NCT02610933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

November 16, 2015

Last Update Submit

January 25, 2019

Conditions

Vascular Calcification

Keywords

vascular calcificationhemodialysisrivaroxabanvitamin K2

Outcome Measures

Primary Outcomes (3)

  • absolute and relative change in coronary artery calcification score

    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)

    18 months

  • absolute and relative change in thoracic aortic calcification score

    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)

    18 months

  • absolute and relative change in pulse wave velocity

    18 months

Secondary Outcomes (8)

  • absolute and relative change in aortic valve calcification score

    18 months

  • absolute and relative change in mitral valve calcification score

    18 months

  • mortality from any cause

    18 months

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

    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.

    18 months

  • +3 more secondary outcomes

Study Arms (3)

Vitamin K antagonist

NO INTERVENTION

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

rivaroxaban

ACTIVE COMPARATOR

Rivaroxaban 10 mg tablet by mouth once daily for 18 months

Drug: rivaroxaban

rivaroxaban and vitamin K2

ACTIVE COMPARATOR

Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months

Drug: rivaroxabanDietary Supplement: Vitamin K2

Interventions

rivaroxabanDRUG

replacement of vitamin K antagonist by rivaroxaban

rivaroxabanrivaroxaban and vitamin K2
Vitamin K2DIETARY_SUPPLEMENT

Vitamin K2 supplementation

Also known as: MK-7
rivaroxaban and vitamin K2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • end stage renal failure treated with chronic hemodialysis
  • atrial fibrillation
  • CHA2DS2-VASc Score ≥ 2
  • ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 38189593DERIVED

MeSH Terms

Conditions

Vascular Calcification

Interventions

RivaroxabanVitamin K 2

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsVitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Rogier Caluwé, MD

    Nephrology Department OLV Hospital Aalst Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rogier Caluwé, MD

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

January 23, 2019

Study Completion

January 23, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

BE(1)