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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02610933
• Date of registration: 16/11/2015
• Prospective Registration: No
• Primary sponsor: Onze Lieve Vrouw Hospital
• Public title: Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients
• Scientific 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
• Date of first enrolment: November 2015
• Target sample size: 117
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02610933
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Rogier Caluwé, MD
• Affiliation: Nephrology Department OLV Hospital Aalst Belgium

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vascular Calcification

Intervention(s)

Drug: rivaroxaban

Dietary Supplement: Vitamin K2

Primary Outcome(s)

absolute and relative change in thoracic aortic calcification score [Time Frame: 18 months]

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

absolute and relative change in coronary artery calcification score [Time Frame: 18 months]

Secondary Outcome(s)

myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause [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]

absolute and relative change in mitral valve calcification score [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]

mortality from any cause [Time Frame: 18 months]

absolute and relative change in aortic valve calcification score [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]

Secondary ID(s)

2014/065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors