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

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ClinicalTrials.gov Identifier: NCT02610933
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rogier Caluwe, Onze Lieve Vrouw Hospital

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.


Condition or disease Intervention/treatment Phase
Vascular Calcification Drug: rivaroxaban Dietary Supplement: Vitamin K2 Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2015
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Vitamin K antagonist
Vitamin K antagonist treatment targeting an international normalized ratio of 2 to 3 for 18 months
Active Comparator: rivaroxaban
Rivaroxaban 10 mg tablet by mouth once daily for 18 months
Drug: rivaroxaban
replacement of vitamin K antagonist by rivaroxaban

Active Comparator: rivaroxaban and vitamin K2
Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months
Drug: rivaroxaban
replacement of vitamin K antagonist by rivaroxaban

Dietary Supplement: Vitamin K2
Vitamin K2 supplementation
Other Name: MK-7




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610933


Locations
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Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Rogier Caluwé, MD Nephrology Department OLV Hospital Aalst Belgium

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Responsible Party: Rogier Caluwe, Dr. Rogier Caluwé, MD, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT02610933     History of Changes
Other Study ID Numbers: 2014/065
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Keywords provided by Rogier Caluwe, Onze Lieve Vrouw Hospital:
vascular calcification
hemodialysis
rivaroxaban
vitamin K2
Additional relevant MeSH terms:
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Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin K
Vitamin K 2
Rivaroxaban
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants