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Completed

NCT Number: NCT02610933

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

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.

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Key information

Conditions

Vascular Calcification Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OLV Hospital

Aalst, 9300, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

replacement of vitamin K antagonist by rivaroxaban

vitamin K2

Dietary Supplement

Vitamin K2 supplementation

Other names: MK-7

Primary outcomes

  1. absolute and relative change in coronary artery calcification score

    Time frame: 18 months

    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)

  2. absolute and relative change in thoracic aortic calcification score

    Time frame: 18 months

    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)

  3. absolute and relative change in pulse wave velocity

    Time frame: 18 months

Secondary outcomes

  1. absolute and relative change in aortic valve calcification score

    Time frame: 18 months

    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)

  2. absolute and relative change in mitral valve calcification score

    Time frame: 18 months

    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)

  3. mortality from any cause

    Time frame: 18 months

  4. myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause

    Time frame: 18 months

  5. 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

  6. Systemic embolism, defined as an acute vascular occlusion of a limb or organ documented by imaging, surgery, or autopsy.

    Time frame: 18 months

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2015
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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