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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary: 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.
Sponsor: Onze Lieve Vrouw Hospital

Current Primary Outcome:

  • 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)
  • 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)
  • absolute and relative change in pulse wave velocity [ Time Frame: 18 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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)
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Onze Lieve Vrouw Hospital

Dates:
Date Received: November 16, 2015
Date Started: November 2015
Date Completion: December 2018
Last Updated: September 26, 2016
Last Verified: September 2016