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

NCT ID: NCT02610933

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-01-23

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 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.

Conditions

Vascular Calcification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin K antagonist

Vitamin K antagonist treatment targeting an international normalized ratio of 2 to 3 for 18 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

rivaroxaban

Rivaroxaban 10 mg tablet by mouth once daily for 18 months

Group Type: ACTIVE_COMPARATOR

rivaroxaban

Intervention Type: DRUG

replacement of vitamin K antagonist by rivaroxaban

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

Group Type: ACTIVE_COMPARATOR

rivaroxaban

Intervention Type: DRUG

replacement of vitamin K antagonist by rivaroxaban

Vitamin K2

Intervention Type: DIETARY_SUPPLEMENT

Vitamin K2 supplementation

Interventions

rivaroxaban

replacement of vitamin K antagonist by rivaroxaban

Intervention Type: DRUG

Vitamin K2

Vitamin K2 supplementation

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MK-7

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rogier Caluwe

Dr. Rogier Caluwé, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rogier Caluwé, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department OLV Hospital Aalst Belgium

Locations

OLV Hospital

Aalst, , Belgium

Countries

Belgium

References

Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

Reference Type: DERIVED

PMID: 38189593 (View on PubMed)

Other Identifiers

2014/065

Identifier Type: -

Identifier Source: org_study_id