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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02610933
Other study ID # 2014/065
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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