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

• Status: Completed
• Trial end date: 2019-01-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Onze Lieve Vrouw Hospital
• Treatments: Rivaroxaban; Vitamin K; Vitamin K 2; Vitamin MK 7; Vitamins

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