation

• CHA2DS2-VASc Score = 2

• ability to provide informed consent

Exclusion Criteria:

• known intestinal malabsorption or inability to take oral medication

• inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort)

• investigator's assessment that the subject's life expectancy is less than 1 year

• prosthetic mechanical heart valve

• contraindication for anticoagulation

• liver dysfunction Child-Pugh grade B-C

• pregnancy, breastfeeding, inadequate contraception

• incompliance with medication and scheduled investigations

Related Conditions & MeSH terms

• Calcinosis
• Vascular Calcification

Intervention

Drug:
• rivaroxaban
replacement of vitamin K antagonist by rivaroxaban

Dietary Supplement:
• Vitamin K2
Vitamin K2 supplementation

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	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)	18 months
Primary	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)	18 months
Primary	absolute and relative change in pulse wave velocity		18 months
Secondary	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)	18 months
Secondary	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)	18 months
Secondary	mortality from any cause		18 months
Secondary	myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause		18 months
Secondary	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.		18 months
Secondary	Systemic embolism, defined as an acute vascular occlusion of a limb or organ documented by imaging, surgery, or autopsy.		18 months
Secondary	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.		18 months
Secondary	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.		18 months